The manufacturer of a product can be held accountable for a consumer’s injury if the company failed to warn of side effects. Federal law requires manufacturers of a generic drug to provide users with the same warning as the brand name product. Massachusetts’ highest court recently issued an opinion outlining when and how an injured patient can pursue a Massachusetts product liability action against the brand name manufacturer after she or he has been injured following the use of a generic prescription. The court ultimately concluded an injured patient is precluded from pursuing a negligence action against the brand name manufacturer, nor are they able to bring or join a class action claim. However, an injured patient is able to pursue a claim of recklessness if there was an intentional failure to to update the label when the company knew or had reason to know of an unreasonable risk associated with the use of its product, since federal law requires generic medication to use warnings identical to brand name drugs.
Drug manufacturers that innovate a new product must go through a rigorous approval process overseen by the Food and Drug Administration (FDA). Drugs must be safe and effective, and they must come with a label that is accurate and adequate. The process is lengthy and expensive. In order to provide lower-cost alternatives, the U.S. Congress enacted legislation that allowed generic drugs to use an abbreviated application process as long as their product was the “bioequivalent” of its brand name counterpart. The generic manufacturer must then use the same warning label as the brand name. To balance the brand name’s research and development interest against the public’s need for affordable medicine, the brand name manufacturer enjoys an extended patent monopoly while simultaneously shouldering greater responsibilities for the adequacy and accuracy of its warning label. Generics cannot change their label without approval, but brand names can.
The case at hand arose from the use of a generic drug prescribed to treat protastic hyperplasia in those who have an enlarged prostate. After the patient began the use of this drug, he experienced several side effects, including erectile dysfunction and a decreased libido. These side effects persisted and worsened, even after he ceased taking the medicine. Eventually, the patient was diagnosed with an androgen deficiency and hypogodanism, which was connected with his use of the generic prostate drug. The condition continued and could potentially continue indefinitely. The warning label, styled after the brand name drug, warned that sexual side effects could occur but would stop after use of the drug ceased.