Tersigni v. Wyeth et al
Filing
72
Judge Richard G. Stearns: MEMORANDUM & ORDER entered denying 37 Motion for Summary Judgment. (RGS, law1)
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
CIVIL ACTION NO. 11-10466-RGS
MICHAEL J. TERSIGNI
v.
WYETH-AYERST PHARMACEUTICALS, INC., et al.
MEMORANDUM AND ORDER
ON DEFENDANT’S MOTION FOR SUMMARY JUDGMENT
December 13, 2013
STEARNS, D.J.
Plaintiff Michael Tersigni brought this action against Wyeth-Ayerst
Pharmeceuticals, Inc. (Wyeth) on March 17, 2011, alleging that he contracted
Primary Pulmonary Hypertension1 (PPH) from ingesting Wyeth’s proprietary
drug Pondimin2 in 1997. In a Second Amended Complaint (SAC), Tersigni
asserts claims of Breach of Warranty - defective design (Count I), Breach of
Warranty - failure to warn (Count II), Negligence or Products Liability (Count
III), Fraudulent Misrepresentation (Count IV), and Fraudulent Concealment
(Count V). Wyeth, invoking the “learned intermediary” doctrine, now moves
1
PPH is also known as Pulmonary Arterial Hypertension (PAH).
2
Pondimin is a trade name for the drug fenfluramine.
for summary judgment, contesting Tersigni’s ability to prove causation.3
TRAVEL OF THE CASE
Tersigni’s is one of a myriad of “diet drug” cases spawned by an antiobesity medication known as “Fen-Phen,” a combination of the drugs
fenfluramine and phentermine.
The medication operates to enhance a
patient’s levels of serotonin, thereby engendering a sensation of fullness and
a resulting loss of appetite. Wyeth, the U.S. manufacturer and distributer of
Pondimin, withdrew Pondimin from the market on September 15, 1997
(together with dexfenfluramine, a similarly acting drug branded as “Redux”),
in response to a Food and Drug Administration (FDA) advisory.
The
thousands of Fen-Phen lawsuits blame the drug combination for a host of
illnesses, including cardiac valvulopathy, pulmonary hypertension, and
neurotoxicity.
The federal Fen-Phen cases were consolidated and transferred by the
Judicial Panel on Multidistrict Litigation (MDL) to Judge Louis Bechtle in the
Eastern District of Pennsylvania, pursuant to 28 U.S.C. § 1407, for pretrial
3
Wyeth disputes that Tersigni’s PPH was caused by Pondimin, but this
cause-in-fact argument is not the focus of this motion for summary judgment.
Wyeth also moves to exclude the testimony of Tersigni’s expert economist, Dr.
Cheryl Blume. The admissibility of her testimony also has no bearing on the
outcome of this motion.
2
management (MDL 1203). A majority of the Fen-Phen cases were resolved
by Judge Bechtle pursuant to a nationwide class settlement. Pretrial Order
No. 1415 (PTO 1415). See In re Diet Drugs, MDL 1203, 2000 WL 1222042
(E.D. Pa. Aug. 28, 2000). The settlement included “all persons in the United
States who ingested Pondimin and Redux,” and while excluding claims based
on PPH, it “fully preserved” the right of persons who might develop symptoms
of PPH to bring suit. Id. at *19 and *31.
After being filed in 2011 in Massachusetts, Tersigni’s case was
transferred to the MDL 1203 docket for pretrial discovery. In December of
2012, the case was remanded to this court with the notation that all discovery
(except that of the economic experts) was complete. After an unsuccessful
effort at mediation, Wyeth moved for summary judgment on August 29, 2013.
The court heard oral argument on November 22, 2013.
FACTUAL BACKGROUND
Fen-Phen Diet Drugs
The idea of using “Fen-Phen” as a treatment for obesity originated in a
controversial study published in 1992 by Dr. Michael Weintraub, a University
of Rochester pharmacologist (and later a senior official at the FDA).
According to the Weintraub study, Fen-Phen had been shown to be
significantly more effective than dieting or exercise in treating chronic obesity.
3
Fen-Phen combined fenfluramine, which causes drowsiness, with
phentermine, a mild stimulant, for its countervailing effect. After the
Weintraub study was widely publicized in 1995, sales of Pondimin
skyrocketed. From January of 1995 to mid-September of 1997, some 4 million
persons in the U.S. took Pondimin, while another 2 million took Redux.
