State Law Was Not Preempted

Teva Pharmaceuticals USA, Inc. v. Superior Court
(Cal. Ct. of App., 4th Dist.), filed June 13, 2013, published June 13, 2013

Olga Pikerie used the prescription medication Fosamax and Alendronate sodium, its generic version, for the treatment and prevention of osteoporosis. Prolonged use of these was linked to fractures of the femur due to suppression of bone turnover.  Pikerie sued both the manufacture of Fosamax and of its generic version.

Although she asserted 11 separate causes of action, the gist of her claims against the various defendants was the same — they failed to produce a safe product, failed to adequately warn of the safety issues regarding the products, and failed to take other available steps within their control to warn plaintiff or protect her from injury.

The generic drug manufacturers demurred to Pikerie’s complaint, arguing that, under the United States Supreme Court’s decision in PLIVA, Inc. v. Mensing, federal law preempted all of Pikerie’s claims.

The trial court overruled the demurrer.

In the ensuing writ proceeding, the Court of Appeal held that Mensing was inapplicable and did not preempt California law.

The court reasoned that in Mensing, the United States Supreme Court held that federal law preempted any claims that a generic drug manufacturer should have included stronger warning labels than those approved for use on the equivalent brand-name drug.  The Supreme Court also held that a state could not require a generic drug manufacturer to provide information on its label in addition to information required on the brand-name drug’s label, because that would make it impossible for the generic drug manufacturer to comply with both its duty under federal law to match the brand-name label and any claimed duty under state law to do more.  As a result of this impossibility, such a state requirement would be preempted by federal law.

However, with respect to Pikerie’s action, she alleged that the brand-name drug label was updated, but the generic drug manufacturers failed to update their products’ labels accordingly.  Based on the allegation that the generic drug labels did not match the brand-name drug label, Pikerie’s claims were not preempted by federal law.  Therefore, the trial court correctly overruled the demurrer.