Most people are familiar with the substitution by pharmacies of a “generic” version of the drug their doctor has prescribed for them. Indeed, the FDA estimates that 8 out of every 10 prescriptions is now filled with a generic. And in most instances, use of a generic version of a drug poses little risk of harm to the patient. FDA regulations require generic manufacturers to demonstrate that their drugs provide an “equivalent” therapeutic level of the drug in the bloodstream, meaning within plus or minus 10% of the therapeutic level provided by the brand name drug.
There are circumstances, however, where generic drugs may not provide an adequate level of protection to the patient. Narrow index drugs, those in which the difference between the therapeutic range of the drug and drug toxicity is small, require chemical tolerances in production that generic manufacturers may not be able to meet. These drugs include anticoagulants and certain anti-hypertensive medications. In such cases, use of a brand name drug might be warranted rather than a generic.
Regardless of the efficacy of generics compared to brand name drugs, however, there is a major implication to using generics that most people are not aware of: if you use a generic drug and are injured as a result of taking that drug, it is likely that you will not be able to sue the manufacturer in court to recover for your injuries. The reason: generic manufacturers have immunity from suit under a concept known as Federal Pre-Emption.
Federal Pre-Emption and immunity from suit first reared its head in the context of medical devices. The U.S. Supreme Court ruled in Riegel v. Medtronic that where a medical device has undergone pre-market approval process by the FDA, state law personal injury lawsuits are in conflict with federal law and are therefore “pre-empted” by federal law.
In the context of Federal Pre-Emption, generic drug manufacturers cannot be sued for defective design of their product, nor can they be sued for failing to provide adequate warnings of risks that are associated with the drug. Generic drug makers therefore enjoy immunity from lawsuits. As a result, patients injured by a generic drug may not sue the drug manufacturer even though such risks were known by the manufacturer and not disclosed.
While the risk of injury from generic drugs may be small, in many cases such injuries can be catastrophic. In the most recent generic drug case to be heard by the Supreme Court, the patient developed a reaction that caused her to lose nearly two-thirds of her skin and to become legally blind after she took a generic drug for a sore shoulder. A $21 million verdict in her favor by a New Hampshire jury was tossed aside by the Supreme Court, which held in a 5-4 decision that the generic drug maker was immune from suit, leaving the horrifically injured patient without any remedy or recourse. The case is Mutual Pharmaceutical Co v. Bartlett.
It’s therefore appropriate to suggest that in certain cases, patients should consider whether they want to give up their constitutional rights to seek justice in court just to save a few dollars on a generic version of their prescription medication.