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FDA Approval Not a Shield from Damages

On March 4th the U.S. Supreme Court decided a case in favor of consumer rights, one that has the potential to reach further than first appearance. In the case of Wyeth v. Levine the Court upheld a $6.7 million verdict in which the jury found that Wyeth’s label had inadequate warnings, thus ruling against the drug manufacturer Wyeth. In doing so, the court allowed state juries to award damages for harm done by unsafe drugs, even in cases where the drugs had been approved by the Food and Drug Administration (FDA).

In 2000, Ms. Levine, attended a health clinic for treatment of a migraine, received Phenergan® via IV-push (despite the warnings) directly into a vein, reaching an artery and causing gangrene. She eventually lost her arm. She had previously settled with the clinic.

Wyeth had argued that Ms. Levine was preempted from suing because Phenergan® was FDA approved. They argued that FDA approval freed Wyeth from liability for damages caused by the drug. Unlike certain medical device cases (see Riegel v. Medtronic) in which federal statutory law expressly barred certain state claims, in this case Wyeth relied on what could be termed an implied preemption from the federal approval, not on any express language in a statute enacted by Congress. Wyeth claimed in part that it could not comply with its state law duties of providing clear instruction and stricter warnings on the label or the federal labeling requirements.

The Court disagreed (6-3) and may have opened the door for more products liability lawsuits, or a flood of companies seeking direct regulation and protection. Drug companies and other businesses have sought federal regulation believing it would shield them from liability damage caused by their products.

For the Certified Legal Nurse Consultant this helps widen the field of products liability cases to include those products that are not specifically exempted by federal statute. Both plaintiff and defense will have plenty to keep busy for years after this case. Remember as a legal nurse consultant, your job is not to know the law, but to know what caused the injury, its extent and how it could have been prevented.

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*The opinions and statements made by Vickie Milazzo, the founder of Medical-Legal Consulting Institute, Inc. are based on her experiences and expertise, should not be applied beyond the specific context provided, and do not guaranty or project actual results. Vickie Milazzo is no longer involved in the operations or management of the business, but is involved as an independent education consultant.

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