Published in Medec Pulse, December 2004.
Medical device companies operate globally, but their products are regulated locally. Canadian companies selling into the United States must navigate not only Canadian law and policy, as applied by Health Canada and Canadian courts, but also U.S. law and policy, as applied by the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), various state regulators, and state and federal courts. Cross-border sellers should be particularly mindful of the following issues:
Licensing Requirements. The U.S. and Canadian federal licensing regimes are similar, imposing risk-based premarket review and product licence classification requirements. In some cases, the Medical Devices Bureau even informally looks to FDA guidelines. Nevertheless, Canadian companies should be careful to review the specific testing and other premarket review submission requirements that apply to their particular devices. Some states, such as California, also have their own medical device requirements.
Advertising. U.S. law respecting advertising medical devices is generally less restrictive than Canada’s. U.S. law has no equivalent of Canada’s "Schedule A" prohibition, which prohibits advertising a device to the general public as a treatment for 40 broadly defined conditions, including heart disease and obesity. Instead, for certain restricted devices (i.e., those sold only by prescription), U.S. law requires that manufacturers, packers and distributors include a "brief statement" about the product’s uses and risks. Although these brief statement requirements are currently more onerous than the equivalent requirements for prescription drug ads, the FDA recently circulated a guidance document that proposes the relaxation of the medical device brief statement requirements so that they are the same as the prescription drug requirements. The FTC has commented favourably on this document.
Preemption and "Negligence Per Se". In Canada, non-compliance with government regulatory requirements may be cited by a plaintiff in a product liability suit only as evidence of negligence. Many U.S. state courts, however, use a "negligence per se" rule – a statutory standard that displaces the common law standard of negligence where the plaintiff shows that the statutory standard should apply.
The U.S. Medical Devices Amendments Act of 1976 contains a federal "preemption" clause, which prohibits states from establishing standards different from those under the Federal Food, Drug, and Cosmetic Act. Defendant device companies have long relied on this to ensure that they are subject only to federal, not state, requirements. However, in 1996, in the U.S. Supreme Court decision of Medtronic Inc. v. Lohr, the preemption clause was found not to apply to a 501(k) approved product. The federal circuit courts have since been divided on its application.
In the summer of 2004, the balance tipped slightly in favour of defendants when the U.S. Circuit Court of Appeals for the 3rd Circuit upheld a motion for summary judgment on the grounds that Pennsylvania state common law was preempted by federal law. The case involved a suit brought by a woman who claimed that a defective heart pump killed her husband – a screw ring attached to an elbow tube on the device had worn off, causing a disconnection to allow an air embolus to travel to his brain.
The complaint alleged defective design and manufacture, and failure to warn of the alleged defects. The claims were not allowed, however, because the pump was subject to review under the FDA’s premarket approval process, and the Court found that the plaintiff’s claims would impose substantive requirements on the manufacturer that would conflict with, or add to, the requirements imposed by the FDA involved in the design, manufacturing, fabrication and labelling of the device. However, despite this ruling, Canadian companies marketing into the United States should exercise caution and consider carefully whether their devices are protected by the preemption clause.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
