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Plavix Decision Raises Questions About Learned Intermediary Doctrine

A federal judge in New Jersey recently granted summary judgment to Plavix drug makers Bristol Myers-Squibb Company (“BMS”), Sanofi-Aventis U.S., L.L.C., Sanofi-Aventis U.S., Inc., and Sanofi-Synthelabo, Inc. in a lawsuit alleging that plaintiff’s gastrointestinal bleeding was caused by defendants’ prescription drug Plavix.

Plaintiff alleged that she suffered injuries as a result of defendants’ design, development, manufacture, promoting, marketing, distributing, labeling, and sale of Plavix, an anti-clotting medication.

Plavix was initially approved by the FDA for individuals with recent heart attack, stroke (including Transient Ischemic Attack or “TIA”), or peripheral arterial disease. Plavix inhibits blood platelets from forming clots and therefore increases the risk of bleeding. Its labeling has included information about that risk.

Plaintiff’s complaint asserts product liability related causes of action under California state law, for defective design, manufacturing defect, failure to warn, and negligence.

Defendants argued that the learned intermediary doctrine precludes plaintiff’s failure to warn claim, because the manufacturers adequately warned the prescribing physicians of Plavix’s risks and had no duty to warn plaintiff individually.

The U.S. District Court for the District of New Jersey found that the learned intermediary doctrine barred plaintiff’s claims for failure to warn and design defect. The Court held that plaintiff failed to show that her physician would have made a different decision in terms of prescribing medication if the physician had been provided with additional information about the bleeding risk associated with Plavix.

In its decision, the District Court relied on California’s learned intermediary doctrine in granting summary judgment in favor of the drug companies. To overcome the learned intermediary doctrine on a summary judgment motion, plaintiff must present evidence to show that a non-disclosed risk would have changed the treating physician’s decision to prescribe the product and that the failure to warn the physician was a cause of plaintiff’s injury.

In the case, Chaiken v. Squibb (In re Plavix Mktg., Sales Practices & Prods. Liab. Litig.), there was no dispute that plaintiff’s two physicians testified that they considered the bleeding risks and that, even with additional warnings, they would have prescribed Plavix to plaintiff due to her aspirin intolerance.

Plaintiff’s opposition to summary judgment focused on a declaration that plaintiff’s neurologist made to plaintiff’s counsel — after the neurologist’s deposition and after defendants’ summary judgment motion was filed. In that statement, the physician related that, after having reviewed a clinical study (the “Chan study”) provided to him by counsel, he was of the opinion that Plavix should have included a warning about the risk of recurrent bleeding ulcers associated with Plavix and a placebo over aspirin and a proton pump inhibitor. Plaintiff then argued that this statement showed that the physician would have changed his decision to prescribe Plavix to plaintiff.

In applying the law of plaintiff’s home state of California, the District Court rejected plaintiff’s assertion. First, the Court found that a dispositive issue was simply whether the neurologist was the prescribing physician during the time period that led to plaintiff’s GI bleeding. In the case of prescription drugs, under California law, the duty to warn only applies to the prescribing physician. The neurologist treated plaintiff during her September 2011 hospitalization, and administered the initial dose of Plavix to plaintiff. He testified that plaintiff’s primary care physician was responsible to prescribe any medication after plaintiff was discharged.

Plaintiff’s discharge summary was clear that her primary care physician made an independent medical decision to prescribe Plavix to plaintiff. Two months later, in November 2011, plaintiff suffered GI bleeding. Thus, plaintiff’s primary care physician was the prescribing physician under California law. For purposes of applying the learned intermediary doctrine under California law, the prescribing physician testified that defendants sufficiently warned her of the risks of Plavix and that she would have prescribed Plavix to plaintiff even with the additional warnings proposed by plaintiff. Finding the prescribing physician concluded that the benefits of placing plaintiff on Plavix outweighed the bleeding risk, the Court rejected plaintiff’s “11th-hour submission” of the neurologist’s declaration.

