BEE et al v. NOVARTIS PHARMACEUTICALS CORPORATION
Filing
50
ORDER denying 38 Motion for Summary Judgment. For the reasons set forth herein, the Court denies Novartiss motion for summary judgment in its entirety, and denies Novartiss Daubert motion to exclude the specific causation testimony of Dr. Kraut. SO ORDERED. Ordered by Judge Joseph F. Bianco on 5/9/2014. (Chipev, George)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
_____________________
No 12-CV-1421 (JFB)(WDW)
_____________________
BRIAN BEE & DONNA BEE,
Plaintiffs,
VERSUS
NOVARTIS PHARMACEUTICALS CORP.,
Defendant.
___________________
MEMORANDUM AND ORDER
May 9, 2014
___________________
JOSEPH F. BIANCO, District Judge:
Plaintiffs Brian Bee (“Bee” or
“plaintiff”) and Donna Bee (“D. Bee”)
(collectively, “plaintiffs”) bring this
products liability action against Novartis
Pharmaceuticals Corporation (“Novartis,”
“NPC,” or “defendant”), alleging that
Novartis’s drugs Zometa and Aredia,
prescribed to Bee as part of a regimen to
treat
his
ankylosing
spondylitis,
osteoporosis, and bone pain, caused him to
develop osteonecrosis of the jaw (“ONJ”).1
1
Osteonecrosis is a medical term for bone death
arising from poor blood supply to the bone. (See
Compl. ¶ 1.) Plaintiffs refer to the condition as
“BRONJ,” or bisphosphonate related osteonecrosis of
the jaw. (See Pls. Opp’n to Def. Mot. for Summ. J.
(“Pls. Opp’n”) at 1.) For reasons set forth infra, the
Court concludes that there are genuine issues of
material fact as to whether the bisphosphonates at
issue in this case (specifically, Aredia and Zometa)
caused plaintiff’s injury. Accordingly, the Court
refers to the alleged risk and injury at issue here as
“ONJ” instead of BRONJ.
Plaintiffs allege claims of strict liability,
negligent manufacture, negligent failure to
warn, breach of express warranty, breach of
implied warranty, and loss of consortium
against defendant. They assert that Novartis
(1) negligently (i) tested Aredia and Zometa
and (ii) failed to warn about the drugs’
potential risks and precautions that could be
taken to minimize such risks; (2) is strictly
liable for (i) Aredia’s and Zometa’s
allegedly
defective
design
and
manufacturing, and (ii) its failure to warn of
the possible risk of ONJ; and (3) breached
its products’ express and implied
warranties.2
2
In their opposition, plaintiffs voluntarily dismiss the
express warranty and manufacturing defect claims.
(See Pls. Opp’n at 25 (“Plaintiff does not oppose
judgment on express warranty or manufacturing (as
opposed to design) defect but implied warranty
claims survive.”).) Accordingly, the Court grants
defendant’s motion for summary judgment as to the
manufacturing defect and express warranty claims.
derivative claim, and plaintiff’s other claims
all fail, summary judgment is warranted to
defendant as to this claim.
Presently before the Court are several
motions brought by Novartis. These include
six Daubert motions seeking to exclude the
testimony of plaintiffs’ case-wide experts,
and a motion for summary judgment.
Because Novartis’s six Daubert motions
against plaintiffs’ case-wide experts address
issues beyond the scope of the pending
summary judgment motion, the Court limits
its analysis here to those arguments raised in
the motion for summary judgment. Where
certain of these arguments touch upon other
Daubert motions raised previously in this
litigation, these are addressed as necessary
for purposes of resolving the summary
judgment motion.
After careful consideration of the
parties’ arguments and a full review of the
record, the Court denies Novartis’s motion
for summary judgment its entirety for the
following reasons.
I. BACKGROUND
This case is part of “Wave III” of a
multidistrict litigation in the United States
District Court for the Middle District of
Tennessee (“the MDL Court”). The Court
has taken the facts set forth below from the
parties’ depositions, affidavits, exhibits, and
respective Rule 56.1 Statements of Facts.
The Court construes the facts in the light
most favorable to the non-moving party. See
Capobianco v. City of New York, 422 F.3d
47, 50–51 (2d Cir. 2005). Unless otherwise
noted, where a party’s 56.1 statement is
cited, that fact is undisputed or the opposing
party has not pointed to any evidence in the
record to contradict it.3
Turning to the summary judgment
motion itself, Novartis contends that
summary judgment in its favor is warranted
because the uncontroverted evidence in the
record shows that (1) Novartis had no duty
to warn of risks associated with taking
Aredia and Zometa for treatment of
ankylosing spondylitis or osteoporosis; (2)
Novartis adequately warned prescribers
about the risk of ONJ associated with the
challenged medications once it became
aware of such a risk; (3) plaintiffs cannot
show that Novartis’s warning as to ONJ was
the proximate cause of Bee’s injury; (4)
plaintiffs have no evidence that Aredia and
Zometa substantially caused Bee’s ONJ, nor
do they offer admissible expert testimony in
support of the same; (5) plaintiffs proffer no
evidence showing that either Aredia or
Zometa differed in any way from design
specifications; (6) because Novartis
provided an adequate warning, plaintiffs’
strict liability, negligence, and breach of
implied warranty claims, which rely on
allegations that Aredia and Zometa’s
warnings were defective, must fail; (7)
plaintiffs point to no evidence showing that
Novartis made an express warranty upon
which Bee or his doctor relied; and (8)
because a loss of consortium claim is a
A. Plaintiff’s General Medical History
Plaintiffs Brian and Donna Bee are New
York residents. (Def. Rule 56.1 Statement
(“Def. 56.1”) ¶ 96; Pls. Rule 56.1 Response
(“Pls. 56.1”) ¶ 96.) Plaintiff has suffered
from several medical conditions over the
years.4 By 1995, at the age of twenty-nine,
plaintiff had a history of Schmorl’s nodes,5
3
Additionally, although the parties’ Rule 56.1
statements contain specific citations to the record in
support of their statements, the Court generally cites
to the Rule 56.1 statements, rather than to the
underlying citations to the record.
4
Plaintiff began smoking at the age of twenty-one,
and smoked about a pack of cigarettes a day until
approximately January 2011, when he quit for good.
(See Def. 56.1 ¶ 1; Pls. 56.1 ¶ 1.)
5
2
Schmorl’s nodes “are protrusions of the cartilage of
vertebral compression deformity, vertebral
bone spur,6 and osteochonditis.7 (Def. 56.1 ¶
2.) That same year, doctors also diagnosed
plaintiff with ankylosing spondylitis, “‘a
chronic systemic inflammatory disease that
primarily attacks the axial skeleton and
adjacent structures.’” (Id. ¶ 7 (quoting
Michael Weisman, Ankylosing Spondylitis
5 (2011)).) Plaintiff’s medical problems
continued as he entered his thirties, being
diagnosed in July 1996 with multiple
collapsed vertebrae, and in September 1996,
with osteoporosis. (Id. ¶¶ 8–9.)
prevent further fractures or associated pain.
(Def. 56.1 ¶ 107; Pls. 56.1 ¶ 107.) In
October 1996, Bee was prescribed the oral
bisphosponate, Fosamax, an approved drug
for strengthening the bones of patients with
osteoporosis. (Def. 56.1 ¶¶ 13–14; Pls. 56.1
¶¶ 13–14.)
Plaintiff’s health problems continued.
After October 1996, he continued to lose
height, and bone scans showed several of his
vertebrae to be deteriorating. (Def. 56.1 ¶
15; Pls. 56.1 ¶ 15.) The tests also showed
formation of new Schmorl’s nodes and
increasingly abnormal bone signals. (Def.
56.1 ¶ 16; Pls. 56.1 ¶ 16.)
Bee’s youth, as well as the severity of
his medical condition, made him a unique
patient for doctors. (Def. 56.1 ¶¶ 101, 107.)
In light of plaintiff’s poor bone condition,
doctors referred Bee to an oncologist, Dr.
Edward Samuel (“Dr. Samuel”), in August
1996 to determine whether a malignancy
had caused his vertebrae to weaken and
collapse; tests, however, were negative. (Id.
¶ 10; see also Pls. 56.1 ¶ 10.) After
conducting various examinations, Dr.
Samuel concluded that plaintiff did not have
cancer. (Def. 56.1 ¶ 11; Pls. 56.1 ¶ 11.)
Nevertheless, Dr. Samuel—whose practice
consisted predominantly of cancer patients
(see Def. 56.1 ¶ 102)—offered to treat
plaintiff by using some of the same methods
he applied to his cancer patients. (Id. ¶ 12;
Pls. 56.1 ¶ 12.) Dr. Samuel hoped to
strengthen plaintiff’s bones in order to
As time passed, Fosamax proved to be a
difficult drug for plaintiff; it hurt his
stomach and he had trouble regularly taking
it. (Def. 56.1 ¶ 17; Pls. 56.1 ¶ 17.)
Accordingly, on August 27, 1997, Dr.
Samuel, based on his medical judgment and
the available literature at the time, decided
to switch plaintiff to Aredia, a drug that
would similarly aid Bee’s pain and bone
problems, but which did not have the same
side effects as Fosamax. (Pls. 56.1 ¶ 18; see
also Def. 56.1 ¶¶ 18, 104.)8 Plaintiff, after
thinking it over, decided to make the
switch.9 (See Pls. 56.1 ¶ 104.) In contrast to
8
the intervertebral disc through the vertebral body
endplate and into the adjacent vertebra.” (Def. 56.1 ¶
3 (quoting Stedman’s Medical Dictionary 1222–23
(27th ed., 2000)).)
When Dr. Samuel began prescribing Aredia for
plaintiff, the doctor had been board certified in
internal medicine, hematology, and oncology for at
least fifteen years, and had prior experience treating
osteoporosis with bisphosphonates. (Def. 56.1 ¶ 122;
Pls. 56.1 ¶ 122.)
6
9
Plaintiff testified that he was “[d]esperate to find a
solution” to manage his pain, and also, to curb the
development of his osteoporosis when he first began
seeing Dr. Samuel. (Def. 56.1 ¶ 103; Pls. 56.1 ¶ 103;
see also Def. 56.1 ¶ 115 (stating that Bee testified he
was willing to take whatever Dr. Samuel prescribed
him, even if it was intended for other conditions, on
account of the extreme pain that he was in); Pls. 56.1
¶ 115 (noting that Bee carefully considered those
A bone spur, also known in the medical field as an
osteophyte, is “a bony excrescence or osseous
outgrowth.” (Def. 56.1 ¶ 4 (quoting Doreland’s
Illustrated Medical Dictionary 1336 (30th ed.,
2003)).)
7
Osteochondritis is “inflammation of both bone and
cartilage.” (Def. 56.1 ¶ 4 (quoting Doreland’s
Illustrated Medical Dictionary 133 (30th ed., 2003)).)
3
Fosamax, an oral medication, Aredia was an
intravenous bisphosphonate “indicated for
the treatment of hypercalcemia of
malignancy, bone metastases from certain
types of cancer, multiple myeloma, and
Paget’s disease.” (Def. 56.1 ¶ 19.) Although
plaintiff did not have any of these specific
conditions (see Pls. 56.1 ¶ 19), it was hoped
that Aredia would allow him to receive the
bisphosphonates he needed without causing
the problems he experienced when trying to
ingest them gastrointestinally (id. ¶ 18). For
a cancer patient, the recommended dose of
Arcadia is a 90 mg intravenous infusion
over ninety minutes; plaintiff received such
cancer-level doses from August 27, 1997
through October 2002. (Def. 56.1 ¶¶ 20–21;
Pls. 56.1 ¶¶ 20–21.)10 Plaintiff received all
of his Aredia infusions in New York. (Def.
56.1 ¶ 97; Pls. 56.1 ¶ 97.)
(Def. 56.1 ¶ 27), plaintiffs assert that Bee
only had two treatments of the drug during
2000 and 2002, and that Dr. Samuel
“prescribed [p]rednisone for Bee for a short
period in July 2001 because of an acute
severe exacerbation of Bee’s back pain
accompanied by left sided sciatica” (Pls.
56.1 ¶ 27). Plaintiff was advised that
prednisone could possibly have an adverse
impact on his osteoporosis should it be taken
for an extended period of time. (Def. 56.1 ¶
28; Pls. 56.1 ¶ 28.)
In 2002, plaintiff was diagnosed with
arthritis and early osteoarthritis. (Def. 56.1 ¶
29; Pls. 56.1 ¶ 29.) That same year, he
suffered back pain so severe that he was on
bed rest for two weeks. (Def. 56.1 ¶ 30; Pls.
56.1 ¶ 30.) In December 2002, plaintiff,
under Dr. Samuel’s guidance, began taking
Zometa, “an intravenous bisphosphonate
indicated for hypercalcemia of malignancy,
the treatment of bone metastases from
certain types of cancer, multiple myeloma,
and Paget’s disease.” (Def. 56.1 ¶ 23; see
also id. ¶ 104.) Bee took Zometa through
September 2004. (Id. ¶ 24; Pls. 56.1 ¶ 24.)
He received all of his infusions in New
York. (Def. 56.1 ¶ 97; Pls. 56.1 ¶ 97.) It
seems that after plaintiff stopped taking
Zometa, his skeletal disease continued to
progress, and his pain, while fluctuating in
intensity levels, continued. (Def. 56.1 ¶ 33;
Pls. 56.1 ¶ 33.)
As plaintiff underwent these medical
treatments, his health status altered over the
years. For instance, by 1998, plaintiff’s
osteoporosis had worsened to severe
osteoporotic bone disease. (Def. 56.1 ¶ 25;
Pls. 56.1 ¶ 25.) By June of 2000, plaintiff
developed a hunched back, or “90 degree
severe kyphosis,” which required surgery
that included fusing several of his spinal
vertebrae and implanting surgical rods. (Def.
56.1 ¶ 26; Pls. 56.1 ¶ 26.) Plaintiff
subsequently received the corticosteroid
prednisone; although defendant contends
that plaintiff received this “periodically”
In 2005, plaintiff was diagnosed with
right deep vein thrombosis, a pulmonary
embolism, chronic obstructive pulmonary
disease, and peptic ulcer disease. (Def. 56.1
¶¶ 31–32; Pls. 56.1 ¶¶ 31–32.) In May 2007,
plaintiff had another spinal fusion surgery in
which more of his vertebrae were fused
together and additional instruments were
implanted into his spine for support. (Def.
56.1 ¶ 34; Pls. 56.1 ¶ 34.)
drugs he was willing to take and noting another drug
he elected not to take due to its side effects).)
10
Although defendant asserts that plaintiff received
such doses of Aredia on an “almost monthly” basis
during this time period, plaintiffs clarify that
“approximately 10 of the treatments took place over
two months apart, with 4 of those instances occurring
more than three months apart,” and that “[t]hey were
less than that, depending upon whether practitioners
evaluated Bee and determined that the treatment was
appropriate.” (Pls. 56.1 ¶ 21.)
4
B. Plaintiff’s Dental History
surgeries. (Def. 56.1 ¶ 42; Pls. 56.1 ¶ 42.) A
little over three months later, in March 2004,
plaintiff visited Dr. Arcati again, this time
with exposed bone that required Dr. Arcati
to smooth a large bone spicule in plaintiff’s
mandible. (Def. 56.1 ¶ 43; Pls. 56.1 ¶ 43.)
Plaintiffs contend this was not the only visit
that Bee made to Dr. Arcati in March 2004;
instead, they claim that Bee visited him
approximately six times “with exposed
bone, jaw pain and other related issues.”
(Pls. 56.1 ¶ 43.) During this time, Dr. Arcati
encouraged plaintiff to quit smoking; he also
noted that the area from which he had
removed the spicule was healing well. (Id. ¶
44; see also Def. 56.1 ¶ 44.)
From 1999 through 2003, plaintiff
experienced various dental difficulties.
Specifically, he had periodontal disease,
bleeding gums, multiple dental caries, dental
fillings, painful and sensitive teeth, a root
canal, and a mobile tooth.11 (Def. 56.1 ¶ 37;
Pls. 56.1 ¶ 37.) In May 2003, Bee informed
Dr. O’Lear that he was experiencing pain in
his lower-right mouth; Dr. O’Lear noticed
that several of the teeth he had previously
restored in plaintiff’s mouth were missing
fillings, and further, that other teeth might
be in need of root canals. (Def. 56.1 ¶ 38;
Pls. 56.1 ¶ 38.) Several months later, Dr.
O’Lear referred plaintiff to an oral surgeon,
Dr. Thomas Arcati (“Dr. Arcati”), upon
discovering that plaintiff had “rampant
caries.” (Def. 56.1 ¶ 39; Pls. 56.1 ¶ 39.)
