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DTCI: The broad scope of MDA preemption

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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.•

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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.

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  1. A traditional parade of attorneys? Really Evansville? Y'all need to get out more. When is the traditional parade of notaries? Nurses? Sanitation workers? Pole dancers? I gotta wonder, do throngs of admiring citizens gather to laud these marching servants of the constitution? "Show us your billing records!!!" Hoping some video gets posted. Ours is not a narcissistic profession by any chance, is it? Nah .....

  2. My previous comment not an aside at court. I agree with smith. Good call. Just thought posting here a bit on the if it bleeds it leads side. Most attorneys need to think of last lines of story above.

  3. Hello everyone I'm Gina and I'm here for the exact same thing you are. I have the wonderful joy of waking up every morning to my heart being pulled out and sheer terror of what DCS is going to Throw at me and my family today.Let me start from the !bebeginning.My daughter lost all rights to her 3beautiful children due to Severe mental issues she no longer lives in our state and has cut all ties.DCS led her to belive that once she done signed over her right the babies would be with their family. We have faught screamed begged and anything else we could possibly due I hired a lawyer five grand down the drain.You know all I want is my babies home.I've done everything they have even asked me to do.Now their saying I can't see my grandchildren cause I'M on a prescription for paipain.I have a very rare blood disease it causes cellulitis a form of blood poisoning to stay dormant in my tissues and nervous system it also causes a ,blood clotting disorder.even with the two blood thinners I'm on I still Continue to develop them them also.DCS knows about my illness and still they refuse to let me see my grandchildren. I Love and miss them so much Please can anyone help Us my grandchildren and I they should be worrying about what toy there going to play with but instead there worrying about if there ever coming home again.THANK YOU DCS FOR ALL YOU'VE DONE. ( And if anyone at all has any ideals or knows who can help. Please contact (765)960~5096.only serious callers

  4. He must be a Rethuglican, for if from the other side of the aisle such acts would be merely personal and thus not something that attaches to his professional life. AND ... gotta love this ... oh, and on top of talking dirty on the phone, he also, as an aside, guess we should mention, might be important, not sure, but .... "In addition to these allegations, Keaton was accused of failing to file an appeal after he collected advance payment from a client seeking to challenge a ruling that the client repay benefits because of unreported income." rimshot

  5. I am not a fan of some of the 8.4 discipline we have seen for private conduct-- but this was so egregious and abusive and had so many points of bad conduct relates to the law and the lawyer's status as a lawyer that it is clearly a proper and just disbarment. A truly despicable account of bad acts showing unfit character to practice law. I applaud the outcome.

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