Rutz v. Novartis Pharmaceuticals Corporation

Filing 127

ORDER denying 86 Motion for Summary Judgment. Signed by Judge Michael J. Reagan on 12/17/12. (caa)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF ILLINOIS
CHRISTOPHER RUTZ,
Plaintiff,
vs.
Case No. 12-CV-0026-MJR
NOVARTIS PHARMACEUTICALS CORP.,
Defendant.

MEMORANDUM AND ORDER
REAGAN, District Judge:
I.

Introduction
Plaintiff Christopher Rutz 1 brings this strict liability action against Defendant

Novartis Pharmaceuticals Corporation (NPC), alleging that Carolyn Rutz (Rutz), developed
osteonecrosis of the jaw (ONJ) as a result of Zometa infusions prescribed by her oncologist to
treat her breast cancer and to prevent the effects of skeletal-related events. 2 Pursuant to Rule
56(c) of the Federal Rules of Civil Procedure, NPC moves the Court to grant summary judgment
on all claims (Doc. 86). NPC contends that: (1) Plaintiff has no admissible evidence that Rutz
developed the injury alleged in this case – bisphosphonate-related osteonecrosis of the jaw
(BRONJ); (2) Plaintiff has no evidence that NPC’s warnings were inadequate; (3) even if
Plaintiff could prove that NPC’s warnings were inadequate, he has no evidence that a different
warning would have changed the outcome of Rutz’s alleged injuries.

1

Christopher Rutz was substituted as Plaintiff in this litigation upon the death of his mother, Carolyn
Rutz.
2
Manufactured and sold by NPC, Zometa was approved by the FDA in 2001 and remains on the market
today as an FDA-approved drug with FDA-approved labeling.

1

Plaintiff responds that NPC’s motion should be denied because a jury could find
that Zometa caused Rutz’s injury based on Plaintiff’s competent medical evidence of causation.
Plaintiff states that Dr. Alan Schwimmer and Dr. Michael Hesterberg, oral and maxillofacial
surgeons, testified that Zometa caused Rutz’s ONJ. Plaintiff submits that he can show that
Zometa’s warning was inadequate and that an adequate warning about BRONJ could have
changed the outcome of Rutz’s injuries. Plaintiff contends that he can prove that Dr. Guillermo
Rodriguez, Rutz’s oncologist, was not a learned intermediary and, consequently, there is a
“heeding presumption” that Dr. Rodriguez would have heeded an adequate warning about ONJ.
Moreover, according to Plaintiff, there is circumstantial evidence that Dr. Rodriguez and Rutz
would have acted differently with an adequate warning about ONJ.
NPC’s motion is fully briefed, and oral argument was held on November 9, 2012.
Analysis begins with reference to the standard governing this Court’s review of the summary
judgment motion.
II.

Legal standard
Summary judgment is appropriate where the pleadings, discovery materials, and

any affidavits show that there are no genuine issues of material fact and that the moving party is
entitled to judgment as a matter of law.

Turner v. The Saloon, Ltd., 595 F.3d 679, 683 (7th

Cir. 2010); Breneisen v. Motorola, Inc., 512 F.3d 972 (7th Cir. 2008), citing Celotex Corp. v.
Catrett, 477 U.S. 317, 322-23 (1986).
In ruling on a summary judgment motion, the district court must construe all facts
in the light most favorable to, draw all legitimate inferences in favor of, and resolve all doubts in
favor of the non-moving party. National Athletic Sportswear, Inc. v. Westfield Ins. Co., 528

2

F.3d 508, 512 (7th Cir. 2008).

Accord Reget v. City of La Crosse, 595 F.3d 691 (7th Cir.

