Opinion
No. C0 1-20460 RMW, No. C 01-20497 RMW, No. C 01-20693 RMW
August 28, 2002
ORDER GRANTING IN PART DEFENDANTS' MOTION FOR SUMMARY JUDGMENT ON PREEMPTION GROUNDS
Defendants have moved for summary judgment in three related cases contending that all of plaintiffs' claims are preempted by 21 U.S.C. § 360k(a), the Medical Devices Amendment of 1976 to the Food, Drug and Cosmetics Act. The identical motion is pending in three cases: Hochberg v. Medtronic, C01-20497 RMW, Gilleon v. Medtronic, C01-20460 RMW and Frederick v. Medtronic, C 01-20693 RMW. This order will be issued in each of the three cases.
In addition, the identical preemption issue appears to be presented in a host of other related actions, each of which involves a plaintiff claiming injury by defendants' AneuRx Stent Graft device.
Defendants' motion came on for hearing on April 19, 2002. Plaintiffs oppose the motion. Having considered the papers submitted by the parties and the arguments of counsel at oral argument, for good cause appearing for the reasons set forth below, defendants' motion is granted in part.
BACKGROUND
The medical device at issue in this case is defendants' AneuRx Stent Graft System, a minimally invasive alternative to "open repair" surgery to repair abdominal aortic aneurysms. Open repair surgery is major surgery, involving the opening of the abdomen and the movement of organs in order to surgically repair the aorta. By contrast, the AneuRx device is a self-expanding stent pre-loaded on a delivery catheter which is inserted through a small incision in the femoral artery and deployed to cover and reinforce the diseased section of the aorta. The procedure takes less time, is less invasive, is available to a number of patients who cannot undergo open repair surgery, and requires less hospitalization. Medical devices are categorized into three classes based on the degree of regulation needed to assure the safety and effectiveness of the medical device. Class I devices, such as tongue depressors, do not present an unreasonable risk of illness or injury and are subject to only general controls. § 360c(a)(1)(A); 21 C.F.R. § 880.6230. Class II devices, such as certain hearing aids, for which such general controls are insufficient, standing alone, to provide reasonable assurance of the safety and effectiveness of the device, are subject to certain special controls. Finally, Class III devices are those for which there is insufficient information to determine that Class I or Class II controls are enough to provide a reasonable assurance of the device's safety or effectiveness and (i) are to be used for supporting or sustaining human life, or are of substantial importance in preventing impairment of human health, or (ii) present a potential unreasonable risk of illness or injury. 21 U.S.C. § 360c(a)(1)(c). To reach the market, Class III devices must receive premarket approval ("PMA") from the FDA which involves submission of a detailed application including clinical data, information regarding the device's components and manufacturing processes, proposed instructions for use and product labeling, and any additional information required by the FDA. Swanson Decl. ¶ 16, 17, 19. The AneuRx is classified as a Class III medical device. Swanson Decl. ¶ 5, 14(c).
The AneuRx underwent clinical trials and received pre-market approval by the FDA on September 28, 1999. The AneuRx remains subject to FDA review, but despite various incidents involving the device, the FDA has not sought to recall the device, prevent its farther sale or use, or place any restrictions on the use or sale of the device. Swanson Decl. ¶ 68.
On April 27, 2001, however, the FDA issued a Public Health Notification informing physicians and Other regulatory bodies of concerns with both the AneuRx stent graft system and a competitor's device. The notification advised physicians of the FDA's concerns regarding reports of 25 aneurysm ruptures and other serious adverse events, along with the factors thought to be associated with those adverse events. Those factors include: sub-optimal placement of the graft; endoleak; migration, problems with device integrity due to metal frame fractures, suture breaks, or fabric tears; and aneurysm anatomy. Abrams Decl. Exh. A. The FDA recommended that physicians stay informed, make sure that all implanted patients are carefully followed and undergo periodic follow-up imaging, and report all problems and adverse incidents. Id.
