According to the U.S. Food and Drug Administration (FDA), a generic drug is a medication created to be the same as an existing, approved brand-name drug. It is the same in dosage form, safety, strength, route of administration, quality and performance characteristics.
Generic drugs are used by millions of Americans across the country each day. They rely on them for the benefit of their health but as it turns out, if things go wrong it is difficult to hold a generic drug manufacturer responsible.
One might think that a product liability case against a manufacturer could handle an injury sustained from a malfunctioning generic drug, but it turns out it is not so simple. When it comes to generic drugs and the like, the warning labels that describe possible side effects and provide warnings can be enough to keep the manufacturer safe.
When it comes to bringing forth a successful product liability claim, consumers may direct attention to their side effect not being mentioned in the warning or the fact the warning label may not have been clear as to the drug’s potential dangers. It seems like a worthwhile route but unfortunately, a 2011 ruling made those routes somewhat ineffective.
It was the PLIVA, INC. v. Mensing that brought about the decision that basically says generic drug makers are not liable for injuries caused by their drugs. The case saw two plaintiffs looking to sue the manufacturers after the plaintiffs’ use of their drug led to the development of tardive dyskinesia, a serious neurological disorder.
When it was all said and done, the drug manufacturer argued they were not liable because it is close to impossible to comply with both federal and state laws. Since federal law, which are regulations set by the FDA, preempts state laws, and the manufacturer met those regulations, the court agreed to not hold them liable for the plaintiffs’ injuries.
This decision sets a dangerous precedent for all users of generic drugs, basically asserting that in the event you are injured or develop an illness by using a generic drug there exists no legal recourse where a drug manufacturer can be held responsible.
Still, that ruling should not keep you from making your case. Speaking with an attorney about your generic drug-related injury could provide you the right to pursue damages in the future, regardless of the 2011 decision.
In Alabama, the attorneys at the law office of Salter Ferguson, LLC, will do all they can to help you make your case. Those who left you injured should be held responsible for their actions and Salter Ferguson, LLC, has the tools and experience to do so.
The articles on this blog are for informative purposes only and are no substitute for legal advice or an attorney-client relationship. If you are seeking legal advice, please contact our law firm directly.