Johnson v. Mylan Inc.

Decision Date01 June 2015
Docket NumberCase No. 12–cv–772–pp.
Citation107 F.Supp.3d 967
Parties James Sherman JOHNSON, Individually, Diamond Johnson, Individually, and Karen Marie Hayden–Jefferson as Administrator of the Estate of James Hayden and as Next Friend to the minor Plaintiffs, Plaintiffs, v. MYLAN INC., Mylan Pharmaceuticals, Inc., Mylan Technologies, Inc., John Doe Manufacturers A–Z, and John Doe Distributors A–Z, Defendants.
CourtU.S. District Court — Eastern District of Wisconsin

Trent B. Miracle, David F. Miceli, Simmons Browder Gianaris Angelides & Barnerd LLC, Alton, IL, Christopher W. Rose, Rose & Rose, Kenosha, WI, for Plaintiff.

Clem C. Trischler, Ryan J. King, Pietragallo Gordon Alfano Bosick & Raspanti LLP, Pittsburgh, PA, Mark K. Longua, Patrick J. Lubenow, SmithAmundsen LLC, Milwaukee, WI, for Defendant.


PAMELA PEPPER, District Judge.

This is a products liability action in which the plaintiffs allege that a transdermal fentanyl patch manufactured by defendant Mylan Technologies, Inc. malfunctioned and caused the death of James Hayden. Earlier in this litigation, the court dismissed a number of the plaintiffs' claims, leaving only their design and manufacturing defect claims remaining. After the court granted the defendants' motion to exclude the testimony of the plaintiffs' expert witness, the plaintiffs elected to proceed on a "malfunction theory" under the doctrine of res ipsa loquitur. Collectively, the Mylan defendants have moved for summary judgment. The court held oral arguments on Mylan's motion on March 9, 2015. Upon review of the record, the parties' submissions, and the oral arguments presented, the court concludes that summary judgment is appropriate because there is no genuine dispute as to any issue of material fact, and the doctrine of res ipsa loquitur is not applicable based on the facts of the case. For the reasons discussed below, the court grants Mylan's motion.


The parties agree on the following facts. Hayden was diagnosed with sickle cell anemia when he was eleven months old, and he was twenty-four years old at the time of death. Pls.' Resp. to Defs.' Stm. of Proposed Material Facts, Dkt. No. 40, ¶ 12. On the morning of October 29, 2007, Hayden went to the emergency department at Kenosha Memorial Hospital, complaining of sickle cell pain and difficulty breathing due to nasal congestion. Id., ¶ 14. Dr. Suzanne Siegel initially administered I.V. fluids, Demerol and Benadryl. Id., ¶ 14–15. After Dr. Siegel administered those medications, she ordered a 100 mcg fentanyl patch1 , which was applied to Hayden's right arm. Id., ¶ 16.

Hayden returned home and showed no signs or symptoms of overmedication. Id., ¶ 17. He showed no such signs as late as 5:00 a.m. on October 30, 2007, approximately 16 hours after the patch was applied, which is consistent with the delivery of fentanyl at the rate it was designed to release. Id. At approximately 2:32 p.m. on October 30, 2007, Hayden was found unresponsive and not breathing. Id., ¶ 18. Following CPR efforts, he was transported to the Kenosha Medical Center and was pronounced dead that day. Id. After performing an autopsy and receiving toxicology results from a postmortem blood draw, medical examiner Dr. Mary Mainland listed Hayden's cause of death as "Fentanyl Toxicity," based on the toxicology analysis that showed a postmortem fentanyl concentration of 30 mg/ml. Id., ¶ 19. The plaintiffs allege that Hayden's death was the result of an allegedly defective fentanyl patch, designed, manufactured and distributed by the Mylan defendants. Id., ¶ 3.

The fentanyl patch applied to Hayden's arm was discarded following the autopsy, per the standard protocol of Dr. Mainland's office.Id., ¶ 31. Dr. Mainland testified at her deposition that nothing uncovered during her investigation indicated that there was any deficiency or problem with the fentanyl patch. Id., ¶ 20. However, her finding that the cause of Hayden's death was related to fentanyl did not indicate that there was a defect or malfunction in the patch. Id. The postmortem concentration of fentanyl in the blood did not reflect the concentration of the drug in the systemic circulation during lifetime, and the exact concentration of fentanyl in Hayden's body at the time of his death is unknown. Id., ¶ 21. That is because fentanyl may undergo postmortem redistribution, which is the process by which a substance stored in the body tissue at relatively high concentrations while a person is living migrates elsewhere in the body (such as to the blood) after death. Id., ¶ 22. Postmortem redistribution creates the potential for artificially elevated blood levels, and postmortem redistributive changes for fentanyl can be significant. Id., ¶ 23. Accordingly, one cannot infer or suggest that an elevated postmortem fentanyl level proves a causal connection to a defect in a transdermal drug delivery system, because postmortem fentanyl levels are not representative of antemortem fentanyl levels. Id., ¶ 24.