Thus, the AneuRx is not a risk-free medical device. The Frederick, Gilleon, and Hochberg cases each include claims for injuries by persons who were implanted with the device. Joe Frederick was implanted with the device and claims to have suffered injuries. Frederick Complaint ¶ 26. Edward Gilleon was implanted with an AneuRx stent graft system for repair of an abdominal aortic aneurysm, but the device has migrated from its intended location and has required further surgery to remove the graft. Gilleon Complaint, ¶ 22. Finally, Leonard Hochberg was implanted with the AneuRx stent graft system but subsequently died after complications from the system arose. Hochberg Complaint ¶ 22.
The plaintiffs in Hochberg are Mr. Hochberg's wife and daughter, his heirs, who bring the claims as his survivors.
The three lawsuits are nearly identical, other than the relatively few factual allegations particularized to each case identifying the plaintiffs and describing, briefly, the nature of the individual facts involved. Each case asserts nine causes of action. All three assert the following eight claims:
1) strict liability (failure to warn);
2) strict products liability (per Restatement 2d Torts, § 402A);
3) negligence (duty to properly manufacture, compound, test, inspect, package, label, distribute, market, examine, maintain supply, provide proper warnings and prepare for use and sell the device);
4) breach of implied warranty (defendants impliedly warranted to plaintiffs and their agents that the product was of merchantable quality and safe for the use for which it was intended);
5) breach of express warranty (express warranty that product was safe for use by plaintiff and members of the general public);
6) fraud (false representations to the patient, his physicians and the general public that the product was safe for use to aid in repair of abdominal aneurysms, representations that were false because there was inadequate testing, known frequent severe effects and because product caused injuries);
7) negligent misrepresentation (same as in the fraud claim, representations were made to the physicians who used the AneuRx prior to its insertion in the patients and their physician relied on those representations);
8) fraud by concealment (defendants concealed the true facts that product was dangerous and defective and likely to cause serious consequences to user).
In addition, both Gilleon and Frederick assert a claim for loss of consortium, and Hochberg asserts a "survivorship claim."
Defendants have moved for summary judgment on the ground that plaintiffs' state law tort claims are preempted. Specifically, defendants contend that all of plaintiffs' claims are preempted by the MDA because the AneuRx is a Class III device that has received PMA approval by the FDA. Additionally, defendants argue that plaintiffs' fraud and misrepresentation claims are "fraud-on-the-FDA" claims that are preempted by the Supreme Court's decision in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 343 (2001).
DISCUSSION
The predominant issue on defendants' motion is whether the Medical Device Amendments ("MDA") to the Food, Drug and Cosmetics Act preempt plaintiffs' state law claims in these actions. 21 U.S.C. § 360k(a). As recognized by nearly every case that has addressed the issue, the MiDA contains an express, but highly ambiguous, provision for the preemption of state law. See, e.g., Medtronic v. Lohr, 518 U.S. 470 (1996); Papike v. Tambrands. Inc., 107 F.3d 737 (9th Cir. 1997. The preemption provision provides that:
No State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement —
(1) which is different from, or in addition to, any requirement applicable under this [Act] to the device, and
(2) which relates to the safety or effectiveness of the device or to any other mater included in a requirement applicable to the device under this [Act].
U.S.C. § 360k(a). The FDA interprets this provision to mean that:
State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements.
C.F.R. § 808.1(d). Nevertheless, state or local requirements of general applicability are not preempted "where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes or the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices." 21 C.F.R. § 808.1(d)(1).
The preemption question generally boils down to three issues: 1) are there any federal regulations or other requirements specifically applicable to the AneuRx device relating to the safety or effectiveness of the device; 2) do the state common law claims asserted by plaintiffs seek to impose requirements on the defendants that are different or in addition to the federal requirements; and 3) do the purposes of the state law requirements relate either to other products in addition to devices or to unfair trade practices in which the requirements are not limited to devices. 21 C.F.R. § 808.1(d)(1). If the court were writing on a blank slate, many additional issues would be presented by these general preemption questions, including whether PMA approval constitutes a "federal requirement" applicable to the device and whether state common law torts of general applicability may constitute state law "requirements" which may impose different requirements than the federal law. The slate is not entirely clean, however.