Prior to being marketed, Fen-Phen did not undergo safety testing. On
August 28, 1997, Dr. Heidi Connelly, a Mayo Clinic researcher, published an
article in the New England Journal of Medicine, reporting an abnormal
incidence of valvular heart disease among women taking Fen-Phen.4 After
receiving a number of additional reports of cases of heart-valve disease among
Fen-Phen users, on September 15, 1997, the FDA requested the voluntary
withdrawal of Pondimin and Redux from the market.5 Wyeth immediately
complied.
4
Prior to the Mayo study, there had been reports of an increased
incidence of PPH among Fen-Phen takers, including an International Primary
Pulmonary Hypertension Study that was published on August 29, 1996, in the
New England Journal of Medicine. The study concluded that patients who had
taken fenfluramine for longer than three months had a twenty-three fold risk
of developing PPH. PTO 1415, at *17. A study published in 2000 in the
journal CHEST confirmed this association. Id.
5
After a July 8, 1997 press release gave a preliminary account of the
Mayo results, the FDA issued a public health advisory regarding Fen-Phen,
followed by letters to 700,000 physicians soliciting information about patients
taking Fen-Phen.
4
Primary Pulmonary Hypertension (PPH)
As described by Judge Bechtle, a diagnosis of PPH is “a virtual death
sentence.” More specifically, he wrote:
PPH is a disease that affects pulmonary circulation. PPH is
characterized by scarring and fibrosis of the pulmonary
arteries which carry deoxygenated blood from the right side
of the heart to the lungs. This scarring prevents blood cells
from effectively absorbing oxygen as they pass the alveoli in
the lungs. . . . Ultimately, this dilation and hypertrophy of the
right ventricle will cause the heart to fail and result in the
patient’s death. . . . PPH is a relentlessly progressive disease
that leads to death in virtually all circumstances.
PTO 1415, at *16.
Judge Bechtle also noted that PPH is a “diagnosis of exclusion.” This
means that other “secondary” causes of pulmonary hypertension must be ruled
out in order to reach a diagnosis of PPH. Some of these other causes are
diseases known to be associated with pulmonary hypertension, including
“significant obstructive sleep apnea.” PTO 1415, at *17.
Tersigni’s Ingestion of Pondimin
On February 4, 1997, Tersigni presented to Dr. Kent E. Sharian, a
Connecticut-based physiatrist. Dr. Sharian diagnosed Tersigni with extreme
obesity with a BMI over 30 and with other “comorbidities,” including
hypertension, high cholesterol, and high triglycerides. Dr. Sharian prescribed
Tersigni 20 mg doses of Pondimin for six months, from February 4, 1997,
5
through July 16, 1997. Tersigni had no direct communications with Wyeth.
Rather, Tersigni relied on Dr. Sharian’s recommendation,6 as well as the
endorsement of a personal friend, in deciding to take Pondimin.
Tersigni stopped taking Pondimin in July of 1997 after Dr. Sharian
discontinued his prescriptions in response to medical warnings about the side
effects of fenfluramine.7 Prior to beginning the Pondimin regime, Tersigni had
signed a consent form provided by Dr. Sharian. The consent form listed
pulmonary hypertension as a possible side effect, but did not mention
“primary pulmonary hypertension.”
As of February 2011, Tersigni has been diagnosed with PPH with a poor
and limited prognosis. Dr. Richard Channick, Tersigni’s treating physician,
is of the opinion that Tersigni’s PPH is attributable to his ingestion of
Pondimin. Tersigni has been prescribed medication (Tracleer) to treat his
PPH since February of 2012. He has been advised by Dr. Channick that the
disease may make it impossible for him to continue working.
Tersigni’s Claims Against Wyeth
6
drug.”
Tersigni alleges that Dr. Sharian described Fen-Phen as a “wonder-
7
Between February and July of 1997, Tersigni’s weight decreased from
264 lbs to 236.5 lbs. After discontinuing Fen-Phen, Tersigni regained all of the
lost weight.
6
Tersigni alleges that Wyeth failed to adequately warn Dr. Sharian about
the dangerous side effects of Pondimin. Tersigni further alleges that the
labeling of Pondimin was inadequate, and that Wyeth concealed vital safety
information from Dr. Sharian and the FDA. Specifically, the Complaint alleges
that “[b]etween 1989 and 1996, Defendants misrepresented in the Pondimin
labeling that only four (4) cases of Pulmonary Hypertensions (PH) had been
reported in association with fenfluramine use, including only one fatality,
despite Defendants’ ongoing receipt of ever-increasing numbers of pulmonary
hypertension reports (over 100) and fatalities.”8 Moreover, according to the
Complaint, despite its awareness of the dangers of pulmonary hypertension,
Wyeth did nothing to revise the Pondimin warning label between 1990 and
1996.
