(New) Medical Device Preemption Scorecard

After Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), was decided, we decided it was time to retire our old device preemption scorecard. The big question, whether PMA device manufacturers are protected by preemption, was resoundingly answered “yes.”

But since then, we’ve said repeatedly that we don’t expect plaintiffs to just fold their tents and go away - and they haven't. Rather, we expect the other side to look for loopholes in Riegel – even if we don’t think there are any – especially in the area of so-called “parallel” claims.

Anyway, it’s been six months since Riegel was decided, and the decisions addressing such arguments are starting to pile up. So we’ve decided to resurrect and revamp our device preemption scorecard with special emphasis on what Riegel “loophole” arguments are made and how courts decide them. So here goes (drumroll, please), the new and updated druganddevicelaw device preemption scorecard:

1. Strini v. Edwards Lifesciences Corp., 2008 WL 820192 (Mag. N.D.N.Y. March 26, 2008). Preemption issues cannot be decided in context of a discovery motion. “Parallel” violation claims might escape preemption.
2. Stevens v. Pacesetter, Inc., 2008 WL 2637417 (D.S.C. April 1, 2008). No “parallel” violation claims pleaded; action preempted in its entirety.
3. Despain v. Bradburn, 282 S.W.3d 814 (Ark. April 10, 2008). Plaintiff’s claims preempted. No manufacturing defect claim pleaded.
4. O’Shea v. Cordis Corp., 2008 WL 3139428 (Fla. Cir. May 19, 2008). Off-label use does not preclude preemption where the defect (in design claim) or risk (in warning claim) is common to both on- and off-label use. True “parallel” violation claims, including off-label promotion are not preempted. Express warranty claims are not preempted. Fraud claims amounting to fraud on the FDA are preempted under Buckman. Unfair trade practice claims are preempted.
5. Johnson v. Endovascular Technologies, Inc., 2008 WL 3139424 (Cal. Super. May 19, 2008). Express warranty and failure to test claims are preempted under Riegel. Allegations amounting to fraud on the FDA are preempted by Buckman. Plaintiff has appealed this case.
6. McGuan v. Endovascular Technologies, Inc., 2008 WL 3139418 (Cal. Super. May 19, 2008). Express warranty and failure to test claims are preempted under Riegel. Allegations amounting to fraud on the FDA are preempted by Buckman. Plaintiff has appealed this case.
7. Troutman v. Curtis, 185 P.3d 930 (Kan. June 20, 2008). Plaintiff barely pleaded, and entirely failed to prove, any unpreempted “parallel” violation claims.
8. Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008). A claim based on the activities of defendant’s on-site representative escapes preemption as not regulated by the FDA.
9. Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008). Taking judicial notice of FDA PMA. Plaintiff failed to plead any unpreempted “parallel” violation claims either before or after FDA approval. Express warranty claims are unpreempted but inadequately pleaded. Leave granted to amend.
10. Mattingly v. Hubbard, 2008 WL 3895381 (Ky. Cir. July 31, 2008). Plaintiff failed to prove any unpreempted “parallel” violation claims. Negligent failure to train claims are preempted as “in addition to” the FDA’s requirements imposed upon the device.
11. McCutcheon v. Zimmer Holdings, Inc., 586 F. Supp.2d 917 (N.D. Ill. Aug. 6, 2008). Violation claims involving information the defendant provided to the FDA are preempted by Buckman. No evidence supports post-approval claims, even if they could be unpreempted. Riegel overrules contrary anti-preemption precedent. Congressional legislation to overturn Riegel is of no significance until it is passed.
12. Purcel v. Advanced Bionics Corp., 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008). FDA filed suit against manufacturer for violating Good Manufacturing Practices requirements. Plaintiff's strict liability and implied warranty claims that manufacturer sold adulterated product not preempted under Riegel.
13. Clark v. Medtronic, Inc., 572 F. Supp.2d 1090 (D. Minn. Aug. 18, 2008). Doctrine of res ipsa loquitur cannot be invoked to show that a device that failed had necessarily been manufactured improperly. Allegations about information withheld from FDA are preempted by Buckman, and would be an improper private right of action to enforce the FDCA. All claims, including consumer protection, and breach of unspecified warranties, are preempted.
