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Avoiding Physician Liability for Off-Label Use of Drugs and Devices

The increased level of enforcement activity by the FDA has focused the attention of consumers and the plaintiffs' bar on the increased frequency with which physicians prescribe FDA-approved drugs and medical devices for unapproved uses. Plaintiffs' attorneys increasingly choose to name prescribing physicians in their products liability suits as co-defendants, pleading both medical malpractice and other associated tort claims against these physicians, and often premising such claims upon the decision to prescribe for a so-called "off-label" or unapproved use. Thus, the continuing expansion of off-label uses of drugs and devices has led to numerous potential legal minefields for the prescribing physicians.

20 minute read October 28, 2010 at 12:24 PM
By
Lori G. Cohen and Sara K. Thompson
Avoiding Physician Liability for Off-Label Use of Drugs and Devices

Plaintiffs' attorneys continually seek new and novel ways to circumvent the defenses afforded to manufacturers of FDA-approved medical products, such as federal preemption and the learned intermediary doctrine.

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