As addressed periodically on this blog, powerful drug companies such as Baxter, have advocated for complete immunity from the majority of suits involving unsafe medical drugs and devices under a legal concept called “preemption.” Specifically, they have argued that regardless of misconduct or failures on their part, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA.

It looked like for a time, the drug companies were winning in this battle against victims harmed by their defective drugs. This was particularly true a little over a year ago in February 2008, when the United States Supreme Court severely curbed the rights of injured victims in the case of Riegel v. Medtronic, which held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA. (The harsh effects of this decision are now being sought to be reversed in a bill sponsored by Congressmen Pallone and Waxman.)

The United States Supreme Court then accepted a case, Wyeth v. Levine, that involved the labeling of a medical drug. Until this morning, the case had not been decided.
In the case, Diana Levine, a professional musician, went to the hospital to treat a migraine headache. However, after being injected with a drug manufactured by Wyeth, she was left with injuries that led quickly to the amputation of her right arm, harming her profession and lifelong passion to be a musician. The drug, Phenergan, was given to Ms. Levine using a method of administration that was permissible under Wyeth’s label instructions. However, Wyeth knew for decades that this method increased risk of contact with arteries and serious injuries, and specifically chose not to warn the medical community and the public of this danger.

After a trial in the case, a Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein. However, the drug company appealed and, backed by the Bush administration, argued that since the FDA had approved the drug’s labeling instructions, victims such as Ms. Levine are barred (i.e. “preempted”) from being able to hold them accountable, even where the company knew its warnings were not adequate.

In a 6-3 decision released this morning, the United States Supreme Court rejected Wyeth's claim that federal approval of its drug should have shielded the drug company from lawsuits like the one filed by Ms. Levine.

This is an important victory, particularly for the injured Americans who will not be denied their constitutional to seek and obtain justice in a court of law.

A copy of the decision is available by clicking here.

Labels: Baxter, Baxter Heparin, China, Heparin, heparin attorney, heparin lawsuit, Levine, OSCS, Pallone, preemption, Waxman, Wyeth