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From Products Liability Law Daily, December 14, 2015

Sufferer of known, warned-of side effect finds no relief on appeal

By Kayla R. Bryant, J.D.

The dismissal of a patient’s claims against the manufacturer of ORTHO EVRA® birth control patch was proper according to a decision by the U.S. Court of Appeals for the Sixth Circuit. The patient had alleged that the product caused her to have a stroke. The appellate court dismissed all five of the patient’s claims against Ortho-McNeil-Janssen Pharmaceuticals, Inc., Alza Corporation, and two Johnson & Johnson companies after finding that the companies’ warnings regarding the product’s risks were deemed adequate and that there was no evidence that the patch the patient used was defective (Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., December 11, 2015, Gibbons, J.).

Background. The patient originally sought contraceptives in November 2004. During this appointment, she was counseled by a physician assistant (PA) about various types of contraceptives, including their risks and benefits. The PA testified that it would have been her usual practice to advise the patient that all of the methods of birth control carried risks, including breakthrough bleeding, headaches, nausea, blood clots, and stroke, among others. The patient admitted that she was counseled concerning the risk of a stroke and clotting associated with ORTHO EVRA. She chose one type of treatment involving injections, and then, after experiencing unwanted side effects, returned to the PA several times in the spring of 2005 to facilitate a switch to the ORTHO EVRA patch. She was given a sample of the patch on April 15, 2005. She first used the patch two days later and experienced a stroke April 24, 2005.

Warnings. The package insert for the patch contains warnings of various risks, including an increased risk of stroke. New York law, which governs in this case, extends the manufacturer’s duty to warn to the treating physician under the learned intermediary doctrine. The appeals court found that the patient’s failure to warn claim was properly dismissed on the grounds that the PA was well aware of the risk of a stroke and that she counseled the patient about these risks.

Design and manufacturing defects. The patient also brought a state law claim alleging that the patch’s design was defective. However, the court of appeals found that none of the companies owed the woman a duty to design the patch differently because the product was approved by the Food and Drug Administration (FDA). Therefore, the patient’s claim was preempted under federal law, as there was no way to simultaneously comply with federal law and an alleged New York state law duty to design a safer drug prior to submission for FDA approval. In addition, her claims for negligence and breach of implied warranty were preempted under New York case law.

The woman also claimed that her patch was defectively manufactured. The district court found no evidence that her specific patch differed from other patches or manufacturing specifications. The appeals court reviewed the patient’s assertion that the companies experienced difficulties increasing production from clinical trial amounts to commercial production amounts, noting that the only evidence of this allegation came from an expert witness’s opinion that the companies did not comply with good manufacturing practices. The appeals court ruled that a side effect that is known and for which a warning has been issued cannot be used as a basis for a manufacturing defect claim.

The case is No. 15-3104.

Attorneys: Daniel G. Tronolone (Tronolone & Surgalla, PC) for Stephanie Yates. Julie A. Callsen (Tucker Ellis, LLP), Jennifer La Mont (Drinker Biddle & Reath LLP) and John D. Winter (Patterson Belknap Webb & Tyler LLP) for Ortho-McNeil-Janssen Pharmaceuticals, Inc., Alza Corp., Johnson & Johnson Pharmaceutical Research & Development, LLC and Johnson & Johnson.

Companies: Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Alza Corp.; Johnson & Johnson Pharmaceutical Research & Development, LLC; Johnson & Johnson

MainStory: TopStory CourtDecisions PreemptionNews DesignManufacturingNews WarningsNews DrugsNews KentuckyNews MichiganNews OhioNews TennesseeNews

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