Major Pharmaceutical Opinion Expected Soon from U.S. Supreme Court

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by Eric Pearson

A major opinion in the area of pharmaceutical litigation is expected soon from the U.S. Supreme Court.  The case of Mensing v. Wyeth was argued before the Supreme Court on March 30, 2001, and an opinion is expected by the end of July.

In Mensing, the plaintiff, Gladys Mensing, used the drug Metoclopramide, a generic version of the Wyeth drug Reglan. After prolonged use of the drug for treatment of her stomach disorder, Mensing, like many others, developed Tardive Dyskinesia, a devastating and permanent neurological disorder that causes involuntary muscle movement, particularly in the face.  As a result, she lost control of the muscles in her face, tongue, arms and legs, rendering her helpless and unable to speak.

Mrs. Mensing sued Wyeth and the generic manufacturer in 2007, alleging that they failed to adequately warn users of the drug of the risks of contracting Tardive Dyskinesia.  Later, in February 2009, the FDA forced the manufacturers of this drug to issue a “black box” warning, the strongest warning possible, warning users of their drug of the risk of contracting this terrible disease.  For Gladys Mensing, it was too little, too late.

Unfortunately, after Mensing filed suit, the federal court dismissed her case, holding that Wyeth was not liable because Mensing did not take its drug, Reglan, but instead took a generic version of the drug manufactured by other companies.  As to the generic manufacturers who actually made the drug she took, the court held that they could not be held liable for failing to change their drug label to warn of the risks of Tardive Dyskinesia because they were legally required to use the exact same warnings and labels used by the non-generic manufacturer, Wyeth, whose label similarly carried no warnings regarding Tardive Dyskinesia.

In an opinion released in November 2009, the Eight Circuit Court of Appeals partially reversed the holding of the lower court, ruling that the generic manufacturers could be held liable for a failure to warn.  In rendering its decision, the court held that the law “does not permit generic manufacturers passively to accept the inadequacy of their drug’s label as they market and profit from it.”  Mensing v. Wyeth, 588 F.3d 603, 608 (8th Cir. 2009).  Following this opinion, the drug manufacturers appealed to the U.S. Supreme Court.

While the ultimate decision in Mensing will likely depend on an interpretation of federal regulations, a more pragmatic analysis would yield only one possible result: generic manufacturers would be held liable when they failed to take steps to warn the public of the risks inherent in their products.  While defenders of the big drug companies argue this is simply not feasible, they are wrong.  There are numerous ways a generic drug manufacturer can seek to strengthen their warnings when they learn of a previously undisclosed risk. They can:

  • Ask the FDA for permission to strengthen the warnings;
  • Provide information to the name-brand drug manufacturer and ask them to take the necessary steps to strengthen the warnings;
  • Send “Dear Doctor” letters to health care professionals and pharmacies warning them directly of the risk at issue; or
  • Unilaterally strengthen their warnings without prior FDA approval, knowing that the FDA would be extremely unlikely to penalize them for adding additional warnings to their product.

Of course, if they legitimately cannot change the warnings, the generic drug companies can simply make the decision not to sell a dangerous drug that carries undisclosed risks of injury or death.  As the Eight Circuit stated:

“The generic defendants were not compelled to market metoclopramide.  If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product.  Instead, they are alleged to have placed a drug with inadequate labeling on the market and profited from its sales.  If Mensing’s injuries resulted from their failure to take steps to warn their customers sufficiently of the risks from taking their drugs, they may be held liable.”

Mensing v. Wyeth, 588 F.3d 603, 611 (8th Cir. 2009).

Simply put, no company is forced to sell a product it knows is unsafe.  If they choose to do so, they should be held accountable, whether they are a name-brand manufacturer or a generic manufacturer.  Let’s hope the U.S. Supreme Court agrees.