Instead, as a result of the highly ambiguous statutory preemption provision and a fractured decision by the United States Supreme Court,Medtronic v. Lohr, 518 U.S. 470 (1996), there has developed a substantial split in authority regarding whether the MDA preempts state products liability lawsuits over medical devices that have received PMA approval. The majority of circuits to have addressed the issue have held that the PMA process results in preemption, at least of common law claims contending that the approved product design is defective or unreasonably dangerous or that allege that the approved labeling or warnings are inadequate. See Brooks v. Howmedica, Inc., 273 F.3d 785, 799 (8th Cir. 2001); Martin v. Medtronic, 254 F.3d 573, 584 (5th Cir. 2001); Kemp v. Medtronic, 231 F.3d 216, 226-28 (6th Cir. 2000); Mitchell v. Collagen Corp., 126 F.3d 902, 911 (7th Cir. 1997). The Eleventh Circuit, however, reached a contrary conclusion, in Goodlin v. Medtronic, 167 F.3d 1367 (11th. Cir 1999), finding that the common law tort claims are not preempted by the MDA. Both parties contend that the opposing party has misread the case law, or that the cases relied upon the opposing party are poorly reasoned. Contrary to both parties' arguments, however, the cases on both sides of the split are well-reasoned and defensible.
Similarly, a California appellate court has reached the same conclusion. Steele v. Collagen Corp., 54 Cal.App.4th 1476, 1487 (1997).
The district court in Webster v. Pacesetter. Inc., 171 F. Supp.2d 1 (D.D.C. 2001), set forth a thoughtful analysis of the issues presented, as well as an analysis of the split among the circuits. The Webster court concluded that "[t]he substantive split among the circuits reveals a methodological difference: the majority focuses on the rigor of the PMA process and often restrictive post-approval conditions, whereas the minority focus on congressional intent as expressed in the statute" Id 171 F. Supp.2d at 9. Thus, courts that look to the rigors of the PMA approval process, the FDA's involvement in approving the design of the device, the warnings to be given for the device, and the contents of labeling, conclude that the PMA approval constitutes device specific federal requirements which would be undermined if state common law claims could be brought and which would impose different or additional requirements.
The Ninth Circuit has not yet been presented with the preemption issue presented in the context of a Class III device receiving PMA approval. Nevertheless, the Ninth Circuit has not been wholly silent on the issue. In Papike, 107 F.3d 737, the Ninth Circuit was presented with the issue of whether or not state common law tort claims were preempted by the MDA for a Class II device as to which the FDA had promulgated specific regulations. The court read the Supreme Court's Lohr decision to establish that state common law claims can amount to "requirements" which may be preempted under the MDA, even though the tort claims are laws of general applicability and are not limited to medical devices. Papike at 740-41. The Ninth Circuit held that the common law tort claims were preempted under the MDA because of the specific FDA regulations. 107 F.3d at 740. In doing so, the court distinguished prior MDA preemption cases in which there was no device-specific or disease-specific FDA regulation. Id. The Ninth Circuit explained that "[w]e have previously held that "the scope of preemption is limited to instances where there are specific FDA requirements applicable to a particular device," id at 741 citing with approval its prior decisions in Anguiano v. E.I. DuPont de Nemours Co., 44 F.3d 806 (9th Cir. 1995), and Committee of Dental Amalgam Mfrs. Distribs. v. Stratton, 92 F.3d 807 (9th Cir. 1996). Ultimately, the court summarized its holding that "preemption is triggered by and `the scope of preemption is limited to instances where there are specific FDA requirements applicable to a particular device.'"Papike, 107 F.3d at 742, quoting Anguiano, 44 F.3d at 809.