On November 13, 2012, the court granted Mylan's Partial Motion to Dismiss, dismissing the plaintiffs' fraud, misrepresentation and failure-to-warn claims. Id., ¶ 4. The plaintiffs now are proceeding only on their claims of design defect and manufacturing defect. Id. In support of these claims, the plaintiffs proffered the testimony of a single expert, Dr. Mark Dershwitz, who intended to base his opinion that there was a defect or malfunction in the fentanyl patch on (a) Dr. Mainland's s determination that Hayden's death was caused by fentanyl toxicity and (b) Hayden's postmortem blood concentration of fentanyl. Id., ¶ 27. On August 6, 2014, the court granted Mylan's motion to exclude Dr. Dershwitz's testimony, based on the court's determination that Dr. Dershwitz "ha[d] nothing to support his conclusion of patch failure—no method, test or scientific process supports [his opinion]." Id., ¶ 7 As a result of this decision, the plaintiffs now have no expert witness to testify regarding any alleged manufacturing or design defect or malfunction in the fentanyl patch Hayden wore. Id., ¶¶ 29–30.


This is a diversity action. The plaintiffs are Wisconsin citizens. Mylan, Inc. is a Pennsylvania corporation with its principal place of business in Canonsburg, Pennsylvania. Mylan Pharmaceuticals, Inc., is a West Virginia corporation with its principal place of business in Morgantown, West Virginia. Mylan Technologies, Inc. is a West Virginia corporation with its principal place of business in St. Albans, Vermont. The court applies federal procedural law and state substantive law, including the state's choice of law rules. Allen v. Cedar Real Estate Grp., LLP, 236 F.3d 374, 380 (7th Cir.2001) (citing Erie R.R. v. Tompkins, 304 U.S. 64, 78, 58 S.Ct. 817, 82 L.Ed. 1188 (1938) ).

Under Wisconsin law, the law of the forum state governs a tort case unless it is clear that nonforum contacts are more significant. State Farm Mut. Auto. Ins. Co. v. Gillette, 251 Wis.2d 561, 587–88, 641 N.W.2d 662, 675–76 (2002). This case has a significant relationship to Wisconsin—Hayden's illness, treatment and death occurred in Wisconsin. The parties do not dispute that Wisconsin substantive law applies, and when that is so, "the default rule is to apply the law of the state where the district court sits." Schultz v. Akzo Nobel Paints, LLC, 721 F.3d 426, 433 (7th Cir.2013). Therefore, the court applies Wisconsin substantive law.

A. Applicable Standards
1. Summary Judgment

A court must grant summary judgment when there is no genuine dispute as to any material fact and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(a) ; Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). A court appropriately grants summary judgment "against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Id. The "purpose of summary judgment is to pierce the pleadings and to assess the proof in order to see whether there is a genuine need for trial." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) (internal quotation marks omitted) (citation omitted). "A party will be successful in opposing summary judgment only when they present definite, competent evidence to rebut the motion." EEOC v. Sears, Roebuck & Co., 233 F.3d 432, 437 (7th Cir.2000). The nonmoving party is entitled to all reasonable inferences in its favor, but "inferences that are supported by only speculation or conjecture will not defeat a summary judgment motion." Herzog v. Graphic Packaging Int'l, Inc., 742 F.3d 802, 806 (7th Cir.2014) (quoting Tubergen v. St. Vincent Hosp. & Health Care Ctr., Inc., 517 F.3d 470, 473 (7th Cir.2008) ).

2. The Doctrine of Res Ipsa Loquitur

Under § 895.047, Wisconsin's products liability statute, a plaintiff must establish the following five elements to prevail: (1) the product is defective in design, manufacture or warnings; (2) the defect rendered the product unreasonably dangerous; (3) the defective condition existed at the time the product left control of the manufacturer; (4) the product reached the user without substantial change in condition; and (5) the defective condition was the cause of the complained-of harm. Wis. Stat. Ann. § 895.047(1)(a)(e). In this case, however, the plaintiffs explain that they are not attempting to establish liability under § 895.047 or "traditional tort causes of action," and they argue that Mylan's arguments under that statute are "entirely moot." Dkt. No. 39, at 5, 10. Instead, they explain that they are proceeding under a "malfunction theory" based on the doctrine of res ipsa loquitur. Id., at 5.

Wisconsin courts characterize the doctrine of res ipsa loquitur as a rule of circumstantial evidence that allows a fact-finder to infer negligence (or in this...

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