Generic Drug Makers Protected by Courts
Written by Andrew Sarski on June 30, 2011
The Importance of Drug Warning Labels
The debate over drug warning labels reaches back to the early 2000s when two women from Minnesota and Louisiana took generic versions of Reglan, a drug containing the active ingredient metoclopramide, which is prescribed to individuals suffering from digestive tract problems. Both of these women developed a severe neurological disorder called tardive dyskinesia and sued pharmaceutical company, Pliva, Inc. and other generic manufacturers under their respective state laws. The plaintiffs alleged that the manufacturers failed to perform their duty to change their drugs’ warning labels as the side effects of long-term use of metoclopramide became evident.
Lower U.S. courts of appeals determined that these plaintiffs could move forward with their claims, rejecting manufacturers’ arguments that they were required by federal law to imitate the warning label on the brand-name drug, Reglan. However, the recent 5-4 Supreme Court decision overturned these rulings and essentially provided a legal shield for generic drug manufacturers. This decision claims that it is impossible for makers of generic drugs to meet the requirements of state laws, which require amended warning labels as safety problems surface, while also following federal law, which requires only that the generic label be the same as the brand-name equivalent.
Generic vs. Brand-Name Drugs
According to Supreme Court Justice Sonia Sotomayer, writing for dissenters, 75% of all prescription medications dispensed in the United States are generics. According to Justice Clarence Thomas, the federal regulations that are in place, which require generic drugs to have the same warning labels as the brand-name prescription, override state laws which dictate that drug manufacturers are required to update their warnings labels as they become aware of new side effects and risks. State personal injury law allows consumers to sue drug manufacturers for allegedly inadequate warning labels.
This Supreme Court ruling protecting generic drug makers was based largely on the fact that federal regulations require generic drugs to have warning labels identical to those of the brand-name prescription. This court decision is especially disturbing given that a 6-3 majority decided in 2009 in Wyeth v. Levine that brand-name manufacturers should not be protected from failure-to-warn claims. In other words, had the women who developed tardive dyskinesia been taking brand-name Reglan, the drug prescribed by their doctors, their lawsuits would not be pre-empted by federal law. However, because their pharmacists substituted generic metoclopramide for Reglan, federal law pre-empts their lawsuits.
What the Supreme Court Decision Means for American Consumers
Dissenters of the Supreme Court decision maintain that generic manufacturers, who dominate the drug market, have a duty under federal law to monitor the safety of their products. They argue that generic drug companies should be held to the same laws as brand-name manufacturers, and should be responsible for approaching the Food and Drug Administration to propose changes to drug warning labels. According to the minority opinion, this ruling will have serious consequences for American consumers, many of whom take generic drugs on a daily basis.
According to representatives of generic drug makers, the Supreme Court has made it clear that “federal law does not permit states to hold generic drug manufacturers liable for using the very warnings federal law required them to use.” In addition, the ruling has been called an “important and necessary step by the Supreme Court to clarify the proper interpretation of regulations governing pharmaceutical labeling.” However, if generic manufacturers simply made the attempt to prompt the FDA to change brand-name drug warning labels, the FDA may require brand-name manufacturers to change their safety labels, potentially preventing unnecessary consumer harm.
Regardless of whether a pharmaceutical company is producing brand-name or generic drugs, drug manufacturers are responsible for the safety and effectiveness of their medications, and should be held accountable for any injuries incurred by consumers of their products. However, this Supreme Court ruling protects generic drug manufacturers, thereby preventing the millions of Americans who take generic pharmaceutical drugs from collecting the financial compensation they deserve after sustaining injuries caused by a generic drug. This ruling deals an unfortunate hand to consumers taking generic drugs and makes little sense to those who have been harmed by generic drugs and are unable to sue drug makers.