Anguiano, cited several times with approval by Papike, is therefore instructive. The case involved a products liability lawsuit by patients who had received Teflon-based temporomandibular joint implants. The patients suffered tissue reaction when the implants fragmented. Defendant contended that the common-law claims were preempted by the MDA. The court held that the claims were not preempted:
There is no federal preemption here because the FDA has issued only identification and classification regulations relating to PTFE vitreous carbon material, 21 C.F.R. § 872.3695, and PTFE with carbon fibers composite implant material, 21 C.F.R. § 878.3500. As identification provisions, these regulations do not "relate to the safety or effectiveness of the device," 21 U.S.C. § 360k(a), and so are not specific requirements which preempt state law. "An "identification provision' in the federal regulations does not act as a specific requirement which would preempt state common law." Bravman v. Baxter Healtheare Corp., 842 F. Supp. 747, 757 (S.D.N.Y. 1994); Elbert v. Howmedica, Inc., 841 F. Supp. 327, 331 (D. Haw. 1993); but see Cameron v. Howmedica, 820 F. Supp. 317, 320 (E.D. Mich. 1993). Thus, as regards PTFE, the MDA does not provide specific requirements which preempt state law.44 F.3d at 809-10. The product at issue in Anguiano, however, was a Class II medical device. In contrasting the Class II device from Class III devices, which pose a more serious risk of injury, the court noted that:
Because of the more extensive requirements imposed on Class III devices, the MDA preempts state law regarding a Class III device even if the only MDA regulation specifically addressing the device is an identification regulation. Bravman, 842 F. Supp. at 761. Class II devices, however, must carry some specific regulation beyond the identification regulation for preemption to apply. Thus, DuPont's argument that the MDA regulatory framework preempts state law, even absent specific provisions, applies only to Class III devices, not Class II devices like Proplast.Anguiano, 44 F.3d at 810 (internal cites omitted, emphasis added). The highlighted language strongly indicates that the Ninth Circuit would agree with the majority view and hold that PMA approval of a Class III device gives rise to preemption of state law claims.
The Ninth Circuit's citation to Bravman, in particular, andElbert, to some degree, also suggests that the Ninth Circuit would find preemption for Class III devices having PMA approval. Bravman held that PMA approval of a Class III device results in preemption under the MDA. 842 F. Supp. at 761. In Elbert, the district court found that state law claims were not preempted for Class III devices, distinguishing case law finding preemption for Class III devices because of the substantial regulatory scheme applicable to such Class III devices. 841 F. Supp. at 831. The Ninth Circuit's citation to these cases, coupled with the language of Anguiano lead the court to conclude that Class III PMA approval results in MDA preemption of state law claims.
Accordingly, the court elects to follow the majority view and concludes that PMA approval of the AneuRx device results in preemption of state common law claims, to the extent those claims seek to impose requirements that are different or in addition to those required by federal law. Deciding to follow the majority approach does not end the inquiry, however, for it still must be determined whether the particular claims asserted by the plaintiffs are preempted.
1. Products Liability Claims
Plaintiffs assert several species of products liability claims, including claims based on failures to warn, product design, and product manufacture. It is not entirely clear from the complaints, however, whether the products liability claims are premised on an underlying theory that the product at issue was defective as approved by the FDA, or whether instead the product is defective because it deviated from what was approved by the FDA. To the extent plaintiffs' claims seek to impose liability even though the AneuRx device at issue in the particular case complies with the design as approved by the FDA or complies with the approved manufacturing process, the claims are preempted. Similarly, to the extent plaintiffs' claims are based on alleged failures to warn, or inadequate warnings, arising from the warnings and labeling approved by the FDA, those claims too are preempted.5 To the extent that plaintiffs' claims are based on the theory that the particular device at issue was defective in that it did not comply with the approved design or manufacturing process or that the warnings or labeling deviated from those required by the FDA, however, then the claims are not preempted.