Tersigni also alleges that the database of Wyeth’s Clinical Drug Safety
Surveillance System (CDSSS) contained reports of Adverse Drug Events
(ADE’s) that Wyeth failed (or delayed) to report to the FDA in a deliberate
effort to mislead the FDA and treating physicians.
More specifically, the Complaint alleges that the report for Pondimin
submitted by Wyeth to the FDA in June of 1992 disclosed zero reports of
8
SAC ¶ 60.
7
pulmonary hypertension among Pondimin patients for the period ending May
1992, while the CDSSS had recorded at least nine cases. Wyeth’s August of
1996 report disclosed four instances of pulmonary hypertension for the period
ending May 1996, while the CDSSS had compiled thirteen cases during the
same period.9
Wyeth knew by June of 1994 of a cumulative total of 41 cases of
pulmonary hypertension associated with Pondimin, but did not revise the
Pondimin label, which listed only four such cases. By the end of 1996, Wyeth
was aware of over 90 cases of pulmonary hypertension associated with
Pondimin, and of at least 132 associated with Redux worldwide. By the end of
1996, Wyeth knew of twelve deaths from Pondimin-associated pulmonary
hypertension, and of twenty-five deaths worldwide associated with Redux.
Notwithstanding, the 1996 entry on Pondimin submitted by Wyeth to the
Physician’s Desk Reference (PDR) continued to falsely state that there had
been only four related pulmonary hypertension occurrences and only one
fatality.
On June 20, 1996, Wyeth revised the Pondimin label to contain a
warnings section that read: “Primary Pulmonary Hypertension: A two-year,
9
SAC ¶ 69.
8
international (five country), case control (epidemiological) study identified 95
PPH cases; 20 of these had been exposed to anorexigens in the past and 9 of
the 20 had been exposed to anorexigens for longer than three months. In this
study, the use of anorexignes for longer than three months was associated with
an increase in the risk of developing PPH.” In November of 1996, Wyeth
updated its label stating that “PPH is a serious condition; the four year survival
rate is reported to be 55%.”
Deposition Testimony of Dr. Sharian
Dr. Sharian testified that the 1992 Weintraub study had given him the
medical confidence to prescribe Fen-Phen for his patients. Dr. Sharian stated
that Weintraub was the “primary source that I relied on” and that “there may
have been other publications, but I don’t recall those.”10 After reading
Weintraub, he “felt very confident that this combination [Fen-Phen] was safe
and effective. And after a four year study by this prestigious medical center, I
felt secure in prescribing it.”11 He also stated that after he began prescribing
Fen-Phen, he “didn’t come across . . . any of those studies” that showed the
Weintraub study to be clinically flawed.12
10
Sharian Dep. 50:2-4.
11
Id. at 269:2-5.
12
Id. at 269:11-12.
9
When asked about the 1996 PDR entry regarding Pondimin, Dr. Sharian
testified that he recalled that it did not mention PPH, although it did warn of
less serious “pulmonary hypertension.” When asked about the risks of
pulmonary hypertension, Dr. Sharian answered “well, according to
Weintraub’s studies, there weren’t any major side effects, so I wasn’t very
much concerned.”13 He emphasized that “there wasn’t much concern,” in his
view, “because they did this long-term study, placebo, and they didn’t report
any major side effects . . . and most of the side effects that they recorded were
transient, they reversed themselves. . . . I didn’t see any life-threatening
complications from the Weintraub study.”14
Dr. Sharian was repeatedly asked about his “custom and practice” in
reviewing relevant medical literature and labels. Dr. Sharian testified that his
practice was to read the PDR quarterly updates for the medications that he
regularly prescribed and that he would have done so for Pondimin.15 He also
testified that it was his custom and practice to read all “dear doctor” letters
received
from
pharmaceutical
manufacturers
13
Id. at 285:9-11.
14
Id. at 285:17-24.
15
Id. at 66:1 - 67:4 and 92:11-24.
10
discussing
familiar
medications.16
Dr. Sharian testified that it also was his practice to weigh the risks and
benefits of a medication before prescribing it for a patient. He stated that he
considered whether “the advantages of prescribing the medication and
avoiding the comorbidities of the future will warrant [his] prescribing it in
spite of the potential side effects. In other words, the benefits should exceed
the potential side effects.”17 When shown the PDR entries, labeling, and “dear
doctor” letters discussing Pondimin that were published in 1996 and 1997, Dr.
Sharian testified that he had no specific memory of what he did or did not
receive or look at, including the June 1996 revision of the Pondimin label,
although it would have been his practice to review the label in conducting his
risk/benefit analysis. He did remember that upon leaning of the growing
interest in 1995 and 1996 of Pondimin as an effective treatment for obesity, he
went back and studied the label to remind himself about the drug.
