Supreme Court Hears Arguments Over the Liability of Generic Drug Makers

Thursday, March 28, 2013

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.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm's attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
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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:

Hurley, Lawrence. “High Court Weights Generic Drugmaker Liability.” Reuters. (March 19, 2013). From:

Savage, David. “Supreme Court Hears Suit Over Liability of Generic Drug Makers.” Los Angeles Times. (Mach 19, 2013). From:,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.  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Tag Words: Food and Drug Administration (FDA), FDA drug approval, generic drugs, name brand prescriptions, prescriptions, pharmacy, pharmacist, drug manufacturers, generic drug manufacturers, Supreme Court, lawsuits against drug manufacturers, warnings of side effects, drug safety, defense attorney, defense lawyer, health law attorney, health law lawyer, health care attorney, health care lawyer

"The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.
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Response to: Supreme Court Hears Arguments Over the Liability of Generic Drug Makers
Tuesday, April 2, 2013
Penny Smith Life Science Law Group, LLC says:

Thanks for this informative post. We're looking forward to hearing what the Supreme Court has to say on this topic since it may change how an entire industry conducts its business! Best wishes, Penny Smith Life Science Law Group, LLC

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