The FDA approved Merck's New Drug Application (“NDA”) for Fosamax in September 1995. Teva Pharmaceuticals USA, Inc., one of the generic manufacturers, then developed alendronate sodium—a generic form of the branded drug—and obtained FDA approval on its Abbreviated New Drug Application (“ANDA”) in February 2008. The other generic manufacturers subsequently obtained approval for alendronate sodium formulations as well.
Alendronate sodium is a bisphosphonate drug used for treating bone conditions such as osteoporosis and Paget's disease. The drug acts by inhibiting bone resorption or absorption and suppressing bone turnover. Bone turnover, or bone remodeling, is the absorption of bone tissue and simultaneous deposition of new bone; in normal bone the two processes are in dynamic equilibrium. Up to the age of 30 to 40, the two activities, absorption and formation are balanced. Later in life, absorption exceeds new bone formation. Consequently, it also inhibits primary mineralization, which is involved in the formation of new bone. Mineralization refers to the introduction of minerals into a structure, as in the normal mineralization of bones.
Meanwhile, secondary mineralization of existing bone continues, which increases the bone's mineral content and results in higher bone mineral density. Higher bone mineral density does not necessarily correspond with reduction of fracture risk. Rather, it can make bone highly mineralized, homogenous, brittle, and more susceptible to fracture. According to some studies, the effects of alendronate sodium linger after treatment ends, with one study reporting that bone turnover may be inhibited by 50% even 5 years after discontinuing treatment.
Individuals who allegedly suffered bone fractures because they took Fosamax or the generic equivalent of that drug sued Merck, as well as several entities that manufacture the generic equivalent for damages related to long bone fractures that they suffered after taking prescribed doses of Fosamax or alendronate sodium. The grounds they asserted for liability focused on the manufacturers' alleged concealment of risks associated with alendronate sodium; gross exaggeration of the purported fracture reduction benefits conferred by the drugs; and overpromotion of the drugs for non-approved, or off-label, indications. Specifically, they brought product liability claims under theories of design defect, failure-to-warn, negligence, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, and negligent misrepresentation.
Following removal and centralization of the action in a multi-district litigation (MDL), the United States District Court for the District of New Jersey granted the generic manufacturers' motion for judgment on the pleadings because it determined that the state-law claims against them were pre-empted by federal law. In a series of orders, the district court dismissed all of the generic manufacturers from the case, leaving only Merck as a defendant.
The Third Circuit United States Court of Appeals affirmed. The court held that the consumers waived any argument on appeal regarding the dismissal of their negligence-based design-defect claims against generic drug manufacturers and the consumers' state-law strict-liability design-defect claims against generic drug manufacturers were pre-empted by the Federal Food, Drug, and Cosmetic Act (FDCA).
The court held that Consumers waived any argument on appeal regarding the dismissal of their negligence-based design-defect claims against generic drug manufacturers by raising the argument for the first time in their reply brief. Although consumers claimed their use of the words design defect claims in the opening brief were broad enough to encompass negligence-based design-defect claims, the consumers' summary of the argument in their opening brief stated more specifically that the district court erred in dismissing consumers' risk-utility based design defect claims, and the count titled “STRICT LIABILITY—DEFECTIVE DESIGN” was the only design-defect claim against the generic manufacturers brought under a risk-utility based theory. It was also the only count from the consumers' complaint that they mentioned in their opening brief.
The consumers' state-law strict-liability design-defect claims against the generic drug manufacturers were pre-empted by the FDCA. Circumstances giving rise to pre-emption are typically divided into three categories: state law must yield (1) when a federal statute includes an express provision for pre-emption; (2) when Congress intends federal law to occupy the field in an area of law; and (3) when a state and federal statute are in conflict. Conflict pre-emption comes in two sub-varieties: impossibility pre-emption, which is when compliance with both federal and state regulations is a physical impossibility, and obstacle pre-emption, which is when a state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Field pre-emption and conflict pre-emption may be viewed as “implied” pre-emption, as opposed to “express” pre-emption; the categories of pre-emption, however, are not rigidly distinct. The consumers' state-law strict-liability design-defect claims against the generic drug manufacturers were pre-empted by the FDCA, where, short of exiting the market, there was nothing the manufacturers could have done to reconcile their conflicting duties under state and federal law. Under the FDCA a generic drug manufacturer may not unilaterally change its labeling or change its design or formulation, and cannot be required to exit the market or accept state tort liability. Thus, to the extent it is impossible for a generic drug manufacturer to comply with its duty under a state tort law unless it takes one of those actions, that law is pre-empted by the FDCA.
The Third Circuit United States Court of Appeals affirmed the district court’s grant of the generic manufacturers' motion for judgment on the pleadings because it determined that the state-law claims against them were pre-empted by federal law.
See: In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2014 WL 1687811 (C.A.3 (N.J.), April 30, 2014) (not designated for publication).
See also Medical Law Perspectives, March 2012 Report: Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion?
See also Medical Law Perspectives May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication