PLIVA, Inc. v. Mensing
Written by Faith Anderson on January 26, 2012
Adverse Effects of Defective Drugs
Defective drugs and medical devices present a real risk to individuals who are injured or ill and put their trust in doctors, the FDA, and drug and medical device companies to provide safe and effective medical care. Unfortunately, when defective drugs and medical devices lead to severe injuries, ongoing medical bills, loss of income, and other expenses, the plaintiff may no longer be entitled to fair financial compensation in some cases. The recent Supreme Court decision indicating that certain types of state-court actions are preempted by federal law has implications for drug lawsuits plaintiffs across the country.
Metoclopramide is a pharmaceutical drug commonly prescribed to patients suffering from digestive tract problems like diabetic gastroparesis and gastroesophageal reflux disorder. Five years after the Food and Drug Administration first approved Reglan in 1980, generic manufacturers also began producing metoclopramide. However, in light of mounting evidence that long-term use of metoclopramide can cause tardive dyskinesia, warning labels for the medication have been strengthened several times, most recently in 2009.
A Drug Company’s Duty to Warn of Side Effects
The Mensing case consolidated two closely related legal actions involving the use of the medication metoclopramide, and a drug company’s obligation to warn consumers of generic equivalents about safety hazards. The two plaintiffs involved in PLIVA, Inc. v. Mensing had each been prescribed Reglan a decade ago, and both received the generic, metoclopramide, from their pharmacists. After several years of using the drug to relieve their digestive tract problems, both of the women developed a severe neurological disorder called tardive dyskinesia, characterized by involuntary repetitive movements like rapid eye blinking, tongue protrusion and movement of the extremities.
Due to increasing evidence indicating that long-term metoclopramide use increases an individual’s risk of developing neurological problems like tardive dyskinesia, Reglan warning labels have since been modified to warn patients about the risks associated with metoclopramide therapy lasting longer than 12 weeks. After being diagnosed with tardive dyskinesia, the two women filed state common law claims against generic drug manufacturers in Minnesota and Louisiana, claiming that the firms did not provide adequate warnings about the danger of developing the debilitating neurological condition.
Supreme Court Rules in Favor of Drug Companies
The generic drug companies, however, argued that the state-law claims should be dismissed due to the fact that they are required by federal law to mimic the safety labeling of a drug’s brand-name counterpart. Although the plaintiffs were successful in federal appellate courts concerning this issue, the Supreme Court held that it was impossible to expect drug firms to simultaneously meet the requirements of federal drug laws regarding labeling and state common-law tort duties. Therefore, under the Supremacy Clause of the U.S. Constitution, state law provisions must give way to federal laws when the two come in conflict with one another. Unfortunately, the Supreme Court’s decision marks a significant change in the rights of injured plaintiffs to sue generic drug companies under state laws that require drug firms to warn consumers about potential dangers.