In late March 2004, plaintiff had
exposed bone on both his right mandible and
left maxilla; he returned to Dr. Arcati, who
instructed plaintiff to return for weekly
treatment. (Def. 56.1 ¶¶ 45–46; Pls. 56.1 ¶¶
45–46.) Because of travel limitations,
plaintiff did not see Dr. Arcati again until
late April. (Pls. 56.1 ¶ 47.) At that time, Dr.
Arcati referred plaintiff to Dr. Salvatore
Ruggerio (“Dr. Ruggiero”), an oral surgeon,
whom plaintiff visited approximately two
and a half months later. (Def. 56.1 ¶ 48; Pls.
56.1 ¶ 48.)
According to Dr. Arcati, plaintiff failed
to disclose that he was taking Zometa. (Def.
56.1 ¶ 118; Pls. 56.1 ¶ 118.) Dr. Arcati also
testified that he was aware of a relation
between bisphosphonates and ONJ as of
September 2003, and stated that he would
not have extracted plaintiff’s teeth had he
known that plaintiff was taking Zometa.
(Def. 56.1 ¶ 119.)
After examining plaintiff’s mouth, Dr.
Arcati determined that surgery was needed;
of the sixteen non-restorable teeth in
plaintiff’s mouth, Dr. Arcati extracted eight
of those in October 2003 and the remaining
eight in November 2003. (Def. 56.1 ¶¶ 40–
41; Pls. 56.1 ¶¶ 40–41.) Dr. Arcati found
plaintiff to be healing well following both
After examining plaintiff, Dr. Ruggiero
concluded that plaintiff’s exposed bone
likely was attributable to bisphosphonate
use. (Def. 56.1 ¶ 49; Pls. 56.1 ¶ 49.)12 Bee,
who was taking Zometa at the time, went for
two more infusions of Zometa during his
12
Although defendant contends that Dr. Ruggiero
believed plaintiff’s exposed bone “was likely
secondary to bisphosphonate use,” (Def. 56.1 ¶ 49
(emphasis added)), plaintiffs assert that “there is no
doubt in Dr. Arcati’s mind that Bee’s ONJ was
caused by his bisphosphonate use,” and that “none of
Bee’s treating physicians have ever challenged the
origin of Bee’s ONJ as being something other than
bisphosphonate use” (Pls. 56.1 ¶ 49).
11
Although no records indicate whether plaintiff
visited the dentist between July 1993 and December
1997, plaintiff asserts that he visited his dentist, Dr.
Brian O’Lear (“Dr. O’Lear”) during this time for
routine cleanings. (Pls. 56.1 ¶ 35.) In December
1997, plaintiff visited Dr. O’Lear to have several
cavities filled. (Def. 56.1 ¶ 36; Pls. 56.1 ¶ 36.)
5
treatment with Dr. Ruggiero. (Def. 56.1 ¶
50; Pls. 56.1 ¶ 50.) According to plaintiffs,
Bee asked Dr. Ruggiero if stopping of the
Zometa treatments would help his condition;
plaintiffs contend that the doctor informed
him it would not, as “once it’s in your
system it’s always going to be there.” (Pls.
56.1 ¶ 50.) It appears that Bee also informed
Dr. Samuel of Dr. Ruggiero’s determination
that plaintiff’s exposed bone was due to the
bisphosphonates; when Dr. Samuel saw the
exposed bone in plaintiff’s mouth, he
ultimately decided to cease treatment, which
occurred in September 2004. (Def. 56.1
¶ 110; Pls. 56.1 ¶ 110.)
soft tissue to have healed; Dr. Arcati stated
it was the “healthiest this area has looked.”
(Def. 56.1 ¶ 57; Pls. 56.1 ¶ 57.) Since that
time, plaintiff has not suffered any further
exposed bone in his mouth. (Pls. 56.1 ¶ 58.)
C. Aredia, Zometa, and the FDA
The United States Food and Drug
Administration (the “FDA”) approved
Aredia—an intravenous bisphosphonate
manufactured by Novartis—as safe and
effective for treatment of hypercalcemia of
malignancy in 1991, as well as for Paget’s
disease (in 1994), multiple myeloma (in
1995), and bone metastases arising from
breast cancer (in 1996). (Def. 56.1 ¶¶ 59–60;
Pls. 56.1 ¶¶ 59–60.)
In November 2004, plaintiff went back
to Dr. Arcati; when Dr. Arcati saw him the
following month, the exposed bone in
plaintiff’s maxilla had healed, and the
exposed bone in his right mandible area was
improving. (Def. 56.1 ¶¶ 51–52; Pls. 56.1 ¶¶
51–52.) Dr. Arcati instructed plaintiff to
return in a few days for another
debridement.13 (Def. 56.1 ¶ 53; Pls. 56.1 ¶
53.) After December 2004, plaintiff did not
see Dr. Arcati for nearly three years. (Def.
56.1 ¶ 54; Pls. 56.1 ¶ 54.) During that next
visit (on November 16, 2007), Dr. Arcati
saw and debrided a large sequestrum on
plaintiff’s right mandible. (Def. 56.1 ¶ 55;
Pls. 56.1 ¶ 55.) A bone pathology report
issued at that time noted that there was
necrotic bone with “associated bacterial
debris and inflammation consistent with
bisphosphonate related osteonecrosis.” (Def.
56.1 ¶ 56; Pls. 56.1 ¶ 56.) Approximately a
week later, Dr. Arcati observed plaintiff’s
Approximately a decade after approving
Aredia, the FDA approved Zometa—also a
Novartis-manufactured
intravenous
bisphosphonate—as a safe and effective
treatment for hypercalcemia of malignancy;
the FDA also approved Zometa’s labeling.
(Def. 56.1 ¶ 61; Pls. 56.1 ¶ 61.) In 2002, the
FDA approved Zometa for treatment of
multiple myeloma. (Def. 56.1 ¶ 62; Pls. 56.1
¶ 62.) Both Zometa and Aredia presently
remain on the market as FDA-approved
drugs, although their labeling has changed
over the years. (Pls. 56.1 ¶¶ 63–64.)
Neither Aredia nor Zometa are approved
for the treatment of osteoporosis, ankylosing
spondylitis, or general bone pain. (Def. 56.1
¶ 69.) Plaintiffs note, however, that the main
ingredient in Zometa, zoledronic acid, is the
same active ingredient in a different drug,
Reclast, which has been approved for
osteoporosis. (Pls. 56.1 ¶ 69.) Plaintiffs
contend that Novartis’s sales persons were
encouraging the use of Zometa for
osteoporosis on account of this ingredient.
(Id.) Defendant counters that the dose and
dosing regimen for Reclast differs from that
of Zometa, and further, that “[n]either
Reclast nor Zometa was FDA approved for
13
Debridement is “the removal of foreign material
and devitalized or contaminated residue from or
adjacent to a traumatic or infected lesion until
surrounding healthy tissue is exposed.” Bisson v.
Sec’y of Dep’t of Health & Human Servs., No. 98121V, 2003 WL 21730914, at *9 n.10 (Fed. Cl. June
30, 2003) (citation and internal quotation marks
omitted).
6
the treatment of osteoporosis during the time
that [plaintiff] was treated with Aredia and
Zometa.” (Def. Mem. in Supp. of Mot. for
Summ. J. in the Bee Case (“Def. Summ. J.
Mot.”) at 6 n.8).)
literature reports the existence of ONJ, or at
least a condition similar to it, as early as at
least the 19th century, well before Aredia or
Zometa came onto the market in
approximately 1977. (Def. 56.1 ¶¶ 75, 78;
Pls. 56.1 ¶ 75.)15
Aredia and Zometa are “medicine[s]
proven to reduce the incidence of pathologic
fractures and spinal cord compression in
patients with multiple myeloma and whose
cancers have spread to the bone.” (Def. 56.1
¶ 70; Pls. 56.1 ¶ 70.)14 Although the parties
contest the extent to which Zometa has
successfully served as an anti-cancer
treatment (compare Def. 56.1 ¶ 71, with Pls.
56.1 ¶ 71), or the extent to which either
Aredia or Zometa have extended patients’
lives or significantly impacted the treatment
of metastatic cancer to the bone (compare
Def. 56.1 ¶ 73, with Pls. 56.1 ¶ 73),
plaintiffs’ expert, Dr. Robert Marx (“Dr.
Marx”), has acknowledged both Aredia and
Zometa to have “dramatically extended life,
reduced skeletal complications, reduced
pain, and thus improved the quality of life”
for patients who have taken these drugs
(Def. 56.1 ¶ 72; Pls. 56.1 ¶ 72). In sum,
Aredia and Zometa have been approved for
treatment of various conditions; plaintiff,
however, did not have one of the conditions
for which these drugs had specifically been
approved at the time he was taking the
medications. (Def. 56.1 ¶ 74; Pls. 56.1 ¶ 74.)
There were no reports of ONJ during the
animal studies of Aredia and Zometa. (Def.
Summ. J. Mot. at 7.) Defendant contends
that there also were no reported events in the
clinical trials leading to the FDA’s approval
of these drugs for their labeled indications.
(Def. 56.1 ¶ 76.)16 Defendant also contends
that it did not receive its first report of a
patient who was taking Aredia and/or
Zometa and developed ONJ until December
6, 2002. (Id. ¶ 79.) Plaintiffs dispute this,
asserting that “there were at least 6 incidents
of ONJ in [Novartis’s] clinical trials” (Pls.
56.1 ¶ 76), and that “Novartis had cases of
ONJ in its Aredia and Zometa clinical trials
going back to 1991” (id. ¶ 79).
Within fifteen days of receiving the
ONJ-patient news in December 2002,
Novartis reported the adverse event to the
FDA and began an investigation, reviewing
the animal and other studies conducted
prior to the marketing of Aredia and
Zometa, to determine whether osteonecrosis
of any site—not simply the jaw—had
occurred during the pre-clinical studies.
15
D. Novartis’s Response to Reports of
Osteonecrosis of the Jaw
Plaintiffs assert that a condition called, “phossy
jaw,” was reported as early as the 19th century in
workers who had been exposed to white
phosphorous. (Pls. 56.1 ¶ 75.) Although “phossy jaw”
appears to have disappeared as a medical condition
following the banning of white phosphorous in
manufacturing processes, plaintiffs contend that it
essentially reappeared when Aredia and Zometa
came onto the market. (Id.)
The medical condition of ONJ is not a
recent medical development. Medical
14
Although defendant describes Aredia and Zometa
as “the standard of care medicines” for purposes of
treating these conditions (Def. 56.1 ¶ 70), plaintiffs
claim that these medications may only be construed
as such on account of Novartis’s alleged failure to
warn of the true risks concerning ONJ associated
with the drug (Pls. 56.1 ¶ 70).
16
Defendant notes one exception to this statement: a
single report of osteonecrosis in the rib and femur of
a dog that received a dose of zoledronic acid
equivalent to eight times the approved human dose.
(Def. 56.1 ¶ 76.)
7
label change as submitted. (Def. 56.1 ¶ 89;
Pls. 56.1 ¶ 89.) In February 2004, Novartis
made an additional revision to the
informative language associated with
Zometa; specifically, it edited the PostMarketing Experience section of the Zometa
label to state: “Although causality cannot be
determined, it is prudent to avoid dental
surgery as recovery may be prolonged.”
(Def. 56.1 ¶ 90; Pls. 56.1 ¶ 90.)
(Def. 56.1 ¶ 80; Pls. 56.1 ¶ 80.)
Additionally, in June 2003, Novartis
reviewed several medical databases,
including Medline, Embase, Biosos, Current
Contents, and International Pharmaceuticals
Abstracts, to determine whether any
publications addressed the occurrence of
osteonecrosis arising in animals taking
bisphosphonates. (Def. 56.1 ¶ 81; Pls. 56.1 ¶
81.) Defendant contends that it was unable
to identify any articles specifically
mentioning osteonecrosis as being caused or
occurring with the use of bisphosphonates in
animals. (Def. 56.1 ¶ 81.) Plaintiffs counter
this, arguing that Novartis’s head of
Zometa’s preclinical studies testified that
Novartis had a 1981 study showing ONJ as
occurring in rats with exposure to
bisphosphonates as early as 1986. (Pls. 56.1
¶ 81.) According to defendant, before
January 2003, no cases, specifically
identified as osteonecrosis of the
maxillofacial area (including the jaw), had
appeared in Novartis’s worldwide postmarketing safety database. (Def. 56.1 ¶ 82.)
Defendant also states that, as of 2002, it
understood that bisphosphonates were being
considered as a potential preventative
treatment for osteonecrosis. (Def. 56.1 ¶ 85.)
On February 27, 2004, the FDA
approved the following label revision:
Cases of osteonecrosis (primarily
involving the jaws) have been
reported in patients treated with
bisphosphonates. The majority of the
reported cases are in cancer patients
attendant to a dental procedure.
Osteonecrosis of the jaws has
multiple well documented risk
factors including a diagnosis of
cancer, concomitant therapies (e.g.,
chemotherapy,
radiotherapy,
corticosteroids)
and
co-morbid
conditions
(e.g.
anemia,
coagulopathies,
infection,
preexisting oral disease). Although
causality cannot be determined, it is
prudent to avoid dental surgery as
recovery may be prolonged.
On September 26, 2003, Novartis
informed the FDA that it had decided to
revise the Adverse Reactions section of
Aredia and Zometa’s labeling so that it
reflected the recent reports of ONJ with the
intravenous intake of bisphosphonates. (Def.
56.1 ¶ 83; Pls. 56.1 ¶ 83.) Specifically,
Novartis informed the FDA that it was
altering its labeling language. (Def. 56.1 ¶
86.) Such label alteration is permissible
pursuant to the FDA’s “Changes Being
Effected” regulations (“CBE”). (Def. 56.1 ¶
87; Pls. 56.1 ¶ 87.) Novartis made its label
change under a “CBE 0,” which allowed it
to make the label change as quickly as
possible under FDA regulations. (Def. 56.1
¶ 88; Pls. 56.1 ¶ 88.) The FDA accepted this
(Def. 56.1 ¶ 91; Pls. 56.1 ¶ 91.)
On September 24, 2004, Novartis
updated Zometa’s drug label again to warn
physicians about the possible link between
Zometa use and ONJ. (Def. 56.1 ¶¶ 92–93.)
That same month, Novartis also sent a “Dear
Doctor” letter to over 17,200 hematologists,
urologists, oral surgeons, and oncologists,
both alerting physicians to the change in
Zometa’s labeling, and highlighting the
relevant label language, including:
Precautions: Osteonecrosis of the
jaw (ONJ) has been reported in
8
patients with cancer receiving
treatment
regimens
including
bisphosphonates . . . A dental
examination
with
appropriate
dentistry should be considered prior
to treatment with bisphosphonates in
patients with concomitant risk
factors (e.g., cancer, chemotherapy,
corticosteroids, poor oral hygiene).
While on treatment, these patients
should avoid invasive dental
procedures
if
possible. . . . For
patients requiring dental procedures,
there are no data available to suggest
whether
discontinuation
of
bisphosphonate treatment reduces
the risk of ONJ. Clinical judgment of
the treating physician should guide
the management plan of each patient
based on individual benefit/risk
assessment.
Judge John D. Bates granted the motion, and
the case was transferred to this Court on
March 22, 2012.
Magistrate Judge William D. Wall
handled pretrial matters and discovery. On
November 19, 2012, defendant filed a
motion “to advise the Court of pending
summary judgment motions and to request
consolidated Daubert briefing.” (ECF No.
20.) Before the case was transferred, the
parties had engaged in summary judgment
and Daubert briefing, in accordance with the
MDL Court’s scheduling order. Thus,
defendant asked this Court to consider the
pending motions and to hold argument to
address the same. Plaintiffs agreed that this
Court should address the pending motions.
On January 2, 2013, this Court held a
telephone conference with the parties to
discuss the pending motions, and it set a
briefing schedule for the consolidated
motions. The parties submitted their
respective motions in compliance with the
scheduling order. The Court held oral on
May 3, 2013. This matter is fully submitted,
and the Court has considered all of the
parties’ submissions.
(Def. 56.1 ¶ 93.) Members of the medical
community received this letter. (Def. 56.1 ¶
94; Pls. 56.1 ¶ 94.) However, plaintiff
asserts that, by the time of these warnings in
September 2004, he had had tooth
extractions and had developed a case of
osteonecrosis of the jaw.
III. STANDARD OF REVIEW
II. PROCEDURAL HISTORY
Pursuant to Federal Rule of Civil
Procedure 56(a), a court may grant a motion
for summary judgment only if “the movant
shows that there is no genuine dispute as to
any material fact and the movant is entitled
to judgment as a matter of law.” Fed. R. Civ.