In any event, since the neurologist was not the prescriber of the medication that led to plaintiff’s GI bleeding, the Court found that his statement did not raise a genuine issue of material fact on the learned intermediary analysis. The neurologist’s speculative statement as to what the treating physician might have concluded was insufficient to raise any doubt as to that testimony.

The Court concluded that plaintiff failed to show that her treating physician would have made a different prescription decision if presented with additional information about Plavix’s bleeding risk, i.e., the clinical study provided to the neurologist. In fact, the prescribing physician addressed that study in her deposition and explained why she found the study not to have any impact on her decision to prescribe Plavix. Accordingly, plaintiff failed to raise a genuine issue of material fact on causation. Plaintiff’s failure to warn claims were dismissed on summary judgment. Under California law, plaintiff cannot pursue a design defect claim when her failure to warn claim has been dismissed.

Again, this was a Multidistrict Litigation Court sitting in New Jersey, which was interpreting California law. There is some question as to whether the Court would have come to the same conclusion under the New Jersey Product Liability Act. Similar to California law, New Jersey law holds that a product is unreasonably dangerous if not accompanied by adequate warnings. New Jersey has also specifically codified the learned intermediary doctrine. See NJSA 2A:58C-4. Notwithstanding, the seminal New Jersey Supreme Court ruling in Perez v. Wyeth Lab., Inc., 161 N.J. 1 (1999), notes various exceptions to the doctrine, including: 1) evidence of either “deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects” or economically-driven manipulation of the post-market regulatory process will rebut a presumption of adequate warning; and 2) the doctrine does not apply in certain instances to pharmaceutical products that manufacturers market directly to consumers. The existence of the Chan study, coupled with the New Jersey courts’ traditionally more lenient application of the doctrine, could very well have led to a different outcome.

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About this Author

Stefanie Colella Walsh, Pharmaceutical Litigation Attorney, Stark Law Firm
Shareholder

Stefanie Colella-Walsh is a Shareholder and member of Stark & Stark’s Litigation, Insurance Coverage & Liability, Intellectual Property and Mass Torts Groups where she concentrates her practice in complex litigation with a focus in mass tort and pharmaceutical litigation. She also handles litigation related to nursing home negligence and abuse claims, elder abuse, and assisted living facility litigation.

Recently, Ms. Colella-Walsh was a member of the national trial team involved the first trial in the country of a TVT-Secur transvaginal...

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Martin P. Schrama, Stark and Stark Law, Commercial Litigation, Mass Tort Lawyer,
Shareholder

Martin P. Schrama is a Shareholder in Stark & Stark's Commercial Litigation, Mass Tort, Intellectual Property and Green Litigation Groups. Mr. Schrama has extensive experience litigating on both the trial and appellate levels of the federal and state courts of New Jersey and New York, as well as numerous other jurisdictions throughout the nation in a pro hac vice capacity. This experience also extends to regular practice before AAA, JAMS and various other alternate dispute resolution fora.

The primary focus of Mr. Schrama’s practice is complex civil litigation matters, with a concentration in mass tort/class action prosecution and defense, and complex commercial litigation. Mr. Schrama is currently co-lead trial counsel representing numerous plaintiffs in the mass tort environmental contamination case of In Re Bristol-Myers Squibb Environmental Contamination Litigation, Case No. 281. Mr. Schrama is also currently involved in representing numerous plaintiffs in mass tort pharmaceutical cases pending in the New Jersey Superior Court case of In Re Yaz®, Yasmin®, and Ocella® Litigation, Case No. 287; In Re Nuvaring® Litigation, Case No. 284; and In Re Depuy ASR® Hip Implants Litigation, Case No. 293. Mr. Schrama frequently writes about timely legal and legislative developments impacting plaintiffs in mass tort and product liability actions for Stark & Stark's Mass Tort Law Blog.

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