Massachusetts Supreme Judicial Court Says Patient Who Took Generic Drug Could Have Claim Against Manufacturer of Name Brand Drug for Failure to Warn, if Defendant Acted Recklessly

Approximately seven out of every 10 Americans take a prescription medication. While the majority of these drugs are reasonably safe (virtually every medicine has some side effect), there has been a trend in recent years for drugs to be put on the market before the full effects are adequately studied.

A number of Massachusetts product liability lawsuits have arisen as a result of personal injuries or wrongful deaths allegedly caused by prescription medications. One common claim in such lawsuits is an allegation that the patient was not adequately warned of the medication’s side effects. A complication arises, however, when the patient takes a generic version of a drug. This is because federal law requires that a generic drug provide an identical label to its name-brand counterpart, even though the drugs may be made by different manufacturers.

Facts of the Case

In a recently decided Massachusetts appellate court case, the plaintiff was a man whose physician prescribed the generic drug “finasteride” to treat his enlarged prostate. Unfortunately, the plaintiff experienced  adverse side effects from the drug that eventually resulted in his being diagnosed with hypogodanism and androgen deficiency. Although the plaintiff was weaned off the drug, the side effects worsened over time.

In 2013, the plaintiff filed suit against the defendant name-brand drug manufacturer, asserting claims for negligent failure to warn, as well as a violation of Massachusetts General Laws ch. 93A, § 9. Importantly, the plaintiff maintained that, although he took a generic version of the name brand drug made by the defendant (Proscar), the defendant nevertheless owed him a duty under federal law to warn of the dangers of the generic version of the drug because the defendant controlled the label on the generic version.

The trial court dismissed the plaintiff’s complaint on the ground that the defendant did not owe a duty of care to the plaintiff. The plaintiff appealed. On its own authority, the supreme judicial court (the state highest court) transferred the case from the intermediate appeals court.

Resolution of the Issues

The supreme judicial court vacated the order dismissing the plaintiff’s common law claim and remanded the case to the trial court with instructions that the plaintiff be granted 30 days in which to amend his complaint. According to the court, the issue of whether the plaintiff had stated a failure to warn claim that met the standard for “reckless disregard of an unreasonable risk” had to be determined by a trial court judge. In so holding, the court noted that the defendant did owe the plaintiff a limited duty to warn but that the plaintiff’s failure to warn claim had to sound in recklessness, rather than mere negligence, in order to be successful.

The order dismissing the plaintiff’s claim under ch. 93A was affirmed. According to the court, the defendant’s alleged unfair and deceptive action (i.e., its failure to warn the plaintiff of the side effects of the drug) was not taken in the course of “any trade or commerce” because it was not taken in the course of the advertising, offer to sell, or sale of any of the defendant’s products. Thus, the plaintiff’s ch. 93A claim failed.

Contact a Product Liability Lawyer in Cape Cod

At the Law Offices of John C. Manoog, III, our experienced dangerous drug attorneys are currently reviewing pharmaceutical injury claims. We also handle medical malpractice cases, including those involving injuries or death caused by improperly filled prescriptions, birth injuries, and surgical errors. Remember that the time for filing a medical negligence claim is limited by both the Massachusetts statute of limitations and statute of repose, so talk to a lawyer soon if you believe you have a claim. Call us at 888-262-6664 to schedule an appointment.

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