Dr. Sharian was shown a “dear doctor” letter from Wyeth, dated August
of 1996. He answered “I probably did,” in response to a question about
whether he considered the letter before he prescribed Pondimin to Tersigni,
16
Id. at 106:2-7.
17
Id. at 67:22 - 68:3.
11
but he also said that he could not be certain. Regarding a January 1997 “dear
doctor” letter sent by Wyeth, Dr. Sharian agreed (after reading it at the
deposition) that the letter conveyed a warning that Pondimin carried a risk of
PPH, although he did not specifically recall having received it.18 In response
to the question “do you have any reason to believe that you did not receive the
Dear Doctor letter?” Dr. Sharian responded “I don’t know. That I can’t
recall.”19 Later, after being shown a Wyeth mailing list that contained his
name and address, he responded: “Yes, if it says so, I must have received it,
yes.”20
In a separate line of questioning, Dr. Sharian stated that he was not
aware in early 1997 of concerns about the dangers of Fen-Phen, nor was he
aware of a warning that the combination had not been “systematically
evaluated in large, multi-center placebo-controlled trials.”21 He stated that his
first concrete knowledge of serious safety concerns about Fen-Phen was
acquired from publicity surrounding the July 1997 warnings. He testified that
18
19
Id. at 109:12-23.
Id. at 110:15.
20
Id. at 113:16-17. The letter was addressed to Dr. Sharian’s business
address at 55 Whiting Street, Plainville, CT.
21
Id. at 307:18 - 308:5.
12
“knowing what I know now with the benefit of hindsight, I probably [would]
not choose the Fen-Phen combination.”22 He said that he had stopped
prescribing Pondimin in July of 1997 “because it was withdrawn from the
market, or there were those big warnings.”23 He further stated that “I told
[my patients] about too much risk of valvulopathy and pulmonary
hypertension and the warnings. I told them that I’m not going to prescribe
that anymore.”24
ANALYSIS
“Under Massachusetts law, a product may be unreasonably dangerous
if the manufacturer fails to warn of a non-obvious risk associated with the
normal use of the product about which the manufacturer knows or has reason
to know.” Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir. 1992). In the
ordinary course, the manufacturer of a product that is dangerous in nature or
is in a dangerous condition has a duty to warn consumers or others who will
foreseeably come in contact with the product. H.P. Hood & Sons v. Ford
Motor Co., 370 Mass. 69, 75 (1976). The “learned intermediary” doctrine
carves out a “middleman” exception that has a particular relevance to
22
Id. at 303:5-7.
23
Id. at 209:18-19 (emphasis added).
24
Id. at 211:10-13.
13
pharmaceutical drugs: it permits a drug manufacturer to discharge its duty to
warn the consumer by instead providing appropriate warnings to the
prescribing physician. See MacDonald v. Ortho Pharm. Corp., 394 Mass. 131,
135 (1985). The justification for the doctrine is that “the prescribing physician,
as the ‘learned intermediary’ standing between the manufacturer and the
consumer/patient, is generally in the best position to evaluate the potential
risks and benefits of ingesting a certain drug and to advise the patient
accordingly.” Garside, 976 F. 2d at 80. The immunity conferred by the
doctrine is, however, limited: when the manufacturer breaches the duty to
warn the doctor, it is directly liable to the patient. MacDonald, 394 Mass. at
136.
Massachusetts courts apply a burden-shifting test (summarized in
Garside) in determining whether a plaintiff can establish the elements of a
prima facie case of a failure to warn despite the interposition of a learned
intermediary: (1) the plaintiff must initially produce evidence raising a triable
issue of fact as to whether the manufacturer failed to warn of a non-obvious
risk about which it knew (or should have known); (2) if the plaintiff satisfies
this burden, a rebuttable presumption arises that the failure to warn was a
proximate cause of the plaintiff’s consumption of the drug (that is, that the
prescribing physician would have heeded an adequate warning); (3) the
14
manufacturer may then come forward with evidence rebutting the
presumption (that is, that the prescribing physician continued to prescribe the
drug to other patients despite the warning); (4) in which case, “the plaintiff
must produce sufficient evidence to create a triable issue on the question of
causation.” Id. at 81 (citing MacDonald, 394 Mass. at 135 and Restatement
(Second) of Torts § 402A cmt. j (1965)).
In satisfaction of his burden under Garside, Tersigni relies principally
on evidence of Wyeth’s failure to adequately and timely warn about the extent
of the risk of PPH (and to a lesser degree of Valvular Heart Disease (VHD)).
