Plavix is used to treat individuals at risk for heart attack, stroke, and circulation problems. Because Plavix inhibits the formation of blood clots, it increases the risk of bleeding. The Plavix label disclosed this risk. The FDA approved the use of Plavix with aspirin to treat individuals suffering from acute coronary syndrome (“ACS”). Since aspirin also inhibits the formation of blood clots, using the two drugs together increases the risk of bleeding, and the Plavix label described this risk.
A man suffered from ACS, and after two heart attacks and other complications from the ACS, his physician prescribed Plavix and aspirin. The man had maintained this drug regimen for about 17 months when he hit his head. Two weeks later, he developed a severe headache and became unconscious. His doctors determined that the man suffered a brain hemorrhage typically associated with trauma. He died as a result of the brain hemorrhage. The death certificate indicated that the hemorrhage was a consequence of his Plavix therapy.
Another patient suffered from ACS, and after undergoing a stent implant, her physician prescribed Plavix and aspirin. With only brief interruptions, the patient took this combination of drugs for about two years. During that time she suffered rectal bleeding and gastrointestinal bleeding.
The man’s wife as surviving spouse and the administrator of his estate and the patient separately sued the manufacturers of Plavix raising failure to warn, design defect, manufacturing defect, and negligence claims. The wife’s claims were governed by Florida law. The patient’s claims were governed by Illinois law. The parties conducted joint discovery.
The wife and patient deposed the prescribing physicians. Before expert designations were due and before the wife and patient deposed any of the manufacturers’ employees, the manufacturers moved for summary judgment. The United States District Court for the District of New Jersey stayed discovery pending its decision on the motion. Pursuant to F.R.C.P. 56(d), the wife and patient filed an affidavit stating that they sought “more information concerning the inefficacy of Plavix.” The court denied the request for additional discovery concerning Plavix's efficacy since it found that Plavix's efficacy was irrelevant under both Florida and Illinois law. The court granted summary judgment in favor of the manufacturers in both cases.
The wife and patient appealed. Both argued that the district court erred by denying their request for additional discovery. The wife also argued that the district court erred in granting summary judgment on her failure to warn and design defect claims.
The Third Circuit United States Court of Appeals affirmed holding that the district court did not abuse its discretion when it ruled on the manufacturer's summary judgment motion on the failure to warn claim before the expert reports were due as a manufacturer’s duty to warn physicians does not extend to warning about a drug’s efficacy, the estate was required to present expert opinion on the adequacy of warnings for the blood thinner, and the benefits of the blood thinner outweighed the known risks.
First, the court held that the district court did not abuse its discretion when it ruled on the manufacturers' summary judgment motion on the failure to warn claim before the expert reports were due. Generally, a district court may grant summary judgment before discovery is completed so long as the party opposing summary judgment has had an adequate opportunity to obtain discovery. If a party opposing summary judgment believes that he or she needs additional time for discovery of facts essential to justify its opposition, F.R.C.P. 56(d) specifies the procedure to be followed. The rule requires a party seeking further discovery in response to a summary judgment motion to submit an affidavit specifying what particular information is sought; how, if uncovered, it would preclude summary judgment; and why it has not previously been obtained.
The court reasoned that the estate and the patient’s affidavit sought only additional information from the manufacturers about the drug's efficacy. They did not submit an affidavit requesting additional time to obtain expert testimony about warnings. Because the estate and the patient did not submit a Rule 56(d) affidavit requesting additional time to obtain such expert testimony, the district court had no reason to lift the discovery stay or withhold deciding the summary judgment motion based on a potential need for expert testimony.
Next, the court determined that the wife’s failure to warn claim failed for two reasons. Under Florida law, a manufacturer's duty to warn physicians only extends to risks or dangers posed by the drug. The court held that this duty does not extend to warning about a drug's efficacy. Thus, the man’s physician's purported lack of information about Plavix’s efficacy was irrelevant to the estate's failure to warn claim against the manufacturers. The wife’s failure to warn claim also failed because she did not proffer expert testimony that the warnings were not adequate to warn a physician of the possibility that Plavix might be causing the condition experienced. Her expert witness provided no opinions about Plavix's label or the adequacy of its warnings.
Finally, the court determined that the wife’s design defect claim failed because the manufacturers established the affirmative defense that the benefits of Plavix outweighed known risks. Under Florida law, to invoke this defense, a seller must establish that: (1) the product's benefits must outweigh its known risks as of the date the product is distributed; (2) the product must be incapable of being made safe; (3) the product must be properly prepared and marketed; and (4) the product must be accompanied by a proper warning. On appeal, the wife focused on the first element of the defense, arguing that there is a genuine dispute as to whether Plavix's risks outweigh its benefits. The man’s family physician and cardiologist testified that considering the man’s ACS and complications, as well as the risks and benefits of Plavix, they believed Plavix with aspirin was an appropriate treatment for him. Additionally, a third medical expert, proffered by the wife to provide opinions concerning Plavix's efficacy and risks for certain patients, testified that for patients suffering from ACS, like her husband, Plavix provides a benefit that is relatively small but clear, and at no point stated that the risks of Plavix outweigh its benefits.
See: LaBarre v. Bristol-Myers Squibb Co., 2013 WL 6053840 (C.A.3 (N.J.), November 18, 2013) (not designated for publication).
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues
See also Medical Law Perspectives, October 2013 Report: Brain Aneurysm and Subarachnoid Hemorrhage: Failure to Diagnose, Delayed Diagnosis, Misdiagnosis
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication