Generic Drugs: Difficulties in Proving Liability

January 22, 2016

warning on side of prescription medicine bottleFrom the day the decision in PLIVA Inc. v Mensing (131 S.Ct. 2567) came down in 2011, the plaintiffs bar has sought ways to establish liability for injuries from generic drugs.  All this activity has been to get around the Supreme Court’s holding that sellers of generic forms of FDA-approved drugs have no duty to change their initially approved labels over time based upon medical developments. The majority of the Supeme Court held that labeling claims against generic sellers were pre-empted by law.

With the current advent of litigation over the drug Zofran, renewed effort  is being exerted by the plaintiffs bar to get around the limits placed in PLIVA.  Zofran was a prescription drug first marketed in 1991 by the company presently known as GlaxoSmithKline LLC.  The FDA-approved use was for nausea and vomiting associated with cancer treatments.  In short fashion, however, physicians began to make use of the drug “off label” for vomiting associated with pregnancy, so-called morning sickness.

The new spate of cases all allege that birth defects have occurred in women who used the drug in the first trimester, that is that Zofran has teratologic effects.  The chief injuries sued on, as supported by some scientific studies, are heart defects, including septal holes, and cleft palate and lip.

As time passed,  Zofran became a generic drug, losing its patent protection.   Today, dozens of companies sell ondansetron in its generic form.  The labeling these generic manufacturers used at the time they first began to sell ondansetron, and today, has only a passing warning about these risks.  The statement in the generic label is a direct copy of the one used for the brand-name Zofran.  That label has also not changed.

The first method of trying to get around the PLIVA rule has been for counsel representing children with birth defects and their family where a generic was used is to sue GlaxoSmithKline (GSK), often as the only defendant.  The claim is that GSK originated the drug and its labeling and  remains responsible for the adequacy of the labeling.  This is sometimes referred to as “innovator liability.”  That basis for liability has been accepted in a few decisions., such as Conte v. Wyeth, Inc., 168 Cal.App.4th 89 (2008), but it has been rejected in others.

As to the actual maker, liability has been asserted on the basis that an off-label use was made of the ondansetron when a doctor prescribed it for morning sickness, and that the maker was aware of and profited from this use.  Such an argument, however, may not make for an exception to the holding in PLIVA.  Off label marketing has been recognized potentially as a basis to hold generic manufacturers liable, Allain v. Wyeth Pharmaceuticals Inc., 2:14-cv-00280. N.D. Ala. (2015).

A more expedient way to create responsibility on generics for keeping an up-to-dated label would be for Congress to pass a law clarifying that it never intended by the Hatch Waxman Act of 1984 to limit their duties.  Legislation has been pending to accomplish this change for some time, but currently has little prospect of passage.  Similarly, the FDA could accomplish this through regulations, which is currently a pending matter.

Zofran and the other drugs involved in this brand name-generic litigation are mass tort actions for the most part. The Zofran litigation has been multi-districted, MDL 2657, D.Mass. 2015.  Multi-district litigation is discussed in detail in chapter 3 of my book.