Supreme Court considering generic drugmaker safety liability

The Supreme Court is weighing if generic drugmakers can be sued over the safety of their drugs or if federal regulators' safety approval is enough to block all such legal challenges.

Los Angeles Times: Supreme Court Hears Suit Over Liability Of Generic Drug Makers
Nearly 80 percent of prescriptions that Americans now fill are for generic drugs, and the high court finds itself at a crossroads on how to resolve claims from patients who are badly injured by these copycat products. Should patients have a right to take their cases to a jury and seek damages? Or should the court block all such claims on the grounds that federal regulators already decided the drug was safe for sale? (Savage, 3/19).

Reuters: High Court Weighs Generic Drugmaker Liability
Supreme Court justices weighed on Tuesday whether makers of generic drugs already approved by the Food and Drug Administration can be held liable under state law for claims of design defects. During a one-hour oral argument justices questioned whether federal law, in this case the requirement that generics have same design as the name-brand version, prevents plaintiffs from making such claims under state law (Hurley, 3/19).

In the meantime, the federal government will not -- at least for now -- continue to pursue putting graphic images on packs of cigarettes meant to deter people from smoking --

The Washington Post: Government Quits Legal Battle Over Graphic Cigarette Warnings
The federal government, facing a court-imposed deadline and fierce opposition from the tobacco industry, has decided to abandon its legal fight to require cigarette makers to place large, graphic labels on their products warning of the dangers of smoking. The decision marks a setback for the Food and Drug Administration, which two years ago announced that it would require tobacco manufacturers to include ghastly images on all cigarette packages (Dennis, 3/19).

The Wall Street Journal: FDA Scraps Graphic Cigarette Warnings
The decision is at least a temporary victory for tobacco makers and leaves it up to the Food and Drug Administration to propose a new set of labels aimed at discouraging smoking. Any new labels aren't expected to appear on cigarette packages for years. The government opted against seeking Supreme Court review of a case that challenged warning labels bearing striking images, such as diseased lungs and a dead body. In August, the U.S. Court of Appeals for the District of Columbia Circuit, in a 2-1 decision, ruled that the proposed labels violated the tobacco industry's free-speech rights under the First Amendment (Dooren, 3/19).

http://www.kaiserhealthnews.orgThis article was reprinted from with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.



The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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