Amicus Briefs

Washington, D.C.—AdvaMed, the Medtech Association, asked the US District Court for the District of Massachusetts to rule as a matter of law that independent sales agent (ISA) arrangements do not — by themselves — violate the Anti-Kickback Statute (AKS) and, accordingly, grant summary judgment in the Langer v Zimmer Biomet case.

Washington, DC.—AdvaMed, the medtech association, asked the Court of Appeals for the Third Circuit to vacate the judgment of the District Court, which if allowed to stand, would have significant and deleterious effects on patient care.

AdvaMed® filed an amicus brief in the case of Smith v. Terumo BCT, Inc. The case concerns whether the court should create a cause of action for asymptomatic plaintiffs, permitting recovery based solely on the possibility of future injury.

This case involves a patent infringement dispute between EcoFactor and Google, but the Court’s decision will reach every aspect of district court patent litigation in cases involving parties in every technological sector, including medtech. AdvaMed® highlighted the importance of Daubert’s screening and gatekeeping at the district court level.

The issue at hand is patent infringement and an overly broad interpretation of the Hatch-Waxman Act’s safe harbor. AdvaMed® pointed out that this would harm innovation. The decision has profound consequences for the medical technology industry, which relies on clear rules and a fair patent system to incentivize the development of life-changing technologies.

The case arises from Gilead Sciences’ successful HIV/AIDS drug, tenofovir disoproxil fumarate (TDF). Plaintiffs allege injury from TDF but do not allege any defect with the design, manufacture, marketing, or labeling of TDF. In denying Gilead’s summary judgment motion, the trial court held that Gilead could be held liable in tort for not developing and selling a completely different drug. AdvaMed® noted the decision imposes unfair and unworkable liability upon the life science industry.

Relator was contending that commission-based contract sales arrangements are per se violations of the AKS. AdvaMed® noted that this suit is the first time a plaintiff has alleged that a device manufacturer violates the AKS anytime it uses independent contractors on a 1099 basis and pays them a commission, thereby rendering any claim for payment for the manufacturer’s devices a violation of the FCA and similar state FCAs.

The case involved expansive Biometric Privacy Act (BIPA) liability for medical device manufacturers. The device at issue was a medstation manufactured by BD that stores patient pharmaceuticals that can be unlocked only by authorized users by scanning their fingers. AdvaMed® took the position that health care workers’ biometric information, used to permit access to medication dispensing stations for patient care, falls under information collected, used, or stored for health care treatment, payment, or operations under HIPAA and is exempt from BIPA’s protections.