By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On March 19, 2013, the Supreme Court justices discussed whether makers of generic drugs already approved by the Food and Drug Administration (FDA) can be held liable under state law for claims of design defects.
According to the Los Angeles Times, nearly eighty percent (80%) of prescriptions that Americans fill are for generic drugs. The high court finds itself at a crossroads on how to resolve claims from patients who are injured by these generic drugs. Federal law requires generic drugs to have the same design as their brand-name equivalents. Click here to read the entire article from the Los Angeles Times.
A Patient’s True Story.
According to media reports, in 2004, a generic anti-inflammatory drug severely injured a New Hampshire woman. The woman suffered a rare, but serious reaction to a generic form of a drug prescribed to her by a doctor. The reaction permanently damaged her lungs and esophagus, disfigured her face and body, and left her legally blind.
For the past nine years she has been trying to hold the drug manufacturer, Mutual Pharmaceutical Company, liable. Mutual Pharmaceutical is seeking to overturn a $21 million jury award using a 2011, Supreme Court decision that limited the liability of generic drug manufacturers. You can follow the developments of this case on the Supreme Court’s blog, or by clicking here.
The Concerns of the Supreme Court Justices.
During the arguments, justices questioned whether federal law, in this case, the requirement that generic drugs have the same design as the name-brand version, prevents plaintiffs from making claim against the manufacturers under state law, according to Reuters.
Two years ago, the court handed down a 5-4 decision that shielded generic drug makers from being held liable for failing to warn patients of harmful side effects. The court reasoned that since the makers of these generic drugs must use the same warning label that was approved by the FDA for the original maker, they cannot be faulted for not including stronger warnings. Click here to read the entire article from Reuters.
The Supreme Court is expected to render its decision in this case before July 1, 2013.
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Do you think generic drug makers should be held liable? Please leave any thoughtful comments below.
Editorial. “Hold Generic Drug Makers Accountable.” The New York Times. (March 10, 2013). From: http://www.nytimes.com/2013/03/11/opinion/hold-generic-drug-makers-accountable.html?_r=0
Hurley, Lawrence. “High Court Weights Generic Drugmaker Liability.” Reuters. (March 19, 2013). From: http://www.reuters.com/article/2013/03/19/us-usa-court-generic-idUSBRE92I15E20130319
Savage, David. “Supreme Court Hears Suit Over Liability of Generic Drug Makers.” Los Angeles Times. (Mach 19, 2013). From: http://www.latimes.com/business/la-fi-court-generics-20130320,0,668011.story
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
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