2010).
When the non-moving party bears the burden of proof, though, he must
demonstrate the existence of a genuine fact issue to defeat summary judgment. Reget, 595 F.3d
at 695. To survive summary judgment, the non-movant must provide admissible evidence on
which the jury or court could find in his favor. See Maclin v. SBC Ameritech, 520 F.3d 781,
786 (7th Cir. 2008).
In deciding a summary judgment motion, the court may not evaluate the weight of
the evidence, judge the credibility of witnesses, or determine the truth of the matter. The court’s
only role is to determine whether there is a genuine issue of triable fact. National Athletic, 528
F.3d at 512, citing Doe v. R.R. Donnelley & Sons Co., 42 F.3d 439, 443 (7th Cir. 1994). As
succinctly stated by the Seventh Circuit Court of Appeals, “There is no genuine issue of material
fact when no reasonable jury could find in favor of the nonmoving party.” Van Antwerp v. City
of Peoria, Ill., 627 F.3d 295, 297 (7th Cir. 2010, quoting Brewer v. Bd. of Trs. of the Univ. of
Ill., 479 F.3d 908, 915 (7th Cir. 2007).
Stated another way, summary judgment is the “put up or shut up” moment in
litigation – the point at which the non-movant must marshal and present to the court the
admissible evidence which he contends will prove his case. Goodman v. National Sec. Agency,
Inc., 621 F.3d 651, 654 (7th Cir. 2010) (citations omitted). With these principles in mind, the
Court turns to the motion in the instant case.
III.

Discussion
A.

Factual background

3

The following facts regarding Rutz’s medical and dental history are undisputed.
Rutz was diagnosed with breast cancer in 1997.

Initially treated with radiation and

chemotherapy, Rutz underwent a left breast mastectomy in April 1998. She developed a local
recurrence as well as a malignant mass in her right breast. She again underwent chemotherapy
followed by treatment with Tamoxifen. 3

In January 2002, Rutz had a bone scan that

demonstrated a metastatic lesion of the left femur. She began Zometa therapy in June 2002,
which she continued through August 2005. During much of the time that Rutz was receiving
chemotherapy, she was also being treated with Decadron, a corticosteroid, taking about 15 doses
a month between December 1997 and February 2002.
In April 2003, Dr. Ron Thouvenot, Rutz’s family dentist, extracted six maxillary
(upper jaw) teeth and inserted a maxillary prosthesis. Following extraction, Rutz developed nonhealing wounds of teeth #7 and #8. In September 2003, Rutz was referred to Dr. Hesterberg for
further evaluation. Dr. Hesterberg performed an alveoplasty 4 in the right and left maxillary
quadrants. Rutz underwent multiple procedures by Dr. Hesterberg between November 2003 and
June 2006.

A September 2004 biopsy demonstrated boney sequestra 5 with inflammation

consistent with acute and chronic osteomyelitis. Referred to Dr. Omer Badahman, an infectious
disease specialist, for further evaluation, Rutz was seen by him from August 2005 through March
2006. During this period, she underwent extensive antibiotic treatment. Dr. Badahman’s last
entry in Rutz’s medical record indicates osteonecrosis of the maxilla secondary to Zometa

3

Tamoxifen citrate is a nonsteroidal oral antiestrogen also having weak estrogenic effects; used as an
antineoplastic in the prophylaxis and treatment of breast cancer. http://dorlands.com (visited
December 10, 2012).
4
Alveoplasty is conservative contouring of the alveolar process (the portion of bone in either the
maxilla or the mandible that surrounds and supports the teeth), in preparation for immediate or future
denture construction. http://dorlands.com (visited December 10, 2012).
5
Sequestra are pieces of dead bone that have become separated during the process of necrosis from
the sound bone. http://dorlands.com (visited December 10, 2012).

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therapy, as well as a superimposed soft tissue infection. A February 2006 maxillofacial CT scan
documented the presence of a 12 mm x 13 mm area of boney destruction involving the maxilla
immediately below the maxillary spine. Rutz’s metastatic disease progressed, and she passed
away from breast cancer on August 15, 2011.
B.

Causation

NPC asserts that Plaintiff lacks evidence to establish that Zometa caused Rutz’s
alleged injuries. First, according to NPC, Plaintiff’s own specific causation expert admitted that
his records showed that Rutz’s condition did not meet the accepted definition of BRONJ.
Second, Plaintiff has no evidence to rule out other risk factors, such as osteomyelitis or
metastatic cancer, that may have been the sole cause of Rutz’s ONJ. And, third, without
admissible expert testimony, Plaintiff’s case fails.
Plaintiff responds that a jury could find that Zometa caused Rutz’s injury because
competent medical evidence of causation supports this conclusion. Plaintiff submits that Dr.
Schwimmer and Dr. Hesterberg testified that Zometa caused Rutz’s ONJ to a reasonable degree
of medical certainty. Plaintiff maintains that these experts used a differential diagnosis to arrive
at their opinion that Zometa caused Rutz’s injury, and that differential diagnosis is a well-known
and widely-accepted methodology in the Seventh Circuit.

