After medical device harm, getting your day in court

by Hooman Noorchashm M.D. PhD and Amy Reed M.D. PhD

Published Jun. 14, 2016, 2:52 p.m. ET

On June 8, a bipartisan bill in the U.S. House of Representatives was proposed to allow citizens claiming they were harmed by certain medical devices access to the court system.

Ariel Grace's law (H.R. 5403),was prompted by a U.S. Supreme Court ruling (Riegel vs. Medtronic) that shields certain devices from litigation.

Thousands of American women have claimed that a permanent sterilization coil, Essure, has caused them avoidable harm. Yet, Essure is shielded from litigation because of the "Pre-Market Approval" pathway used to win Food and Drug Administration assent.

How can the Supreme Court justify excluding American citizens from taking their claims of harm to court?

State constitutions guarantee citizens a right of access to the courts. So the Supreme Court's decision not only infringes on individual rights to justice in America, it also violates the sovereignty of state constitutions.

But even more shocking is that the Supreme Court decision implies that these devices cannot cause unreasonable harm to a patient – this is an absurd and dangerous implication. It takes away the incentive for constant re-evaluation and improvement of medical devices that may, in truth, be causing unreasonable harm.

In a response to H.R. 5403, Bayer Health, the maker of Essure, stated that the bill "upends the very carefully crafted balance established by Congress to promote medical device research and innovation, and could potentially delay or stifle significant health benefits such devices provide."

Bayer's response to this bill is self-serving.

First, it is not only Congressional mandate that exempted Essure from litigation. Rather it is the Supreme Court's interpretation of the exemption clause in the 1976 Medical Device Amendment (MDA) that is at issue. Riegel vs. Medtronic introduced a dangerous judicial barrier, which in the case of Essure is providing Bayer with unreasonable exemption and distorting market signals to the manufacturer.

Second, contrary to Bayer's claim, adequate market signals in the form of liability signals from the court, are absolutely essential to incentivize improvement and correct flaws. The notion that a balanced free-market equation would "stifle" innovation and health benefits in the medical device space is an inappropriate corporate smoke screen.

Ariel Grace's law was presented to honor the in utero loss of an unborn child.

But H.R. 5403 is not about the Right to Life controversy. Rather it is about recognizing that no medical device can possibly be perfect. That unreasonable harm is possible in the realm of medical technology, even after FDA approval. That American citizens are guaranteed access to the court. And that without liability signals from the marketplace, via the court system, industry will not have an adequate incentive to improve and eliminate hazards.

Recently, a federal judge in Philadelphia, Judge John R. Padova, seems to have recognized that there is a serious problem with the legal shield Essure is enjoying. One can only hope that he will seriously consider whether an assumption that an FDA approved medical device cannot cause "unreasonable harm" is justified.

Though H.R. 5403 may not succeed in Congress, and its opponents may seek advantage in politicizing it, perhaps its introduction will help our federal judiciary recognize the dangerous infringement Riegel vs. Medtronic is posing to patient safety and the right to justice in America's healthcare sector.