P. 56(a); Gonzalez v. City of Schenectady,
728 F.3d 149, 154 (2d Cir. 2013). The
moving party bears the burden of showing
that he or she is entitled to summary
judgment. Huminski v. Corsones, 396 F.3d
53, 69 (2d Cir. 2005). “A party asserting that
a fact cannot be or is genuinely disputed
must support the assertion by: (A) citing to
particular parts of materials in the record,
including
depositions,
documents,
On February 2, 2007, plaintiffs filed the
instant action against defendants in the
district court for the District of Columbia.
The Judicial Panel on Multidistrict
Litigation subsequently transferred this case
to the Middle District of Tennessee (“the
MDL Court”), pursuant to 28 U.S.C. § 1407,
on April 13, 2007, pursuant to a Conditional
Transfer Order. On January 9, 2012, the
Judicial Panel on Multidistrict Litigation
directed remand of the case to the transferor
court (i.e., the district court for the District
of Columbia). On March 6, 2012, plaintiffs
filed an unopposed motion to transfer the
case to the Eastern District of New York.
9
denials but must set forth “‘concrete
particulars’” showing that a trial is needed.
R.G. Grp., Inc. v. Horn & Hardart Co., 751
F.2d 69, 77 (2d Cir. 1984) (quoting SEC v.
Research Automation Corp., 585 F.2d 31, 33
(2d Cir. 1978)). Accordingly, it is
insufficient for a party opposing summary
judgment “‘merely to assert a conclusion
without supplying supporting arguments or
facts.’” BellSouth Telecomms., Inc. v. W.R.
Grace & Co., 77 F.3d 603, 615 (2d Cir.
1996) (quoting Research Automation Corp.,
585 F.2d at 33).
electronically stored information, affidavits
or declarations, stipulations (including those
made for purposes of the motion only),
admissions, interrogatory answers, or other
materials; or (B) showing that the materials
cited do not establish the absence or
presence of a genuine dispute, or that an
adverse party cannot produce admissible
evidence to support the fact.” Fed. R. Civ. P.
56(c)(1). The court “is not to weigh the
evidence but is instead required to view the
evidence in the light most favorable to the
party opposing summary judgment, to draw
all reasonable inferences in favor of that
party,
and
to
eschew
credibility
assessments.” Amnesty Am. v. Town of W.
Hartford, 361 F.3d 113, 122 (2d Cir. 2004)
(quoting Weyant v. Okst, 101 F.3d 845, 854
(2d Cir. 1996)); see Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 248 (1986)
(summary judgment is unwarranted if “the
evidence is such that a reasonable jury could
return a verdict for the nonmoving party”).
IV. DISCUSSION
A. Failure to Warn (Strict Liability and
Negligence)
Plaintiffs assert that Novartis (1)
negligently failed to test Aredia and Zometa,
(2) negligently failed to warn about (i) the
drugs’ potential risks or (ii) available
precautions to minimize such risks, and (3)
failed to adequately warn as to the risk of
ONJ. Plaintiffs also bring a cause of action
sounding in strict liability, i.e., that Novartis
defectively designed and manufactured
Aredia and Zometa. Defendant counters that
(1) Novartis had no duty to warn Bee’s
physicians as to off-label uses of the drugs,
(2) the warnings that Novartis gave were
adequate, (3) no evidence in the record
shows that, had a different warning issued,
Bee’s use of Aredia or Zometa might have
been different, and (4) plaintiffs proffer no
evidence that Aredia and Zometa
substantially caused Bee’s ONJ.
Once the moving party has met its
burden, the opposing party “‘must do more
than simply show that there is some
metaphysical doubt as to the material
facts . . . . [T]he nonmoving party must
come forward with specific facts showing
that there is a genuine issue for trial.’”
Caldarola v. Calabrese, 298 F.3d 156, 160
(2d Cir. 2002) (alteration and emphasis in
original) (quoting Matsushita Elec. Indus.
Co. v. Zenith Radio Corp., 475 U.S. 574,
586–87 (1986)). As the Supreme Court
stated in Anderson, “[i]f the evidence is
merely colorable, or is not significantly
probative, summary judgment may be
granted.” 477 U.S. at 249–50 (citations
omitted). Indeed, “the mere existence of
some alleged factual dispute between the
parties alone will not defeat an otherwise
properly supported motion for summary
judgment.” Id. at 247–48 (emphasis in
original). Thus, the nonmoving party may
not rest upon mere conclusory allegations or
In order to establish a prima facie case
for failure to warn under New York law,17 a
plaintiff must show the following: (1) the
manufacturer had a duty to warn; (2) the
17
It is uncontested that New York law governs the
substantive claims at issue. (See Def. Summ. J. Mot.
at 9; Pls. Opp’n. at 18.)
10
218 (N.Y. App. Div. 2012) (citation and
internal quotation marks omitted).
manufacturer breached the duty to warn in a
manner that rendered the product defective,
i.e., reasonably certain to be dangerous; (3)
the defect was the proximate cause of the
plaintiff’s injury; and (4) the plaintiff
suffered loss or damage. See McCarthy v.
Olin Corp., 119 F.3d 148, 156 (2d Cir.
1997) (citing Becker v. Schwartz, 46 N.Y.2d
401, 410 (1978)); see also In re Fosamax
Prods. Liab. Litig., 924 F. Supp. 2d 477, 486
(S.D.N.Y. 2013); Mustafa v. Halkin Tool,
Ltd., No. 00-CV-4851, 2007 WL 959704, at
*17 (E.D.N.Y. Mar. 29, 2007). These prima
facie elements of a failure to warn claim
remain the same under New York law
regardless of whether they sound in
negligence or strict liability. See Martin v.
Hacker, 83 N.Y.2d 1, 8 n.1 (1993); see also
Fane v. Zimmer, Inc., 927 F.2d 124, 130 (2d
Cir. 1991) (“‘Regardless of the descriptive
terminology used to denominate the cause of
action . . . where the theory of liability is
failure to warn, negligence and strict
liability
are
equivalent.’”
(quoting
Wolfgruber v. Upjohn Co., 423 N.Y.S.2d 95,
97 (N.Y. App. Div. 1979))).
Typically, summary judgment is
appropriate where a plaintiff has not
introduced any evidence that a manufacturer
knew or should have known of the danger at
issue. See Colon ex rel. Molina v. BIC USA,
Inc., 199 F. Supp. 2d 53, 93–94 (S.D.N.Y.
2001); see also Wolfgruber, 423 N.Y.S.2d at
97–98 (granting defendant summary
judgment in failure to warn case when there
were no disputed facts). On the other hand,
“the adequacy of a warning generally is a
question of fact,” best reserved for trial.
Kandt v. Taser Int’l, Inc., No. 09-CV-0507,
2012 WL 2861583, at *3 (N.D.N.Y. July 10,
2012) (emphasis added) (quoting Fisher,
949 N.Y.S.2d at 218); see also Urena v.
Biro Mfg. Co., 114 F.3d 359, 366 (2d Cir.
1997) (“‘The adequacy of the instruction or
warning is generally a question of fact to be
determined at trial and is not ordinarily
susceptible to the drastic remedy of
summary judgment’” (quoting Beyrle v.
Finneron, 606 N.Y.S.2d 465, 465 (N.Y.
App. Div. 1993))). When evaluating failure
to warn liability, a court must conduct an
“intensely fact-specific” analysis, “including
but not limited to such issues as feasibility
and difficulty of issuing warnings in the
circumstances; obviousness of the risk from
actual use of the product; knowledge of the
particular product user; and proximate
cause.” Anderson v. Hedstrom Corp., 76 F.
Supp. 2d 422, 440 (S.D.N.Y. 1999) (quoting
Liriano, 92 N.Y.2d at 243) (internal
quotation marks omitted).
Generally, a manufacturer has a duty to
warn (1) “against latent dangers resulting
from foreseeable uses of its product of
which it knew or should have known,” and
(2) “of the danger of unintended uses of a
product provided these uses are reasonably
foreseeable.” Liriano v. Hobart Corp., 92
N.Y.2d 232, 237 (1998); see also State
Farm Fire & Cas. Co. v. Nutone, Inc., 426
F. App’x 8, 10 (2d Cir. 2011). “This duty is
a continuous one, and requires that the
manufacturer be aware of the current
information concerning the safety of its
product.” Krasnopolsky v. Warner-Lambert
Co., 799 F. Supp. 1342, 1345–46 (E.D.N.Y.
1992). “Liability for failure to warn may be
imposed based upon either the complete
failure to warn of a particular hazard or the
inclusion of warnings that are insufficient.”
Fisher v. Multiquip, Inc., 949 N.Y.S.2d 214,
Where a manufacturer owes a duty to
warn, it can satisfy this obligation by
“warn[ing] of all potential dangers in its
prescription drugs that it knew, or, in the
exercise of reasonable care, should have
known to exist.” Davids v. Novartis Pharm.
Corp., 857 F. Supp. 2d 267, 286 (E.D.N.Y.
2012) (quoting Sita v. Danek Med., Inc., 43
11
F. Supp. 2d 245 (E.D.N.Y. 1999))
(alternation in original and internal
quotation marks omitted). In the prescription
drug context, courts have recognized that a
manufacturer’s duty to warn extends to a
patient’s doctor (and not to the patient
himself) pursuant to the “learned
intermediary” rule. See Bravman v. Baxter
Healthcare Corp., 984 F.2d 71, 75 (2d Cir.
1993); Lindsay v. Ortho Pharm. Corp., 637
F.2d 87, 91 (2d Cir. 1980) (stating that “the
manufacturing defect is to warn the doctor,
not the patient”). The logic underlying this
rule is that “[t]he doctor acts as an ‘informed
intermediary’ between the manufacturer and
the patient, evaluating the patient’s needs,
assessing the risks and benefits of available
drugs, and prescribing and supervising their
use.” Davids, 857 F. Supp. 2d at 286
(quoting Glucksman v. Halsey Drug Co.,
Inc., 553 N.Y.S.2d 724, 726 (N.Y. App.
Div. 1990)) (internal quotation marks
omitted).18 Thus, if a defendant fails to
adequately warn a patient’s physician of the
dangers
presented
by
a
given
pharmaceutical, and the patient suffers an
injury on account of such failure to warn, a
failure to warn claim may lie. That being
said, where a treating physician elects “not
to inform a patient of a side effect,” this
“acts as an intervening cause which shields
the drug manufacturer from any possible
liability under a failure to warn theory.”
Krasnoplosky, 799 F. Supp. at 1346.
Similarly, where a defendant can show,
via “specific facts,” that any given warning
would have been futile—either because any
such warnings would not have been heeded
or because the injury would have occurred,
regardless of the given warnings—a
defendant will have successfully rebutted
the general presumption that “‘a user would
have heeded warnings if they had been
given, and that the injury would not have
occurred.’” Adesina v. Aladan Corp., 438 F.
Supp. 2d 329, 338 (S.D.N.Y. 2006) (quoting
G.E. Capital Corp. v. A. O. Smith Corp., No.
01-CV-1849, 2003 WL 21498901, at *5
(S.D.N.Y. July 1, 2003)); see In re
Fosamax, 924 F. Supp. 2d at 486
(explaining that heeding presumption “may
only be rebutted by specific facts showing
that the warning would have been futile”). If
a defendant can make such a showing, a
plaintiff will not be able to establish the
proximate causation element of a failure to
warn claim. 438 F. Supp. 2d at 338.
18
Courts have questioned whether the scope of this
doctrine is limited simply to the prescribing
physician, or whether it also may extend to nonprescribing, treating doctors. See, e.g., Hogan v.
Novartis Pharm. Corp., No. 06-CV-0260, 2011 WL
1533467, at *10 (E.D.N.Y. Apr. 24, 2011) (citing
cases discussing the broader scope of the learned
intermediary doctrine to any healthcare professional
involved in decisions concerning a patient’s care);
see also Davids, 857 F. Supp. 2d at 287 (noting that
“other courts have recognized that proximate
causation can be satisfied for purposes of the learned
intermediary doctrine where a non-prescribing
physician testifies that the physician was aware of the
patient’s use of a given drug and would have
recommended taking the patient off of that
medication if a different warning had been given”).
The Court considers the scope of this doctrine for
purposes of this case in greater detail infra.
Novartis argues that it is entitled to
summary judgment as to the failure to warn
claims because plaintiffs cannot show (1)
that Novartis had a duty to warn, (2) that
Novartis breached that duty, or (3) that
Bee’s injury was proximately caused by the
alleged breach. Based on the evidence in the
record, construed most favorably to
plaintiffs, the Court concludes that genuine
issues of material fact preclude summary
judgment on these grounds. The Court
addresses each element in turn.
12
other plaintiff’s trial case has addressed
because his doctor prescribed Aredia and
Zometa for severe osteoporosis related to a
rare orthopedic condition, ankylosing
spondylitis. This is not one of the metastatic
cancers to bone for which Novartis
developed, labeled, and sold Aredia and
Zometa and for which the litigation-wide
experts identified by the Plaintiffs’ Steering
Committee developed their reports.”).)
Thus, because Bee was a non-cancer patient
using these drugs in an off-label context,
Novartis again contends that it held no duty
to warn.
1. Duty to Warn
a. The Parties’ Arguments
At the outset, Novartis claims that any
alleged duty to warn only extended to
plaintiff’s prescribing physicians (and not to
any members of the dental community, such
as plaintiff’s dentists) pursuant to the
learned intermediary doctrine. (See Def.
Summ. J. Mot. at 11.) Novartis also
contends that it had no duty to warn of the
contested risks at issue here because plaintiff
was engaged in off-label use of Aredia and
Zometa. (See id.) That is, Aredia’s and
Zometa’s labels clearly indicated the FDAapproved use for these particular drugs, and
neither osteoporosis nor ankylosing
spondylitis were listed as conditions for
which these drugs were to be prescribed.
(See id.) Accordingly, defendant argues that
Bee’s use of these drugs—for non-FDA
approved purposes—was not foreseeable,
and thus, Novartis held no duty to warn
Bee’s physicians as to these drugs’
associated risks. (See id. at 11 (“[B]ecause
[Novartis] has warned that Aredia and
Zometa are only intended for FDA approved
uses, [plaintiff’s] use of these drugs was
unforeseeable and [Novartis] owed no duty
to warn the prescriber of these drugs to
[plaintiff] of risks associated with his Aredia
and Zometa uses.”); Def. Reply in Supp. of
Summ. J. (“Def. Reply”) at 2–3; id. at 3
(“[Novartis] owed no duty to warn a doctor
prescribing [plaintiff] these drugs about the
risks associated with his off-label Aredia
and Zometa use.”).) An additional argument
Novartis raises in support of ONJunforeseeability here is that this case is
distinguishable from other Aredia/Zometa
lawsuits in that, unlike those other cases,
Bee was not a cancer patient at the time he
took the drugs. (See Def. Mot. to Advise
Court of Pending Summ. J. Mots. & Request
Consol. Briefing (“Def. Mot. to Advise”) at
5 (“Mr. Bee’s claim presents issues that no
Plaintiffs counter that Novartis had a
duty to warn because it was foreseeable that
a patient treated with Aredia and/or Zometa
might develop ONJ. (See Pls. Opp’n at 18–
20.) Plaintiffs assert that the issue of
foreseeability goes not to whether the drugs
here were used in an intended or off-label
fashion (as defendant so frames it), but
instead, to whether there was a risk of
developing ONJ if and when a patient was
treated with these drugs. In other words, if a
patient might develop ONJ after taking
Zometa and/or Aredia—particularly if such
a patient had dental procedures performed
while taking such medications—and such a
risk was foreseeable, defendant had a duty to
warn, period (i.e., regardless of whether the
drug use was in an off-label context). (See
id. at 19–20 (“Novartis knew very early on
that for most patients ONJ is triggered by a
tooth extraction or other invasive dental
procedure. . . . Novartis knew that the risk of
ONJ in users of its drugs was greatly
increased when the patient had a tooth
extracted or oral surgery.”).)
Turning to the scope of this duty,
plaintiffs assert that Novartis’s duty
extended not only to Bee’s prescribing
physicians, but also to the “oral
maxillofacial and dental communities.” (See
Pls. Opp’n at 19 (citing Lindsay, 637 F.2d at
13
92).)19 Plaintiffs contend that, because it is
foreseeable that patients with more tooth
decay than the average individual likely will
go to the dentist, Novartis—which “knew
very early on” that a tooth extraction, or
other form of invasive dental procedure,
would trigger ONJ in most patients with the
condition of ONJ, and that the risk of ONJ
increased in users of Novartis’ drugs where
such users had dental medical procedures—
held a duty to warn that extended to
plaintiff’s dentists and oral surgeons. (Id. at
19–20 (citing Decl. of John J. Vecchione
(“Vecchione Decl.”) Ex. 32, Email of
Carsten Goessel (“Goessel Email”); see also
id. at 20 (stating that Novartis kept “the
information
oncologists
and
oral
maxillofacial surgeon[s] had apart from one
another”(citing Vecchione Decl. Ex. 23,
Email
from
Stefano
Fratarcangeli
(“Fratarcangeli Email”)).)
and regardless of whether it was an
intended-or-off-label-use context.
