How the Supreme Court has Limited the Rights of Victims of Dangerous Drugs

A 22-year-old woman took what her family believed was a routine prescription pain medication. The drug, a generic form of Darvocet, was supposed to help relieve pain before the woman had knee surgery. Instead, it killed her.

The young woman was found dead in her apartment eight days after taking the drug. The cause of her death was acute cardiac failure with evidence of pulmonary edema, also known as fluid buildup in her lungs. According to her parents, she had taken the medication as prescribed and had no history of heart problems or other medical troubles. Darvocet and its generic versions, however, had a history of safety concerns.

Despite the known problems with these drugs, a Supreme Court ruling prevented this family and many others from obtaining justice for loved ones who died after taking generic versions of the drug. Now, a case under consideration by the Supreme Court could further restrict the rights of those harmed by generic drugs and of their loved ones to file wrongful death lawsuits in the event of their death.

No Recourse For Victims Of Generic Drugs

Darvon and Darvocet are two related drugs that contain propoxyphene. Safety concerns about the drug had existed for decades. In 2010, these concerns culminated in the Food and Drug Administration (FDA) announcing that the manufacturer had agreed to stop marketing the drugs in the U.S. The FDA urged the manufacturers of generic versions of the drugs to do the same.

Meanwhile, hundreds of individuals and families harmed by the dangerous medicine were filing lawsuits that accused drug manufacturers of not providing enough information about potentially deadly side effects. As the website Take Justice Back notes, some of those lawsuits were dismissed before the court system ever had a chance to decide whether the drugs had caused the patients harm. Specifically, the U.S. District Court that handled these cases dismissed claims in which the patient took only the generic form of Darvocet or Darvon.

Pliva V. Mensing

The reason was the U.S. Supreme Court case. In Pliva v. Mensing, the court held that generic drug manufacturers do not need to warn patients when they learn of new and dangerous side effects. It held that state laws regarding failures to warn directly conflicted with FDA rules for generic drugs, which require generics to be chemically equivalent to the brand-name drug and to have identical labeling. It does not matter if the manufacturer knew that the drugs were dangerous or potentially deadly.

In the aftermath of the ruling, the Patient Safety and Generic Labeling Act was introduced into Congress in 2012. The bill aimed to fix the inconsistency between how generic and brand-name manufacturers are held accountable, but Congress has not yet acted on this bill or other related legislation. Until the law changes, the court ruling in Pliva v. Mensing has the potential to leave people who have been harmed by generic drugs or lost a loved one as a result of adverse side effects without a remedy.

Will The Supreme Court Further Limit Rights?

Meanwhile, the Supreme Court recently heard arguments on another case that could affect the rights of people harmed by generic drugs. The case involves a woman who experienced severe side effects and permanent damage after she took a generic version of the anti-inflammatory drug sulindac. She sued the drug manufacturer, alleging that the drug was dangerous and defective. A trial court awarded her a $21 million verdict, and a lower appeals court upheld her verdict. The Supreme Court will decide whether to do the same in several months.

For people who have been harmed by generic drugs, the Supreme Court’s previous rulings and pending decisions can create a feeling of uncertainty. If you have been harmed or lost a loved one because of a dangerous medicine, an experienced Denver attorney can explain the current law, evaluate your case and provide you with options.


Michael established The Sawaya Law Firm in 1977 and built it into one of the largest personal injury law firms in Colorado, with more than 20 lawyers and 80 staff members serving clients from five offices located in Denver, Greeley and Colorado Springs. Throughout its history, the firm has stayed true to its 12 Core Values, which emphasize excellence in advocacy and a commitment to providing outstanding client service. Michael studied sociology and economics as an undergraduate student at The Colorado College, and he earned his law degree from the Texas Tech University School of Law. In addition to being involved in several legal and community organizations, Michael enjoys playing music and cooking, and he has written a book on spiritual matters.