According to Plaintiff, NPC’s

argument is merely a rehash of its Daubert motion, and the identification of flaws in reliable
scientific evidence is the role of cross-examination. 6
As the Illinois Court of Appeals for the Third District explained regarding
medical expert opinion testimony,

6

On December 7, 2012, the Court denied NPC’s motion to exclude the testimony of Dr. Hesterberg and
Dr. Schwimmer (Doc. 126).

5

To be probative on the issue of causation, a medical expert is not required
to give an opinion regarding a specific cause. Rather, a medical expert is
permitted to testify to what might or could have caused an injury, despite any
objection that the testimony is inconclusive. Testimony from a physician
regarding what might or could have caused an injury is merely a medical opinion
given on facts assumed to be true. For evidence to be relevant, it need only tend
to make the existence of any fact more probable or less probable than it would
otherwise be.

Hahn v. Union Pacific R. Co., 816 N.E.2d 834, 841 (Ill.App.Ct. 2004) (internal citations and
citation omitted) (emphasis in original). The medical expert testimony on causation, however,
may not be “contingent, speculative or merely possible.” Northern Trust Co. v. Univ. of
Chicago Hospitals and Clinics, 821 N.E.2d 757, 768 (Ill.App.Ct. 2004) (citations omitted).
An expert opinion held to a reasonable degree of medical certainty provides a sufficient basis for
a jury finding that causation was proven. Id. (citations omitted). “Unquestionably, the relative
weight, sufficiency and credibility assessed to medical expert testimony is ‘peculiarly within the
province of the jury[.]’” Id. at 769 (citations omitted).
Probative on the issue of causation is Dr. Schwimmer’s opinion that Rutz had
BRONJ and that Zometa therapy was the cause of her ONJ and development of osteomyelitis.
Additionally, Dr. Schwimmer opined that the extraction sites involved with the removal of her
teeth would have resolved without significant complication, despite her history of smoking and
Decadron therapy, if she had not been on Zometa.
NPC asserts that Rutz’s condition did not meet the American Academy of Oral
and Maxillofacial Surgeons’ (AAOMS) definition of BRONJ, strongly disputing that Rutz met
the first element of the test - that she had 8 weeks of exposed bone. But Dr. Schwimmer
disagreed, stating that, based on his clinical experience, 4 to 5 weeks of exposed bone was the
minimum. Doc. 74-9, Schwimmer Dep., 244:13-25. He agreed, however, that Dr. Thouvenot

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did not document the existence of exposed bone in May, July, August or October 2003, stating,
“We don’t know exactly when the bone was exposed or whether she developed exposed bone.”
A failure to document exposed bone does not doom Plaintiff’s case.

Rutz’s

condition predates the AAOMS’s definition of BRONJ. Since exposed bone was not yet known
to be an indicator of BRONJ, records created at that earlier date would not necessarily reflect
whether exposed bone was present. So, for Dr. Schwimmer to diagnose BRONJ based on his
clinical experience was not unreasonable. Given that Rutz may have had exposed bone which
was not recorded, it would be unfair to permit NPC to use the absence of a record to conclude
that BRONJ was not present, and then to obtain summary judgment on that basis. See Deutsch,
768 F.Supp.2d at 449-50. A jury could determine that other indicia of BRONJ – such as nonhealing wounds - made it likely that exposed bone was present. Moreover, as the Court decided
in its December 7 Order, Dr. Schwimmer’s testimony is admissible and may be challenged on
cross-examination. His disagreement with the AAOMS standard does not provide a basis for
excluding his testimony or granting summary judgment on this issue.
Because genuine issues of material fact exist with respect to causation, summary
judgment is not warranted.
C.

