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

facebook - twitter on Facebook & Twitter

Indiana State Bar Association

Indianapolis Bar Association

Evansville Bar Association

Allen County Bar Association

Indiana Lawyer on Facebook

facebook
ADVERTISEMENT
Subscribe to Indiana Lawyer
  1. The child support award is many times what the custodial parent earns, and exceeds the actual costs of providing for the children's needs. My fiance and I have agreed that if we divorce, that the children will be provided for using a shared checking account like this one(http://www.mediate.com/articles/if_they_can_do_parenting_plans.cfm) to avoid the hidden alimony in Indiana's child support guidelines.

  2. Fiat justitia ruat caelum is a Latin legal phrase, meaning "Let justice be done though the heavens fall." The maxim signifies the belief that justice must be realized regardless of consequences.

  3. Indiana up holds this behavior. the state police know they got it made.

  4. Additional Points: -Civility in the profession: Treating others with respect will not only move others to respect you, it will show a shared respect for the legal system we are all sworn to protect. When attorneys engage in unnecessary personal attacks, they lose the respect and favor of judges, jurors, the person being attacked, and others witnessing or reading the communication. It's not always easy to put anger aside, but if you don't, you will lose respect, credibility, cases, clients & jobs or job opportunities. -Read Rule 22 of the Admission & Discipline Rules. Capture that spirit and apply those principles in your daily work. -Strive to represent clients in a manner that communicates the importance you place on the legal matter you're privileged to handle for them. -There are good lawyers of all ages, but no one is perfect. Older lawyers can learn valuable skills from younger lawyers who tend to be more adept with new technologies that can improve work quality and speed. Older lawyers have already tackled more legal issues and worked through more of the problems encountered when representing clients on various types of legal matters. If there's mutual respect and a willingness to learn from each other, it will help make both attorneys better lawyers. -Erosion of the public trust in lawyers wears down public confidence in the rule of law. Always keep your duty to the profession in mind. -You can learn so much by asking questions & actively listening to instructions and advice from more experienced attorneys, regardless of how many years or decades you've each practiced law. Don't miss out on that chance.

  5. Agreed on 4th Amendment call - that was just bad policing that resulted in dismissal for repeat offender. What kind of parent names their boy "Kriston"?

ADVERTISEMENT