“There are differences with respect to
whether warnings are required for the offlabel use of a drug.” Blain v. SmithKline
Beecham Corp., 240 F.R.D. 179, 194 (E.D.
Pa. 2007). As noted in Blain,
Some states require no warning, see
Robak v. Abbott Labs., 797 F. Supp.
475, 476 (D. Md. 1992), while others
have varying levels of requirements
for adequate warning of an off-label
use. Miles Labs., Inc. v. Superior
Court, 133 Cal. App. 3d 587, 184
(1982) (manufacturer liable for
failure to warn of risks of off-label
uses of its product if the
manufacturer knew or should have
known of the off-label use and that
use accounted for a significant
portion of the manufacturer’s sales
of the drug); Peterson v. Parke Davis
& Co., 705 P.2d 1001, 1003 (Colo.
Ct. App. 1985); Reeder v. Hammond,
336 N.W.2d 3, 5–6 (Mich. Ct. App.
1983) (intervening negligence of a
physician
precludes
the
manufacturer’s liability for failure to
warn of risks of off-label use).
b. Analysis
As is apparent from their respective
framing of the issue, the parties dispute both
whether the alleged risk at issue (ONJ) was
foreseeable, and the scope of foreseeability.
As previously set forth, Novartis argues that
the question of foreseeability goes to the
particular purpose for which plaintiff was
taking the drugs—here, in an off-label
capacity for a non-cancer patient’s treatment
of ankylosing spondylitis and osteoporosis.
Plaintiffs, on the other hand, assert that the
issue of foreseeability goes simply to
whether a patient taking these particular
drugs stood the risk of developing ONJ,
regardless of whether he or she had cancer,
Id. at 194–95. Cases from other federal
courts applying state law have expressly
found that a pharmaceutical manufacturer
had a duty to warn of risks associated with
off-label use. See, e.g., McNeil v. Wyeth, 462
F.3d 364, 370–71 (5th Cir. 2006) (under
Texas law, plaintiffs can pursue failure to
warn action despite off-label use of drug);
Knipe v. SmithKline Beecham, 583 F. Supp.
2d 602, 628–29 (E.D. Pa. 2008)
(concluding, under New Jersey law, that
manufacturer owed duty to warn of dangers
associated with off-label uses of drugs
where manufacture knows or should have
known of danger of side effects); Southern
19
In making this argument, plaintiffs note that only
New Jersey has adopted defendant’s more limited
view of the duty to warn (as limited solely to
prescribing physicians), and further, that Judge Spatt
of the District Court of the Eastern District of New
York ruled against Novartis’s interpretation of this
same issue in a similar case. (Pls. Opp’n at 19.)
14
Synthesizing such principles, a patient
prescribed an off-label use of a drug may be
a reasonably foreseeable user of the product,
such that a manufacturer has a duty to warn
of all known adverse effects associated with
such use. Novartis cites to no New York
case law (and the Court could not find any)
holding that a pharmaceutical company is
not required to warn of the dangers of offlabel uses of its drugs, despite having
information of such dangers. In Sita, a
medical device case cited by Novartis, the
warning at issue stated that nearly all of the
components of the medical device were
intended for specific uses “only.” 43 F.
Supp. 2d at 259–60. Intended use and
approved use are distinct, however, and
there is no evidence that Novartis expressly
stated that its drugs should only be used for
FDA approved purposes. Moreover, the
Second Circuit also has recognized, in
dictum,
that
“[p]hysicians
and
pharmaceutical manufacturers can be held
liable for off-label drug use through medical
malpractice and negligence theories of
liability.” Caronia, 703 F.3d at 168 n.11
(citing Boyle v. Revici, 961 F.2d 1060 (2d
Cir. 1992); Sita v. Danek Med. Inc., 43 F.
Supp. 2d 245 (E.D.N.Y. 1999); Retkwa v.
Orentreich, 584 N.Y.S.2d 710 (N.Y. Sup.
Ct. 1992)). Therefore, under New York law,
the Court finds that a drug manufacturer can
have a duty to warn even in cases involving
off-label use.
v. Pfizer, Inc., 471 F. Supp. 2d 1207, 1218
(N.D. Ala. 2006) (recognizing, under
Alabama law, that drug’s manufacturer
owed duty to warn about potential dangers
of using prescription drug for an off-label to
patient’s prescribing physician by drug’s
manufacturer.); Woodbury v. Janssen
Pharm., Inc., Civ. A. No. 93-7118, 1997
WL 201571, at *9 (N.D. Ill. Apr. 10, 1997)
(recognizing, under Illinois law, that
pharmaceutical manufacturer has duty to
warn of any dangers associated with offlabel use of product if such dangers were
reasonably known).
As a general rule, under New York law,
“[t]he manufacturer’s duty is to warn of all
potential dangers in its prescription drugs
that it knew, or, in the exercise of reasonable
care, should have known to exist.” Martin v.
Hacker, 83 N.Y.2d 1, 8 (1993). The
“warning must be commensurate with the
risk involved in the ordinary use of the
product.” Id. at 11 (citation and internal
quotation marks omitted). Further, to avoid
liability, drug manufacturers have a two-fold
“continuing obligation,” as well. Baker v. St.
Agnes Hosp., 421 N.Y.S.2d 81, 85 (N.Y.
App. Div. 1979); see also Glucksman v.
Halsey Drug Co., 553 N.Y.S.2d 724, 726
(N.Y. App. Div. 1990). First, they “must
keep abreast of knowledge of [their]
products as gained through research, adverse
reaction reports, scientific literature and
other available methods. Second, and
equally important, [they] must take such
steps as are reasonably necessary to bring
that knowledge to the attention of the
medical profession.” 421 N.Y.S.2d at 85
(citations omitted). In addition, “off-label
drug usage is not unlawful, and the FDA’s
drug
approval
process
generally
contemplates that approved drugs will be
used in off-label ways.” United States v.
Caronia, 703 F.3d 149, 166 (2d Cir. 2012).
Thus, to determine whether defendant
had a duty to warn, the Court must first
consider whether the potential development
of ONJ was a foreseeable, or reasonably
foreseeable, risk to Novartis for those
patients who might take its drugs. See
Liriano, 92 N.Y.2d at 237 (noting that a
manufacturer’s duty to warn is triggered
where the company knew or should have
known of “latent dangers resulting from
foreseeable uses of its product” or “of the
danger of unintended uses . . . provided
15
claiming a link, as early as the 1980s,
between bisphosphonates treatment and the
development of ONJ, or the presence of
ONJ in Novartis’s early 1990s Aredia
clinical trials. Instead, Novartis simply states
that “plaintiffs have no evidence that
[Novartis] knew or should have known
about a possible risk of ONJ prior to
September 2003.” (Def. Summ. J. Mot. at
12.)
these uses [were] reasonably foreseeable”).
On reviewing the evidence in the record, the
Court concludes that plaintiffs have raised
genuine issues of material fact that preclude
summary judgment as to whether defendant
knew or should have known (and when)
about the risk of developing ONJ upon
taking the aforementioned medications.
Specifically, plaintiffs point to a 1981
study involving rats showing a connection
between bisphosphonates and ONJ, which,
according to the testimony of Jonathan
Green, the head of Zometa preclinical
studies, allegedly was in defendant’s
possession as early as 1986. (See Pls. Opp’n
at 22; see also id. Vecchione Decl. Ex. 22,
Dep. of Jonathan Green (“Green Dep.”) at
125–27).) Plaintiffs also reference multiple
cases of ONJ allegedly reported during
Aredia and Zometa’s clinical trials, which
date back to 1991. (Pls. Opp’n at 22; see
also id. Vecchione Decl. Ex. 19, Email and
Attachments of Annmarie Petraglia, Jan. 27,
2005 (“Petraglia Doc.”).)
On reviewing the parties’ arguments and
supporting evidence, it is clear that the
question of what was foreseeable to
Novartis, and when, is a disputed issue of
material fact in this case. The parties have
presented evidence that shows more than
unsupported speculation or conclusory
assertions, on both sides, as to whether
Novartis knew, or should have known, of
the risk of developing ONJ while taking
Aredia and/or Zometa during the period
relevant to this dispute. The fact that such
drugs were possibly prescribed to cancer
patients more often than not, or that such
drugs might be used in on-or-off label
capacity during the pre-warning phase does
not weaken the medical evidence to which
plaintiff directs the Court’s attention, which
(if credited) largely shows a correlation
between bisphosphonate usage and the
development of ONJ. This evidence does
not affirmatively show that the correlation
between these drugs and developing ONJ
was exclusively dependent on a patient’s
cancer status or, for that matter, the drugs’
use in an intended or off-label context.
Summary judgment is only appropriate
where the moving party (Novartis) can show
that there is “no genuine dispute as to any
material fact” and that the moving party is
entitled to judgment as a matter of law. Fed.
R. Civ. P. 56(a); see Gallo v. Prudential
Residential Servs., L.P., 22 F.3d 1219, 1223
(2d Cir. 1994) (noting that moving party
bears burden of proving there is no genuine
Novartis
disputes
this
evidence,
asserting
that
the
first
case
of
bisphosphonate-induced ONJ was not
reported to it until December 6, 2002. (See
Def. Summ. J. Mot. at 13 (citing Def. 56.1 ¶
79).) Thus, when Bee first began his Aredia
therapy (in August 1997), defendant had no
notice “of a single case of ONJ in
bisphosphonate users, and no published data
existed that rendered ONJ a ‘knowable’
risk.” (Id. (citing Def. 56.1 ¶¶ 79, 81–82,
99).) Defendant notes that plaintiffs’ expert,
Dr. Suzanne Parisian (“Dr. Parisian”), has
testified to the same, stating that she “agrees
that, prior to approval of Aredia and
Zometa, no published study indicated
necrosis of the jaw in bisphosphonate
users.” (Id. (citing Def. 56.1 ¶ 100 Ex. 91,
Dep. of Dr. Suzanne Parisian (“Parisian
Dep.”) at 209).) Defendant does not
explicitly address plaintiffs’ evidence
16
bisphosphonate
treatments
and
the
development of ONJ following the
December 2002 alert; (4) evidence showing
that the FDA approved defendant’s labels
for Aredia and Zometa throughout the time
when Bee was undergoing treatment with
these drugs (see Def. 56.1 ¶¶ 59–64); and
(5) excerpts from plaintiffs’ experts’
testimonies suggesting that Novartis was not
in possession of information concerning the
risk of ONJ before 2002 or 2003 (see id.
¶ 100). Based on this evidence in the record,
defendant contends that it satisfied its duty
to warn by issuing adequate warnings—once
it had notice of the drugs’ associated risks—
to Bee’s prescribing physicians at the time
period relevant to this dispute. (See
generally Def. Summ. J. Mot. at 12–14.)
issue of material fact). Novartis has not
carried that burden here.
2. Adequacy of the Warnings
Although Novartis’s main position is
that it had no duty to warn in light of Bee’s
off-label usage of the medications, Novartis
also argues that it fulfilled its obligation to
adequately warn physicians of any danger or
risk posed by Aredia and/or Zometa. (See
Def. Summ. J. Mot. at 12–19.) In support of
its argument, defendant points to the
following evidence: (1) the adverse event
report from December 2002 showing a link
between the treatment drugs and ONJ,
which Novartis asserts was the first such
report it received concerning such a risk (see
Def. 56.1 ¶ 79; see id. Ex. 72); (2) exhibits
showing that once Novartis received the
December 2002 adverse event report, it
immediately alerted the FDA and promptly
put into action steps to implement a label
change in 2003 (see Def. Summ. J. Mot. at
13; see also Def. 56.1 ¶¶ 86–93); (3)
evidence (including a September 2003 letter
to the FDA requesting a revision of the
Adverse Reactions section to the Aredia and
Zometa labeling (Def. 56.1 Ex. 76), a March
2004 letter confirming the FDA’s
acceptance of the proposed Adverse
Reactions-labeling change (id. Ex. 82), a
letter indicating that Novartis revised its
Post-Marketing Experience section of the
Zometa label in February 2004 to add
additional language concerning the risk of
ONJ (id. Ex. 83), a letter indicating that the
FDA approved the proposed February 2004
labeling revision (id. ¶ 91), and a “Dear
Doctor” letter, sent to more than 17,200
hematologists, urologists, oral surgeons, and
oncologists, warning that ONJ had been
reported in cancer patients receiving
bisphosphonate treatment (id. ¶¶ 92–94; id.
Ex. 87)) indicating defendant’s efforts to
alert the medical community of the
discovered
correlation
between
Plaintiffs argue that defendant’s
warnings were inadequate because they
were not issued until long after Novartis had
notice of the risk of ONJ in patients
receiving bisphosphonate treatment with
Aredia and Zometa. (See Pls. Opp’n at 21–
22.) Plaintiffs again direct the Court’s
attention to evidence indicating there were
cases of ONJ in Aredia and Zometa’s
clinical trials dating back to 1991 (see id.
Vechhione Decl. Ex. 19, Petraglia Doc.),
and Green’s testimony that, as early as 1986,
Novartis possessed a 1981 study showing
ONJ in rats exposed to bisphosphonates (see
id. Vecchione Decl. Ex. 22, Green Dep. at
125–27). Plaintiffs also point to evidence
showing that defendant has acknowledged
that there were at least six incidents of ONJ
in its clinical trials (see id. Vecchione Decl.
Ex. 20, Series of Emails Addressing
Slides).20 Lastly, plaintiffs note that, at the
20
Plaintiffs note that this six-incident estimate may
be inaccurate, given that an internal Novartis report
referencing these clinical trials also refers to the fact
that Novartis lost approximately one half of its data
during this particular time period. (See Pls. Opp’n
Vecchione Decl. Ex. 20.)
17
3. General Causation
time Dr. Arcati extracted Bee’s teeth in
2003, there still was no language in the
warning label section of the drugs, even
though Novartis had knowledge of the risk
of ONJ before that time. (Id. at 22.)
In assessing proximate cause, the Court
must consider whether a lack of adequate
warnings contributed to plaintiff’s use of the
drugs, and whether plaintiff’s use of the
drugs constitutes a proximate cause of Bee’s
injury. See Golod v. La Roche, 964 F. Supp.
841, 856 (S.D.N.Y. 1997) (“A plaintiff
suing a prescription drug manufacturer on a
failure to warn theory must prove that the
failure to warn was a proximate cause of the
plaintiff’s injury. Thus, the plaintiff must
generally demonstrate that had appropriate
warnings been given, the treating physicians
would not have prescribed or would have
discontinued use of the drug.” (internal
citations omitted)); see also Lindsay, 637
F.2d at 90–91 (“A plaintiff who seeks
recovery for an injurious side effect from a
properly manufactured prescription drug
must prove that the drug caused her injury
and that the manufacturer breached a duty to
warn of the possibility that the injurious
reaction might occur.”). Because plaintiffs
allege that Novartis failed to provide
adequate warnings, and further, that this
case concerns pharmaceutical drugs, the
learned intermediary doctrine applies. As
previously set forth, pursuant to this
doctrine, “a defendant manufacturer has an
obligation to inform the treating physician of
the risks of a medical device” so that the
physician,
acting
as
the
learned
intermediary, may properly inform the
patient. Henson v. Wright Med. Tech., Inc.,
No. 12-CV-805, 2013 WL 1296388, at *3
(N.D.N.Y. Mar. 28, 2013) (citing
Glucksman, 553 N.Y.S.2d at 726); see also
Steinman v. Spinal Concepts, Inc., No. 05CV-774S, 2011 WL 4442836, at *9
(W.D.N.Y. Sept. 22, 2011) (“It is well
settled with respect to prescription drugs and
medical devices that a manufacturer’s duty
to warn is owed not [to] the patient, but to
the treating physician as the ‘learned
intermediary.’”).
It is undisputed that Novartis issued no
explicit warnings concerning the risk of ONJ
until sometime after December 2002. This is
about the only point upon which the parties
agree concerning the alleged adequacy of
Novartis’s warnings. Given the factual
dispute (coupled with supporting evidence)
between the parties concerning the adequacy
of the information provided to the doctors in
this case, the Court concludes that this is a
question properly left for the jury.
