Prescription Drug Company Liability and the “Learned Intermediary Doctrine” – Muzichuck v. Forest Laboratories, Inc.

The “learned intermediary doctrine” is a legal principle that limits drugmaker liability in certain situation and has been recognized in some jurisdictions across the country. It holds generally that a pharmaceutical company isn’t required to warn each and every individual user of the risks associated with using its drugs, so long as it properly warns prescribing doctors (“learned intermediaries”).

perscription-drugs-2-1160103-m.jpgThe doctrine has already been generally rejected in West Virginia by the state’s highest court. In Muzichuck v. Forest Laboratories, Inc., a local federal court recently explained that the doctrine doesn’t apply even to cases in which the manufacturer doesn’t directly market the drug to end users.

Ms. Muzichuck filed suit against Forest Labs in state court in 2006, alleging that Lexapro – an antidepressant drug manufactured by the company – had caused her husband to commit suicide after being prescribed the drug. Mr. Muzichuck had recently been prescribed an increased dosage of the drug shortly before his death. The company later removed the case to federal district court. It also asserted a number of defenses, including that it shouldn’t be held liable as a result of the learned intermediary doctrine.

The West Virginia Supreme Court rejected the learned intermediary doctrine in a pivotal 2007 ruling in Johnson & Johnson v. Karl. That case was brought on behalf of a person who died suddenly, three days after being prescribed a drug called Propulsid for digestive problems.

Denying the drugmaker’s claim that it wasn’t liable because it satisfied its duty to warn the deceased person’s physician, the high court noted in Karl that a number of exceptions had already been made to the learned intermediary doctrine, leaving the doctrine itself of questionable value. “[I]f drug manufacturers are able to adequately provide warnings to consumers under the numerous exceptions…, then they should experience no substantial impediment to providing adequate warnings to consumers in general,” the court concluded. As a result, the court said drugmakers are generally under the same duty to warn consumers about risks associated with their products as other manufacturers.

Here, however, Forest Labs argued that the doctrine should nevertheless apply because the company didn’t directly market Lexipro to patients. Instead, the company worked with doctors to make them aware of the drug, its benefits, and its risks. But the District Court noted that the Supreme Court didn’t distinguish between drugmakers who directly market to end users and those who don’t in rejecting the doctrine in Karl. As a result, the District Court said the ban on using the doctrine as a defense set forth in Karl “applies squarely to prohibit the defense” in this case. The Court granted Muzichuk’s motion to strike the defense.

The Wolfe Law Firm has been serving clients throughout the state in pharmaceutical and other personal injury cases for more than 25 years. Located in Elkins, West Virginia, the firm represents clients in a wide range of injury, criminal defense, and bankruptcy matters. Call us at 1-877-637-5756 or contact us online for a free consultation.

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