Are generic drug manufacturers liable for injuries to consumers?


Millions of prescriptions made by generic drug manufacturers are filled every day. Statistics indicate that more than 80% of all prescription drugs are generics. A reader has asked us if generic drug manufacturers can be held liable for injuries that consumers experience as a result of taking generic brands. However, the Supreme Court set a precedent in 2011, when it issued a ruling in the Pliva v. Mensing case which made generic drug manufacturers not liable for the injuries that might be caused to consumers.

How Does A Drug Product Liability Claim Work?

Product liability is when a consumer is harmed by a dangerous or defective product and it can be grounds for establishing personal injury case. Product liability also applies to products that are ingested, such as food and prescription drugs. In most cases, product liability is seen as a strict liability type of tort case. This means that drug makers are responsible for any defect and dangerous action of the drug, regardless if the manufacturer was negligent or not. However, drug liability cases require an additional theory of liability since most prescription drugs have clear warning labels to inform consumers beforehand. Some alternative theories that have been used by lawyers include those when the side effect experienced by the consumer was not indicated on the warning, when the manufacturer was caught advertising it’s product for off-label use or if the warning label was not explicitly clear in the danger the drug posed to the consumer.

How the Pliva v. Mensing Case Changed Things

The decision of 2011 is rather complex, but in short it stated that generic manufacturers are immunized from liability of the injuries caused by their products. One of the reasons for this decision is that in order for a plaintiff to have a case against the pharmaceutical company, he/she must sue the drug maker under state laws, which happen to be more strict than even the FDA’s regulations. This is in part because the FDA, being a federal agency, has already approved the generics under federal law. Because federal law usually takes precedence over state laws, the generic companies that were being sued appealed the liability, saying that that they couldn’t comply with both state and federal laws (as they don’t decide the composition of the drug — that is solely the responsibility of the brand name) and therefore the FDA regulations, that is the federal law, should preempt state laws. The Supreme Court agreed, leaving millions of Americans defenseless against pharmaceutical companies whose generic drugs harmed them.

Plaintiff’s attorneys are looking for a solution that would allow plaintiffs a way by which they can have their grievances heard in the pending case.

Don’t Give Up Hope

Despite this ruling, if you suffered injuries as a result of using a generic prescription drug, you should still speak to a personal injury attorney. Even if the Supreme Court’s decision changes, product liability claims have a narrow time frame in which they can be used as a claim against drug manufacturers. This depends on the state in which you’re situated, and if you don’t act soon, the statute of limitations might prevent you from filing a drug liability claim.