The “Great Divide” in medical device preemption law is well known and reasonably well established – pending possible United States Supreme Court review (in the pending certiorari petition from Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006), the high court recently requested a brief from the FDA). In all circuits save one, a manufacturer of a medical device approved by the FDA for marketing through the pre-marketing approval process (“PMA”) has available a preemption defense to most product liability claims. See, e.g., Riegel, 451 F.3d at 118-20; Horn v. Thoratec Corp., 376 F.3d 163, 169-70 (3d Cir. 2004); Gomez v. St. Jude Medical Daig Division Inc., 442 F.3d 919, 929-30 (5th Cir. 2006); Cupek v. Medtronic, Inc., 405 F.3d 421, 424-25 (6th Cir. 2005); McMullen v. Medtronic, Inc., 421 F.3d 482, 487 (7th Cir. 2005); Brooks v. Howmedica, Inc., 273 F.3d 785, 799 (8th Cir. 2001) (en banc); Papike v. Tambrands, Inc., 107 F.3d 737, 741 (9th Cir. 1997); contra Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1377 (11th Cir. 1999).
In accordance with the decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the large majority of devices, cleared by the FDA through its 510k (named after a section of the uncodified 1976 Medical Device Amendments) “substantial equivalence” process, constitute the “great unwashed” – unable to rely upon preemption as a defense.
“Investigational” devices – essentially PMA devices still in the process of being studied prior to approval – are somewhere in between, with most federal courts analogizing investigational devices to PMA devices and finding extensive preemption, and most state courts going the other way. Compare Martin v. Telectronics, 105 F.3d 1090, 1099-1100 (6th Cir. 1997), and Chambers v. Osteonics Corp., 109 F.3d 1243, 1248 (7th Cir. 1997) (finding extensive preemption), with Niehoff v. Surgidev, 950 S.W.3d 816, 821 (Ky, 1997) and Conelly v. Iolab Corp., 927 S.W.3d 848, 853 (Mo. 1996) (finding no preemption).
A recent case, however, reminded us that these categories are not as immutable as the case law commonly considers them, and we decided it might be interesting to look at what else may be out there. In Rousseau v. DePuy Orthopaedics, Inc., 2006 WL 3716061 (W.D. La. Dec. 13, 2006), the plaintiff brought product liability claims against the manufacturer of a medical device that had started out as a drug before the Medical Device Amendments existed, then became a PMA device, and was finally downclassified to a Class II device, arguably no longer subject to the rigid post-marketing requirements imposed upon PMA devices.
Analyzing this rather singular heritage (we have not seen any other preemption case addressing such an involved regulatory pedigree), the court ultimately applied extensive preemption similar to how PMA devices are treated in the Fifth Circuit. Interestingly, the court looked first to the new drug requirements, and found them every bit as preemptive as the PMA process. This was due in large part to the FDA’s regulations deeming any prior device that had an NDA to have completed the PMA process. 2006 WL 3716061, at *8. The dicier aspect of the case was the downclassification, which the plaintiff claimed freed the defendant from the strictures of PMA regulation, and thus precluded the continued existence of preemptive federal requirements. The court reviewed the facts and issued a fact-specific decision. After the downclassification “no changes ha[d] been made to the product, the manufacturing process, or the labeling.” Id. There being no change in any relevant aspect of the device, the court found no change in its prior entitlement to broad PMA preemption. Id.
Having thus been reminded that there are other device statuses (stati?) than just PMA, 510k and IDE, we decided to look at the preemption cases a little more closely. The most commonly litigated other category is the “PMA supplement” device. See 21 C.F.R. §814.39(a). Basically, the supplement is a modification to the original PMA application. The modified portions of the device are subject to full PMA review, but the unchanged portions of a PMA supplement device are not so re-evaluated. It turns out that a number of leading PMA preemption cases actually involved PMA supplements. Most of the cases have treated PMA supplement devices as being entitled to full PMA preemption. Riegel, 451 F.3d 104; McMullen, 421 F.3d 482; Cupek, 405 F.3d 421; Kemp v. Medtronic, Inc., 231 F.3d 236 (6th Cir. 2001); Hughes v. Cook, 452 F. Supp.2d 832 (W.D. Tenn. 2006); Steele v. Orthopaedics, Inc., 295 F. Supp.2d 439 (D.N.J. 2003); Enlow v. St. Jude Medical, Inc., 210 F. Supp.2d 853 (W.D. Ky. 2001); In re Medtronic Polyurethane Insulated Pacing Lead Product Liability Litigation, 96 F. Supp.2d 568 (E.D. Tex. 1999); Isbell v. Medtronic, Inc., 97 F. Supp.2d 849 (W.D. Tenn. 1998); Easterling v. Cardiac Pacemakers, Inc., 986 F. Supp. 366 (E.D. La. 1997); Troutman v. Curtis, 143 P.3d 74 (Kan. App. 2006); Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127 (Tex. App. 2005); Steele v. Collagen Corp., 63 Cal. Rptr. 879 (Cal. App. 1997); Mears v. Marshall, 944 P.2d 984 (Or. App. 1997).
A number of courts have distinguished between PMA supplements and the PMA itself for preemption purposes, finding or suggesting there would not be as much (or any) preemption with respect to PMA supplements. Goodlin, 167 F.3d 1367; In re St. Jude Medical, Inc. Silzone Heart Valves Product Liability Litigation, 2004 WL 45503 (D. Minn. Jan. 5, 2004); Comeau v. Heller, 945 F. Supp. 7 (D. Mass. 1996).
Another variant of the PMA process is the “product development protocol” (“PDP”) See 21 U.S.C. 360e(f)(3)(B)(I)-(viii). Although arguably not as strict as a full PMA, the PDP, like NDA approval, is limited to Class III devices and the FDA has declared a PDP approval to be equivalent of a PMA for regulatory purposes. 21 C.F.R. §814.19. Courts have found broad PMA-equivalent preemption applicable to PDP devices. Cowen v. American Medical Systems, 2006 WL 3542704, at *1-2 (E.D. Mich. Dec. 7, 2006); Betterton v. Evans, 351 F. Supp.2d 529, 535-36 (N.D. Miss. 2004); Clement v. Kaiser Foundation Health Plan, Inc., 2004 WL 3049753, at *4-5 (C.D. Cal. Dec. 17, 2004).
Summing things up, there is precedent supportive of broad preemption with respect to medical devices with the following FDA pedigrees: (1) PMA devices; (2) PMA supplement devices; (3) downclassified PMA devices; (4) product development protocol devices; and (5) IDE devices.