SCOTUS’s New Year Starts; PPACA, Adverse Event, Off-Label Use Cases Looming

The U.S. Supreme Court started its fall session October 7 with several possible cases to consider in the areas of health care reform, reporting adverse events related to medical devices, and federal reimbursement for off-label use of prescriptions drugs.


In its first day back at work, the Court made no announcements regarding two petitions involving the mandate under the Patient Protection and Affordable Care Act (PPACA) (P.L. 111-148) that employers include coverage for contraception and family planning services in health plans they offer to their employees. In September, the U.S. government requested that the Court hear the case of Hobby Lobby Stores, Inc. v Sebelius, in which the craft store (along with another chain owned by the family) requested an exemption from the PPACA mandate to provide contraceptive coverage to its employees on the basis of religious objection by the owners.

The petition of a writ of certiorari was filed by the U.S. Departments of Health and Human Services, Labor, and the Treasury, along with their respective Secretaries (Kathleen Sebelius, Thomas E. Perez, and Jacob J. Lew). The Tenth Circuit previously ruled that for-profit corporations could deny coverage that employees are otherwise entitled under federal law based on the religious objections of the individuals controlling the corporation. The government requests review, claiming in part that the Tenth Circuit’s holding conflicts with recent decisions of other appeals courts, and that the companies are not entitled to raise individual rights to raise religious exemptions when they chose to create a corporate entity.

Also in September, a Mennonite family that owns a wood-component business petitioned the Court on whether the religious owners of a family business, or their closely-held, for-profit corporation, have free exercise rights that are violated by the application of PPACA’s contraceptive coverage mandate. The case is Conestoga Wood Specialties Corp. v Secretary of HHS.

Other Cases

The Court asked the U.S. Solicitor General to offer the federal government’s views on whether the Court should hear two other cases related to health care. One — Medtronic v. Stengel (12-1351), involves a decision from the Ninth Circuit Court of Appeals concerning whether the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA) preempt a state-law claim alleging that Medtronic violated a duty under federal law to report adverse-event information.

The second case, U.S. ex rel. Nathan v. Takeda Pharmaceuticals (12-1349) involves a Fourth Circuit Court of Appeals decision that held that the sales manager’s complaint under the False Claims Act (FCA) concerning federal reimbursement for off-label use of prescription drugs did not sufficiently state with particularity the circumstances constituting fraud.

Denying Certiorari

The Court has declined to hear the following cases:

  • Atlantic Medical Center, Inc. v Feliciano (12-1043), a First Circuit Court of Appeals decision in which the appellate court concluded that the formula used to reimburse federally qualified health centers (FQHCs) for payments owed to them under the Commonwealth of Puerto Rico’s (Commonwealth) Medicaid program endorsed by the district court in its preliminary injunction is not sufficiently supported by the factual record.
  • Demahy v Schwarz Pharma, Inc. (12-1093), a Fifth Circuit decision in which the court held that a patient’s motion to set aside judgment against Actavis, the generic manufacturer of generic metoclopramide, and her motion for relief from judgment related to Wyeth and Schwarz, the brand name manufacturers of the drug, was properly denied by the district court.
  • Safari v Kaiser Foundation Health Plan (12-1392) in which the judgment of the Superior Court of California denying Dr. Hamid Safari’s request for the court to vacate the decision by Kaiser Foundation Health Plan (KFHP) and Kaiser Foundation Hospitals (KFH) (together, Kaiser) to terminate his privileges and permit him to file an action for damages and reinstatement was affirmed by the California Appellate Court.
  • Novartis Pharmaceuticals, Corp., v. Department of Consumer Affairs (13-77), regarding whether the dormant Commerce Clause of the U.S. Constitution would prohibit Puerto Rico from regulating the price of pharmaceutical products sold by Novartis to wholesalers in the territory.
  • Americans For Safe Access, et al., v. DEA (13-84), concerning a decision upholding the Drug Enforcement Agency’s (DEA) denial of a petition to reschedule marijuana from a Schedule I classification based on the DEA’s determination that there was limited existing clinical evidence to prove marijuana’s safety and efficacy for medical use.