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Plaintiff’s Claims Against Generic Drug Manufacturer Fail in Light of Supreme Court’s Decision in Pliva, Inc. v. Mensing

Gross v. Pfizer, Inc., et al.
Case No. 10-CV-00110-AW (United States District Court for the District of Maryland, November 22, 2011)

by Eric M. Leppo, Associate
Semmes, Bowen & Semmes (

In this recently issued opinion from the U.S. District Court for the District of Maryland, the claims of Plaintiff Shirley Gross were dismissed pursuant to Defendant Pliva, USA’s Motion for Judgment. In an opinion authored by Judge Alexander Williams, Jr., the Court held that Ms. Gross’ claims against Pliva were preempted by federal law in light of the Supreme Court’s June 2011 decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

Ms. Gross filed suit against Pliva, along with Pfizer, Wyeth, and Schwartz, alleging she sustained injuries from taking the prescription drug metoclopramide, which is used to patients with slow emptying of the stomach or intestinal tract often caused by cancer treatment or surgery. The Complaint sought damages on theories of negligence, breach of warranty, strict liability, and misrepresentation. The claims against Pfizer, Wyeth, and Schwartz were previously dismissed as those companies manufactured “Reglan” the brand-name form, as opposed to the generic version of the drug, “metoclopramide” that Ms. Gross actually took and Pliva manufactured.

In April 2011, the U.S. District Court stayed the proceedings in Gross in light of the pending Supreme Court decision in Mensing, a case with substantially similar facts. The Supreme Court was considering a state tort law claim based on the alleged failure of a manufacturer to provide adequate warning labels for generic metoclopramide. Mensing, 131 S.Ct. at 2572. Judge Williams described the Supreme Court holding in Mensing as follows:

Under FDA regulations, generic drug manufacturers are required to make their warning labels identical to those provided by the brand-name manufacturers. Id. at 2577. Because FDA regulations do not allow generic manufacturers to independently change or strengthen their product labeling, the Court found that it would be impossible for a generic manufacturer to comply with both federal law and state tort law. Id. at 2578. As a result, the Court held that the federal regulations preempt state law failure to warn claims.

Gross, at *2.

In light of the Supreme Court’s opinion in Mensing, Pliva sought dismissal of Plaintiff’s claims on the pleadings pursuant to FED. R. CIV. PROC. 12. Pliva argued that all of Plaintiff’s state tort law claims were preempted by federal drug regulation and as such the case should properly be dismissed.

Plaintiff argued that Mensing only preempted failure to warn claims, and that she was entitled to pursue claims that Pliva was negligent for continuing to sell metoclopramide with an inadequate label, continuing to put a dangerous product into the stream of commerce, and negligent in concealing safety information. The Court rejected Plaintiff’s contention that her case was not entirely preempted noting that the Supreme Court itself had rejected similar arguments.

Specifically the Court noted that under Maryland law the Plaintiff’s product liability claims must be based on a design defect, a manufacturing defect, or a failure to warn. There was no claim of manufacturing defect, and “[d]esign defect claims are generally incompatible with actions concerning prescription medications because these medications are thought to be ‘unavoidably unsafe.’” King v. Pfizer Pharm. Co., Inc., No. RWT 11cv00127, 2011 WL 3157305, at *2 (D. Md. Jul. 25, 2011). Therefore, the Court held that Plaintiff’s allegations regarding the continued sale of the generic drug must come under the failure to warn umbrella. As such, the claims were preempted by federal drug regulation.

The Court then addressed briefly the unfortunate nature of Plaintiff’s position of no redress, and stated as follows regarding the judiciary’s ability to remedy the same: “Federal drug regulations have foreclosed Plaintiff’s means of seeking a judicial remedy in the instant action, and legislative action remains the most appropriate means of redress at this juncture.” Gross, at *9.