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In re Avandia Marketing, Sales Practices and Products Liability Litigation

United States District Court, E.D. Pennsylvania

December 12, 2017



          Rufe, J.

         Plaintiffs John and Sarah Siddoway allege that Mr. Siddoway was harmed as a result of his use of Defendant GlaxoSmithKline LLC's (“GSK”) diabetes medication Avandia. Mr. Siddoway's physician, Dr. Dennis Peterson, prescribed Avandia to Mr. Siddoway for two years, from 2001 through 2002. In 2003, Mr. Siddoway suffered two heart attacks, and ultimately underwent a successful heart transplant operation. Four years after Mr. Siddoway's heart transplant, the FDA issued a safety alert describing a potential increased risk of heart attack associated with Avandia use.

         Plaintiffs subsequently sued GSK, raising nine claims against the drug manufacturer: (1) negligence, (2) strict liability, (3) failure to warn, (4) breach of express warranty, (5) breach of implied warranty, (6) breach of implied warranty of merchantability, (7) negligent misrepresentation, (8) violation of Utah's Consumer Protection Sales Act, and (9) loss of consortium. GSK now moves for summary judgment, arguing that all of Plaintiffs' claims are premised on GSK's alleged failure to adequately warn of an increased risk of heart attack associated with Avandia use, and Plaintiffs are unable offer evidence showing that GSK's failure to warn of this association was the proximate cause of Mr. Siddoway's injuries. For reasons that follow, the Court will grant the motion.

         I. Factual and Procedural Background

         A. Mr. Siddoway's Health History

         Mr. Siddoway was diagnosed with Type II diabetes by his primary care physician, Dr. Peterson. Dr. Peterson initially prescribed Metformin and Amaryl (a sulfonylurea), two common diabetes medications, to treat Mr. Siddoway. On July 6, 2001, however, Dr. Peterson replaced the Amaryl prescription with Avandia. Dr. Peterson prescribed Avandia to Mr. Siddoway until May 22, 2002. His last office visit with Mr. Siddoway was in October 2002.

         In July 2003, Mr. Siddoway suffered a heart attack and underwent stent replacement surgery. In October 2003, he suffered another heart attack and needed a heart transplant, which he received in December 2003. Following the heart transplant, a different doctor-Dr. Edward Gilbert-prescribed Avandia to Mr. Siddoway. Mr. Siddoway continued to take Avandia from December 2003 through June 2007, and did not experience any other adverse cardiovascular condition or event. Mr. Siddoway does not smoke or drink alcohol and is not obese.[1]

         B. The Availability of Information About Avandia and an Increased Risk of Heart Attack

         When Avandia was initially approved by the FDA in 1999 to treat Type II diabetes, the drug's package insert (“label”) contained no warning of an increased risk of heart attack. On May 21, 2007, however, the FDA issued a safety alert for Avandia, notifying consumers that “data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”[2] Although this safety alert acknowledged that the data from clinical trials “provide[d] contradictory evidence about the risks in patients treated with Avandia, ” it nonetheless sought to warn consumers of a potential risk of heart attack and encouraged patients taking Avandia to discuss treatment options with their physicians.[3] At this time, the FDA directed GSK to add this information in a boxed warning on the Avandia label.

         After this change to the label and after Plaintiffs filed this lawsuit, GSK and the FDA conducted extensive research on Avandia's safety. In 2013, the FDA ultimately concluded that there was no increased risk of heart attack associated with Avandia use compared to alternative diabetes medications. In a decisional memorandum dated November 19, 2013, the FDA wrote that the data “support no statistically significant difference between rosiglitazone [Avandia] and metformin/sulfonylurea for the risk of death or major adverse cardiovascular outcomes, other than the known class effect of heart failure.”[4] Rather, re-adjudication of long-term trials of Avandia “provide[d] considerable reassurance regarding the cardiovascular safety of rosiglitazone.”[5] Therefore, in 2014, the FDA approved an updated Avandia label that removed the boxed warning for a potential increased risk of heart attack.

