Wednesday, September 26, 2007

Device Preemption Scorecard

It was probably inevitable, but our drug preemption scorecard has prompted some folks who must be gluttons for punishment to request a similar rundown of how medical device preemption has been faring lately. Since we’re always looking for things to blog about (and because of the identity of some of the people asking us) we’re happy to oblige.

The first problem is where to start. Because, as we’ve discussed recently, express medical device preemption is different from (and somewhat more established than) the kind of preemption available to prescription drug manufacturers, the January 2006 FDA Final Rule isn’t the kind of watershed event for medical device preemption cases that it is for our prescription drug defense.

We’re going to be practical and not go back to Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which was the last true watershed event for device preemption. (Back when Beck and Herrmann were toiling in the Bone Screw fields together, they collected every device preemption decision known to man. The original list appears in the footnotes of Mark Herrmann & Geoffrey J. Ritts, "Preemption and Medical Devices: A Response to Adler and Mann," 51 Food & Drug L.J. 1 (1996). Bexis’ book [we've decided that it's "Beck and Herrmann" in the aggregate, but "Bexis" in the singular] again gathers the pre-Lohr device preemption cases, along with the post-Lohr cases through late 2006.) So, in this post, we’ve decided to go back only as far as the beginning of 2007.

So here’s our 2007 scorecard on medical device preemption although there are a couple of earlier cases that even Bexis didn’t know about until recently:

  1. Teplitsky v. Gershman, 2005 WL 4926167 (Cal. Super. Nov. 4, 2005), finding broad preemption with respect to a Class III pre-market approved (“PMA”) device (“CoreTherm”) used to treat benign prostrate growths. To our knowledge, Teplitsky was never appealed.
  2. Weston v. Kim’s Dollar Store, 2006 WL 4911566 (S.C. C.P. Nov. 28, 2006), finding broad preemption with respect to a Class III pre-market supplement approved device (non-corrective contact lenses). Since a distributor was sued on an independent basis, this does not appear to be an appealable final judgment.
  3. Dreyfus v. Advanced Medical Optics, Inc., 2007 WL 148437 (E.D. La. Jan. 12, 2007), finding “likely” broad preemption with respect to a Class III pre-market approved (“PMA”) device (implantable ocular lens), with “only the claim of manufacturing defect viable” after preemption. Id. at *1. This is not a final judgment, as the manufacturing defect claim escaped summary judgment on non-preemption related grounds.
  4. Tuttle v. CIBA Vision Corp., 2007 WL 677134 (D. Utah Mar. 1, 2007), finding preemption specifically with respect to a warning defect claim involving a 510k-cleared device (contact lens disinfectant). After Lohr, 510k preemption is rare, but the court found preemption because the FDA had issued something device specific - “a comprehensive Guidance Document which governs the form, content and requirements for [that device’s] labels.” Id. at *2. It’s a final judgment, but there are alternative causation grounds for summary judgment. The Westlaw docket does not indicate an appeal, but doesn’t appear to be complete.
  5. Alfred v. Mentor Corp., 2007 WL 708631 (W.D. Ky. Mar. 5, 2007), finding broad preemption with respect to a Class III pre-market approved (“PMA”) device (breast implants). Claims for manufacturing defect, non-FDA-related fraud, and the Kentucky Consumer Fraud Act excaped preemption, although it does not appear that the defendant claimed preemption against the consumer fraud claim. All the unpreempted claims failed for other reasons, so this is a final judgment. We are not aware of any appeal, and it may not have been, given that the plaintiff’s expert was excluded in a prior ruling.
  6. Mattingly v. Medtronic Inc., 486 F. Supp.2d 964 (E.D. Mo. 2007), finding broad preemption with respect to a Class III PMA device (an implantable cardiac defibrillator) against a claim that it short circuited. The court allowed plaintiff to pursue an unpreempted claim of failure to comply with unspecified FDA regulations. As it stands, there is no final order, and thus no appeal.
  7. Rattay v. Medtronic, Inc., 482 F. Supp.2d 746 (N.D.W. Va. 2007), finding relatively broad preemption with respect to a Class III PMA supplement device (a catheter). A claim for implied warranty escaped preemption. Rattay is the first post-Lohr PMA preemption case in the Fourth Circuit. There is no final order, and thus no appeal.
  8. Brown v. DePuy Spine, Inc., 22 Mass. L. Rptr. 425, 2007 WL 1089337 (Mass. Super. Apr. 9, 2007), finding no preemption with respect to an investigational (“IDE”) device (an artificial spinal disc), against a plaintiff who was a participant in a clinical trial. The plaintiff did not, however, bring traditional product liability claims, which the court indicated would have been preempted. Id. at *11. Instead, he “advance[d] claims based on. . .alleged departures from the standards set forth in the. . .IDE and PMA application.” Id. Those claims were held to be unpreempted violation claims. Also as to these claims, the court rejected an implied preemption claim based upon Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
  9. Thornburg v. Stryker Corp., 2007 WL 1742172 (Mag. S.D. Ind. June 12, 2007), adopted, 2007 WL 1959117 (S.D. Ind. July 3, 2007), finding broad preemption with respect to a Class III PMA device (hip prosthesis). Plaintiff did not assert a noncompliance claim. This is a final judgment, and we don’t know if there’s been an appeal.
  10. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation (Duron), 2007 WL 1725289 (D. Minn. June 12, 2007), finding no preemption with respect to a recalled Class III PMA supplement device (an implantable cardiac defibrillator) that had an increased risk of failure, but which was explanted before any failure. The court construed most of the plaintiff’s claims as unpreempted non-compliance claims, and also held that implied warranty claims were not preempted. Finally, the court rejected an implied preemption claim based upon Buckman. We suspect this case is part of the recent Guidant settlement.
  11. Von Essen v. C.R. Bard, Inc., 2007 WL 2086483 (D.N.J. June 18, 2007), is not really a preemption case, but involves “complete preemption” as a basis for “arising under” federal question jurisdiction (for any non-lawyers who are unaccountably still reading this, that’s a reason why the case could be heard by a federal, rather than a state, judge). In reaching its jurisdictional decision, the court took a narrow view of preemption under Buckman.
  12. Carson v. Depuy Spine, Inc., 2007 WL 1839324 (C.D. Cal. June 21, 2007), finding broad preemption with respect to a Class III PMA device (an artificial spinal disc). Plaintiffs did not assert a noncompliance claim. This was not a final judgment, there have been further developments post-Riegel. See our post-Riegel scorecard.
  13. Blunt v. Medtronic, Inc., 738 N.W.2d 143 (Wis. App. 2007), finding broad preemption with respect to a Class III PMA device (implantable cardiac defibrillator). We've blogged on this case before. There was a dissent, and we've been informed that the case is on appeal to the Wisconsin Supreme Court.
  14. Notmeyer v. Stryker Corp., 502 F. Supp. 2d 1051 (N.D. Cal. 2007), declining to find broad preemption with respect to a Class III PMA supplement device (hip prosthesis). It’s the first case in a while to following the post-Lohr minority view (Goodlin) that the PMA process is insufficiently “device specific” to be preemptive. Id. at *5-6. This is obviously not a final order, and after a petition for interlocutory appeal was denied the case settled.
  15. Cottengim v. Mentor Corp., 2007 WL 2782885 (E.D. Ky. Sep. 24, 2007), finding broad preemption with respect to a Class III PMA device (breast implant). Plaintifffs did not pursue a noncompliance claim. This is a final judgment, it might be on appeal, but there are non-preemption issues, such as exclusion of the plaintiff's expert, involved in the case.
  16. Herbert v. Mentor Corp., 2007 WL 2893387 (D.N.J. Sep. 28, 2007), finding broad preemption with respect to a Class III PMA device (breast implant). Plaintifffs did not pursue a noncompliance claim. This is a final judgment. An express warranty claim would not be preempted, but plaintiffs did not plead such a claim, and any amendment would be futile.
  17. Wawrzynek v. Statprobe, Inc., 2007 WL 3146792 (E.D. Pa. Oct. 25, 2007), finding no preemption of a fraud on the FDA claim with respect to contract research organization, where the FDA had successfully prosecuted the manufacturer (which settled a separate suit in this case) for fraud in connection with the study that the CRO carried out. The product was a Class III PMA device (ADCON-L) used to prevent formation of scar tissue after spinal surgery.
  18. Ehrhart v. Synthes (USA), 2007 WL 4591276 (D.N.J. Dec 28, 2007), finding no preemption of a possible fraud on the FDA claim with respect to a medical device (radial plates). The class is not stated, but is probably Class II. The court refused to find preemption on a motion to dismiss.
  19. Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039; 70 Cal. Rptr. 3d 566 (Cal. App. 4th Dist. 2008), finding broad preemption with respect to a Class III PMA device (heart valve). Plaintifffs did not pursue a noncompliance claim. The case is subject to further appellate review. An implied warranty claim was barred on state-law grounds (privity) and preemption not reached as to that claim. Further appeal is possible.
  20. Mathis v. E.I. DuPont de Nemours & Co,, C.A. No. 06-0825 (W.D. La. Jan. 16, 2008), finding broad preemption with respect to a "transitional device" (injectable vocal cord paste) that was approved as a drug by the FDA prior to 1976 and deemed to be a Class III PMA device following enactment of the Medical Device Amendments. This is a final judgment subject to appeal.
  21. Jessen v. Mentor Corp., 2008 WL 142824 (Cal. App. Jan. 16, 2008), finding broad preemption with respect to a class III PMA supplement device (testicular prosthesis). There was no proof of noncompliance. Further appeal is possible.
  22. Despain v. Bradburn, ___ S.W.3d ___, 2008 WL 324356 (Ark. Feb. 7, 2008), finding no preemption with respect to a class III PMA device (implantable hearing aid), following minority Goodlin reasoning. After Riegel, a motion to reconsider was granted, the decision was reversed, and preemption was affirmed. Despain v. Bradburn, ___ S.W.3d ___, 2008 WL 1067202 (Ark. April 10, 2008).
  23. Riegel v. Medtronic, Inc., ___ S. Ct. ___, 2008 WL 440744 (U.S. Feb. 20, 2008), providing definitive answer - there is broad preemption with respect to class III PMA devices (in this case a balloon catheter). Strict liability, negligence, and warranty actions that challenge the safety or effectiveness of a PMA device are preempted. A noncompliance claim was dismissed in the lower courts on state-law grounds and was not before the court.
That’s everything we know about medical device preemption cases since January 1, 2007. Again, if we’ve missed any cases, don’t be shy in telling us. Many of our readers, like us, follow this issue with interest – especially in light of the pending Supreme Court Riegel case and yesterday’s certiorari grant on the fraud on the FDA issue. We’d like to have a complete list available for those who care.

1 comment:

Anonymous said...

It's amazing to me that the Supreme Court can rule as it did in Riegel when one of the amicus curiae, Edward Kennedy, was the original sponsor of the bill that ultimately became the 1976 MDA, and his brief essentially said "we, as Congress, did not intend to preempt state common-law claims."

The Supreme Court is to look at Congressional intent as the "touchstone" in interpreting preemption, with deference to non-preemption. Miraculously, though, the Court held in direct opposition to what the very man who sponsored the bill said was the legislative intent behind it.