Tersigni contends that Wyeth’s labeling of Pondimin to warn of the risk of
PPH was belated and that it understated the extent of Wyeth’s knowledge of
the association between Pondimin use and PPH. Tersigni notes that Wyeth
failed to include the words “primary pulmonary hypertension” on the
Pondimin label, as it appeared in the PDR, until November of 1996, well after
the risks of PPH were known to Wyeth. A full warning of the risks of PPH
appeared only in September of 1997, after the drug had been withdrawn from
the market. While not contesting the applicability of the learned intermediary
doctrine, Tersigni relies on the deposition testimony of Dr. Sharian that he had
no reason, based on the information he had been supplied, to believe that
Pondimin posed a fatal risk of contracting PPH, and that given the publicity
15
surrounding the Weintraub study, he was convinced that Pondimin in a FenPhen dosage had no “major side effects.”
Wyeth’s main contention, which also relies on Dr. Sharian’s testimony,
is that Tersigni “cannot show that a different or additional warning would have
changed the outcome because the prescribing physician was already aware of
an association between Pondimin and a risk of PAH [PPH] when he prescribed
the medication to plaintiff.” Wyeth Mem. at 7. More specifically, Wyeth
contends that “Dr. Sharian already knew of the PPH risk between February
and July 1997, when he prescribed Pondimin to Mr. Tersigni, but prescribed
the drug anyway because of the potential benefit of treating Mr. Tersigni’s
obesity.” Wyeth Reply at 4.
While Wyeth maintains that on this point the evidence is “undisputed,”
that seems something of an overstatement, particularly given Dr. Sharian’s
testimony that “knowing what I know now with the benefit of hindsight, I
probably [would] not choose the Fen-Phen combination.”25 Moreover, Dr.
Sharian’s repeated statements that he had relied implicitly on Weintraub –
e.g., “I didn’t see any life-threatening complications from the Weintraub
25
Sharian Dep. 303:5-7.
16
study”26 – raises a reasonable inference in light of his customary practice of
reviewing letters and other information provided about the drugs he was
prescribing, that he had received no warning from Wyeth that the Weintraub
study was flawed, or that if he did receive a warning, it was insufficient to
disabuse him of his belief to the contrary.27
In sum, while Dr. Sharian’s testimony is ambiguous in some respects, it
is sufficient, when considered with evidence that Wyeth suppressed
information about the extent of the Pondimin ADE’s that it had compiled, to
make out a prima facie case of a failure to warn about the risks of PPH.28
26
Id. at 302:5-7.
27
There is evidence in the record that Wyeth arguably resisted the
placement of a black box label on Pondimin. Dr. Sharian referred to “big
warnings” (specifically the publicity generated by the Mayo study in July of
1997) as a decisive factor in his decision to stop prescribing Pondimin.
28
Given this conclusion, the court will only briefly comment on Wyeth’s
second argument on summary judgment, which is directed to the conceded
absence of warnings of the risk of VHD. While recognizing that the learned
intermediary defense does not apply with regard to VHD, Wyeth argues that
Tersigni cannot make out causation where there is no evidence that he in fact
suffers from VHD. For this proposition, Wyeth relies on a Pennsylvania
Superior Court decision, Cochran v. Wyeth, 3 A.3d 673, 681 (2010), which
held that the plaintiff in that case could not “prove proximate causation
because the non-disclosed risk did not materialize in physical injury.”
Cochran, of course, is not binding on this court and is directly contradicted by
a Massachusetts district court case, Sanderson v. Upjohn Co., 578 F. Supp.
338, 339 (D. Mass. 1984). Sanderson held that the nature of a plaintiff’s
illness, while relevant to damages, is “not dispositive on the issue of the
adequacy of [a defendant’s] warning.” While again, this court is not bound by
17
ORDER
For the foregoing reasons, Wyeth’s motion for summary judgment is
DENIED.
SO ORDERED.
/s/ Richard G. Stearns
UNITED STATES DISTRICT JUDGE
the decision of another of its sessions, it deems Sanderson to be the stronger
of the two opinions. Cochran relies for its holding on the law of informed
consent, which presumes an objective actor, while Sanderson more correctly
recognizes that the learned intermediary doctrine calls for a subjective inquiry
as to what the prescribing physician would have done had he been supplied
with a full and effective warning. The court notes Dr. Sharian’s testimony in
this regard that an additional warning about a second potentially fatal disease
would have influenced his decision not to prescribe Pondimin. See Sharian
Dep. 211:10-13.
18
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