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From Products Liability Law Daily, July 16, 2014

Learned intermediary defense not available in West Virginia to pharmaceutical makers

By John W. Scanlan, J.D.

An anti-depressant drug maker’s affirmative defense based on the learned intermediary doctrine was stricken by the U.S. District Court for the District of West Virginia because this defense was not available to pharmaceutical manufacturers in that state (Muzichuck v. Forest Laboratories, Inc., July 15, 2014, Keeley, I.).

Background. Bruce Muzichuck had recently been prescribed an increase in his dosage of the anti-depressant drug Lexapro when he committed suicide in 2004. His wife Tammy Muzichuck brought claims in West Virginia state court for negligent failure to warn, strict liability, fraud, wrongful death, breach of implied warranty, and punitive damages against Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (together, Forest), the manufacturer of Lexapro. Forest removed the case and asserted several affirmative defenses, including the “learned intermediary doctrine.” In 2007, the case was consolidated for pre-trial proceedings as part of multidistrict litigation involving Lexapro; in 2013, it was remanded to the District of West Virginia. Tammy Muzichuck moved to strike the learned intermediary doctrine defense from Forest’s answer, asserting that the West Virginia Supreme Court held in West Virginia ex. rel. Johnson & Johnson v. Karl that this defense did not exist in the state’s substantive law; Forest argued that the holding of Karl was limited to cases involving direct-to-consumer advertising, and also that this doctrine did not violate the state’s public policy.

Direct-to-consumer advertising rationale. The court found that the learned intermediary doctrine applied in cases when a pharmaceutical company did not market its drug directly to consumers because the case law in West Virginia did not draw this distinction. Although federal courts had speculated prior toKarl that the West Virginia Supreme Court would adopt the learned intermediary doctrine, the state high court refused to do so. In Karl, the state high court reasoned that adopting the learned intermediary doctrine also would require adopting the “plethora of exceptions” that went along with it; if manufacturers could adequately warn consumers under these exceptions, they should have no problem providing adequate warnings generally. The court also stated that it was reasonable to require prescription drug manufacturers to provide appropriate warnings to the ultimate users of their products because they benefit financially from the sale of prescription drugs and consumers bear the risks of using them.

Forest relied upon two post-Karl federal cases: one in which the court believed that the holding of Karl did not mean that West Virginia would reject the “sophisticated user” defense and one in which the court based its dismissal of a claim based on the learned intermediary doctrine on its belief that Karl was based upon a direct-to-consumer advertising rationale and Karl did not discuss this doctrine in the context of a pharmacist’s duty to warn. However, the present court found that Karl did not distinguish between cases that involve direct-to-consumer advertising and those that do not, and neither of the two cases upon which Forest relied recognized such a distinction in the context of a prescription drug manufacturer asserting the learned intermediary doctrine. The first case involved the sophisticated user defense as it applied to a worker for a chemical manufacturer, and the second case involved a retail pharmacy rather than a pharmaceutical manufacturer such as in the present case and in Karl. Both cases cited by Forest explicitly recognized that Karl prohibited drug manufacturers from asserting the learned intermediary doctrine as a defense, the court observed.

Public policy. Other post-Karl cases determining that the prohibition of the learned intermediary defense to drug manufacturers was also grounded in the state’s public policy were not wrongly decided, the court ruled. Contrary to Forest’s argument, recent West Virginia legislation on “Choice of Law in Pharmaceutical Product Liability Actions” had not “gutted” Karl but simply provided a choice of law rule for liability actions filed after July 1, 2011, involving prescription drugs and plaintiffs who were not residents of the state. The court further stated that the new legislation would not apply because the present action was filed several years before the effective date of the new law, and finally concluded by stating that even if it was applicable, the state’s substantive product liability law would nevertheless apply because the plaintiff’s husband’s suicide had occurred in West Virginia.

The case number is 1:07CV16.

Attorneys: Adam L. McCoy (Manchin Injury Law Group, PLLC), and Christopher L. Coffin (Pendley, Baudin & Coffin, LLP) for Tammy Muzichuck. Allen M. Lopus (Clark Hill Thorp Reed), and Cash H. Mischka (Ulmer & Berne LLP) for Forest Laboratories, Inc.

Companies: Forest Laboratories, Inc.

MainStory: TopStory WarningsNews DefensesLiabilityNews DrugsNews WestVirginiaNews

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