Beware of Generic Drugs, You May be Forfeiting Your Rights

Written By Mark Atlee

Currently, generic drugs account for 75%-90% of all prescription drugs consumed in the US.  More often than not prescriptions are filled by a pharmacist using a generic drug without the patient’s knowledge.  This is can be due to the pharmacist assisting in providing the cheapest option or because the insurance mandates a generic option be used if available. Regardless of the reason, what the consumer does not know and is not informed of, is that by getting the generic version of the drug, they most likely will be precluded from ever suing either the generic manufacturer or the brand-name manufacturer for side-effects or failure to warn of side-effects of that medication.  That is right, without becoming informed, the patients are unwittingly giving up their rights to any recourse for a product liability case arising from damages in the design and labeling of the medication.

Why Generic Drugs are Immune from Liability

In a 2013 decision, Mutual Pharmaceutical Co. v. Bartlett, the Supreme Court ruled that a manufacturer of a generic medication cannot be held liable for adverse events associated with the medication that they fail to warn the consumer about, as they are not permitted to change the FDA approved brand name manufacturers’ labeling.  The Court reasoned in a 5-4 decision that Federal Preemption prohibits such a suit.  This is true even if the generic manufacturer has direct knowledge of the adverse events, thereby allowing a generic manufacturer to knowingly sell a defective product without the need to warn about the defect.

The Court took it a step further and further held that the brand name manufacturer is not subject to liability in that situation either, because the drug that was consumed was manufactured by the generic company.  So, despite the drugs being exactly the same compounds and the labeling being done by the brand name manufacturer, they are also immune from liability.  This ruling effectively acts to protect both brand name and generic drug manufacturers from all liability for warnings if the consumer is provided a generic version of their prescription, leaving the consumer with no recourse.

The Future of Generic Drugs Accountability

Several challenges in State Courts are ongoing in a hopes to overturn this patently unfair ruling that leaves injured parties unable to assert a claim despite what is often a wanton disregard for patient safety on behalf of drug manufacturers.  At Atlee Hall, we endeavor to protect the rights of patients and consumers’ community that are injured due to the negligence of a corporation.  We will work to protect your rights and obtain justice for you and your loved ones in an effort to make our community a safer place.