Recently in Reglan Category

December 13, 2010

Supreme Court Agrees To Hear Generic Reglan Drug Label Suit

The U.S. Supreme Court has agreed to hear argument over whether generic drug makers can be sued for the failure to warn about dangerous side effects on their drug label even when they follow federal rules.

In PLIVA, Inc. v. Mensing a woman took metoclopramide - the generic equivalent of Reglan - for four years to fight diabetic gastroparesis. She claims that the drug caused a severe neurological movement disorder - tardive dyskinesia - not warned about by the drug's manufacturers and distributors.

The 8th U.S. Circuit Court of Appeals found in favor of the woman, noting that more should have been done to warn consumers about possible risks. The court reasoned, "If they realized their label was insufficient but did not believe they could propose a label change, they could have simply stopped selling the product. Instead they ...placed a drug with inadequate labeling on the market and profited from its sale."

The FDA has now required Reglan to add warnings about tardive dyskinesia in February 2009.

The Supreme Court will hear argument in the spring.

Continue reading "Supreme Court Agrees To Hear Generic Reglan Drug Label Suit" »

July 20, 2010

Manufacturers of dangerous drugs should not be immune from liability

The Sixth Circuit Court of Appeals has recently submitted a question to the Food and Drug Administration requesting a response to its position on immunity. At issue is the claim by manufacturers that because the FDA regulates prescription drugs, once the drugs they make have received FDA "approval," drug manufacturers cannot be held liable for the harm - sometimes life threatening - these products cause.

In the landmark case, Wyeth v. Levine, the U.S. Supreme Court determined that federal regulation of prescription drug labels does not grant manufacturers liability.

Makers of Reglan, a generic drug used to treat Gastroesohageal reflux (GER) and Gastroesophaegeal reflus disease (GERD) are now trying to use preemption arguments to avoid liability for harm caused by use of their dangerous products.

Reglan poses the threat of developing Tardive Dyskinesia (TD), a disabling and permanent movement disorder often characterized by shaking spells, blinking and slurred speech. Users have claimed that the generic drug's label failed to warn consumers of the risks of use.

Last year, the Eight Circuit determined that generic manufactures must provide warnings, even if the name-brand drug label doesn't contain the warning.

Continue reading "Manufacturers of dangerous drugs should not be immune from liability" »