14. Kavalir v. Medtronic, Inc., 2008 WL 4087950 (N.D. Ill. Aug. 27, 2008). Preemption motion to dismiss denied because available information did not conclusively establish that the products in question had PMA approval.
15. Walker v. Medtronic, Inc., 2008 WL 4186854 (S.D.W. Va. Sept. 9, 2008). Preemption motion denied without prejudice in infusion pump case. Plaintiff could amend complaint to allege "parallel" FDCA violations, but the issue would be rejoined after discovery concerning the defendant's evidence that it was in full compliance.
16. Parker v. Stryker Corp., 584 F. Supp.2d 1298 (D. Colo. Oct. 22, 2008). Motion to dismiss on preemption grounds granted. Plaintiff failed to plead any facts supporting "parallel" claims. Preemption cannot be avoided by reference to adulteration and misbranding because there is no private right of action under the FDCA. Express warranty claims involving product labeling are preempted.
17. Rollins v. St. Jude Medical, 583 F. Supp.2d 790 (W.D. La. Oct. 20, 2008). Motion to dismiss plaintiff's claim that defendants failed to abide by FDA reporting requirements granted in part and denied in part in Angio-Seal case. Plaintiff conceded that all claims were preempted except failure to manufacture/package in accordance with FDA specifications, failure to train, and failure to abide by reporting requirements. Noncompliance claims not preempted. Manufacturing defect claim based on product recall not preempted. Failure to train claim preempted to the extent of FDA compliance. Failure to report claim dismissed for lack of causation.
18. Link v. Zimmer Holdings, Inc., 604 F. Supp.2d 1174 (N.D. Ill. Nov. 26, 2008). Summary judgment granted against all claims concerning total knee replacement prosthesis. No factual dispute as to compliance with FDA requirements. Rejected loopholes: fraud on the FDA (preempted), post-approval defect (relies on dissent; no proof); congress might change the statute (hasn't).
19. Bausch v. Stryker Corp., 2008 WL 5157940 (N.D. Ill. Dec. 9, 2008), reconsideration denied, 2009 U.S. Dist. Lexis 77572 (Aug. 31, 2009). Motion to dismiss granted ageinst all claims concerning total hip replacement prosthesis. Subsequent recall does not revoke PMA. Tort claims to not become parallel claims escaping preemption simply by adding allegations that FDCA violations were collaterally violated. Parallel claims limited to "a state regulatory enactment that provides damages remedies for violations of FDA regulations."
20. Robinson v. Endovascular Technologies, Inc., 2008 WL 5267874 (Cal. Super. Santa Clara Co. Dec. 17, 2008). Summary judgment granted against all claims concerning Ancure endograft system, an investigational device. Riegel applies to IDE devices.
21. Norks v. Endovascular Technologies, Inc., 2008 WL 5267875 (Cal. Super. Santa Clara Co. Dec. 17, 2008). Summary judgment granted against all claims concerning Ancure endograft system, an investigational device. Riegel applies to IDE devices. This case was appealed to the 6th Division of the California Court of Appeals on March 5, 2009).
22. Lake v. Kardjian, 874 N.Y.S.2d 751 (N.Y. Sup. Dec. 17, 2008). Summary judgment granted against all claims concerning Targis transurethral microwave therapy system. Plaintiff failed to identify any specific statement exceeding FDA-approved warnings that could qualify as an unpreempted express warranty. Post approval failure to report claims are preempted either as fraud on the FDA or prohibited private FDCA violation claims.
23. Huber v. Howmedica Osteonics Corp., 2008 WL 5451072 (D.N.J. Dec. 31, 2008). Motion to dismiss denied against complaint alleging solely a claim for express warranty in total hip replacement litigation. The court considered itself bound by pre-Riegel Third Circuit precedent. The question whether express warranty claims are preempted has been certified to the Third Circuit. Huber v. Howmedica Osteonics Corp., 2009 WL 2998160 (D.N.J. March 10, 2009).