Adequacy and timeliness of NPC’s warnings

NPC asserts that even if Plaintiff could establish that Rutz’s treatment with
Zometa caused her ONJ, he lacks the evidence required to prove that NPC “knew or should have
known” at the relevant times that Zometa could cause ONJ but failed to warn of that fact. NPC
argues that, under the learned intermediary doctrine, it was required to warn only Rutz’s
prescribing physician, who acts as a “learned intermediary” between NPC and Rutz. NPC
submits that it received its first Adverse Event Report (AER) on December 6, 2002, nearly six

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months after Rutz began treatment with Zometa. NPC states that it promptly submitted the AER
to the FDA in compliance with federal regulations and also timely notified the FDA about
additional AERs. According to NPC, after it collected adequate data, it voluntarily changed its
warnings to communicate the occurrence of jaw problems in patients receiving Zometa. NPC
submits that it amended the Zometa label in September 2003 as well as in February and
September 2004. Furthermore, NPC states that it sent a letter on September 24, 2004, to
thousands of doctors – including Rutz’s oncologist – warning, among other things, that “[w]hile
on treatment, these patients should avoid invasive dental procedures if possible.” In sum, NPC
asserts that Plaintiff has no evidence that, based on the available knowledge, NPC should have or
could have acted more quickly to implement an appropriate warning.
Plaintiff responds that a jury could find that Zometa’s warning was inadequate
and that adequacy of warning is usually a jury question. Plaintiff asserts that his experts will
opine that NPC knew about the risk of ONJ long before it amended its warning and sent the
letters notifying doctors of the risk. Plaintiff contends that evidence presented to the MDL court
shows that NPC knew its Zometa warning was inadequate. Plaintiff submits that the MDL court
found that the plaintiffs had submitted a “myriad of evidence” to rebut the statutory presumption
(under Florida law) of adequacy when the drug is FDA-approved, such that a jury could find that
the Zometa warning was inadequate. Plaintiff notes that Illinois law has no such presumption.
As this Court previously found, precedent teaches that, ‘[a]s most commonly
defined, the [law of the case] doctrine ... posits that when a court decides upon a rule of law, that
decision should continue to govern the same issues in subsequent stages in the same case.”
Jarrard v. CDI Telecommunications, Inc., 408 F.3d 905, 912 (7th Cir. 2005), quoting
Christianson v. Colt Indus. Operating Corp., 486 U.S. 800, 815–16 (1988) (citation omitted)

8

(emphasis added in Jarrard); see also id. at 816 (“[T]he doctrine applies as much to the
decisions of a coordinate court in the same case as to a court's own decisions.”). “The
doctrine ‘is a rule of practice, based on sound policy that, when an issue is once litigated and
decided, that should be the end of the matter.’” Id. (citations omitted).
Finding that genuine issues of material fact remained, the MDL court (Chief
District Judge Todd J. Campbell) denied NPC’s motion for summary judgment as to the
adequacy of NPC’s Zometa warnings. Judge Campbell observed, “Generally, whether a warning
is adequate is an issue of fact to be determined at trial.” In re Aredia and Zometa Prods.
Liability Litigation, 2009 WL 2496873, at *2 (M.D.Tenn. 2009), quoting Figueroa v. Boston
Scientific Corp., 254 F.Supp.2d 361, 370 (S.D.N.Y. 2003). This same presumption holds true
in Illinois where courts have found that “[i]n a strict liability case, the adequacy of the warning
usually presents a jury question.” Hernandez v. Schering Corp., 958 N.E.2d 447, 455
(Ill.App.Ct. 2011), citing Palmer v. Avco Distributing Corp., 412 N.E.2d 959 (1980). This
issue having been previously been litigated before and decided by the MDL court, it is the law of
the case and continues to govern this issue in the current stage of the case.
If the Court were to consider the adequacy and timeliness of NPC’s warnings
beyond the MDL court’s decision, it would arrive at the same conclusion – that these are jury
questions. For example, NPC states that it voluntarily changed its warnings after it collected
adequate data. This statement, standing alone, presents obvious questions of adequacy and
timeliness such that summary judgment is not warranted. NPC waited approximately 10 months
after receiving the first AER to notify the FDA that it was revising the Adverse Reactions section
of Zometa labeling to include language reflecting reports of ONJ associated with the use of
intravenous bisphosphonates. And it waited approximately 22 months before sending its “Dear

9

Doctor” letter notifying prescribing doctors of the label change. To rebut Plaintiff’s claims, NPC
must establish before the trier of fact that its course of action was appropriate, i.e., that its
judgment that a particular quantum of data was needed and was unavailable until a given date
such that its warnings were adequate and timely. NPC must refute expert testimony that it knew
or should have known at an earlier date that Zometa could cause ONJ and delayed amending its
warning and notifying the FDA.
For these reasons, the Court concludes that summary judgment is not warranted
on the adequacy and timeliness of NPC’s warnings.
D.

