Victory for Patients Injured By Defective Drugs; Supreme Court Upholds Right to Sue Drug Companies
In a major victory for people who have been injured or killed by defective drugs, the U.S. Supreme Court has ruled that drug companies are not immune from state personal injury lawsuits.
By a 6-3 vote, the nation’s highest court ruled on March 4, 2009 that Food and Drug Administration approvals of a drug’s labeling do not pre-empt state laws or protect drug companies from liability lawsuits filed by injured patients.
Wyeth Challenged Jury Award
Wyeth, one of the world’s largest drug makers, had challenged a $6.7 million jury award to Diana Levine, a guitarist who lost part of an arm to infection after she was given the company’s anti-nausea drug, Phenergan, during treatment for a migrane.
Wyeth argued that since Phenergan’s labeling had been approved by the FDA, the company could not be sued in a state court for injuries. Wyeth claimed the legal principle of preemption, which says that federal laws pre-empt conflicting state laws, shielded the company from such state lawsuits.
But the Supreme Court sided with Levine and issued a landmark legal ruling that paves the way for thousands of other personal injury claims relating to injuries caused by defective drugs to move forward.
“The question we must decide is whether the FDA’s approvals provide Wyeth with a complete defense to Levine’s tort claims. We conclude that they do not,” Justice John Paul Stevens concluded in the court’s majority opinion.
Joining Stevens in the majority were justices Anthony Kennedy, David Souter, Ruth Bader Ginsburg, Stephen Breyer, and Clarence Thomas, who joined the majority under a different line of legal reasoning. Chief Justice John Roberts Jr. and justices Antonin Scalia and Samuel Alito dissented.
Stronger Warnings Needed
Wyeth, represented in court by the U.S. Justice Department under then-President George W. Bush, had argued that the FDA knew of the drug’s risks and benefits and instructed the drug maker to how to word the product’s labeling. Wyeth said the company could not change the warnings on the label without further FDA approval.
The U.S. drug industry has been fighting for years to be shielded from state personal injury lawsuits, which have resulted in large, multi-million-dollar jury awards for injuries caused by defectively dangerous drugs.
The court supported Levine’s position and agreed that Wyeth should have included stronger warnings about how to administer Phenergan. Hospital officials who administered the drug to Levine used a method, called IV push, which resulted in an infection, forcing physicians to later amputate one of her arms above the elbow.
The majority of justices held that there is no evidence that the FDA would have rejected stronger warnings against using IV push to adminster Phenergan if Wyeth had proposed doing so.
A Great Day for Patients’ Rights
People injured by FDA approved drugs should circle March 4, 2009 on their calendars as the day their legal rights were upheld. The Supreme Court strongly supported patients’ rights by holding that drug companies are not immune from state personal injury lawsuits for injuries caused by defective drugs. As a result, countless people will now get their day in court to seek financial compensation and justice for their injuries caused by defectively dangerous drugs.
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