Drager v. PLIVA USA, Inc., No. 12-1259

Decided: January 28, 2014

The Fourth Circuit held that the United States District Court for the District of Maryland did not abuse its discretion by denying Shirley Gross’s (Gross) request to amend her complaint, and that the district court did not commit error by finding Gross’s state law tort causes of action to be preempted by the Federal Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. §§ 301 et seq.  The Fourth Circuit therefore affirmed the judgment of the district court.

Gross was prescribed the drug Reglan in 2006.  Reglan, a brand of metoclopramide, is “used to treat gastroesophageal reflux disease and other ailments.”  Gross also took a generic metoclopramide produced by PLIVA USA, Inc. (PLIVA) for ten months.  Gross developed permanent injuries as a result of her long-term use of metoclopramide.  In January 2010, Gross sued PLIVA and certain manufacturers of brand name Reglan, alleging “state law claims of negligence, breach of warranty, fraud and misrepresentation, strict liability, and failure to warn.   In November 2010, the district court dismissed Gross’s claims against the brand name producers; in April 2011, the district court stayed the proceedings against PLIVA pending the decision of the Supreme Court in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567.   The district court lifted the stay after the Supreme Court issued its decision in Mensing.  PLIVA then filed motion for judgment on the pleadings, arguing that under Mensing, the FDCA preempted Gross’s claims.  In her response to this motion, Gross asked the district court for leave to amend her complaint, seeking to make allegations “that PLIVA violated a state law duty by failing to update its warnings to include changes made by brand name manufacturers in 2004.”  The district court granted PLIVA’s motion in November 2011 and denied Gross’s request to amend her complaint.  Gross then filed a motion to alter or amend the judgment; the district court denied the motion in January 2012.  Gross died during the pendency of the present action, and Arthur L. Drager (Drager) continued the case as a personal representative for her estate.  On appeal, Drager argued that the district court abused its discretion by denying Gross’s request to amend her complaint; Drager further contended that the district court committed error by finding Gross’s state law tort causes of action to be preempted by the FDCA.

With regard to the district court’s denial of Gross’s request to amend her complaint, the Fourth Circuit noted that Gross never actually filed a motion to amend or a proposed amended complaint.  With regard to Drager’s contentions regarding Gross’s state tort claims, the Fourth Circuit noted that, under Mensing and Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2471, manufacturers of generic drugs cannot—under the FDCA—unilaterally change their labeling, change their product formulations, be required to leave the market, or accept liability for state torts.  The Fourth Circuit then found that the district court’s failure to conduct a full preemption analysis did not constitute reversible error.  With regard to Gross’s negligence claims, the Fourth Circuit found it questionable as to whether Maryland recognizes “specific causes of action for negligent testing, inspection, and [post-market] surveillance”—and that, even if Maryland recognizes a general duty to protect consumers from injuries resulting from negligent marketing and sales, a manufacturer of generic drugs with a product that is unreasonably dangerous as sold could not satisfy the general duty without taking one of the four prohibited actions from Mensing and Bartlett.  With regard to Gross’s strict liability claims, the Fourth Circuit found that Drager’s arguments were based on the “stop selling” rationale prohibited by Bartlett; the Fourth Circuit also found the difference between the state law method of assessing the unreasonableness of a products’ danger at issue in Bartlett (risk utility) and at issue under Maryland law (consumer expectations) immaterial.  Next, the Fourth Circuit found that PLIVA breached the implied warranty of merchantability and the implied warranty of fitness for a particular purpose by selling metoclopramide—but that PLIVA’s only method of avoiding liability for breach of these warranties was leaving the market.  Furthermore, while Drager contended that breach of express warranty is a violation of contract law—and therefore not preempted by the FDCA—the Fourth Circuit noted that “the content of generic drug manufacturers’ product descriptions and other assertions is mandated by federal law,” and found that PLIVA could only avoid liability for breaching this warranty by exiting the market.  Lastly, with regard to Gross’s allegations regarding negligent misrepresentation and fraudulent concealment of safety information, the Fourth Circuit found that—assuming PLIVA made false or misleading representations—PLIVA’s only recourse would be to exit the market or accept state tort liability.

Full Opinion

– Stephen Sutherland

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