ILNews

DTCI: The broad scope of MDA preemption

Back to TopCommentsE-mailPrintBookmark and Share

Twohy No photoThe Medical Device Amend-ments of 1976 to the Food, Drug, and Cosmetics Act (MDA) authorized the federal Food and Drug Administration to regulate medical devices while preempting state efforts to enforce any legal requirement that (1) relates to the device’s safety, effectiveness, or other matters committed to the FDA and (2) “is different from, or in addition to,” any requirement imposed under the MDA. 21 U.S.C. § 360k(a).

In a series of decisions culminating in Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1008 (2008), federal courts came to recognize that the MDA preempted not only traditional products liability claims such as those based on an alleged defect or implied warranty but also causes of action premised on theories such as consumer fraud. Since any legal “requirement” for a device that is “different from, or in addition to” that imposed by the MDA (or FDA in its regulatory capacity) is preempted, the only way to avoid preemption is to allege a failure to meet FDA requirements.

The broad scope of MDA preemption has become apparent as District courts around the country have applied § 360k(a), as interpreted in Riegel, to dispose of one products liability case after another, all of which allege injuries from Class III medical devices and seek recovery under various theories, including strict products liability, breach of warranty, and negligence. In general, claims that have alleged something other than a failure by the device manufacturer to adhere to FDA requirements with respect to the device at issue (either with respect to its manufacture or the directions for its use) have been dismissed on preemption grounds.

Congress may amend § 360k to overrule Riegel. The Medical Device Safety Act of 2008, H.R. 1346, currently before the House Subcommittee on Health, would add a new subsection (c) to § 360k (entitled “No Effect on Liability under State Law”) to make clear that “[n]othing in this section [360k] shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.” (An identical bill, S. 540, is pending before the Senate Committee on Health, Education, Labor and Pensions.) The enactment of the bill has been identified as a top legislative priority by the American Association for Justice.

Nonetheless, pending congressional action, Riegel applies to bar even claims by plaintiffs who have suffered injuries caused by devices that malfunctioned or were arguably defective in their manufacture. In one of the many post-Riegel cases that illustrate this phenomenon, a New Jersey District Court recently granted summary judgment for the defendant manufacturer of a Class III device that was alleged to have injured the plaintiff, where the plaintiff failed to present admissible evidence that the manufacturer had deviated from FDA requirements when it manufactured the device. Banner v. Cyberonics, Inc., 2010 WL 455286 (D.N.J. Feb. 4, 2010). In unusually blunt language, the court emphatically rejected plaintiff’s argument that the device, an implantable VNS therapy unit, could be manufactured according to FDA requirements yet still contain an “anomaly” leading to plaintiff’s injury that would support liability on a non-preempted theory.

Applying Riegel to grant the manufacturer’s summary judgment motion, the court observed that “[t]he FDA approves the process by which a Class III device is manufactured, but it does not guarantee that every device manufactured in that process will work. Thus, if the FDA approves a manufacturing process and the defendant-manufacturer conforms with it, a device thereby produced that nevertheless does not function as intended does not give rise to liability.” Banner, 2010 WL 455286 at *4. The fact that a device may in fact be “defective” (differing from its design in a way that may cause it to malfunction) does not take it outside the scope of MDA preemption. As the court recognized, “[i]t is distinctly possible that the FDA-approved process introduces a margin of error wherein a properly manufactured device may nevertheless depart from its intended design. Under Riegel, state law cannot capture this departure and create liability for it because that would, in effect, require the manufacturer to use greater care than required by the FDA.” Banner at *4. The scope of MDA preemption thus parallels the risk calculus employed by FDA in determining whether to grant premarket approval for a Class III medical device.•

__________

John P. Twohy is a partner in the Hammond office of Eichhorn & Eichhorn and is a director of the DTCI. The opinions expressed in this article are those of the author.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in Indiana Lawyer editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT
Subscribe to Indiana Lawyer
  1. Where may I find an attorney working Pro Bono? Many issues with divorce, my Disability, distribution of IRA's, property, money's and pressured into agreement by my attorney. Leaving me far less than 5% of all after 15 years of marriage. No money to appeal, disabled living on disability income. Attorney's decision brought forward to judge, no evidence ever to finalize divorce. Just 2 weeks ago. Please help.

  2. For the record no one could answer the equal protection / substantive due process challenge I issued in the first post below. The lawless and accountable only to power bureaucrats never did either. All who interface with the Indiana law examiners or JLAP be warned.

  3. Hi there I really need help with getting my old divorce case back into court - I am still paying support on a 24 year old who has not been in school since age 16 - now living independent. My visitation with my 14 year old has never been modified; however, when convenient for her I can have him... I am paying past balance from over due support, yet earn several thousand dollars less. I would contact my original attorney but he basically molest me multiple times in Indy when I would visit.. Todd Woodmansee - I had just came out and had know idea what to do... I have heard he no longer practices. Please help1

  4. Yes diversity is so very important. With justice Rucker off ... the court is too white. Still too male. No Hispanic justice. No LGBT justice. And there are other checkboxes missing as well. This will not do. I say hold the seat until a physically handicapped Black Lesbian of Hispanic heritage and eastern religious creed with bipolar issues can be located. Perhaps an international search, with a preference for third world candidates, is indicated. A non English speaker would surely increase our diversity quotient!!!

  5. First, I want to thank Justice Rucker for his many years of public service, not just at the appellate court level for over 25 years, but also when he served the people of Lake County as a Deputy Prosecutor, City Attorney for Gary, IN, and in private practice in a smaller, highly diverse community with a history of serious economic challenges, ethnic tensions, and recently publicized but apparently long-standing environmental health risks to some of its poorest residents. Congratulations for having the dedication & courage to practice law in areas many in our state might have considered too dangerous or too poor at different points in time. It was also courageous to step into a prominent and highly visible position of public service & respect in the early 1990's, remaining in a position that left you open to state-wide public scrutiny (without any glitches) for over 25 years. Yes, Hoosiers of all backgrounds can take pride in your many years of public service. But people of color who watched your ascent to the highest levels of state government no doubt felt even more as you transcended some real & perhaps some perceived social, economic, academic and professional barriers. You were living proof that, with hard work, dedication & a spirit of public service, a person who shared their same skin tone or came from the same county they grew up in could achieve great success. At the same time, perhaps unknowingly, you helped fellow members of the judiciary, court staff, litigants and the public better understand that differences that are only skin-deep neither define nor limit a person's character, abilities or prospects in life. You also helped others appreciate that people of different races & backgrounds can live and work together peacefully & productively for the greater good of all. Those are truths that didn't have to be written down in court opinions. Anyone paying attention could see that truth lived out every day you devoted to public service. I believe you have been a "trailblazer" in Indiana's legal community and its judiciary. I also embrace your belief that society's needs can be better served when people in positions of governmental power reflect the many complexions of the population that they serve. Whether through greater understanding across the existing racial spectrum or through the removal of some real and some perceived color-based, hope-crushing barriers to life opportunities & success, movement toward a more reflective representation of the population being governed will lead to greater and uninterrupted respect for laws designed to protect all peoples' rights to life, liberty & the pursuit of happiness. Thanks again for a job well-done & for the inevitable positive impact your service has had - and will continue to have - on countless Hoosiers of all backgrounds & colors.

ADVERTISEMENT