Brand-name drug makers to be liable for generic dangerous product

On Behalf of | Jun 18, 2014 | Products Liability

Residents of Florida likely use, or know someone who uses, prescription drugs. Head to any Panama City drug store and you’ll find brand-name medications and many corresponding generic versions. An interesting ruling by a federal appeals court this week may change how victims of a dangerous or defective drug can file a products liability action to seek compensation for a loss.

Current Food and Drug Administration regulations require generic drug makers to keep brand-name manufacturer labels intact on their products. Even if the generic drug maker learns of a safety concern, the brand-name drug maker must change its warning label first.

The FDA has proposed a new rule, not yet approved, that would allow generic drug makers to independently change labeling. Generic drug makers are fighting the FDA’s proposal, however, citing fear of increased liability.They are reportedly upset that they should be held responsible for personal injury lawsuits based on consumption of a drug they didn’t manufacture.

According to the U.S. Supreme Court, makers of generic drugs can’t be liable for harm to consumers. For this reason, many injured parties are looking to sue the brand-name drug makers. Thus far, these companies have managed to avoid most liability. The appeals court ruling may change that going forward. It denied one company’s request to dismiss a lawsuit filed by the widow of a suicide victim. She claims he took his own life after taking the generic version of Paxil, an antidepressant.

Allowing the case to proceed supports the argument that although the company didn’t produce the generic drugs, because it was responsible for the labeling, warnings and design, any fix of a problem would impact both the brand-name and the generic drug equally.This lawsuit is not the only one involving the issue.

Product liability questions and claims are complex and require knowledgeable, in-depth evaluation. An effective presentation in court, combined with a sound strategy that includes the appropriate parties to the lawsuit, will help in seeking compensation for victims of defective or dangerous pharmaceuticals.

Source: The Wall Street Journal, “A Case of Mistaken Identity? Glaxo Faces a Lawsuit Over Generic Liability” Ed Silverman, Jun. 06, 2014


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