pharmaceutical injuries

Sen. Mary Landrieu Examines Mensing Decision, Urges FDA to Offer Consumers Proper Protection

By on March 11, 2013 - Comments off

United States Senator Mary L. Landrieu has drawn attention to and taken a stand for consumer protection in regards to the safety of generic drugs through proper labeling and labeling changes for making side effect risks known. The American Association for Justice (AAJ) worked with Sen. Landrieu’€™s office to complete the letter, which was given to Dr. Margaret Hamburg, the Commissioner of the U.S. Food and Drug Administration (FDA), on February 15, 2013. As consumer advocates, the mass tort lawyers at Robinson Calcagnie Robinson Shapiro Davis, Inc., are pleased with and support Sen. Landrieu’€™s efforts.

One of the main points of the letter highlights that as the regulatory framework exists now per the recent decision by the United States Supreme Court in Pliva, Inc. v. Mensing, consumers are not being offered appropriate protection. The letter urges the FDA to call for new regulations that will concentrate on the problematic aspects of the Mensing decision. Overall, Sen. Landrieu is asking the FDA to allow for generic drug manufacturers to initiate alterations to a drug’s approved labeling through the Changes Being Affected process and Prior Approval Supplement process.

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Punitive Damages: Failure To Warn

By on May 25, 2011 - Comments off

Johnson & Johnson v. Superior Court, (Second District, January 20, 2011) — Cal.Rptr.3d —-, 192 Cal.App.4th 757, 2011 WL 169407, 11 Cal.Daily Op. Serv. 1918, 2011 Daily Journal D.A.R. 2268
A boy who developed a serious skin condition as a result of a severe adverse reaction to an over-the-counter (OTC) pain reliever filed a products liability action against the manufacturer of the drug and its parent company, alleging that the defendants had failed to provide adequate warnings of the risks to consumers. The plaintiffs complaint asserted a claim for punitive damages, contending that the defendants had long known of the risk of the syndrome suffered by the plaintiff, but had misrepresented study results to the FDA in obtaining approval for the drug.

The Defendants moved for summary adjudication of the punitive damages claim, arguing that the product’s label had been approved by the FDA consistent with FDA regulations, and that regardless of whether they could or should have said something more explicit, their “FDA-approved labeling cannot conceivably evidence despicable conduct or a conscious disregard for safety.” The trial court denied the motion, and the Court of Appeal denied the defendants’ petition for a writ of mandate, holding that the evidence raised a triable issue of fact as to whether the manufacturer failed to warn, and whether there was a conscious disregard for safety: Read the rest »