Plaintiffs point to evidence indicating
that Novartis had knowledge of the dangers
of
ONJ
in
patients
undergoing
bisphosphonate treatments, like Aredia and
Zometa, well before December 2002—a
time when the products’ labels bore no
mention of any such risk. Defendant has
pointed to evidence countering this, both
summarizing the steps it took to warn upon
allegedly first learning of the dangers of
ONJ, and indicating evidence that supports
its position that there was no actual,
“knowable” risk of ONJ before December
2002, whether in the medical literature or
otherwise. Testimony from plaintiff’s
doctors raises genuine issues of material fact
as to the extent of information concerning
Aredia and Zometa that was available at the
time relevant to this dispute. In light of these
genuine issues of material fact concerning
the adequacy of the warnings for Aredia and
Zometa during the time when Bee was
taking these drugs, the Court concludes that
summary judgment cannot be appropriately
granted as to this element of the failure to
warn claim.
18
Zometa for the off-label treatment of
osteoporosis (id.).21
Here, there is no dispute that the drugs at
issue did not contain warnings or language
explicitly addressing the particular risk of
ONJ until sometime after December 2002.
Defendant argues that Bee would have
developed ONJ, even if Novartis had issued
different or earlier warnings. The crux of
defendant’s argument is twofold: (1) Dr.
Samuel still would have prescribed Aredia
and/or Zometa to plaintiff, even if different
warnings had issued, evidenced by the fact
that Dr. Samuel continues to prescribe such
drugs to patients today and was prepared to
continue administering the drugs to plaintiff,
even after being told of another doctor’s
opinion that plaintiff had bisphosphonate
related ONJ; and (2) Bee would have taken
Aredia and/or Zometa, even with a proper
warning, because the drugs were necessary
for treating his condition, and he was
desperate for a cure. (See Def. Summ. J.
Mot. at 14–19.) The Court addresses each of
these arguments in turn.
In essence, defendant seeks to break the
causal link between the warning it issued to
Dr. Samuel (via the drugs’ labels), Dr.
Samuel’s subsequent administration of the
drugs to plaintiff, plaintiff’s taking of the
drugs, and plaintiff’s development of ONJ.
It does so by relying on two principles that
may act as intervening events and thereby
sever causation.
The first type of intervening event that
might shield Novartis from liability under a
failure to warn theory occurs where “[a]
treating physician[] [decides] not to inform a
patient of a side effect.” Krasnopolsky, 799
F. Supp. at 1346. Thus, if Dr. Samuel had
independent knowledge concerning the
correlation between Aredia and/or Zometa
and the risk of ONJ, but did not inform
plaintiff of such information, this would
break causation. Although not specifically
stated as such, defendant suggests that Dr.
Samuel may have possessed such
independent knowledge. (See Def. Summ. J.
Mot. at 16 (“Plaintiffs fail to offer evidence
that Dr. Samuel was unaware of the
association between bisphosphonates and
a. Whether Plaintiff’s Physicians’
Treatment Would Have Differed
Because Novartis argues that any duty to
warn here only extended to Bee’s
prescribing physicians (here, Dr. Samuel), it
limits its arguments (that altered warnings
would not have made a difference for Bee)
to Dr. Samuel. In particular, defendant
contends that (1) there is no evidence
indicating that Dr. Samuel did not know of
the association between bisphosphonates
and ONJ during the time when he treated
Bee (id. at 16); (2) Dr. Samuel testified that
he had intended to continue prescribing
Zometa to plaintiff, even after learning of
Dr. Ruggiero’s jaw necrosis diagnosis, until
he observed exposed bone in plaintiff’s
mouth (id.); (3) Dr. Samuel did not rely on
the product labels when deciding whether to
prescribe the drugs (evidenced by plaintiff’s
off-label use of the drugs) (id.); and (4) Dr.
Samuel presently prescribes both Aredia and
21
Novartis additionally argues that “even if Dr.
Samuel had required [] Bee to have a pretreatment
dental evaluation before beginning Aredia and
Zometa therapy, plaintiffs have no evidence, let alone
the required expert testimony, that such a warning
would have avoided his subsequent dental issues.”
(Def. Summ. J. Mot. at 18.) Defendant points to
testimony from several of plaintiff’s proffered
experts in support of this argument. However, as
Novartis itself notes when highlighting this
testimony, the experts themselves cannot say whether
a pretreatment dental screening would (or would not)
have made any difference had different warnings
issued. Given the inconclusive state of the evidence
upon which defendant relies for this point, the Court
cannot say that it supports a finding of summary
judgment, at least as to this particular argument.
19
of ONJ, such that plaintiffs’ causation claim
cannot proceed. Stated differently, there are
genuine issues regarding what Dr. Samuel
might
have
independently
known
concerning bisphosphonates and ONJ during
the time period relevant to this dispute.
Moreover, even if defendant’s argument
here were sufficient to counter any disputed
material fact regarding Dr. Samuel’s ONJrelated knowledge, independent knowledge
of an alleged risk does not necessarily
mandate summary judgment on a claim. See,
e.g., Fussman v. Novartis Pharm. Corp., No.
06-CV-149, 2010 WL 4104707, at *4
(M.D.N.C. Oct. 18, 2010) (citing Holly v.
Burroughs Wellcome Co., 348 S.E.2d 772,
775–77 (N.C. 1986), which denied summary
judgment on proximate cause, even where
treating physician testified that he was
independently aware of risks, because there
were genuine issues of fact as to proximate
cause claim as physician relied in part on
medical literature, which may have been
affected by the drug manufacturer’s product
labeling and promotional information
available at that time). Thus, the Court
concludes that summary judgment on this
issue is unwarranted.
ONJ during the entire period that he treated
Mr. Bee.”).) A review of Dr. Samuel’s
testimony reveals the following.
First, Dr. Samuel testified that he had
used bisphosphonates in treating other
patients before he began seeing plaintiff.
(Pls. Opp’n Vecchione Decl. Ex. 2,
Deposition of Dr. Edward Samuel (“Dr.
Samuel Dep.”) at 41, 44, 78.) Thus,
bisphosphonates were not exactly new
territory for Dr. Samuel when he began
prescribing the medications to Bee. Second,
Dr. Samuel stated that, when he began using
bisphosphonates with his patients, he had
“some familiarity” with the side effects and
risks posed by their use. (Id. at 59.) He did
not state, however, that ONJ was a risk of
which he was aware. Dr. Samuel also did
not recall Aredia’s warnings being changed
or the release of additional information
concerning the drug’s potential side effects
between 1996 and 2002 (with the exception
of information regarding kidney problems).
(See id. at 144.) Regarding the extent of his
knowledge pertaining to bisphosphonates,
Dr. Samuel testified that he likely was aware
of clinical trials concerning the use of
bisphosphonates
for
patients
with
osteoporosis during those same years (see
id. at 61), and also, that he received regular
visits from Novartis representatives, which
included
discussions
and
literature
concerning bisphosphonates sold by
Novartis (id. at 55–56). But, he nowhere
affirmatively states that he had knowledge
concerning the risk of ONJ in these drugs
before approximately November 2004, when
he claims to have first heard about the
association between bisphosphonates and
jaw necrosis or seen a patient with such
diagnosis. (Id. at 181, 264.)
The second doctrine pursuant to which
defendant seeks to sever causation is the
heeding doctrine. As previously set forth, a
defendant may rebut the application of this
presumption by pointing to specific facts
indicating that the issuance of a warning
would have, for all intents and purposes,
been meaningless, whether because it is
clear that any issued warning would not
have been followed or because it is apparent
that the injury would have occurred
regardless of the warnings issued. See
Adesina, 438 F. Supp. 2d at 338; see also
Hoffman-Rattet v. Ortho Pharm. Corp., 516
N.Y.S.2d 856, 861–62 (N.Y. Sup. Ct. 1987).
Novartis’s defense here may best be
understood in two ways: even if a different
warning had been issued, (1) Dr. Samuel
Given this testimony, the Court cannot
say that defendant has demonstrated that it is
uncontroverted that Dr. Samuel held
independent knowledge concerning the risk
20
still would have prescribed Aredia and
Zometa to plaintiff, and (2) plaintiff still
would have taken the drugs. The Court
addresses each point in turn.
a genuine issue of fact on this question,
which precludes summary judgment.
First, it is true that Dr. Samuel testified
that he continues to prescribe Aredia and
Zometa in present day to patients, even
though he is now aware of the risks
associated with such drugs. (See Def. 56.1
Ex. 18 at 38, 187.) Dr. Samuel also testified
that he had intended to continue
administering Zometa to plaintiff, even after
plaintiff informed him of Dr. Ruggiero’s
conclusion of osteonecrosis, and that it was
not until Dr. Samuel saw the exposed bone
in plaintiff’s mouth that he decided
otherwise. (See id. Ex. 18 at 178–79.)
Regarding Bee’s physicians, Novartis
turns to Dr. Samuel’s direct testimony to
support its position that he would have
prescribed Aredia and Zometa to plaintiff,
even if different warnings, indicating the
association between these drugs and ONJ,
had issued. (See Def. Summ J. Mot. at 15–
16 (citing Def. 56.1 ¶¶ 101–02, 104–13).)
Plaintiffs counter this defense, arguing that
Novartis must show, via a physician’s
affirmative statement, that “even if [a
physician were] adequately warned, the
treatment provided would have been
virtually identical to that actually rendered.”
(Pls. Opp’n at 20–21 (quoting HoffmanRattet, 516 N.Y.S.2d at 857–58) (emphasis
added) (internal quotation marks omitted).)
Plaintiffs assert that both the testimony of
Dr. Samuel and Dr. Arcati shows that the
doctors have altered their behavior since
learning of the risk of ONJ, which supports
the inference that these doctors might have
taken different courses of treatment had
different or earlier warnings issued; this
raises genuine issues of material fact
supporting a denial of summary judgment.
(See id.)
However, this testimony is not
necessarily dispositive as to whether Dr.
Samuel would have continued to prescribe
Aredia and Zometa to Bee during his period
of treatment had warnings targeting ONJ
existed at that time. If different or earlier
warnings had issued, Dr. Samuel might have
changed plaintiff’s course of treatment or
altered his prescription regimen in other
ways. Indeed, plaintiffs point to evidence
supporting such a conclusion.
For instance, they cite to Dr. Samuel’s
testimony, which sets forth how his process
for prescribing these same drugs has
changed since he first learned of the drugs’
potential ONJ-related side effects. (See Pls.
Opp’n at 23.) Specifically, Dr. Samuel
testified that he has changed his prescription
process as follows: distributing handouts
about Aredia and Zometa, in printed or
pamphlet form, to patients (Vecchione Decl.
Ex. 2, Dr. Samuel Dep. at 189); informing
patients as to the benefits of the drugs for
their particular condition, but also, of the
risk of ONJ (id. at 190); providing patients
with instructions for their dental care
provider, to be given at the time of dental
work (id. at 190–91); warning patients not to
undergo dental work until they have stopped
The Court has reviewed the physicians’
testimony.22 Based on this review, plaintiffs
have submitted sufficient evidence to create
22
Although Novartis does not specifically address
Dr. Arcati in its arguments (presumably because he
was not the prescribing physician), plaintiffs do. This
makes sense, as plaintiffs assert that the learned
intermediary doctrine should not be limited to the
prescriber, but to any of a plaintiff’s treating
physicians. Accordingly, the Court also considers Dr.
Arcati’s testimony when assessing whether a
causation claim might lie.
21
taking bisphosphonate drugs for a period of
time, unless it is an absolute emergency
(id.); and advising patients to keep dental
work to a minimum (id. at 191). The Court
also notes Dr. Samuel’s testimony that his
practice is to discuss risks and potential
adverse effects with his patients before
starting them on a drug, and that while he
will inform patients of the advantages and
disadvantages of a given drug (as known at
that time), the ultimate decision to take a
drug lies with the patient. (See id. 118–19,
159–60, 208–09.)
Similar cases in other district courts,
including the MDL Court, have held that
even where a physician admits to continued
recommendation of a drug, despite knowing
of its ONJ-related risk, changes to that
doctor’s
prescription
or
treatment
procedures will generate triable questions of
fact on the question of causation. See, e.g.,
Georges v. Novartis Pharm. Corp., No. 06CV-5207, 2012 WL 9083365, at *5–6 (C.D.
Cal. Nov. 2, 2012); In re Aredia & Zometa
Prods. Liab. Litig. (Talley), 3:06-MD-1670,
2010 WL 5092784, at *2 (M.D. Tenn. Dec.
7, 2010) (noting that treating physician
reduced dosage of drugs on learning of
correlation between bisphosphonates and
ONJ); In re Aredia & Zometa Prods. Liab.
Litig. (White), 3:06-MD-1760, 2009 WL
2497692, at *3 (M.D. Tenn. Aug. 13, 2009)
(“Plaintiff’s treating oncologist . . . testified
that if he had known when he prescribed
Zometa to [plaintiff] what he knows today
about ONJ, he would still prescribe it, but
with a change in how he prepares the
patients for the drug . . . . [I]t is sufficient for
Plaintiff to survive summary judgment to
show that one of [plaintiff’s] treating
physicians . . . would
have
behaved
differently.”); In re Aredia v. Zometa Prods.
Liability Litig. (Fussman), 3:06-MD-1760,
2009 WL 2496843, at *2 (M.D. Tenn. Aug.
13, 2009) (denying summary judgment
where treating doctor testified that, if he had
“known about bisphosphonates and ONJ at
the time he treated [plaintiff], his treatment
course for her would have definitely been
different”). Thus, there is a genuine issue of
fact as to whether, had different or earlier
warnings issued, Dr. Samuel would have
behaved identically or instead, have altered
his course of treatment.
This evidence raises a genuine issue of
material fact as to whether Dr. Samuel
would have provided different treatment
and/or advice to plaintiff had different
warnings been provided, given that Dr.
Samuel changed his treatment advice, after
Novartis altered its warning, for other
patients
receiving
bisphosphonates
(including advising patients of the risks
associated with dental procedures while on
these drugs, as well as the particular risks
associated with these drugs in general). It
reasonably can be inferred from this
evidence that, had Dr. Samuel known of the
risk of ONJ, he would have discussed this
with plaintiff before prescribing Aredia and
Zometa to him.23
23
Regarding Novartis’s argument that the issuance of
different labels also would not have made a
difference in Dr. Samuel’s actions here because Dr.
Samuel’s use of the drugs was in an off-label
capacity, the Court disagrees that this is a
determinative factor. The fact that Dr. Samuel used
the drugs here in an off-label context does not per se
mean that he did not look at or consider language on
the drugs’ labels. Indeed, Dr. Samuel’s testimony
makes clear that he continues to prescribe Aredia and
Zometa in an off-label context, but also, that he
advises his patients of the risk of ONJ, seemingly
regardless of whether their use of the drugs falls into
the off-label or intended use category. Accordingly,
the Court does not find the fact that Dr. Samuel
prescribed the drugs here in an off-label capacity to
be a persuasive point requiring summary judgment in
defendant’s favor.
22
Pharm. Corp., 247 P.3d 244, 260 (Mont.
2010) (describing scope of learned
intermediary doctrine as applying to any
healthcare professional responsible for
making decisions regarding the patient’s
case); McEwan v. Ortho Pharm. Corp., 528
P.2d 522, 529 (Or. 1974) (“Although
the [] drug manufacturer’s duty to warn has
been discussed most often with reference to
the prescribing physician, the [doctrine’s]
reasoning applies with equal force to the
treating physician . . . [who] may be more
likely to observe the actual symptoms of the
drug’s
untoward
consequences.”).
Accordingly, the Court considers whether
there are genuine issues of material fact
regarding whether Dr. Arcati’s treatment of
plaintiff also might have varied if Novartis
had administered different warnings to the
medical community.
The Court next turns to Dr. Arcati.
Although Dr. Arcati was plaintiff’s dentist,
and not a prescribing physician, the Court
accepts, for purposes of this motion, that the
learned intermediary doctrine may apply
beyond the prescribing physician. See
Davids, 857 F. Supp. 2d at 287 (“Although a
prescribing physician’s course of conduct is
a relevant issue, other courts have
recognized that proximate causation can be
satisfied for purposes of the learned
intermediary doctrine where a nonprescribing physician testifies that the
physician was aware of the patient’s use of a
given drug and would have recommended
taking the patient off of that medication if a
different warning had been given.” (citing
Golod v. La Roche, 964 F. Supp. 841, 857
(S.D.N.Y. 1997)); Hogan v. Novartis
Pharm. Corp., No. 06-CV-0260, 2011 WL
1533467, at *9 (E.D.N.Y. April 24, 2011)
(stating that “courts routinely identify the
‘prescribing physician’ as the learned
intermediary[; b]ut none of the cases in
defendant’s long list stand for the
proposition that prescribing physicians are
the only treating medical professionals who
must be warned”); id. at *10 (“Nor is there
anything in the rationale behind the [learned
intermediary] doctrine that counsels in favor
of defining the ‘learned intermediary’
narrowly to exclude other treating medical
professionals. Broadly speaking, the learned
intermediary rule seeks to preserve the
doctor-patient relationship and allows the
doctor to interpret the dangers involved in
taking a drug; a warning to the patient, the
rationale suggests, even if practical, could be
detrimental as the patient may not properly
weigh the drug’s risks against its benefits.
