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Federal Preemption in Pharmaceutical Cases

medicationsIn recent years there has been a lot of litigation concerning pharmaceutical drugs and the dangers associated with them.  In 2001, Gladys Mensing went to her physician and was prescribed Reglan to treat her diabetic gastroparesis.  The active ingredient in Reglan is metoclopramide, which is available in both branded and generic forms.  When Ms. Mensing went to her local pharmacy to get the prescription filled, she received generic metoclopramide.  This drug was manufactured by Pliva, Inc.  Ms. Mensing took the drug, as prescribed, for a period of four years.  As a result, she claimed that the long term use of metoclopramide caused her to sustain a tardive dyskinesia (a severe and irreversible neurological disorder characterized by grotesque involuntary movements of the mouth, tongue, lips, and extremities, involuntary chewing movements, and a general sense of agitation).

Ms. Mensing, the Plaintiff, sued the manufactuer of the metoclopramide claiming a state-law products liability claim for a failure to warn.  The case alleged that the Defendant provided inadequate warnings regarding the risk of tardive dyskinesia from long term metoclopramide use and that the absence of adequate warnings of that risk caused her injuries.  The Defendant moved to dismiss the case based on federal preemption.

Under Article VI, Clause 2 of the United States Constitution:

This Constitution, and the Laws of the United States which shall be made in pursuance thereof; and all treaties made, or which shall be made, under the authority of the United States, shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the constitution or laws of any state to the contrary notwithstanding.

Put differently, federal law- including administrative rules and regulations are the supreme law of the land and will supersede and control when there is a conflict between state and federal laws.  In the Mensing case, the Plaintiff argued that state products liability law should control and that the Defendant manufacturer violated a duty to put adequate warnings on labels.  The Defendant argued that the state law is not controlling.  The Defendant argued that Federal drug regulations, as interpreted by the FDA, prevented the generic drug Manufacturers from independently changing their generic drugs safety labels.

One of the reasons that generic drugs retain their cost effective competitive edge from their name brand counterparts is because they don’t have to undergo the grueling testing that their name brand counterparts do.  As a result, the absence of such a grueling step in the process makes the drugs cheaper.  All a generic drug manufacturer must show is sameness between the generic drug and the name brand counterpart.  This sameness applies to the corresponding labels as well.  Because the generic drugs must have the same labels and warning as their name brand counterpart, as required by the FDA, they cannot change the label to reflect any warnings.  Doing so would put the manufacturer in violation of federal law.

As the court held, it would be impossible for the Defendant to comply with both state and federal law.  It was not lawful under federal law for the Defendant to do what state law required of them regarding the adequacy of labels.  As there was a conflict between state and federal law- the federal law trumps the state law as it is the supreme law of the land.

To read more about the case above please read Pliva, Inc. v. Mensing, which was decided by the Supreme Court in June of 2011. If you believe you have a medical malpractice case or a products liability case, our office can help you. To schedule a free consultation with lawyer Daniel Cappetta, call our office today at (508) 969-9505 or fill out or contact form available on the right side of this page.