         II. Standard of Review

         Upon motion of a party, summary judgment is appropriate if “the materials in the record” show “that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”[6] Summary judgment may be granted only if the moving party persuades the district court that “there exists no genuine issue of material fact that would permit a reasonable jury to find for the nonmoving party.”[7] A fact is “material” if it could affect the outcome of the suit, given the applicable substantive law.[8] A dispute about a material fact is “genuine” if the evidence presented “is such that a reasonable jury could return a verdict for the nonmoving party.”[9]

         In evaluating a summary judgment motion, a court “must view the facts in the light most favorable to the non-moving party, ” and make every reasonable inference in that party's favor.[10]Further, a court may not weigh the evidence or make credibility determinations.[11] Nevertheless, the party opposing summary judgment must support each essential element of the opposition with concrete evidence in the record.[12] “If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted.”[13] This requirement upholds the “underlying purpose of summary judgment [which] is to avoid a pointless trial in cases where it is unnecessary and would only cause delay and expense.”[14] Therefore, if, after making all reasonable inferences in favor of the non-moving party, the court determines that there is no genuine dispute as to any material fact, summary judgment is appropriate.[15]

         III. Discussion

         The parties agree that Utah law governs this case.[16] The Court will begin by examining Plaintiffs' negligence and failure to warn claims. Then, the Court will address Plaintiff's remaining claims.

         A. Plaintiffs' Negligence & Failure to Warn Claims

         Plaintiffs raise negligence and failure to warn claims against GSK. Both causes of action essentially allege that GSK negligently failed to warn Plaintiffs of the increased risk of heart attack purportedly associated with Avandia use.[17]

         GSK acknowledges that it had a duty to warn of risks associated with Avandia; however, it argues that any breach of this duty to warn was not the proximate cause of Mr. Siddoway's injuries and thus, the negligence and failure to warn claims must fail under the learned intermediary doctrine.[18]

         Under Utah's learned intermediary doctrine, “manufacturers of prescription drugs have a duty to warn only the physician prescribing the drug, not the end user or patient.”[19] “The contours of this duty include making ‘timely and adequate warnings to the medical profession of any dangerous side effects produced by its drug of which it knows or has reason to know.'”[20]After receiving warnings from the drug manufacturer, the physician acts as a learned intermediary between manufacturer and patient.[21] In this way, the physician is “best situated to weigh the risks and benefits” associated with a drug in relation to the needs of the patient.[22]

         “In any failure to warn claim, a plaintiff must show that the failure to give an adequate warning in fact caused the injury; i.e., that had warnings been provided, the injured party would have altered his use of the product or taken added precautions to avoid the injury.”[23] If the event that produced the plaintiff's injury would have occurred regardless of the defendant's conduct, then the failure to warn is not the proximate cause of the harm and the plaintiff's claim fails.[24]Thus, under the learned intermediary doctrine, to establish that the defendant's failure to warn is a proximate cause of the plaintiff's injury, the prescribing physician must testify that a different warning would have caused the doctor to alter his or her prescribing program for the plaintiff patient.

         Mr. Siddoway's prescribing physician, Dr. Peterson, testified about his opinion on Avandia's association with an increased risk of heart attack. His testimony is crucial to the disposition of this motion. During his deposition in 2015, Dr. Peterson was asked whether his prescribing choices would have changed if he had all the current and historical information on Avandia's association with heart attacks, and he responded that his choices would have remained the same:

Q: The FDA said, first, in that paragraph [of the November 2013 FDA Decisional Memo] I was reading to you before, “The RECORD trial establishes that long-term rosiglitazone use is not associated with an unacceptably increased CV risk that would outweigh rosiglitazone's benefit and warrant removal from the market when rosiglitazone is compared to standard-of-care comparators.” My question for you is, is that consistent with your view of the data, as you sit here today, in terms of the cloud being removed from Avandia based upon the RECORD re-adjudication?
A: Yes.
Q: What does this mean to you as of May of 2014 relative to Avandia and whether it has been demonstrated to have a meaningful cardiovascular risk in comparison to other antidiabetic agents?
A: It's consistent with my general impression that cardiovascular risk was not a true component of ...

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