Drug Label No Defence For Wyeth Says Supreme Court

Featured Article
Main Category: Litigation / Medical Malpractice
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 05 Mar 2009 - 3:00 PDT

email to a friend   printer friendly   view / write opinions

The US Supreme Court ruled in favour of a female musician who had to have part of her right arm amputated after a migraine injection went wrong and who sued the drugmaker Wyeth; the court said the Food and Drug Administration (FDA) approval of the drug label was not sufficient defence and voted 6 to 3 to uphold the state court ruling to award her 6.7 million dollars.

The hight court ruling on Wednesday means that drug companies can be held liable for harm caused by drugs that carry labels approved by federal regulators, and that such approvals do not pre-empt state laws and protect manufacturers from damages, said Reuters.

According to the news agency, the woman's lawyers had argued that Wyeth should have given stronger warnings of the dangers of administering the drug wrongly.

Diane Levine, a musician from Vermont, had to have part of her right arm amputated after gangrene set in following a wrongly administered injection of Wyeth's anti-nausea drug Phenergan which she was receiving as part of treatment for a migraine. The drug ended up in an artery.

Justice John Paul Stevens said:

"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."

Stevens said the majority ruling rejected the argument put by Wyeth and the Bush administration that the FDA approval of the label in 1955 pre-empted claims under state law.

The 1955 approved label warned doctors to be very careful about using the drug in injected form, but it did not prohibit them.

In the 26-page majority ruling, Stevens said that under federal law and FDA regulations, the drug company is responsible at all times for the content of its labels.

The judge said that the FDA had limited resources to monitor the 11,000 or so drugs on the market and drug companies had "superior" access to the information about the drugs anyway, especially once they have been launched on the market and new risks emerge.

Three of the judges disagreed. According to a report by Reuters, Chief Justice John Roberts and justices Antonin Scalia and Samuel Alito were of the view that the case was a good example of tragic facts making bad law.

Alito wrote that neither FDA regulations nor federal law imply that juries may "second guess the FDA's labeling decisions".

63-yearl old Levine, a professional musician who played the guitar, piano and bass, went to a clinic in Plainfield, Vermont, in 2000 seeking treatment for a migraine. According to the Associated Press (AP) she was given painkillers and an intramuscular injection of Phenegarn. She still felt nauseous and was given a second injection of the drug administered as an "IV-push".

This second injection accidentally punctured an artery, said the AP report, and her arm developed gangrene. She had to have it amputated a few weeks later.

Levine told reporters that the amputation took away her "whole musical identity".

"I'd been playing music for 30 years, working with kids, writing songs. I played guitar, piano, bass in a rock band. I couldn't do any of those things anymore," said Levine, according to an AP report.

Judge Stevens said the drug maker could have decided of its own accord to add a stronger warning about the IV-push administration to the label and there was no evidence that the FDA would have rejected the revision.

"Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness," said Stevens in the majority opinion.

The San Francisco Chronicle reported that consumer groups and Democratic lawmakers welcomed the high court decision as a victory for patients and a rejection of the federal pre-emption position supported by the Republican administration of former President George W Bush.

A spokesman for the pharmaceutical industry said that the ruling could prove harmful.

"Patients could ultimately suffer if the Supreme Court's decision forces healthcare providers and patients to second-guess FDA-approved labeling," Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America told Reuters.

Pfizer Inc who have agreed to purchase Wyeth expressed disappointment with the ruling. In a prepared statement the company said that:

"Due to its medical and scientific expertise, the U.S. Food and Drug Administration is the best authority to weigh the benefits and risks of prescription medicines and to ensure that those benefits and risks are being appropriately communicated in product labels."

When told of the decision Levine said this was the next best thing to getting her arm back.

Click here to read the 26-page US Supreme Court court ruling: Wyeth vs. Levine, 06-1249 dated 3 March 2009 (opens as PDF).

Sources: Reuters, Associated Press, San Francisco Chronicle.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today