Whether a different warning would have prevented Rutz’s BRONJ or otherwise
changed the outcome of her treatment
NPC asserts that Plaintiff cannot prove that the alleged inadequate warning was

the proximate cause of Rutz’s jaw injury. NPC points to the testimony of Dr. Rodriguez, Rutz’s
oncologist who prescribed Zometa for her. Dr. Rodriguez testified that he continues to prescribe
bisphosphonates (Zometa and Xgeva) for people with bony metastases and that using a
bisphosphonating agent for a patient with bony metastasis remains the standard of care. Doc.
106-5, Rodriguez Dep. 47:16-19; 48:16-49:6. NPC contends that Plaintiff has no evidence that
Rutz would have refused treatment with Zometa if she had been warned of the risk of ONJ or
that a warning about the risk of ONJ would have changed the outcome of her injuries. NPC also
argues that there is no evidence that a recommendation to see a dentist before commencing
bisphosphonate therapy would have made any difference since Rutz saw her dentist regularly.
Additionally, NPC maintains that there is no evidence that the April 2003 extractions, which
allegedly precipitated the development of Rutz’s ONJ, could have been addressed before she
began Zometa, nearly a year earlier. NPC sums up that without expert evidence that Zometa
would not have been prescribed or that Rutz’s medical or dental treatment would have changed
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in a way that would have prevented her jaw problems, Plaintiff cannot prove that any alleged
failure to warn by NPC caused Rutz’s injuries.
Plaintiff argues that a jury could find that an adequate warning would have
changed the outcome because (1) Dr. Rodriguez was not a learned intermediary; (2) it is
presumed that Dr. Rodriguez would have heeded an adequate warning about ONJ; and (3)
circumstantial evidence from Dr. Rodriguez and Rutz shows that the outcome would have been
different with an adequate warning.
To state a failure-to-warn claim against a drug manufacturer under Illinois law, a
plaintiff must establish that the defendant had a duty to warn, that the defendant knew or should
have known that the drug could cause the plaintiff's injury, that the failure to provide the
necessary information made the warning inadequate, that the drug was “‘defective’ and that this
defect was the proximate cause of plaintiff's injuries.” N. Trust, 572 N.E.2d at 1037. Under the
“learned intermediary” doctrine, a drug manufacturer has a duty to warn the prescribing doctor,
rather than the patient, of any known risks. Hansen v. Baxter Healthcare Corp., 764 N.E.2d 35,
42 (Ill. 2002). It is then the responsibility of the doctor, using his medical judgment, to convey
the warnings to the patient. Id. “Doctors who have not been sufficiently warned of the harmful
effects of a drug cannot be considered ‘learned intermediaries' and the adequacy of warnings is a
question of fact, not law, for the jury to determine….” Id. at 43, quoting Proctor v. Davis, 682
N.E.2d 1203 (Ill. 1997) (emphasis added in Hansen). So, it is a jury question whether a
warning sufficiently apprised doctors of the risks associated with the use of a drug. N. Trust,
572 N.E.2d at 1037. And, as applied herein, it is a jury question whether NPC’s warning
sufficiently apprised Dr. Rodriguez of the risk of ONJ associated with Zometa, such that he
could be considered a learned intermediary.

