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In re Testosterone Replacement Therapy Products Liability Litigation

United States District Court, N.D. Illinois

March 21, 2018

IN RE TESTOSTERONE REPLACEMENT THERAPY PRODUCTS LIABILITY LITIGATION This Document Relates to: Mitchell
v.
AbbVie, No. 1:14-cv-09178

          David M. Bernick Paul, Weiss, Rifkind, Wharton & Garrison LLP Counsel for AbbVie Inc.

          Nathan E. Hoffman Dechert LLP, Michelle Hart Yeary Dechert LLP Counsel for AbbVie Inc. and Abbott Laboratories

          DEFENDANTS' MOTION AND SUPPORTING MEMORANDUM FOR JUDGMENT AS A MATTER OF LAW PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 50(a)

          MATTHEW F. KENNELLY JUDGE

         TABLE OF CONTENTS

         I. PLAINTIFF DID NOT OFFER SUFFICIENT EVIDENCE THAT ANDROGEL WAS A BUT-FOR CAUSE OF HIS HEART ATTACK ................................................................ 1

         II. PLAINTIFF DID NOT OFFER SUFFICIENT EVIDENCE OF INADEQUATE WARNINGS TO SUPPORT STRICT LIABILITY AND NEGLIGENCE ....................... 2

A. Plaintiff Failed to Demonstrate Reasonable Evidence of a Causal Association ..... 4
B. Plaintiff Did Not Prove Inadequate Warnings Under State Law ............................ 6
C. Plaintiff's Warning Claims Also Fail Because His Prescribing Physician Expressly Warned Him of a Potential Heart Attack Risk ....................................... 6

         III. PLAINTIFF'S STRICT LIABILITY CLAIM ALSO FAILS BECAUSE HE DID NOT PRODUCE EVIDENCE THAT ANDROGEL WAS DEFECTIVE OR UNREASONABLY DANGEROUS ........ 7

         IV. THE MISREPRESENTATION CLAIM FAILS BECAUSE THERE IS NO CLEAR AND CONVINCING EVIDENCE THAT PLAINTIFF OR HIS PRESCRIBING PHYSICIAN SAW OR RELIED ON ANY FALSE REPRESENTATION ...................... 8

         A. No Reasonable Jury Could Find that AbbVie Made a False Representation ......... 8

         B. No Reasonable Jury Could Credit Dr. Kessler's Inherently Contradictory Testimony ............................ 11

         C. There Is No Evidence that Plaintiff or His Prescribing Physician Saw or Relied on Any False Representation ...... 12

         V. OREGON LAW AND DUE PROCESS BAR ANY PUNITIVE DAMAGES ............... 14

         The Court should enter judgment for Defendants AbbVie Inc. and Abbott Laboratories (collectively, “AbbVie”) because no reasonable jury could find for Plaintiff on his three claims. See Fed. R. Civ. P. 50(a). First, all three fail because Plaintiff's causation expert, Dr. Ardehali, conceded that Plaintiff had numerous risk factors that completely explained his heart attack. Second, his strict liability and negligence warning claims fail because he did not demonstrate the “reasonable evidence of a causal association” required to add a warning without prior Food and Drug Administration (FDA) approval; he did not prove that it was unreasonable not to include additional cardiovascular (CV) warnings; and his prescriber, Dr. Canzler, expressly warned him of potential CV risk. Third, the strict liability claim fails because Plaintiff did not introduce evidence of consumer expectations. Fourth, Plaintiff's misrepresentation claim fails because he did not prove any false statements, let alone any reliance; the claim rests on inherently contradictory testimony; and Plaintiff admitted that he did not rely on any AbbVie ads in deciding to use AndroGel, while Dr. Canzler admitted that he independently assessed the benefits and risks of AndroGel and relied solely on his medical judgment and experience in making his prescribing decision and continues to prescribe AndroGel today even after Plaintiff's heart attack and reports of potential CV risks in 2014. Finally, the Court should strike Plaintiff's punitive damages request due to the absence of any nexus between Plaintiff's AndroGel treatment and the supposed punitive conduct identified by Plaintiff's counsel.

         ARGUMENT

         I. PLAINTIFF DID NOT OFFER SUFFICIENT EVIDENCE THAT ANDROGEL WAS A BUT-FOR CAUSE OF HIS HEART ATTACK

         Each of Plaintiff's claims required him to prove that AbbVie caused his heart attack. Tr. 152:13-19, attached hereto as Exhibit A. To satisfy this burden under Oregon law, Plaintiff had to demonstrate that the heart attack “would not have occurred but for AbbVie's conduct.” Ex. A at 152:18-19; see Joshi v. Providence Health Sys. of Or. Corp., 149 P.3d 1164, 1169 (Or. 2006). Dr. Ardehali therefore needed to rule out the possibility of Plaintiff having the heart attack without AndroGel. Ex. A at 152:20-22; Joshi, 149 P.3d at 1169 (“[T]he defendant's conduct is not a cause of the event, if the event would have occurred without it.”).

         Dr. Ardehali's opinion did not meet this standard. To the contrary, Dr. Ardehali conceded that Plaintiff suffered from many risk factors that alone sufficed to cause his heart attack. Ex. A at 1445:7-1447:3, 1449:21-1450:9, 1451:6-1453:4, 1454:9-14. At the time of his heart attack, Plaintiff undisputedly had several cardiac risk factors, including a 34-year history of smoking, hypertension, hyperlipidemia, obesity, a family history of heart disease, and lack of exercise. Ex. A at 1449:21-1450:9, 1451:6-1453:4. Dr. Ardehali agreed that without AndroGel, Plaintiff's risk factors gave him a 15-18% 10-year risk estimate for having a heart attack-at least double what Dr. Ardehali considers “high risk.” Ex. A at 1463:15-19, 1469:1-12.

         Significantly, Dr. Ardehali would have told Plaintiff between 2010 and 2012 that he was at risk of a heart attack “any day” due to those factors. Ex. A at 1459:1-11, 1459:24-1460:2. Dr. Ardehali further admitted that there was nothing unusual about Plaintiff's heart attack in his hospital records to suggest a cause besides his risk factors; to the contrary, those records identified the same cardiac risk factors. Ex. A at 1460:24-1462:9. Plaintiff therefore failed to satisfy the requirement under Oregon law of demonstrating that he would have avoided his heart attack had he ...


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