Whatever one thinks of these justifications,
it is difficult to see how they counsel against
requiring drug manufacturers to warn nonprescribing treating doctors and advise them
how to approach a drug’s potential side
effect.”); see also Stevens v. Novartis
Dr. Arcati’s testimony reveals that he
was at least familiar with ONJ at the time he
treated Bee (in 2003), but that his
knowledge concerning the association
between bisphosphonates and ONJ was still
new and developing. (See Pls. Opp’n
Vecchione Decl. Ex. 4 at 109–11, 217, 231–
33.) Thus, construing the evidence most
favorably to plaintiffs, a rational jury could
find that, if different warnings had issued to
plaintiff’s treating physicians during the
period when Dr. Arcati treated plaintiff, Dr.
Arcati’s treatment would have been
different. Such a conclusion could be
supported by Dr. Arcati’s testimony, in
which he states that he has since changed his
patient intake forms so that patients must
expressly answer whether they are taking
bisphosphonates prior to any treatment. (Id.
at 228–30.)
However, Dr. Arcati’s testimony raises
an additional issue. It is clear from his
testimony that he was at least aware of a
possible
correlation
between
bisphosphonates and ONJ when he began
23
administration of different warnings, Dr.
Arcati altered his intake forms. A rational
jury could reasonably infer from this
evidence that, had different or earlier
warnings been given to the medical
community, Dr. Arcati would have changed
his intake forms to include specific
questioning regarding a patient’s possible
bisphosphonate treatment and/or that
plaintiff would have informed Dr. Arcati as
to his drug use. Thus, although this is a
closer question as to Dr. Arcati, the Court
concludes that plaintiffs have shown a
genuine issue of material fact as to
proximate causation.
treating Bee. (See Pls. Opp’n Vecchione
Decl., Ex. 4 at 109–11, 217, 231–33.)
Moreover, Dr. Arcati specifically stated that,
if he had known about Bee’s bisphosphonate
use in 2003, he would have changed his
course of treatment for plaintiff—
specifically, he would have treated Bee with
root canals and capping. (See Pls. Opp’n
Vecchione Decl. Ex. 4 at 109–11.) Thus,
defendant could argue that, if Novartis had
given different warnings to the medical
community regarding the risk of ONJ and
bisphosphonates, Dr. Arcati’s testimony
suggests (1) he already was aware of such a
possible connection, raising a question of
how great an impact any such warnings
might have had, and (2) Dr. Arcati
confirmed that he would have treated
plaintiff differently in 2003 had he known
that plaintiff was on bisphosphonates (which
he did not know simply because plaintiff did
not so inform him). Thus, at least as to Dr.
Arcati, it is not so clear whether an
intervening event might lie: plaintiff’s
failure to inform, the fact that Dr. Arcati
already possessed knowledge concerning a
link between bisphosphonates and ONJ, or
both. Therefore, on the facts of this case,
more than one reasonable inference could be
drawn on this issue, such that summary
judgment is unwarranted.
In sum, the testimony of Dr. Samuel and
Dr. Arcati (if credited), could reasonably
support a finding that, even if they might
have continued to prescribe Aredia and
Zometa to plaintiff, their course of treatment
and manner of administering the drugs to
plaintiff might have varied. This is
sufficient, for purposes of the motion
presently before the Court, to establish a
genuine issue of material fact. Because the
Court concludes that there is a genuine issue
of material fact as to whether the issuance of
different or earlier warnings addressing the
risk of ONJ in these drugs might have
caused plaintiff’s treating physicians to have
behaved differently, defendant’s motion for
summary judgment on this ground is
denied.24
The Court concludes, on reviewing the
evidence in the light most favorable to the
non-moving party, that there is a genuine
issue of material fact as to whether the
issuance of different warnings to Dr. Arcati
(or
other
non-prescribing
treating
physicians) might have led to a different
result here. A rational jury could reasonably
infer that different warnings would have
caused Dr. Samuel to change the manner in
which he treated plaintiff, including advising
Bee to provide information to his dentists
regarding his bisphosphonate usage prior to
any dental work. There is also evidence
showing
that,
upon
Novartis’s
24
The parties do not address Dr. Ruggiero in the
particular context of whether his treatment of plaintiff
might have differed upon the administration of
different warnings. This makes sense, as Dr.
Ruggiero’s testimony confirms that he diagnosed
plaintiff with ONJ in July 2004, after Novartis had
begun taking steps to inform the medical community
and issue different labels. Thus, assessment of Dr.
Ruggiero’s treatment of plaintiff is not informative as
to whether or how his treatment might have differed,
given that the medical literature and warnings already
were changing at that time.
24
plaintiff might have acted had altered
warnings been given. Simply because
plaintiff strongly wanted to end the pain and
suffering he was experiencing, one cannot
say that the only reasonable inference is that
he would have taken any medication, no
matter the cost or risk. Moreover, there is
evidence in the record suggesting the
contrary. Specifically, there is evidence
showing that Bee did not blindly follow his
physicians’ recommendations. For example,
Dr. Samuel testified that when he first
recommended Aredia to plaintiff, plaintiff
requested time to consider whether he
wanted to begin treatment with the drug.
(See Pls. Opp’n Vecchione Decl. Ex. 2, Dr.
Samuel Dep., at 119 (“Q: Can we conclude
from the fact he then started Aredia a month
later that the discussions that we’re talking
about took place, side effects, answering
questions, he agreed; is that a fair
conclusion? A: Yes, it is a fair conclusion. I
didn’t start it when we first discussed it
because I think he wanted to mull it over
and think about it.”).) Thus, the Court
cannot determine on summary judgment
how plaintiff’s actions or decisions might
have varied had different warnings been
given to him before he commenced
treatments with these drugs.
b. Whether Plaintiff’s Actions Would
Have Differed
Defendant’s next argument against
plaintiffs’ causation claim is that “there is no
evidence that [] Bee would not have
consented to Aredia and Zometa therapy had
he been warned of a risk of ONJ.” (Def.
Summ. J. Mot. at 17.) Stated differently,
plaintiff would have accepted these drugs,
regardless of whether a proper warning had
been issued to him from Dr. Samuel (or
otherwise). In support of this argument,
Novartis notes Bee’s testimony, in which he
(1) stated that he was “desperate to find a
solution” for his condition and “[t]o get the
pain managed correctly” (Def. 56.1 Ex. 1 at
128); (2) responded affirmatively to the
question of whether he would have followed
Dr. Samuel’s recommendation to take
Aredia and/or Zometa, even if the doctor
had informed him that such drugs were
intended—and had been approved—to be
used in the treatment of other conditions
(see id. at 145); (3) requested to stay on
prednisone, even after being warned that it
might worsen his osteoporosis (Def. 56.1
¶ 28; see also id. Ex. 28), further illustrating
plaintiff’s “willingness to take anything to
avoid his skeletal pain” (Def. Summ. J. Mot.
at 17); and (4) sought and received two
doses of Zometa, even after Dr. Ruggiero
had informed plaintiff that Zometa likely
had caused his dental condition (id. at 17–
18; see also Def. 56.1 ¶ 50 (citing Def. 56.1
Ex. 1 at 263)).
Additionally, the fact that plaintiff
decided to take prednisone, despite knowing
of the risk that it could worsen his
osteoporosis, also is not dispositive,
particularly when plaintiff’s testimony is
considered in context. Bee’s testimony
makes clear that his decision was based on
his discussions with his doctor, which
caused him to understand that prednisone’s
“side effects didn’t come into play until you
were taking it over an extended period of
time.” (Pls. Opp’n Vecchione Decl. Ex. 1 at
88.) Plaintiff, however, was only to take the
drug for “[t]wo weeks.” (Id.) Furthermore,
although it is true that plaintiff had two more
infusions of Zometa after learning from Dr.
On reviewing the cited evidence, as well
as the evidence in the record, the Court
concludes that there is a genuine issue of
material fact as to how plaintiff might have
acted had different warnings issued. With
respect to defendant’s argument as to
plaintiff’s supposed state of distress, the
extent to which plaintiff was “desperate” for
a solution for his unique and painful
condition is not conclusive regarding how
25
triable issue of fact as to whether plaintiff’s
physicians and/or plaintiff would have acted
differently. Accordingly, the Court denies
Novartis’s motion for summary judgment on
this ground.
Ruggiero that it likely had caused his ONJ,
Bee’s testimony was that he specifically
asked Dr. Ruggiero if he should stop taking
Zometa, and that Dr. Ruggiero’s reply made
clear to plaintiff that stopping the drug at
that point would have been futile for
purposes of preventing or helping his mouth
condition. (See id. at 262–63 (“Q: Did you
ask any questions of Dr. Ruggiero? A: I
might have asked him if I should, or how
long, you know, if stopping it, would it stop
the infection, I believe. I believe that was
one of the questions I asked him. Q:
Stopping it, ‘it’ meaning Zometa? A: I’m
sorry, stopping the Zometa . . . And from
what I remember, it was no, once you have
it, it’s always going to be in your system. I
remember him stating that as well.”).)
B. Specific Causation
Novartis next argues that plaintiffs must
prove, through reliable expert testimony,
that Aredia and Zometa caused Bee to
develop ONJ in order for plaintiffs’ claims
to prevail. (See Def. Summ. J. Mot. at 19–
21.) Because defendant contends that this
Court should exclude the causation opinions
of plaintiffs’ expert, Dr. Richard Kraut (“Dr.
Kraut”), as well as the case-specific
causation opinions of the treating health care
providers designated by plaintiffs as nonretained experts (specifically, Drs. Arcati,
O’Lear, and Ruggiero), Novartis claims that
plaintiffs cannot prove specific causation.
(Id. at 20.)25 Alternatively, Novartis argues
that plaintiffs’ experts failed to rule out
other conditions present in Bee’s medical
history, such as Fosamax and ankylosing
spondylitis, which could have caused his
ONJ. (Id. at 21.)
Lastly, there is evidence in the record
suggesting that once Bee was informed that
his use of bisphosphonates likely had caused
his ONJ, he altered his own practices with
physicians,
informing
dental
care
professionals
of
his
bisphosphonate
treatments thereon out. (See Pls. Opp’n
Vecchione Decl. Ex. 5, Keith M. Hallaian
Decl. (“Hallaian Decl.”) ¶¶ 4–5.)
In order to determine whether plaintiffs
can show that Aredia and Zometa were a
substantial factor in causing Bee’s jaw
Thus, upon considering the evidence in
the record, as well as the parties’ respective
arguments, the Court concludes that it
cannot be determined on summary judgment
just how plaintiff might have acted had Dr.
Samuel (or another treating physician)
informed him of the risk of ONJ associated
with Aredia and Zometa. Construing the
evidence most favorably to plaintiff, a
rational jury could find that plaintiff’s
decision to take the drugs might have been
affected by how Dr. Samuel presented their
associated risks; likewise, plaintiff’s own
approach to dental work might have varied,
following any possible admonition against
such by Dr. Samuel. For these reasons, the
Court concludes that, even if warnings had
issued, the evidence in the record raises a
25
Defendant initially raised its Daubert motion to
exclude the causation testimony of plaintiffs’ experts
before the MDL Court. These motions were not
decided prior to the transfer to this Court. One of the
grounds upon which Novartis presently moves for
summary judgment is that plaintiffs cannot show that
Aredia and/or Zometa substantially caused plaintiff’s
alleged ONJ. (see Def. Summ. J. Mem. at 20–21.)
The evidence plaintiffs offer in support of this claim,
however, is the testimony of the experts whom
Novartis previously challenged before the MDL.
Accordingly, the Court considers, to the extent
necessary, the parties’ previously submitted (but as
yet undecided) Daubert motions solely on the
question of specific causation.
26
is not a talisman against summary
judgment.” Id. at 66. Thus, if the expert
testimony is excluded as inadmissible under
the framework articulated in Daubert and its
progeny,
the
summary
judgment
determination is made by the district court
on a record that does not contain that
evidence. Id. at 66–67. Such an analysis
must be conducted even if precluding the
expert testimony would be outcome
determinative. See Gen. Elec. Co. v. Joiner,
522 U.S. 136, 142–43 (1997). Accordingly,
pursuant to Fed. R. Evid. 104, the court must
examine the admissibility of plaintiffs’
expert testimony in ruling on defendant’s
motion for summary judgment.
condition, the Court must assess the
evidence
(and
its
corresponding
admissibility) presented in support of their
claim—the causation-centered testimony
from plaintiffs’ experts. See Lindsay, 637
F.2d at 90–91 (“A plaintiff who seeks
recovery for an injurious side effect from a
properly manufactured prescription drug
must prove that the drug caused her injury
and that the manufacturer breached a duty to
warn of the possibility that the injurious
reaction might occur.”).
1. Legal Standard
In deciding whether to grant summary
judgment, a district court may only consider
evidence that would be admissible at trial.
Nora Beverages, Inc. v. Perrier Grp. of Am.,
Inc., 164 F.3d 736, 746 (2d Cir. 1998).
Thus, as the Second Circuit has explained, it
is the proper role of the district court to
consider the admissibility of expert
testimony to determine whether summary
judgment is warranted:
The district court must determine the
admissibility of expert testimony under Rule
702 of the Federal Rules of Evidence, which
provides:
A witness who is qualified as an
expert
by
knowledge,
skill,
experience, training, or education
may testify in the form of an opinion
or otherwise if: (a) the expert’s
scientific, technical, or other
specialized knowledge will help the
trier of fact to understand the
evidence or to determine a fact in
issue; (b) the testimony is based on
sufficient facts or data; (c) the
testimony is the product of reliable
principles and methods; and (d) the
expert has reliably applied the
principles and methods to the facts of
the case.
Because the purpose of summary
judgment is to weed out cases in
which ‘there is no genuine issue as to
any material fact and . . . the moving
party is entitled to a judgment as a
matter of law,’ Fed. R. Civ. P. 56(c),
it is appropriate for district courts to
decide questions regarding the
admissibility of evidence on
summary
judgment.
Although
disputes as to the validity of the
underlying data go to the weight of
the evidence, and are for the factfinder to resolve, questions of
admissibility are properly resolved
by the court.
The proponent of the expert testimony
bears the burden of establishing the
admissibility of such testimony under the
Daubert framework by a preponderance of
the evidence. See Daubert v. Merrell Dow
Pharms., Inc., 509 U.S. 579, 592 n.10
(1993) (“These matters should be
established by a preponderance of proof.”
Raskin v. Wyatt Co., 125 F.3d 55, 66 (2d
Cir. 1997) (internal citations omitted;
alteration in original). In other words, “[t]he
court performs the same role at the summary
judgment phase as at trial; an expert’s report
27
witness is qualified to be an expert; (2)
whether the opinion is based upon reliable
data and methodology; and (3) whether the
expert’s testimony on a particular issue will
assist the trier of fact. See Nimely, 414 F.3d
at 396–97. Moreover, if the requirements of
Rule 702 are met, the district court must also
analyze the testimony under Rule 403 and
may exclude the testimony “if its probative
value is substantially outweighed by the
danger of unfair prejudice, confusion of the
issues, or misleading the jury . . . .” Fed. R.
Evid. 403; accord Nimely, 414 F.3d at 397.
(citing Bourjaily v. United States, 483 U.S.
171, 175–76 (1987))); see also Fed. R. Evid.
702 advisory committee’s note (“[T]he
admissibility of all expert testimony is
governed by the principles of Rule 104(a).
Under that Rule, the proponent has the
burden of establishing that the pertinent
admissibility requirements are met by a
preponderance of the evidence.”); Barrett v.
Rhodia, Inc., 606 F.3d 975, 980 (8th Cir.
2010) (“[T]he party offering the expert
testimony “must show by a preponderance
of the evidence both that the expert is
qualified to render the opinion and that the
methodology underlying his conclusions is
scientifically valid.” (internal citations and
quotation marks omitted)); accord Baker v.
Urban Outfitters, Inc., 254 F. Supp. 2d 346,
353 (S.D.N.Y. 2003).
“The district court is the ultimate
‘gatekeeper,’” United States v. Williams,
506 F.3d 151, 160 (2d Cir. 2007), and must
ensure that “any and all scientific testimony
or evidence admitted is not only relevant,
but reliable,” Daubert, 509 U.S. at 589; see
Kumho Tire Co. v. Carmichael, 526 U.S.
137, 152 (1999) (holding that whether the
witness’s area of expertise was technical,
scientific, or more generally “experiencebased,” the court, in its “gatekeeping”
function, must “make certain that an expert,
whether basing testimony upon professional
studies or personal experience, employs in
the courtroom the same level of intellectual
rigor that characterizes the practice of an
expert in the relevant field”); Nimely v. City
of New York, 414 F.3d 381, 396 (2d Cir.