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If Dr. Rodriguez were considered a learned intermediary, the issue of whether a
“heeding presumption” applies has not been clearly addressed by the Illinois Supreme Court.
But the Illinois Appeals Court for the First District offers some guidance, stating that where the
presumption applies, a court “presumes that warnings, if given, will be heeded and followed and
that medical practitioners will act competently.” Mahr v. G.D. Searle & Co., 390 N.E.2d 1214,
1233 (Ill.App.Ct. 1979) (applying Texas law). The Court also finds persuasive the analysis of
Judge Bucklo who assumed the existence of a heeding presumption in Erickson v. Baxter
Healthcare, Inc., 151 F.Supp.2d 952 (N.D.Ill. 2001). In Erickson, the defendants argued that
the causal chain was broken because the plaintiff could not show that his doctors were not
independently aware of the risk or that they would not have treated him in the same way even if
they knew the risk. 151 F.Supp.2d at 970. Judge Bucklo reasoned that this argument presumed
that adequate warnings were given, which she had already decided could not be resolved at that
stage of the proceedings. Id. She concluded, “In any event, the plaintiffs are entitled at this
stage to a presumption that a learned intermediary would have heeded the warnings given.” Id.,
citing Mahr, 390 N.E.2d at 1233.
The undersigned Judge has also decided that whether adequate warnings were
given cannot be resolved at this stage of the proceedings. Moreover, the “heeding presumption”
is a natural result of or corollary to the learned intermediary doctrine. So, the Court concludes
that if Dr. Rodriguez were considered a learned intermediary, there is a presumption that he
would have heeded an adequate warning about ONJ.
Dr. Rodriguez’s testimony shows that he did not know of the risk of ONJ when he
prescribed Zometa for Rutz in June 2002. He warned Rutz of other risks, such as flu-like
symptoms and bone pains. Doc. 106, Exh. 5, Rodriguez Dep. 30:18-23. NPC warned Dr.

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Rodriguez of the risk of ONJ associated with Zometa in September 2004. Dr. Rodriguez stopped
Rutz’s Zometa therapy in 2005. Under the heeding presumption, Plaintiff does not have to prove
what Dr. Rodriguez might or might not have done if given an adequate warning about the risk of
ONJ.
Furthermore, the record shows that since learning of the link between Zometa and
ONJ in September 2004, Dr. Rodriguez changed his advice to patients to whom he is
recommending bisphosphonates to include going over the risks of ONJ with them, encouraging
them to see a dentist if they have not done so within the past six months and encouraging them to
have any necessary dental procedures done before starting on bisphosphonates. Rodriguez Dep.,
78:19-79:6.
Lastly, Plaintiff argues that circumstantial evidence from Dr. Rodriguez and Rutz
shows that the outcome would have been different with an adequate warning. Rutz testified that
she would not have taken Zometa if Dr. Rodriguez had warned her of the risk of ONJ. She
testified that a less than one percent risk that she would have jaw problems, “a dead jaw,” would
have tipped the scale, and she would have said “no, I’m not taking that.” Doc. 106, Exh. 6, Rutz
Dep., 122:22-124:10. NPC asserts that this is a self-serving statement made by a plaintiff after
the commencement of her lawsuit without evidentiary support.
“’Self-serving’ deposition testimony may satisfy a party's evidentiary burden on
summary judgment. Whitlock v. Brown, 596 F.3d 406, 411 (7th Cir. 2010), citing Payne v.
Pauley, 337 F.3d 767, 772 (7th Cir. 2003) (emphasis in original). The Whitlock court
explained that, under the Payne analysis, “the sufficiency of a ‘self-serving’ statement depends
on whether the statement is based on personal knowledge and whether it is grounded in
observation as opposed to mere speculation.” Id. Rutz’s testimony passes this test because she

13

explained, reasonably, that she did not want another “porta cath” and that if she would have had
another excuse – even a small chance of incurring jaw problems - for avoiding the cath, she
would have refused the treatment. Rutz Dep., 123:2-124:10. Rutz was not speculating, and her
testimony was based on personal knowledge.
For these reasons, the Court concludes that summary judgment is not warranted
on the issue of whether a different warning would have prevented Rutz’s BRONJ or changed the
outcome of her treatment.
IV.

Conclusion
Finding that genuine issues of material fact remain for trial, the Court DENIES

NPC’s motion for summary judgment (Doc. 86).
IT IS SO ORDERED.
DATED this 17th day of December, 2012

s/Michael J. Reagan
MICHAEL J. REAGAN
United States District Judge

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