FDA’s Rule Pre-empting State Law Failure-to-Warn Claim is Rejected

On July 3rd, the Vioxx multidistrict litigation court held that the Food and Drug Administrations (FDA)’s rule preempting state products liability law suits against drug companies in failure-to-warn claims is not persuasive. The court also stated that FDA cannot assume that Congress intended to override the long-standing presumption against preempting state law.

The court’s ruling is a victory for consumers injured by medicines that they claim are inaccurately labeled. Though issued in litigation pertaining to Vioxx, the ruling may also end up being applied to Avandia as cases are brought and move forward.

The FDA’s preemption theory is found in … Read the rest

Avandia, a Drug for Diabetes, Another Vioxx?

Reminiscent of Vioxx, which Merck pulled off the market in 2004 after it was shown to cause heart attacks in some patients, an analysis to be published in the New England Journal of Medicine found that Avandia, a widely used pill to treat adult-onset, or Type 2, diabetes, raises the risk of heart attack by 43 percent.

Over a seven-year period, taking Avendia raises the chance of a diabetic having a heart attack from 20.2 to 28.8 percent, meaning that possibly tens of thousands of people had heart attacks as a result of taking the medication. The U.S. Food and … Read the rest