2005) (“The shift under the Federal Rules to
a more permissive approach to expert
testimony did not represent an abdication of
the screening function traditionally played
by trial judges.”).
Under the Daubert standards, the district
court must first determine whether the
expert has sufficient qualifications to testify.
See Zaremba v. Gen. Motors Corp., 360
F.3d 355, 360 (2d Cir. 2004) (stating that,
where the witness lacked qualifications, an
analysis of the remaining Daubert factors
“seems almost superfluous”). Specifically,
under Rule 702, the Court must determine
whether the expert is qualified “by
knowledge, skill, experience, training, or
education.” Fed. R. Evid. 702. A court
should look at the totality of the witness’
qualifications in making this assessment.
See, e.g., Rosco, Inc. v. Mirror Lite Co., 506
F. Supp. 2d 137, 144–45 (E.D.N.Y. 2007)
(“A court must consider the ‘totality of a
witness’s background when evaluating the
witness’s qualifications to testify as an
expert.’” (quoting 29 Wright & Gold, Fed.
Prac. & Proc. § 6265, at 246 (1997)));
accord Arista Records LLC v. Lime Group
LLC, 06 CV 5936, 2011 WL 1674796, at *2
(S.D.N.Y. May 2, 2011). In addition, the
Court must ensure that the expert will be
proffering opinions on issues or subject
matters that are within his or her area of
expertise. See Stagl v. Delta Air Lines, Inc.,
117 F.3d 76, 81 (2d Cir. 1997).
Thus, under Rule 702, the district court
must make several determinations before
allowing expert testimony: (1) whether the
With respect to reliability, “the district
court should consider the indicia of
reliability identified in Rule 702, namely, (1)
28
reached, Daubert and Rule 702 mandate the
exclusion of that unreliable opinion
testimony.”).
that the testimony is grounded on sufficient
facts or data; (2) that the testimony is the
product of reliable principles and methods;
and (3) that the witness has applied the
principles and methods reliably to the facts
of the case.” Williams, 506 F.3d at 160
(internal citation and quotation marks
omitted). As the Second Circuit has
explained, the Daubert Court “has identified
a number of factors bearing on reliability
that district courts may consider, such as (1)
whether a theory or technique can be (and
has been) tested; (2) whether the theory or
technique has been subjected to peer review
and publication; (3) a technique’s known or
potential rate of error, and the existence and
maintenance of standards controlling the
technique’s operation; and (4) whether a
particular technique or theory has gained
general acceptance in the relevant scientific
community.” Amorgianos v. Nat’l R.R.
Passenger Corp., 303 F.3d 256, 266 (2d Cir.
2002) (internal citations and quotation
marks omitted); accord Nimely, 414 F.3d at
396. These criteria are designed to be
instructive, but do not constitute a definitive
test in every case. See Kumho, 526 U.S. at
151; Nimely, 414 F.3d at 396. Moreover, in
addition to these criteria for determining
whether the methodology is reliable, Rule
702 also requires that there be a sufficiently
reliable
connection
between
the
methodology and the expert’s conclusions
for such conclusions to be admissible. See
Gen. Elec. Co., 522 U.S. at 146 (“[N]othing
in either Daubert or the Federal Rules of
Evidence requires a district court to admit
opinion evidence which is connected to
existing data only by the ipse dixit of the
expert. A court may conclude that there is
simply too great an analytical gap between
the data and the opinion proffered.”); see
also Amorgianos, 303 F.3d at 266 (“[W]hen
an expert opinion is based on data, a
methodology, or studies that are simply
inadequate to support the conclusions
With respect to whether the expert’s
testimony will assist the trier of fact, the
Second Circuit has repeatedly emphasized
that “expert testimony that usurps either the
role of the trial judge in instructing the jury
as to the applicable law or the role of the
jury in applying that law to the facts before
it, by definition does not aid the jury in
making a decision; rather, it undertakes to
tell the jury what result to reach, and thus
attempts to substitute the expert’s judgment
for the jury’s.” Nimely, 414 F.3d at 397
(internal citations, quotation marks, and
alterations omitted).
2. Dr. Richard Kraut
At trial, plaintiffs seek to offer Dr.
Richard Kraut’s testimony that Bee had
“bisphosphonate related jaw necrosis.” (Pls.
Causation Resp. Ex. 10, Dr. Richard Kraut
Expert Report (“Ex. 10”) at 6.)26 Novartis,
however, moves to exclude his causation
testimony. The Court begins its analysis
with a review of Dr. Kraut’s background.
Dr. Kraut is a board-certified oral and
maxillofacial surgeon. (Pls. Resp. to Def.
Daubert Mot. to Exclude Expert Witnesses
(“Pls. Causation Resp.”) at 7; see also id.
Ex. 10 at 3.) Upon completing his oral and
maxillofacial surgery training, Dr. Kraut
held various leadership positions with the
United States Army. In 1988, following
eight years of running the Army’s Oral and
Maxillofacial Surgery Residency Programs,
Dr. Kraut was honorably discharged. (Pls.
Causation Resp. at 7; see also Pls. Causation
Resp. Ex. 10 at 3.) He subsequently was
recruited
by
Montefiore
Medical
26
The pages to Dr. Kraut’s report are unnumbered.
The Court adopts the page numbering of ECF.
29
Center/Albert Einstein College of Medicine
to assume the position of Director of Oral
and Maxillofacial Surgery; he has held this
position from 1988 through the present. (Pls.
Causation Resp. at 8; see also Pls. Causation
Resp. Ex. 10 at 3.) In 2003, Dr. Kraut
became Chairman of the Department of
Dentistry
of
Montefiore
Medical
Center/Albert Einstein College of Medicine,
a position he continues to hold to this day.
(Pls. Causation Resp. at 8; see also Pls.
Causation Resp. Ex. 10 at 3.) He has
published numerous articles in the fields of
Dental
Anesthesiology,
Oral
and
Maxillofacial
Surgery,
and
Dental
Implantology. (Pls. Causation Resp. at 8; see
also Pls. Causation Resp. Ex. 10 at 3.) He
also has authored two professional papers in
which he has discussed bisphosphonates.
(Pls. Causation Resp. Ex. 10 at 4.)
Additionally, Dr. Kraut holds editorial
positions as Senior Section Editor of the
Journal of Implant Dentistry, and serves as a
reviewer for Oral Surgery, Oral Medicine,
and Oral Pathology, as well as for the
Journal of Oral and Maxillofacial Surgery;
he has held these positions for over five
years. (Pls. Causation Resp. at 8; see also
Pls. Causation Resp. Ex. 10 at 3.)
8; Pls. Causation Resp. Ex. 10 at 3–4.) In
recent years, he also has treated numerous
patients with jaw necrosis who were on
Fosamax, another type of bisphosphonate.
(Pls. Causation Resp. at 9; Pls. Causation
Resp. Ex. 10 at 4.)
Beginning in or around 2003, Dr. Kraut
observed that patients presented conditions
similar to osteoradionecrosis, but upon
review of their medical history, it was found
that they had not undergone radiation
therapy to the jaw. (Pls. Causation Resp. at
8; Pls. Causation Resp. Ex. 10 at 3); see also
Harvey v. Novartis Pharm. Corp., 895 F.
Supp. 2d 1206, 1213 (N.D. Ala. 2012)
(stating that “[a] physician can rule out
osteoradionecrosis if a patient has no history
of radiation exposure”). Following his
attendance at the Harrigan Society Meeting
at New York University’s College of
Dentistry in December of 2002, when Dr.
Ruggiero’s findings from a series of jaw
necrosis cases were presented (specifically,
linking jaw necrosis to the use of
bisphosphonates), Dr. Kraut became aware
of the association between the two. (Pls.
Causation Resp. at 8; Pls. Causation Resp.
Ex. 10 at 3.) He then reviewed his internal
records and sent questionnaires to female
patients that were over the age of forty,
attempting to elicit information as to
whether they had used either intravenous or
oral bisphosphonates. (Pls. Causation Resp.
at 9; Ex. 10 at 3–4.) The results of that
study, along with an article addressing such
results, were published; in the article, Dr.
Kraut called for the inclusion of specific
questions on health questionnaires that
inquired as to a patient’s use of
bisphosphonates. (Pls. Causation Resp. at 8;
Pls. Causation Resp. Ex. 10 at 4.)
At the beginning of his career (in 1973),
while training at the Brook Army Medical
Center, Dr. Kraut treated patients with
osteoradionecrosis;27
such
experience
allowed him to learn both how to diagnose
the condition, and also, to treat it using
surgery and hyperbaric medicine. (Pls.
Causation Resp. at 8; Pls. Causation Resp.
Ex. 10 at 3.) Over the years, Dr. Kraut has
treated
numerous
cases
of
osteoradionecrosis. (Pls. Causation Resp. at
27
Osteoradionecrosis is “a condition involving dead
bone in the jaw caused by exposure to radiation.”
Harvey v. Novartis Pharm. Corp., 895 F. Supp. 2d
1206, 1213 (N.D. Ala. 2012).
In arriving at his determination that
plaintiff has bisphosphonate related ONJ,
Dr. Kraut relied on: (1) his attendance at the
aforementioned Harrigan Society Meeting in
30
cause”).) This is so because, as defendant
asserts, Dr. Kraut “is admittedly not an
expert” on ankylosing spondylitis, cancer
treatment,
epidemiology,
toxicology,
pharmacology, hematology, chemistry, bone
endocrinology,
statistics,
and
bisphosphonates. (Id. (citing id. Exs. 55, 56,
58, & 61).) However, it is clear that if an
“expert has educational and experiential
qualifications in a general field closely
related to the subject matter in question, the
court will not exclude [an expert’s]
testimony solely on the ground that the
witness lacks expertise in the specialized
areas that are directly pertinent.” Davids,
857 F. Supp. 2d at 277 (quoting In re
Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d
230, 282 (E.D.N.Y. 2007)) (internal
quotation marks omitted); see also Rupolo v.
Oshkosh Truck Corp., 749 F. Supp. 2d 31,
37 (E.D.N.Y. 2010) (“In a product liability
action, an expert witness is not strictly
confined to his area of practice, but may
testify concerning related applications; a
lack of specialization affects the weight of
the opinion, not its admissibility.” (internal
citation and quotation marks omitted)).
December 2002, where medical findings and
corresponding literature were presented
regarding
bisphosphonate-caused
jaw
necrosis; (2) a letter to the editor by Dr.
Robert Marx, which was published in the
Journal of Oral and Maxillofacial Surgery
in 2003; (3) a 2004 article published by Dr.
Ruggiero; (4) a series of position papers
issued by the American Association of Oral
and Maxillofacial Surgeons; (5) “numerous
articles” in the professional literature
addressing
bisphosphonate-caused
jaw
necrosis; and (6) his own personal
experience treating patients with jaw
necrosis who also had taken bisphosphonate
drugs. (Pls. Causation Resp. Ex. 10 at 4.)
Additionally, Dr. Kraut reviewed: (1)
plaintiff’s Fact Sheet and Supplemental
Plaintiff’s Fact Sheet; (2) the records of
North Shore Hematology Oncology
Associates, P.C.; (3) the records of Dr.
Samuel, Dr. O’Lear, and Dr. Ruggiero, as
well as the records of Dr. Laura Ferrier, Dr.
Ira Brand, and Dr. Adam Maslow; (4) the
records of North Shore Implant & Surgery
Associates; (5) the records of Long Island
Jewish Hospital; (6) the records of
Healthplex; (7) specimen slides from the
Long Island Jewish Medical Center; and (8)
records produced by plaintiff. (Pls.
Causation Resp. Ex. 10 at 5.) Dr. Kraut also
physically examined plaintiff, at which time
he “performed a soft tissue examination, as
well as a panoramic radiographic
examination of the patient.” (Id. at 7.)
The Court finds that Dr. Kraut’s
admitted lack of expertise in the
aforementioned fields does not disqualify
him from offering an opinion as to
plaintiff’s ONJ. To begin with, a review of
Dr. Kraut’s report makes clear that he is not
claiming any such expertise as the basis for
his conclusions. Second, Dr. Kraut’s
credentials show him to be a highly
experienced and qualified oral and
maxillofacial surgeon; he has completed
extensive training, held leadership positions,
run residency programs, and authored
several articles, in the oral and maxillofacial
surgery fields. He also has extensive, handson experience treating patients with forms of
jaw necrosis, including ONJ linked to oral
and
intravenous
bisphosphonates.
Additionally, Dr. Kraut has conducted his
Novartis first argues that Dr. Kraut is not
qualified to opine on bisphosphonate
causation of ONJ. (See Def. Mem. in Supp.
of Daubert Mot. to Exclude Causation
Testimony of Pls. Experts (“Def. Causation
Mem.”) at 17 (stating that “Dr. Kraut must
have the expertise both: (1) to determine that
Aredia and Zometa can cause ONJ, and (2)
to consider and rule out other ONJ risk
factors in [] Bee’s case[; h]is ability to treat
ONJ does not qualify him to opine as to its
31
Specifically, Novartis’s arguments go to
the weight, and not to the admissibility, of
Dr. Kraut’s opinion. It is true that
epidemiological studies, case studies, and
clinical trials are generally considered the
“gold standard” of medical research. In re
Rezulin Prods. Liab. Litig., No. MDL 1348,
00-CV-2843, 369 F. Supp. 2d 398, 406
(S.D.N.Y. 2005). However, as Novartis
itself acknowledges in its motion papers,
there have been limited case trials that have
produced meaningful data as to Aredia and
Zometa and their link to ONJ. As previously
highlighted, the Court has found the
question of when, and even how many,
instances of ONJ might have occurred in
these drugs’ clinical trials to be a disputed
fact in this case. Accordingly, the fact that
Dr. Kraut’s opinion is not based on case
studies is, while certainly relevant for
purposes of a cross-examination, not
sufficient for purposes of establishing his
opinion’s inadmissibility here.
own research, and maintained an active
familiarity in the research of other leading
experts, in the subject of jaw necrosis. For
these reasons, the Court finds Dr. Kraut to
be qualified to offer opinions concerning
causation (whether general or specific)
under Daubert. See Davids, 857 F. Supp. 2d
at 277 (finding Dr. Kraut to be qualified for
purposes of offering an expert opinion as to
causation for similar reasons); In re
Fosamax Prods. Liab. Litig., 688 F. Supp.
2d 259, 268 (S.D.N.Y. 2010) (finding a
doctor to be qualified under Rule 702 to
offer expert testimony because the record
showed that “[h]e has practiced dentistry for
over 30 years; he specializes in oralfacial
pain and maxillofacial radiology; he keeps
up to date with the developments in research
regarding BRONJ
and has given
presentations on the issue; he also has
practical experience in that he has treated
many patients that he believes developed
ONJ from a bisphosphonate”); cf. Harvey,
895 F. Supp. 2d at 1211 (finding that a
doctor was not qualified to testify
concerning possible ONJ causation where
doctor’s testimony showed that he had never
conducted medical or scientific research in
the field of ONJ, had never researched
bisphosphonates, and had not published
articles or otherwise hold relevant
experience concerning bisphosphonates or
ONJ).
Novartis also argues that “[a]necdotal
data such as case reports do not form a
reliable basis for a causal inference, because
case reports do not rule out confounding
factors, and, particularly as to ONJ,
[intravenous] bisphosphonates are always
prescribed to patients with comorbid ONJ
risk factors.” (Def. Causation Mem. at 19.)
It is true that “[c]ausal attribution based on
case studies should be viewed with caution.”
See In re Fosamax Prods. Liab. Litig., 645
F. Supp. 2d 164, 184 (S.D.N.Y. 2009)
(citation and internal quotation marks
omitted). However, it is also true that “such
studies may be carefully considered in light
of other information available,” id. (citation
and internal quotation marks omitted), and
that “a large number of case reports adds
greater weight to the reliability of an opinion
on causation” id. (citation and internal
quotation marks omitted); see also In re
Phenylpropanolamine (PPA) Prods. Liab.
Litig., 289 F. Supp. 2d 1230, 1242 (W.D.
Defendant next asserts that “Dr. Kraut’s
general causation opinion must be excluded
because it is not based on reliable data or a
scientifically valid methodology.” (Def.
Causation Mem. at 18.) Novartis rests this
argument on the fact that Dr. Kraut relied on
“anecdotal information,” like case reports, in
forming his opinion, and that he did not
utilize epidemiological studies. (See id. at
18–19.) The Court concludes, however, that
these arguments are insufficient to establish
the inadmissibility of Dr. Kraut’s opinion.
32
(M.D. Tenn. Dec. 7, 2010); In re Aredia and
Zometa Prods. Liab. Litig. (Eberhart), No.
3-06-MD-1760, 2010 WL 5072008, at *1–2
(M.D. Tenn. Dec. 7, 2010); In re Aredia and
Zometa Prods. Liab. Litig. (McDaniel), No.