24. In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. Jan. 5, 2009), reconsideration denied, 2009 WL 294353 (D. Minn. Feb. 5, 2009), leave to amend complaint denied, 2009 WL 1361313 (D. Minn. May 12, 2009). Motion to dismiss granted against all claims in Sprint Fidelis MDL. Manufacturing defect claims not "parallel" because no specific violations alleged, or allegable given generality of FDA regulations. Parallel claims do not exist without a specific FDA regulation for state-law claims to parellel. Adulteration claims amount to prohibited private attempts to enforce the FDCA. Negligence per se only supplies a standard of care, and cannot resurrect an otherwise preempted claim. An express warranty of "safety" would require a jury to find a device unsafe, which is preempted. This is an appealable order, and motion practice in the district court appears exhausted.
25. Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. Jan. 12, 2009). Motion to dismiss denied as to claims "based on theories that [defendant] failed to comply with federal requirements for manufacturing" a hip replacement prosthesis. Surviving claims include those for express and implied warranty and consumer fraud. All non-violation claims had been voluntarily dismissed.
26. Means v. Howmedica Osteonics Corp., 2009 WL 347407 (S.D. Ind. Feb. 11, 2009), minute order following Hofts in hip replacement prosthesis case.
27. Blunt v. Medtronic, Inc., 760 N.W.2d 396 (Wis. Feb. 17, 2009). Pre-Riegel ruling in favor of PMA preemption affirmed in implantable defibrillator case. Both PMA and supplemental PMA have equal preemptive effect. Supplemental approval does not diminish the preemptive effect of initial approval.
28. Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. Feb. 20, 2009). Motion to dismiss granted as to claims involving total hip prosthesis. All claims except manufacturing defect are preempted, including consumer fraud. Warning letters and recalls not involving the device in question do not create parallel claims. A plaintiff must plead how a particular violation caused injury. The manufacturing claim must be more specifically pleaded. Express warranty claims not based on the approved labeling would escape preemption.
29. Shertzer v. Howmedica Osteonics Corp., 2009 WL 535997 (S.D. Ind. March 3, 2009), minute order following Hofts in hip replacement prosthesis case.
30. Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. March 5, 2009). Motion to dismiss granted in part and denied in part as to claims involving hip prosthesis. Violation claims, even if not preempted under Lohr, are preempted as attempted private FDCA enforcement under Buckman. Express warranty claims are not preempted, but are insufficiently pleaded. Manufacturing defect claims are preempted without specific allegations of a deviation from FDA-approved specifications.
31. Dorsey v. Allergan, Inc., 2009 WL 703290, slip op. (M.D. Tenn. March 11, 2009). Summary judgment granted as to claims involving investigational breast implants. Riegel applies to Class III devices marketed pursuant to an IDE or its equivalent. FDA approval of both adjunct (equivalent to an IDE) and core studies (an actual IDE) has preemptive effect.
32. Mitaro v. Medtronic, Inc., 23 Misc. 3d 1122(A), 2009 WL 1272398 (N.Y. Sup. April 9, 2009) (unreported). Motion to dismiss granted against almost all claims, including consumer fraud, in implantable cardiac defibrillator case. Manufacturing defect claim could be a parallel violation claim. Negligence per se claim is preempted both as restating other preempted claims and as attempted private FDCA enforcement. Express warranty claim preempted only to the extent it relies upon FDA-approved statements. Claims predicated on false statements to the FDA are preempted under Buckman. A product recall does not vitiate preemption.
33. Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009). Motion to dismiss granted as to all claims in anti-adhesive surgical barrier case. Negligence per se claims related to events that post-dated plaintiff's injuries and thus couldn't possibly be causal. All other claims are preempted. Express preemption claims based on FDA-approved language are preempted.
34. Miller v. DePuy Spine, Inc., ___ F. Supp. 2d ___, 2009 WL 1767555 (D. Nev. May 1, 2009). Granting summary judgment against all claims in a spinal implant disc case, including express warranty because the claimed warranty concerned aspects of device safety and effectiveness. Plaintiff had no evidence to support allegations of violation of FDA manufacturing standards. Allegations of fraud on the FDA are preempted under Buckman and as they are a prohibited attempt at private FDCA enforcement, would not constitute negligence per se under Nevada law.
