Generic drugs are low-cost alternatives to what can be quite costly name-brand drugs. They contain the same active ingredients and are required by the FDA to have the same pharmacokinetic and pharmacodynamics properties. A generic drug can be legally manufactured when the original patent for the name-brand drug has expired.
Because manufacturers of generic drugs have virtually no control over what their warning labels say, the Supreme Court recently limited how and when a consumer can sue the manufacturer. Under current federal law, generic drug manufacturers are required to use the same warning label that has been approved for their name-brand product counterparts. Generic drug manufacturers argue that because they do not have the power to change the labels, that they should not be held at the same accountability standards as name-brand manufacturers.
This issue came before the Supreme Court recently. The court heard testimony about a woman who had sustained injuries that were severe in nature after taking a generic drug. The drug, an anti-inflammatory that is often prescribed to treat pain associated with arthritis and other joint pain, is a generic of Clinoril known as sulindac.
The woman argued that the drug was unreasonably dangerous and defective. She had previously been awarded a $21 million for her injuries, but that judgment was overturned by the Supreme Court. The award had been made in a state court, but the lawsuit was not allowed to stand in the Supreme Court because of federal drug regulations.
This is a victory for generic drug manufacturers across the country who can continue to market their products without fear of being involved in commercial litigation and being held accountable for a standard over which they have no control.
Source: The Wall Street Journal, “Supreme Court Again Limits Product-Liability Suits on Generic Drugs,” Brent Kendall, June 24, 2013