3-06-MD-1760, 2010 WL 5071851, at *1–2
(M.D. Tenn. Dec. 7, 2010); In re Aredia and
Zometa Prods. Liab. Litig. (Kyle/Mahaney),
No. 3-06-MD-1760, 2010 WL 5071063, at
*1–2 (M.D. Tenn. Dec. 7, 2010).
Wash. 2003) (finding as “significant the
sheer volume of case reports, case series and
spontaneous reports associating PPA with
hemorrhagic stroke in women”); Rider v.
Sandoz Pharms. Corp., 295 F.3d 1194, 1202
(11th Cir. 2002) (stating, in dicta, that
reliable evidence in support of causality may
include “a very large number of case
reports”). As plaintiffs note, “[t]here have
been hundreds of published case reports of
ONJ in [intravenous] bisphosphonate
users[,] in addition to a few retrospective
studies finding a strong association.” (Pls.
Causation Resp. at 18.) In this case, the
Court finds the large number of recent
reports addressing the condition of ONJ—
almost entirely in the context of
bisphosphonate use—to be a factor
supporting the reliability of Dr. Kraut’s
opinion, and not detracting from it. Indeed,
the core of Novartis’s exclusion argument
here, while certainly relevant, is one best left
for cross-examination, where questions
concerning the accuracy or credibility of any
such case reports may serve as valuable
ammunition for countering Dr. Kraut’s
opinion, once given on the stand. They are
insufficient, however, for purposes of
establishing that Dr. Kraut’s opinion as to
causation should be deemed inadmissible
altogether.
Here, Dr. Kraut performed a differential
diagnosis for plaintiff to ultimately
determine whether Zometa caused plaintiff’s
ONJ. “A differential diagnosis is a patientspecific process of elimination that medical
practitioners use to identify the most likely
cause of a set of signs and symptoms from a
list of possible causes.” Ruggiero v. WarnerLambert Co., 424 F.3d 249, 254 (2d Cir.
2005) (citations and internal quotation
marks omitted); see also Hardyman v.
Norfolk & W. Ry. Co., 243 F.3d 255, 260
(6th Cir. 2001) (describing a differential
diagnoses as “the method by which a
physician determines what disease process
caused a patient’s symptoms[; t]he physician
considers all relevant potential causes of the
symptoms and then eliminates alternative
causes based on a physical examination,
clinical tests, and a thorough case history”
(alteration, citation, and internal quotation
marks omitted)). Generally, courts have held
that “[a] medical expert’s opinion based
upon differential diagnosis normally should
not be excluded because the expert has
failed to rule out every possible alternative
cause of a plaintiff’s illness.” Davids, 857 F.
Supp. 2d at 278 (quoting Cooper v. Smith &
Nephew, Inc., 259 F.3d 194, 202 (4th Cir.
2001)). That being said, while “an expert
need not rule out every potential cause in
order to satisfy Daubert, the expert’s
testimony must at least address obvious
alternative causes and provide a reasonable
explanation for dismissing specific alternate
factors identified by the defendant.” Deutsch
Regarding defendant’s argument that Dr.
Kraut relied on a scientifically invalid
methodology in reaching his conclusions,
(see Def. Causation Mem. at 18–19), the
Court notes that this is not a novel question.
The MDL Court has issued orders in
multiple other Aredia/Zometa cases, finding
that both Dr. Kraut’s qualifications and his
methodology
satisfy
the
Daubert
requirements for a specific causation expert
on the precise issue of whether a plaintiff’s
use of Aredia or Zometa caused his or her
ONJ. See In re Aredia and Zometa Prods.
Liab. Litig. (Baldwin/Winter), No. 3-06MD-1760, 2010 WL 5139444, at *1–2
33
that Bee “has not had chemotherapy nor
radiation therapy,” that Bee “had both
maxillary and mandibular exposed bone,”
and that he “did not go on to develop classic
symptoms of osteomyelitis at either of those
two sites.” (Id.) Dr. Kraut also considered
plaintiff’s course of medical treatment,
which he details in the report, as well as
plaintiff’s drug history and clinical course
following his teeth extractions in October
and November of 2003. (Id. at 6.) Dr. Kraut
nowhere dismisses as irrelevant the fact that
plaintiff previously took Fosamax, that he
had teeth extractions performed, or that he
was diagnosed with ankylosing spondylitis.
Regarding the latter point, Dr. Kraut
acknowledges plaintiff’s condition (see id.
(“Mr. Bee’s underlying medical problem of
ankylosing spondylitis requires that he be
maintained on large doses of Oxycontin and
other pain medications.”), and he notes that
“[i]t is remarkable that with the background
of Oxycontin in his system that he would
still report jaw pain” (id.; see also id. (“It
should be noted that during the course of his
bisphosphonate related jaw necrosis, the
patient reported jaw pain, which is
significant in view of the fact that he was
taking Oxycontin in significant dosage to
deal with his ankylosing spondylitis.”)).
Based on all of these considerations, Dr.
Kraut arrived at his ultimate conclusion that
plaintiff developed “bisphosphonate related
jaw necrosis.” (Id.) This methodology is
sufficient to satisfy Daubert.
v. Novartis Pharm. Corp., 768 F. Supp. 2d
420, 474 (E.D.N.Y. 2011) (quoting Israel v.
Spring Indus., Inc., 98-CV-5106, 2006 WL
3196956, at *5 (E.D.N.Y. Nov. 3, 2006)).
Defendant’s arguments against Dr.
Kraut’s differential diagnosis methodology
are as follows: he (1) was not reliable, (2)
failed to consider (i) factors like
“bisphosphonates,
osteomyelitis,
malignancy, oral pathology, chemical
trauma, physical trauma, corticosteroids and
osteoporosis,” (Def. Causation Mem. at 20),
or (ii) that “there are many conditions that
may cause exposed necrotic bone in
bisphosphonate patients” (id.), and (3) did
not “scientifically consider and rule out
critical facts in [] Bee’s history regarding
other possible causes of his ONJ,” like Bee’s
taking of Fosamax (id.). The Court,
however, again concludes in this case that
these issues go to the weight of his
testimony, not its admissibility.
A review of Dr. Kraut’s expert report
shows that Dr. Kraut, after his own
independent research, review of pertinent
research
concerning
ONJ
and
bisphosphonates, a review of plaintiff’s
medical history, and his own examination of
plaintiff (including a soft tissue examination
and a panoramic radiographic examination),
specifically “considered the possibility of
other etiologic factors” when assessing the
possible cause of plaintiff’s condition. (Pls.
Causation Resp. Ex. 10, at 7.) In particular,
Dr. Kraut expressly states that he recognized
the potential effect of Fosamax on plaintiff’s
condition. (See id. (stating that Dr. Kraut
“considered the relative potency and
exposure to Fosamax” that Bee underwent,
as well as his “aware[ness] that Zometa is
10,000 times as potent as Fosamax with a
potency of 500”).) Further, Dr. Kraut
examined “critical facts” in plaintiff’s
history that could have impacted Bee’s
development of ONJ; he specifically notes
As noted above, to the extent Novartis
argues that Dr. Kraut failed to adequately
rule out other factors, or that his diagnoses
at this point regarding bisphosphonatetreated patients who have developed ONJ
are but a “foregone conclusion” (see Def.
Causation Mem. at 21; see also id. at 20
(“Dr.
Kraut
has
diagnosed
every
bisphosphonate patient who has presented
with ONJ with bisphosphonate-related
ONJ . . . and never attributed cause to
34
has concluded that at least Dr. Kraut’s
testimony is admissible as to the question of
causation. It thus proceeds to Novartis’s
next argument, which challenges whether
plaintiffs can show that Aredia and/or
Zometa were a substantial factor in Bee’s
development of ONJ.
anything else”)), these are all points that go
to the weight, and not to the admissibility, of
Dr. Kraut’s opinion. Defendant is free to
highlight any such flaws or weaknesses in
Dr. Kraut’s opinion on cross-examination,
but these are not sufficient grounds upon
which to reject Dr. Kraut’s opinion under
Daubert.
Novartis asserts that in order for a
plaintiff to successfully establish a
negligence claim, the plaintiff must show
that “defendant[’s] conduct was a substantial
causative factor in the sequence of events
that led to [plaintiff’s] injury.” Nallan v.
Helmsley-Spear, Inc., 50 N.Y.2d 507, 520
(1980); see also Galioto v. Lakeside Hosp.,
506 N.Y.S.2d 725, 726 (N.Y. App. Div.
1986). Because “[p]laintiffs cannot show
that Aredia and Zometa were a substantial
factor in [] Bee’s jaw condition,” defendant
contends that summary judgment should be
granted in its favor. (Def. Summ. J. Mot. at
21.) The Court, upon reviewing the evidence
in the record, concludes that there is
sufficient evidence from which a rational
jury would find that Novartis’s drugs were a
substantial causative factor in Bee’s
development of ONJ. Specifically, plaintiffs
offer their expert, Dr. Kraut (along with the
testimony of their other non-retained
experts, Drs. Arcati, Ruggiero, and O’Lear).
Dr. Kraut’s expert report raises a genuine
issue of material fact as to whether Aredia
and/or Zometa were a substantial factor in
plaintiff’s development of ONJ. Although
Novartis asserts otherwise, contending that
Dr. Kraut failed to conduct a valid
differential diagnosis to consider the impact
of plaintiff’s other risk factors on the
development of his ONJ, thereby making it
impossible to establish that Aredia and/or
Zometa could have been a substantial factor
in plaintiff’s jaw condition, a rational jury
could credit Dr. Kraut’s testimony. As
detailed supra, review of Dr. Kraut’s expert
report suggests that he did, in fact, examine
other potential factors when drawing his
For these reasons, the Court denies
Novartis’s Daubert motion to exclude the
specific causation testimony of Dr. Kraut.
3. Plaintiff’s Treating Physicians’
Testimony (Drs. Arcati, Lear, and
Ruggiero)
Defendant also challenges the opinions
of plaintiffs’ non-retained experts (who also
served as Bee’s treating physicians) on the
issue of specific causation. These nonretained experts include Drs. Arcati, O’Lear,
and Ruggiero. Because the Court has
already determined that Dr. Kraut’s
testimony is admissible for purposes of
assessing causation, it is clear that plaintiffs
have evidence directly addressing the
question of causation that is sufficient to
preclude summary judgment on that issue
(as discussed below). Accordingly, the
Court will defer ruling on Novartis’s
Daubert challenges to plaintiffs’ remaining,
non-retained experts at this time.
4. Whether Aredia and/or Zometa
Substantially Caused Plaintiff’s ONJ
Novartis argues that plaintiffs’ claims
fail because they cannot establish a required
element of all their claims: specific
causation. See Heckstall v. Pincus, 797
N.Y.S.2d 445, 447 (N.Y. App. Div. 2005).
As previously set forth, defendant’s first
argument is that plaintiffs do not carry their
evidentiary burden as to specific causation
on summary judgment because plaintiffs’
proffered expert opinions are inadmissible
under Daubert. However, the Court already
35
must render those other causes sufficiently
remote or technical” such that the logical
inference that may be drawn from the
evidence is that “it was ‘more likely’ or
‘more reasonable’ that the alleged injury
was caused by the defendant’s negligence.”
Gayle v. City of New York, 92 N.Y.2d 936,
937 (1998) (citations and internal quotation
marks omitted). The Court concludes that
plaintiff’s evidence, including Dr. Kraut’s
expert report, creates a genuine issue of
material fact as to whether Aredia and/or
Zometa were the “most likely” or “more
reasonable” causes of plaintiff’s jaw
necrosis. Indeed, it is well-settled that
“[w]here a defendant raises alternative
causes to avoid liability for a product’s
failure,” a plaintiff may successfully counter
this by “rais[ing] a triable question of fact
[via] . . . competent evidence which, if
credited by the jury, is sufficient to rebut
defendant’s alternative cause evidence.”
Steinman v. Spinal Concepts, Inc., No. 05CV-774S, 2011 WL 4442836, at *7
(W.D.N.Y. Sept. 22, 2011) (citations and
internal quotation marks omitted). Plaintiffs
have done just that, and a rational jury could
credit such evidence. The role that other
factors may have played in Bee’s ONJ
development is, at this juncture, a matter
inappropriate for summary judgment. Thus,
the Court must step aside to allow the jury to
perform its appropriate role, which at this
point, will require a probing of the facts and
a weighing of the expert’s credibility to
determine whether Novartis’s drugs were a
substantial factor in plaintiff’s subsequent
ONJ development. For these reasons, the
Court denies Novartis’s motion for summary
judgment as to specific causation.
conclusions
that
plaintiff’s
ONJ
development
was
attributable
to
bisphosphonates.
Indeed,
Dr.
Kraut
explicitly states in his report that he
“considered the possibility of other etiologic
factors” (Pls. Causation Resp. Ex. 10, at 7),
that he was aware of the potential effect of
Fosamax on plaintiff’s condition (id.), and
that he took into account other “critical
facts” in plaintiff’s medical history that
could have impacted his development of
ONJ, including the fact that Bee had not had
chemotherapy or radiation treatment (id.),
and that he had been diagnosed with
ankylosing spondylitis (id. at 6). Even after
considering all such factors, Dr. Kraut
concluded that, based on plaintiff’s drug
history (with Aredia and Zometa), as well as
Bee’s clinical course following his teeth
extractions, his jaw necrosis was
bisphosphonate related. (See Pls. Causation
Resp. Ex. 10 at 6.)
Moreover, the fact that Dr. Kraut did not
expressly rule these other factors out does
not mean his opinion would not be credited
by the jury and relied upon to rationally find
specific causation. Although Novartis argues
otherwise, asserting that Dr. Kraut’s report
is not sufficient evidence upon which
plaintiffs can rely to establish specific
causation because he did not “eliminate
[plaintiff’s] other risk factors, such as
Fosamax and ankylosing spondylitis” when
conducting his differential diagnosis (Def.
Summ. J. Mot. at 21 (emphasis added)), the
law is not so rigid. As the case law to which
Novartis cites makes clear, while a plaintiff
must show that a defendant’s alleged
negligence was a substantial causal factor in
bringing about a plaintiff’s claimed injury, it
“need not be the sole cause of the injury.”
Galioto, 506 N.Y.S.2d at 726 (emphasis
added). That is, where a case concerns other
potential causes of an alleged harm, a
plaintiff “need not positively exclude every
other possible cause”; however, “the proof
C. Implied Warranty
As Novartis acknowledges, plaintiffs’
implied warranty claim is also based on an
alleged failure to warn and its corresponding
evidence. (See Def. Summ. J. Mot. at 23–24
36
V. CONCLUSION
(“Bee’s claims for breach of warranty are
subsumed under his failure to warn
claim . . . . Therefore, plaintiffs must rely on
the same evidence and allegations for their
breach of implied warranty claim as they do
for their tort claims, and, thus, is subject to
the same analysis as those claims.”).) For
the same reasons that the Court denies
summary judgment as to plaintiffs’ strict
liability and negligent failure to warn
claims, the Court concludes that there are
genuine issues of material fact precluding
summary judgment on plaintiffs’ breach of
implied warranty claim. It therefore denies
Novartis’s motion for summary judgment as
to plaintiffs’ implied warranty claim.
For the reasons set forth herein, the
Court denies Novartis’s motion for summary
judgment in its entirety, and denies
Novartis’s Daubert motion to exclude the
specific causation testimony of Dr. Kraut.
SO ORDERED.
______________________
JOSEPH F. BIANCO
United States District Judge
D. Loss of Consortium
Dated: May 9, 2014
Central Islip, New York
D. Bee’s loss of consortium claim is
derivative of, and dependent upon,
plaintiffs’ other claims. See Smith v. Herman
Miller, Inc., 03-CV-5358, 2005 WL
3501883, at *3 (E.D.N.Y. Dec. 21, 2005)
(“A loss of consortium claim is a derivative
claim”). Accordingly, the Court denies
defendant’s motion for summary judgment
on this claim. See In re Aredia & Zometa
Prods. Liab. Litig. (Deutsch), No. 3:07-Md1760, 2009 WL 2496891, at *4 (M.D. Tenn.
Aug. 13, 2009) (denying summary judgment
on loss of consortium claim on the grounds
that it derived from plaintiff’s other claims,
for which court also had denied summary
judgment).
***
Plaintiffs are represented by John Julian
Vecchione of Valad and Vecchione, 3863
Plaza Drive, Fairfax, VA 22030. Defendant
is represented by Robert E. Johnston,
Donald McMinn, and James Sullivan of
Hollingsworth LLP, 1350 I St. NW,
Washington, D.C. 20005 and David
Richman of Rivkin Radler LLP 926 RXR
Plaza, Uniondale, NY 11556.
37
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