Hundreds of medical device manufacturers are being protected from legal action by a controversial FDA approval process, which grants companies immunity if they agree to undergo “stringent” quality and safety testing. Currently, around 360,000 medical devices, most of which were deemed “high-risk” from the outset, are protected in this way, NewsChannel 5 reports.

Ariel Grace’s Law

But a new bill, introduced into the House of Representatives on June 8, 2016, wants to change that. H.R. 5403 would add a crucial bit of language to the government’s existing medical device laws, effectively closing the civil immunity loophole by which medical device manufacturers are protected.

A Trade-Off For Costly Approval Process

While numerous medical devices have been linked to severe harm, Essure, a permanent birth control implant, is likely the most notable recent example. More than 25,000 women have spoken out about the device’s devastating consequences, but none are allowed to pursue Bayer in court for damages. Why not?

It all comes down to “Pre-Market Approval” (PMA), a process intended only for medical devices that:

  • support or sustain human life
  • are of substantial importance in preventing impairment of human health
  • present a potential, unreasonable risk of illness or injury


These are “big ticket” medical devices, ones that present either huge benefits or huge risks. They’re so important (or potentially dangerous) that Congress set up a special FDA mechanism to ensure their safety and effectiveness prior to approval. That mechanism is PMA, but of course, manufacturers have to foot the bill for this approval process, at considerable expense. Pushing a device through the PMA process costs an average of $94 million, and around $75 million of that sum goes toward phases directed by the FDA, according to researchers at Stanford University.

That’s a lot of money, and industry lobbyists have long argued that no “high-risk” medical devices would ever be created unless manufacturers received something in exchange for their investment. Apparently, that “something” is immunity from civil lawsuits, even when there’s significant evidence that a medical device was defective or unreasonably dangerous.

Pitting State Law Against Federal Requirements

Sometimes state and federal laws conflict. When someone wants to sue under the conflicting state law, this gets especially tricky. In most cases, these conflicts are resolved in favor of federal requirements, and the claim based on state law is “pre-empted” by federal law. That makes it difficult, if not impossible, to utilize the state law as a foundation for lawsuits.

Unfortunately, the kind of lawsuits that are filed over injuries caused by medical devices are almost always based on state laws. The FDA, however, is a federal agency, and thus the PMA process is a federal regulatory process. That’s a problem, since Section 360k(a) of the Medical Device Amendments, in which the PMA process was established, says that no state can outline requirements that are “different from, or in addition to” the federal ones.

According to the Supreme Court, allowing patients to sue under state law would rely on using requirements “different from, or in addition to” the federal requirements outlined in the Medical Device Amendments. In a 2008 case called Riegel v. Medtronic, Inc., the Court held that the federal requirements “pre-empted” claims based on state law, validating the idea that manufacturers were immune from liability over devices approved through the PMA process. Only Associate Justice Ruth Bader Ginsberg, at the time the Court’s only female Justice, dissented from the decision.

A Clear Change With Major Consequences

Ariel Grace’s Law would modify the Food, Drug & Cosmetic Act with the following language:

“NO EFFECT ON LIABILITY UNDER STATE LAW – Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the laws of any State.”

The bill is named in honor of a newborn girl who died at birth from injuries her mother says were caused by Essure.