2. Misrepresentation Claims
Turning to plaintiffs' misrepresentation claims, defendants again seek summary judgment on the ground that the claims are preempted. Defendants characterize plaintiffs' claims as "fraud on the FDA" claims, pointing to allegations that defendants delayed in providing information to the FDA regarding five ruptures that occurred during the clinical studies. The Supreme Court in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 343 (2001), however, held that such claims for fraud on the FDA are impliedly preempted. The FDA has the power to investigate suspected fraud and has at its disposal an arsenal of enforcement options. Id. at 348. Thus, to the extent that plaintiffs' misrepresentation claims are premised on a theory that defendants are liable for withholding information from the FDA i e that defendants fraudulently secured approval of AneuRx by withholding information from the FDA, those claims are preempted.
Plaintiffs argue, however, that their fraud and misrepresentation claims are based on defendants' misrepresentations to the general public, to plaintiffs, and to plaintiffs' physicians. Accordingly, such claims are not preempted under Buckman because the claims are not "fraud on the FDA" claims. A fair reading of the complaint demonstrates that a "fraud on the FDA" claim is not being asserted. To the contrary, the fraud, negligent misrepresentation, and fraud by concealment claims each allege that misrepresentations were made to (or true facts concealed from) the general public, physicians, the patient-plaintiffs and plaintiffs' physicians. Accordingly, at this juncture it would be improper to grant summary judgment to defendants under Buckman Nevertheless, the court notes that the misrepresentation claims are not sufficiently pleaded under Rule 9, and the "who, what, when and where" facts are wholly absent.
Plaintiffs devote a significant portion of their brief arguing that the preemption doctrine does not apply because defendants did more than merely manufacture and sell the device and instead were involved in physician training and patient selection. Nowhere, however, do plaintiffs explain why this is significant to the preemption question or explain how plaintiffs' claims for relief are premised on defendants' actions in physician training or patient selection.
Thus, it is appropriate to dismiss those claims, with leave to amend to plead the claims with the specificity required by Rule 9.
3. Loss of Consortium Claims
The Gilleon and Frederick actions include claims for loss of consortium. In a footnote, defendants argue that these claims are also preempted because they are derivative of the other preempted claims. Motion at 30 n. 15 (citing case law). Plaintiffs do not appear to have addressed the issue. Based on the present state of the briefing, the court will grant the motion for summary judgment as to the loss of consortium claims that derive from the other preempted claims. At present, it is unclear the extent to which plaintiffs are asserting claims which are not preempted, and it is also not clear whether any remaining claims support a spouse's claim for loss of consortium.
ORDER
For the foregoing reasons, defendants' motion for summary judgment is GRANTED IN PART as follows:
1) To the extent plaintiffs assert products liability claims based upon failures to warn, product design, and product manufacture, even though the AneuRx device at issue complies with the design as approved by the FDA or complies with the approved manufacturing process, the claims are preempted.
2) To the extent plaintiffs' claims are based on alleged failures to warn, or inadequate warnings, arising from warnings and labeling approved by the FDA, the claims are preempted.
3) To the extent that plaintiffs' claims are based on the theory that the particular device at issue was defective in that it did not comply with the approved design or manufacturing process or that the warnings or labeling deviated from those required by the FDA, however, then the claims are not preempted.
4) To the extent plaintiffs assert loss of consortium claims that derive from the other preempted claims, the claims are preempted.
Defendant's motion for summary judgment on plaintiffs' fraud, negligent misrepresentation, and fraud by concealment claims, however, is DENIED. Nevertheless, IT IS FURTHER ORDERED that those claims are dismissed with leave to amend for failure to plead the claim with the particularity required by Rule 9.
Plaintiffs are granted thirty days in which to file an amended complaint, if desired, to clarify the bases underlying their products liability claims and to allege with the requisite degree of particularity their misrepresentation claims. In addition, the parties are hereby ordered to meet and confer within 30 days after the date of this order for the purpose of coordinating a further case management conference. The parties shall contact the court's deputy clerk to schedule the case management conference.