Generic drugs are often offered as an alternative to the name brand medication when consumers go to their pharmacists. Generics are drugs that are identical to the original drug but are offered at a much lower price. The lower price makes the generics much more acceptable to insurance companies than the name brand.
Manufacturers don’t lower the price out of the kindness of their heart. Rather, they usually sell their formula for the medication to another company (the one that will sell the generic drug) for a high price.
Normally, when a manufacturer of a medication makes a drug that is defective and the defect causes death or injury, the injured person has the right to hold the manufacturer strictly liable. The legal premise for holding the manufacturer liable for defective drugs is called product liability. Strict liability means there is no requirement to show negligence. Showing the defect and the harm from the defect ae the key essentials. The theory behind product liability cases is that the manufacturer (of the drug) is in the best position to insure its safety.
The problem for many consumers is that they aren’t injured by the brand name/original drug because they’re taking the generic drug. So, the question that arises is – can the manufacturer of the drug be held liable if someone is hurt or dies because they took the generic drug. Remember, the generic is based on the same formula as the one the manufacturer developed.
Current case law and theories
The litigation issues involving holding manufacturers liable are incredibly complex.
- Numerous questions. The question about holding the manufacturer begins with which manufacturer is to blame. There’s the generic manufacturer of the drug and the manufacturer of the original brand name product. There are other tricky questions too. Who controls the labels on the drugs is a factor. How is the product marketed and who controls the marketing? What side effects need to be disclosed.?
- A controlling case. The Pliva v. Mensing 2011 decision. Here, the court held that generic manufacturers weren’t liable for patient injuries due to the use of the generic medication. In a complicated case, the court ruled that state laws need to be used to hold the generic manufacturer liable. The problem is that generic drugs are normally approved by the Federal Drug Administration (FDA) and federal law trumps state law. So, if the FDA approved the drug, then that federal approval trumps any state decision that could be made about the generic manufacturer’s liability. Essentially, the court decided that a generic drug manufacturer wouldn’t be able to meet both the FDA requirements and the state law requirements – so priority is given to the FDA requirements.
- Additional arguments. There are other theories and arguments the plaintiff’s lawyers are trying to use to hold generic and original manufacturers liable. One such theory is called “innovator liability.” This theory asserts that the original manufacturer, the original innovator, should be liable if the warnings on the labels of the generic drugs were defective.
- Additional cases. Litigation is taking place throughout the country at the state and federal level. The FDA is trying to address the issue.
The Mississippi medical product liability attorneys at Merkel & Cocke, P.A. understand the applicable federal and state laws and court decisions. We fight to hold manufacturers liable when their defective products cause harm or death. If a drug you were prescribed made your feel ill or a loved died, after taking a prescribed mediation, you need help. For immediate help, call us today at 662-627-9641 or complete our contact form to schedule a free consultation in Jackson, Oxford or Clarksdale.