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FDA Seeks to Fill Gap in Generic Drug Liability

The Voices of Thousands Injured Finally Heard

After a 2011 Supreme Court decision left millions of Americans without any remedy for damages caused by dangerous generic drugs, several justice organizations as well as the U.S. Food and Drug Administration are involved in efforts to reestablish accountability for generic drug manufacturers. As the policy stands, generic drug manufactures cannot update and more importantly, are not responsible to update the warning labels on their products in the same way as brand name companies.

As a result, these generic drug companies are not accountable to any undisclosed side-effects or health risks on labels of their drugs. Since the landmark ruling of Pliva v. Mensing (2011), there have been countless tragedies, both publicized and kept private, involving individuals who suffered life altering side-effects from taking generic drugs yet found themselves with not means of getting justice. Under the status quo, when someone takes a generic drug, they are, for all intents and purposes, relinquishing their right to remedy in the event of injuries. It is precisely this inconsistency in the justice system that is the target of the FDA's recent legislative proposal to the 112th Congress, entitled The Patient Safety and Generic Labeling Act (S.2295 / H.R. 4384)

Tied Hands on the Supreme Court Bench

In 2010, the Supreme Court agreed to hear a lawsuit brought by G. Mensing against Pliva Inc. and Actavis Elizabeth LLC, two companies that had produced a drug she had taken to help fight diabetic gastroparesis. The lawsuit was filed because she allegedly suffered from tardive dyskinesia, a severe neurological movement disorder, after taking their drug, a generic equivalent to the brand-name Reglan. At the time, Reglan did not have a warning about the possible side-effect of tardive dyskinesia and consequently, neither did the generic drug she actually took. In the answer to the plaintiff's question of whether generic drug makers can be sued for failing to warn about potential dangers on the labels of their drugs, the Supreme Court answered "No" on a split decision. The reasoning pointed back to an FDA policy that only requires generic drug brands to match their warning labels to their product's brand name equivalent.

In 2013, another suit was brought by K. Barnett, who suffered severe, life-threatening injuries after taking a prescription generic equivalent to Clinoral. Her injuries included Stevens-Johnson syndrome and toxic epidermal necrolysis, a condition that causes the skin to deteriorate by either burning off or turning into an open wound. Resulting injuries include vision loss to the point of near-blindness, esophageal burns and lung damage. After Bartlett was awarded more than $20 million in damages by a federal court, the defendant, Mutual Pharmaceutical Company, appealed the case to the Supreme Court, which granted a writ to hear the case. The Supreme Court, again deferring to the current FDA policies, overturned the decision of the federal court and held to the same conclusion as Pliva.

In both cases, the Supreme Court did include a note confirming the FDA and Congress' authority to change this policy on labeling. While the law is not exempt from reform, the bench simply concluded that the court was not at liberty to go against it while it stood active. In Pliva, the court even included a note calling Congress and the FDA to action concerning this matter and fortunately, the FDA responded accordingly.

The FDA's Response to the Call for Action

These are only two out of thousands of cases dismissed by the court involving individuals who directly suffered from this complex, troubling policy that stands. Seeing the discrepancies in the current system, the FDA proposed legislation in 2013 to reform its policy on warning labels for generic drugs and provide remedial means for consumers. Since its proposition, the legislation has received the support of more than 25,000 consumers through online submissions as well as comments filed by the American Association of Justice in support of the new rule. The Patient Safety and Generic Labeling Act would allow generic drug manufacturers to update the warning labels on their products, thereby making them accountable for any information added to or excluded from the label of the generic drug.

Any proposition that would seek to place added regulation on corporations, especially in the pharmaceutical industry, is sure to receive criticism and the FDA's proposal is not excluded. Legislators and drug companies have reacted coldly to the proposition, claiming that it could cost the U.S. healthcare system up to $4 billion due to an increase in product liability. Other concerns involve an "inconsistency" that would emerge between warning labels on brand-name drugs and their generic equivalent, potentially causing confusion.

The FDA defended its proposition in a letter issued on February 24, 2014, attempting to address each of the concerns and adamantly reaffirming the need for this change in the law. Critics are still dissatisfied with the FDA's response, claiming that the administration failed to adequately the cost concerns. Much like any federal legislation, there will be much more dialogue between the FDA and its opponents on this matter before a resolution is reached but the thousands of patients taking generic drugs across the nation do have one comfort to hold to until then—someone is finally trying to give them a voice.

If you or a loved one has suffered injuries after taking a generic drug, we encourage you to contact the drug injury attorneys to learn more about how this proposed legislation could affect your standing in court.