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PHILADELPHIA — (Mealey’s) Strict liability design defect claims involving generic versions of the osteoporosis drug Fosamax are preempted by federal law despite plaintiffs’ attempts to narrow U.S. Supreme Court case law, a panel of the Third Circuit U.S. Court of Appeals ruled April 30 (In Re: Fosamax [Alendronate Sodium] Products Liability Litigation [No. II], No. 12-2250, 3rd Cir.; 2014 U.S. App. LEXIS 8187 [enhanced opinion available to lexis.com subscribers]).
In 2011, 91 plaintiffs from 28 states sued Merck Sharp & Dohme Corp. and generic drug makers Barr Pharmaceuticals Inc., Teva Pharmaceuticals USA, Watson Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Apotex Corp. and Sun Pharmaceutical Industries Inc. in Missouri state court, alleging that the defendants failed to warn them or their doctors that Fosamax or its generic version, alendronate sodium, can cause bone fractures. The defendants removed the cases to federal court, and they were eventually centralized in a multidistrict litigation in the U.S. District Court for the District of New Jersey.
The generic defendants moved for summary judgment under Federal Rule of Civil Procedure 12(c), arguing that the plaintiffs’ warning claims are preempted by federal law. Judge Joel A. Pisano granted the motion, finding that under federal law, generic manufacturers cannot change the labels of their drugs or the design of their drugs.
Seventy-three plaintiffs appealed the finding that their design defect claims are preempted.
Negligent Design Argument Waived
The Third Circuit panel noted that as precedential rulings were handed down in the interim, the plaintiffs changed their argument to include design defect based on negligent design. The defendants responded that the negligent design argument was not raised until a reply brief and was thus waived. The panel agreed.
Citing the U.S. Supreme Court’s generic drug preemption ruling in PLIVA, Inc. v. Mensing (131 S. Ct. 2567, 2574  [enhanced opinion]), the panel concurred that the generic manufacturers cannot change drug labels to add new or different warnings because, under federal law, their labels must be identical to that of the brand-name predecessor drug, Fosamax in this case.
The panel said its decision on the design defect claim is guided by the Supreme Court’s ruling in Mutual Pharmaceutical Co. v. Bartlett (133 S. Ct. 2466  [enhanced opinion]), which was handed down while the Third Circuit case was pending. Bartlett held that generic drug design defect claims are preempted.
Bartlett Not Narrow
The Third Circuit panel rejected the plaintiffs’ arguments that there is preemption of strict liability design defect claims only when a state imposes a duty to strengthen warnings. Citing Bartlett’s language, the panel said the plaintiffs read the decision too narrowly.
The panel said that during oral arguments, the plaintiffs attempted to avoid Mensing by saying that their design defect claims are not intended to relate to warnings and that they do not seek to change the drug’s design. “The Appellants are left with their position that their strict-liability design-defect claims impose liability ‘for the (Generic Defendants’) wilful choice to sell a particular product’ with an unreasonably dangerous design,” the panel said.
“In other words, they are trying to resurrect the ‘stop-selling’ theory under which the Generic Defendants can only avoid state-law liability by halting their sales of alendronate sodium,” the panel said. “But Bartlett categorically rejected that theory, and that ends the argument.”
No State Law Analysis
The panel admitted that the Supreme Court was careful in Mensing and Bartlett to consider preemption in the context of specific state laws in those cases. But the panel said the plaintiffs in the generic Fosamax case did not point to any specific state law, even when pressed to do so at oral arguments.
“In sum, Mensing and Bartlett recognize that manufacturers have no control over the design or labeling of generic drugs,” the panel concluded. “Short of exiting the market — which Bartlett rejects — the Appellants have failed to identify anything the Generic Defendants can do to reconcile their conflicting duties under state and federal law. Therefore, the Appellants’ strict-liability design-defect claims are preempted.”
Fosamax and its generic versions are members of the bisphosphonate class of drugs. They are oral prescription drugs approved to treat or prevent osteoporosis and Paget’s disease.
The drugs inhibit the resorption of bone by the body and suppress bone turnover. It also inhibits the primary mineralization, which helps form new bone. Secondary mineralization continues, increasing bone mineral density.
Plaintiffs’ Bone Fracture Claim
Plaintiffs allege that higher mineral density does not mean reduced bone fracture risk and can make bone homogenous, brittle and susceptible to fracture. In the Fosamax femur fracture multidistrict litigation, the plaintiffs allege that Fosamax and its generic version led to fractures of the long leg bone.
An earlier Fosamax MDL located in the Southern District of New York involves claims that Fosamax causes osteonecrosis of the jaw (ONJ), in which the jaw fails to grow new bone after oral procedures such as tooth extraction. Merck in December said it would settle ONJ claims for $27.7 million.
Claims against Merck in the Fosamax femur MDL continue.
The opinion was written by Circuit Judge Kent A. Jordon. The other panel members were Circuit Judges Thomas I. Vanaskie and Morton I. Greenberg.
The plaintiffs are represented by Brandon L. Bogle of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor in Pensacola, Fla., and Scott D. Levensten of the Levensten Law Firm in Philadelphia. Merck is represented by Karen A. Confoy of Fox Rothschild in Lawrenceville, N.J.
Barr Pharmaceuticals is represented by John K. Crisham of Kirkland & Ellis in Washington, D.C.; Glenn S. Kerner and Katherine D. Seib of Goodwin Proctor in New York; Jay P. Lefkowitz of Kirtland & Ellis in New York; and George E. McDavid of Reed Smith in Princeton, N.J. Watson Pharmaceuticals is represented by Terry M. Henry of Blank Rome in Philadelphia.
Mylan Inc. is represented by Kelly E. Jones and Steven A. Sadtmauer of Harris Beach in Newark, N.J., and Harvey L. Kaplan of Shook, Hardy & Bacon in Kansas City, Mo. Apotex is represented by Charles A. Fitzpatrick III and Arthur B. Keppel of Rawle & Henderson in Philadelphia.
Sun Pharmaceutical is represented by Sandra J. Wunderlich of Stinson Leonard Street in St. Louis.
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