The So-Called Medical Device Safety Act of 2009: What You Should Know

April 2010

Lurking quietly under the turbulent legislative seas stirred by Congress’ efforts to “reform” health care is H.R. 1346, a bill “to amend the Federal Food, Drug, and Cosmetic Act (FDCA) with respect to liability under state and local requirements respecting devices.” H.R. 1346, 111th Cong. (2009) (the “Medical Device Safety Act”)1.  Do not let this seemingly innocuous piece of legislation fool you: this bill is not about medical device safety. Rather, it is an instrument of the plaintiffs’ trial bar, and its passage this year is a vital priority for them. In a January 2010 press release, the American Association for Justice – plaintiffs’ trial lawyers – set forth their top five legislative priorities, and the enactment of H.R. 1346 is number two on the list. See

What is H.R. 1346?

H.R. 1346 would amend the FDCA by adding these words: “Nothing in this section shall be construed to modify or otherwise affect any action for [money] damages or liability of any [medical device manufacturer] under the law of any State.” H.R. 1346.

Why Does the Plaintiffs’ Bar So Badly Want H.R. 1346?

H.R. 1346 would overturn the Supreme Court’s 2008 decision in Riegel v. Medtronic, 128 S. Ct. 999 (2008), in which the Court upheld Congress’ 1976 decision to bar lawsuits challenging the safety and effectiveness of certain medical devices that were subject to the FDA’s stringent level of review (e.g., coronary artery stents, balloon catheters, spinal cord stimulators, pacemakers).

Charles Riegel’s doctors used a balloon catheter to try to enlarge his diseased and heavily calcified coronary artery, even though the device’s labeling warned against this use. The catheter ruptured when it was inflated to a point beyond its rated burst pressure. Mr. Riegel developed a heart block, was placed on life support, and underwent emergency bypass surgery. He and his wife sued the manufacturer of the catheter claiming it was dangerous. Id. at 1006.

Finding plaintiffs’ claims pre-empted, the Court noted that “[s]tate tort law that requires a manufacturer’s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme” adopted by Congress. Id. at 1008. When Congress passed the Medical Device Amendments of 1976, 21. U.S.C. § 360K, it in effect concluded that the experts at the FDA are in the best position to weigh whether the great risks associated with certain innovative medical devices are outweighed by the greater benefits the device presents.

In their quest for compensation for plaintiffs and themselves, the trial lawyers want to convince lay juries and judges to second-guess the rigorous review undertaken by the experts at the FDA. If the trial lawyers successfully lobby Congress to enact H.R. 1346, states would be flooded with lawsuits seeking money damages for someone alleged to be injured by a device about which the FDA had reasonable assurances of safety and efficacy.

H.R. 1346 is a Bad Idea

H.R. 1346 should be opposed for a number of reasons. First, the reach of Riegel is very limited. It applies to a very small percent of devices and these devices are subject to the most rigorous review by the FDA. The Supreme Court found that the FDA spends “an average of 1,200 hours reviewing” the application to market these devices. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). Moreover, a Class III medical device can only be sold if the FDA experts, having subjected the device to intense scrutiny, are reasonably assured the great risks associated with the device are outweighed by the greater benefits. 

Second, H.R 1346 will stifle innovation of new lifesaving technologies. By definition, a Class III device that undergoes the FDA’s most rigorous review is one that supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury. 21 U.S.C. § 360c. This proposed legislation targets the devices that signify leading edge science. It should come as no surprise that medical device manufacturers will be much less likely to develop and market innovative medical technologies if they are subject to the vagaries of juries. Not only would these juries be permitted to second-guess the FDA experts, but their results likely would be inconsistent. A manufacturer thus would be less likely to innovate and, if it did, it likely would over-warn, thereby diluting the safety and effectiveness of the devices themselves.

The potential loss of these innovative products and technologies is of vital importance to advancing the health and improving the quality of life of millions of Americans, especially disabled veterans. Indeed, a number of veterans groups have opposed passage of this proposed legislation because the innovative technologies have greatly improved the quality of their life. It is true that people are injured when their doctors prescribe or use these devices; their stories are tragic. This fact, however, ignores the reality that countless more lives are saved or improved by the use of these innovative technologies.

One need look no further than the heart-rending story of Michael G. Roman, a husband and father who was able to get his life and family back after enduring years of pain. He is the recipient of a spinal cord stimulator, an innovative medical device. For years he suffered from debilitating pain, but through the use of this innovative product, Mr. Roman was able manage the pain and now helps others do the same.

Third, and equally important, passage of H.R. 1346 will subject medical device manufacturers to the heavy costs associated with modern litigation. When unnecessary costs are foisted upon manufacturers, jobs invariably are lost. The medical device industry is uniquely American and, like other sectors of our economy, can little afford the loss of precious jobs.

Two MIT scholars described the economic impact of this proposed legislation as follows:

Research and development employment will be lower than would otherwise occur. This is a double loss since not only do R&D jobs pay comparatively high wages, but also they create the innovative products that require higher skilled downstream jobs such as production engineering, new product testing, market research and pilot manufacturing. Thus job losses … would be expected to extend to the innovative sectors of manufacturing, engineering, marketing and associated support functions such as human resources, information technology, customer service and accounting…

The medical device industry creates and sustains superior jobs from research to manufacturing. Actions that jeopardize good jobs in the manufacturing sector would be counter to current Federal economic objectives of reviving the U.S. economy.

Ernst Berndt & Mark Trusheim, The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs at 21 (2009). As the authors conclude, passage of this legislation will “result in a reduction in product innovation and introductions, limited patient and physician choice of treatments, lead to adverse impacts on public health, and result in higher overall costs to patients.” Id.

When the legislative seas calm, the personal injury lawyers will push for passage of the so-called Medical Device Safety Act. They must not succeed. This proposed legislation must be scuttled. Otherwise, millions of Americans, including those who sacrificed for our country, will be the ones bearing the burden.

This article reflects the personal views of the author, Albert J. Dahm, in his individual capacity. It does not necessarily represent the views of his law firm (Frost Brown Todd LLC), or any of its clients. This article is not sponsored or endorsed by any law firm or clients, and is intended to disseminate the author’s personal, defense-oriented views of medical device product liability litigation and related issues.

1 The Senate counterpart is Senate bill S 540.

Albert J. Dahm

Mr. Dahm has significant experience in a broad range of product liability (notably medical device manufacturers), complex business, commercial, and multi-district litigation.