Massachusetts Supreme Judicial Court Decision Establishes When a Patient Can File Suit Against a Brand-Name Manufacturer of Prescription Drugs

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.

In his lawsuit against the brand name manufacturer, the injured person alleged the company already knew of these persistent and worsening side effects by the time he was prescribed the generic version of the drug. In support of his argument, the patient pointed to the contemporaneous change in labels in other countries. The brand name did not make a similar effort during this time period to change the label in the United States.

The Commonwealth trial judge dismissed the action against the brand name manufacturer, reasoning the injured patient did not ingest the actual brand name product, and the law did not allow negligence actions against the product of another manufacturer, since liability generally follows control of the product. The injured person appealed, and the Supreme Judicial Court transferred the action on its own motion.

In its lengthy analysis, the court found the brand name manufacturers were in the best position to prevent an injury arising from inadequate or inaccurate labels. However, they did not find a negligence action to be appropriate, since brand name companies take on a lot of risk and costs to develop a product. While negligence stems from inadvertent actions or incompetence, recklessness comes from a conscious course of action with the knowledge of an inherent, serious danger. The Supreme Judicial Court found if the harm from the use of a drug originated from reckless behavior by the company, the public interest tips the balance in favor of the injured patient’s ability to seek relief and accountability for serious, preventable injuries. The dismissal of the claim was vacated and the case remanded to the trial court with instructions to allow the injured plaintiff to amend his complaint.

If you’ve suffered an injury from a defective product, the experienced Massachusetts personal injury attorneys at the Law Office of James K. Meehan can assist you with your claim. For a free, confidential consultation, contact our office at 508-822-6600.

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