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From Products Liability Law Daily, June 24, 2014

Ortho Evra® maker’s warnings okay, design defect issues remain

By Pamela C. Maloney, J.D. and Lisa A. Weder

A Georgia mother’s negligent failure-to-warn claim filed on behalf of her deceased daughter as part of a class action suit against the makers of a birth control patch failed, a federal district court in Ohio ruled. However, the manufacturer’s motion for judgment on the pleadings with regard to the mother’s design defect, manufacturing defect, and intentional infliction of emotional distress claims was denied (Booker v Johnson & Johnson, June 23, 2014, Katz, D.).

Background. Donna Booker's minor daughter, Raissa Booker, was prescribed Ortho Evra®, which was manufactured by Johnson & Johnson, as a means of birth control. The daughter used the patch for less than a year when she died from pulmonary embolism. Her mother claimed that she had not been adequately warned of the patch's risks, stating that the manufacturer failed to use specific language from a 2011 FDA study in its risk pamphlet. The manufacturer moved for summary judgment on the failure-to-warn claims, stating that the mother’s claims were barred because the prescribing physician knew the risks associated with using the patch when she prescribed the patch to Raissa. The manufacturer also moved for summary judgment on the mother’s remaining claims, including negligence, breach of warranty, fraud, design defect, manufacturing defect, and intentional infliction of emotional distress.

Failure to warn. In support of its motion, Johnson & Johnson cited Georgia’s learned intermediary doctrine, which mandates that risks associated with products must be relayed to the prescribing physician and not the patient. The doctor, therefore, serves as an intermediary between the manufacturer and the patient. In this case, the prescribing physician testified that she was aware of the product's risks for blood clots and pulmonary embolism and admitted that she was aware of a 2009 risk pamphlet which warned of possible pulmonary embolism. According to the physician, she felt that the product's benefits outweighed its risks. Because the doctor was aware of the risk, the patient was deemed to have been warned of the risk as well, and, therefore, the failure-to-warn claim could not stand. Johnson & Johnson’s motions for summary judgment on the mother’s negligence, breach of warranty, and fraud claims were likewise granted on the basis of the learned intermediary doctrine.

Other claims. The court denied the manufacturer’s motion for judgment on the pleadings with regard to the design defect, manufacturing defect, and intentional infliction of emotional distress claims. According to the court, the mother successfully pleaded the existence of a feasible alternative design and deviations resulting in a manufacturing defect.

The case number is 3:12 oe 40000.

Attorneys: Amanda H. Kent (Girardi & Keese) for Donna Booker. Julie A. Callsen (Tucker Ellis) for Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development, LLC, and Ortho McNeil Pharmaceutical, Inc.

Companies: Johnson & Johnson; Johnson & Johnson Pharmaceutical Research & Development, LLC; Ortho McNeil Pharmaceutical, Inc.

MainStory: TopStory WarningsNews DesignManufacturingNews DrugsNews OhioNews

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