35. Mullin v. Guidant Corp., 970 A.2d 733, slip op. (Conn. App. May 12, 2009), affirming Mullin v. Guidant Corp., 2008 WL 2785498 (Conn. Super. April 8, 2008). All claims, including manufacturing defect and express and implied warranties, are preempted in action involving implantable defibrillator. Plaintiff did not plead anything that could be considered a “parallel” violation claim. Preemption does not deprive a court of subject matter jurisdiction.
36. Riley v. Cordis Corp., ___ F. Supp.2d ___, 2009 WL 1606650 (D. Minn. June 5, 2009). Judgment on the pleadings granted as to all claims in drug eluding stent case. A "parallel" claim involves conduct "forbidden" by the FDCA. Even a claim involving prohibited conduct may be impliedly preempted as an improper private FDCA action under Buckman. To escape Buckman, a claim must rely on traditional state tort theories. Preemption applies to off-label uses. A combination of a drug and a device will be treated as a device for preemption purposes where the FDA has regulated the product as a device. Allegations that the FDA is poorly run do not defeat preemption. Allegations of promoting off-label use escape preemption only if, in addition to violating the FDCA, the promotion failed to warn of risks in violation of the common law. All other warning related claims are preempted. Fraud claims must be specifically pleaded. Express warranty claims based upo the device's label are preempted. Manufacturing defect claims must allege a violation in the particular device at issue. Any claims not dismissed with prejudice must be repleaded.
37. Bencomo v. Guidant Corp., 2009 WL 1951821, slip op. (E.D. La. June 30, 2009). Summary judgment on preemption granted against express warranty claims involving embolis capture system. Alleged contradiction between patient material and product labeling could not support a claim where the language in both sets of material were FDA approved. A claim dependent upon the falsity of FDA approved language cannot be a parallel claim.
38. Colombini v. Westchester County Health Care Corp., 2009 WL 2170230 (N.Y. Sup. July 6, 2009). Summary judgment granted against all claims in action involving an MRI device. That the device had been downclassified to Class II did not eliminate preemption, as the device was initially PMA approved. Plaintiffs could not point to any FDA design requirement that defendant violated, therefore there was no viable parallel claim.
39. Prudhel v. Endologix Inc., 2009 WL 2045559 (E.D. Cal. July 9, 2009). Motion to dismiss granted in part in aortic stent case. Alleged express warranty of safety was preempted. Alleged parallel claims are preempted when they impose greater requirements on compliant manufacturers. Parallel claims that require "more than mere noncompliance" are not preempted. A manufacturing defect claim, involving product recalls, survives preemption. Strict liability, negligence, and implied warranty claims are preempted.
40. Weston v. Kim's Dollar Store, ___ S.E.2d ___, 2009 WL 2136707 (S.C. App. July 15, 2009). All claims properly held preempted in litigation concerning colored contact lenses. The lenses were regulated by the FDA and were not purely cosmetic. Although a "misbranding" claim was alleged, it was not separately discussed.
41. Wolicki-Gables v. Arrow International, Inc., 641 F. Supp. 2d 1270 (M.D. Fla. July 22, 2009). Summary judgment granted against all claims against the manufacturer and distributor of a pain pump. No parallel claims were alleged.
42. Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009). Motion to dismiss granted against all claims in ceramic total hip replacement case. Finding broad preemption of state tort claims that "incidentally" regulate medical devices. Parallel violation allegations can escape express preemption, but are subject to implied preemption. Rejects argument that preemption may only be decided on summary judgment. Rather than vitiating the preemption defense, allegations of fraud on the FDA are themselves preempted. FDA warning letters issued after plaintiff's surgery, and thus not relating to the product implanted in plaintiff cannot support an unpreempted parallel claim. To plead an unpreempted parallel violation claim requires alleging a specific federal requirement, how it was violated, and how the violation caused this plaintiff's injury. Express warranty and consumer fraud claims are too vaguely pleaded to escape preemption.
43. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 2009 WL 2600517, slip op. (M.D. Ga. Aug. 24, 2009). Motion to dismiss granted against punitive damages claim asserted under New Jersey law because fraud on the FDA exception to the statutory ban on punitive damages against FDA-approved products is barred by preemption under Buckman.
44. William Beaumont Hospital v. Medtronic, Inc., 2009 U.S. Dist. Lexis 77860 (E.D. Mich. Aug. 31, 2009). Motion to dismiss granted in part. All claims based on alleged inadequacy of warnings are preempted in case concerning pain pump refill kits. Contribution claims based upon the negligent distribution of an incorrect free sample that was not in fact the same device as represented are not preempted.
45. Williams v. Cyberonics, Inc., 2009 WL 2914414 (E.D. Pa. Sept. 10, 2009). Summary judgment granted against all claims in two cases involving vagus nerve stimulation devices. Unknown manufacturing defects inferred from alleged device malfunction were preempted because proof of a failure to manufacture the device to comply with FDA design requirements was shown.
46. Williams v. Allergan USA, Inc., 2009 WL 3294873 (D. Ariz. Oct. 14, 2009). Summary judgment granted against all claims in ruptured breast implant case involving IDE device. Claims of lack of valid consent are factually false. No pleaded facts support any violation claim. That PMA approval occurred only after the plaintiff's device was implanted does not prevent preemtion, since essentially the same device was approved. A non-waiver clause in an informed consent form does not override preemption.
47. In re Medtronic Sprint Fidelis Leads State Court Litigation, 2009 WL 3417867, slip op. (Minn. Dist. Hennepin Co. Oct. 20, 2009). Motion to dismiss granted against all claims in state court Sprint Fidelis litigation. Express warranty and consumer fraud claims preempted. Purported "parallel" claims dismissed because: (1) they are disguised private attempts to enforce the FDCA, which are impliedly preempted under Buckman; (2) there is no parallel state law claim for failure to follow the conditions of an FDA PMA; (3) there is no federal requirement to submit a CBE (it's strictly voluntary); (4) claims challenging the sufficiency of a defendant's submissions to the FDA are disguised fraud-on-the-FDA claims; (5) plaintiffs' design claims would impose rigid specificity that FDA regulations do not; (6) nothing in the FDA's regulations requires withdrawal of a device because an allegedly "safer" model was later approved; (7) there is no obligation to submit a PMA supplement immediately after learning of problems with an existing device; (8) certain alleged violations were not causally connected to any plaintiff's injuries; (9) adulteration claims are disguised private attempts to enforce the FDCA; negligence per se claims are disguised private attempts to enforce the FDCA; (10) a statute that does not authorize a private cause of action cannot be the basis of a negligence per se claim under state law; and (11) the regulations subject to plaintiff's negligence per se claims are only administrative requirements and do not prescribe standards of care owed to any individual.
48. Williams v. Endologix, Inc., slip op., 2009 WL 3554581 (Ky. Cir. Oct. 30, 2009). Summary judgment granted against all claims in some kind (aortic stent?) of PMA device litigation, except claims "premised upon" FDCA violations, which the court considered parallel claims.
49. Hughes v. Boston Scientific Corp., 2009 WL 3817586 (S.D. Miss. Nov. 12, 2009). Summary judgment granted against all claims in HydroTherm Ablator case. Negligence per se claim based on post-market reporting procedures allegedly violating the FDCA is preempted under Buckman. Alleged negligent misrepresentation to the FDA is barred for the same reason as fraud on the FDA, because it would second guess FDA reporting requirements. Calling such claims "parallel violation" claims under Riegel is a distinction without a difference. Negligence per se based on FDCA violations does not state a common-law cause of action.
50. McQuiston v. Boston Scientific Corp., C.A. No. 07-1723, slip op. (W.D. La. Nov. 19, 2009). Summary judgment granted against all claims in a drug eluting stent case involving a combination device. Express warranty claim preempted. Plaintiff did not plead a "parallel violation" claim.