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FDA Proposes Rule Change May Resurrect Generic Drug Manufacturer Liability

October 25, 2013

Our Atlanta dangerous drugs attorneys previously discussed the recent Supreme Court decision that overturned a judgment of $21 million awarded to Karen Bartlett that the jury found was caused by a generic drug. The Supreme Court ruled that the generic drug manufacturer was shielded from liability because of the federal requirement that generic drug companies copy the precise composition and labeling of the corresponding name brand drug. The U.S. Food and Drug Administration (FDA) is considering a new regulation in response to the Supreme Court's decision, according to a new ABC report.

The proposed FDA regulation would empower manufacturers of generic drugs to update their labeling based on subsequently acquired information about potential safety risks. The proposed change in FDA rules governing generic medications is a direct response to the tragic consequences of the Supreme Court's ruling that a generic drug maker could not be liable for the horrific injuries suffered by Ms. Bartlett according to ABC.

A jury awarded Ms. Bartlett $21 million after she suffered a rare skin reaction called Stevens-Johnson Syndrome, which the lawsuit alleged was caused by taking the generic drug sulindac. The Supreme Court majority opinion conceded that Ms. Bartlett's situation was tragic. She spent 3 months in a hospital after the skin covering two-thirds of her body eroded. She suffered permanent disfigurement, lung damage and blindness according to the lawsuit. Ms. Bartlett told ABC that she is not able to live independently and supports herself with a disability check that was a fraction of her income from employment prior to the ordeal.

While the drug did not warn of the risk of suffering Stevens-Johnson syndrome at the time Ms. Bartlett was taking the medication, the U.S. Supreme Court ruled that the generic pharmaceutical company could not be liable because of FDA restrictions covering the formula and labeling of generic drugs. Justice Samuel Anthony Alito Jr. wrote for the majority, "Here it is impossible for Mutual [the manufacturer of sulindac] to comply with both its federal-law duty not to alter sulindac's label or composition and its state-law duty to either strengthen the warnings on sulindac's label or change sulindac's design."

The proposed FDA result would eliminate this dilemma by authorizing generic drug companies to modify their labeling based on new clinical studies, adverse incident reports and other new information about potential adverse side effects from generic medications. This proposed rule change would allow consumers to seek the protection of product liability law when they suffer serious injury or medical conditions caused by a generic version of a pharmaceutical product.

If you or your loved one have suffered serious adverse side effects caused by a dangerous drug, our Atlanta personal injury law firm pharmaceutical lawyers are available to provide effective legal representation to those throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. 

No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333).  You can also visit us online at and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

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All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.