United States: Bi-Annual Update Regarding Medical Device and Pharmaceutical Federal Preemption

Federal preemption is one of the most important defenses available to medical device manufacturers defending product liability lawsuits, and it also has been applied successfully in certain pharmaceutical product liability actions.

Because the final word has not yet been written on preemption in either context, however, Reed Smith’s product liability attorneys closely monitor preemption decisions, even courts nationwide and in other contexts, and actively litigate the issue. This update highlights some key preemption opinions issued over the last several months, including last week’s medical device preemption decision by the Seventh Circuit, McMullen v. Medtronic, Inc.

On August 26, the Seventh Circuit affirmed summary judgment for Medtronic, Inc. in a case in which the plaintiffs sought to avoid the preemption defense through several creative arguments.

McMullen involved Medtronic’s Activa Tremor Control System, a PMA-approved Class III medical device used to suppress tremors in patients diagnosed with Parkinson’s Disease. The Activa’s FDA-approved warnings included precautions that recipients should take regarding electrocautery and diathermy treatments.

After Medtronic received a report that an Activa recipient had become comatose during diathermy administered by a dentist, it conducted a careful investigation and coordinated with the FDA. Once its investigation was complete, it sent letters to patients and physicians, and submitted a PMA Supplement for a strengthened diathermy warning.

Mr. McMullen, however, argued for a post-sale duty to warn that Medtronic should have unilaterally issued a new, stronger warning about diathermy immediately after it received the report. Plaintiffs contended that during the investigatory period, he underwent a dental treatment that caused a worsening of his Parkinson’s symptoms.

Following the path it first laid down in Mitchell v. Collagen Corp., 126 F.3d 902, 913 (7th Cir. 1997), the Seventh Circuit affirmed that express medical device preemption can result from state requirements imposed through common law tort claims, and that the FDA imposed device-specific requirements both before and after approval.

Thus, McMullen turned on plaintiffs’ contention that the state common law duty they sought to impose through their lawsuit was one that was "different from, or in addition to" the relevant federal requirements. To support this argument, plaintiffs contended that Medtronic had violated 21 C.F.R. § 821.1, which requires manufacturers to track device recipients, and 21 C.F.R. § 814.39, which permits manufacturers to temporarily amend a warning pending FDA approval of those changes.

But as the Seventh Circuit recognized, section 821.1’s tracking requirements do not impose a duty on, or even authorize, manufacturers to warn the patients they track; rather, it clearly vests the regulatory authorities with the discretion to decide when such warnings must be issued.

The Seventh Circuit also recognized that just because section 814.39 grants manufacturers permission to temporarily change a warning in certain circumstances, that does not make it into a mandatory federal requirement that the manufacturer do so. Because the federal standard is permissive, an analogous mandatory state requirement like the one plaintiffs sought to impose in McMullen is, by definition, an additional requirement and thus preempted.

Thus, the McMullen opinion is significant in a few respects. First, it is another circuit court opinion affirming and applying the majority view of medical device preemption that has taken root over the past few years. Second, because the majority view of preemption has become more established, plaintiffs’ attorneys have become more creative in trying to circumvent the defense. One way has been for plaintiffs to argue that their claims parallel federal requirements (or are for violations of federal requirements), often by pointing to 21 C.F.R. § 814.39’s permissive language regarding the strengthening of warnings. Yet in McMullen, the Seventh Circuit tackled that argument head-on, and rejected it.

The Supreme Court’s Decision. The preemption defense is not, of course, limited to the medical device context. The United States Supreme Court has addressed preemption cases in many contexts, from tobacco to railroads. Unfortunately, the court’s general approach to federal preemption has varied over the years so much so that critics often complain that the court’s analytical approach to preemption is at best confusing and unhelpful, and at worst flatly inconsistent. The Supreme Court’s most recent preemption case, Bates v. Dow Agrosciences LLC, ___ U.S. ___, 125 S. Ct. 1788 (2005)—decided in April is only the latest case in what has been a fairly unpredictable ideological tug-of-war over the last three decades. Although cases like Bates are not directly applicable in the medical device context, they inevitably contain generalized statements on preemption principles that become fodder for litigants.

In Bates, the court addressed whether state law tort claims were preempted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).* FIFRA contains an express preemption clause similar to the express preemption clause applicable to medical devices: "Such State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter." 7 U.S.C. § 136v(b).

The state law tort claims at issue in Bates were brought by peanut farmers alleging that the labeling on Dow’s pesticide was misleading, that their use of the pesticide in reliance on the labeling had damaged their crops. Even though the EPA had some control over the pesticide’s label, the court found that the claims were not preempted.

The court focused its preemption analysis primarily on (1) whether state law claims asserted in litigation constitute "state requirements" that can be preempted; and (2) whether FIFRA imposed specific federal requirements applicable to the product’s labeling. The court held the requirements under FIFRA were general, not specific, and therefore declined to apply preemption.

On the first issue, the court examined the farmers’ claims for alleged violations of Texas’ Deceptive Trade Practices-Consumer Protection Act (DTPA) and common law tort claims (strict liability and negligence), fraud, and breach of warranty. The theory of liability underlying each of these claims was the farmers’ contention that the label for Dow’s pesticide and the representations of salespeople consistent with that label should have warned against use in soils with a pH greater than 7, and the label’s failure to contain such a warning made it deceptive.

Although FIFRA’s express preemption clause states that it preempts state "requirements," the Bates majority concluded that the term did not necessarily bring all state law claims within the ambit of FIFRA preemption. Id. at 1798. Instead, the court drew distinctions between the effect different claims might have and found that it was not enough that a jury verdict might "‘induce’ a pesticide manufacturer to change its label," and it would be "quite wrong" to consider that a prohibited state "requirement." Id. At the same time, however, the court recognized that the term "requirements" reaches beyond statutes and regulations and includes common-law duties. Id.

Applying these principles, the court concluded that common law fraud and failure-to-warn claims could survive preemption if the duties they would impose "are equivalent to FIFRA’s misbranding standards," even if the common law claim does "not explicitly incorporate FIFRA’s standards as an element of a cause of action." Id. at 1800. According to the court, the plain text of FIFRA allows for the possibility that the farmers’ claims might survive preemption, and thus required remand to allow the Court of Appeal to determine whether the state law labeling requirement imposed through the farmers’ claims is in fact the equivalent of the federal requirements. Id. at 1804.

On the second issue, the court found that FIFRA’s regulatory scheme for registering pesticides did not create a specific federal requirement but rather imposed general requirements. For instance, unlike the comprehensive safety and efficacy review of Class III medical devices under the PMA process, under FIFRA, the EPA’s review for pesticides is far more limited than even the review of medical devices under the FDA’s 510k process, much less the PMA process. Although FIFRA requires manufacturers to submit a proposed pesticide label to the EPA which will then be registered if the EPA determines that it is efficacious, the EPA had waived its rights to evaluate the efficacy of the pesticide in question as it had done with other pesticides (for more than two decades), thereby registering pesticides without confirming their efficacy. Id. 1796. The EPA, unlike the FDA, also does not have uniform and central control over the regulation of pesticide labeling because states may ban or restrict EPA-approved pesticides, register pesticides for uses the EPA has not, and even take over primary enforcement authority under grant from the EPA. Id. at 1802. Thus, given the general nature of the EPA’s registration process, the court did not find that the process imposed specific federal requirements governing the contents of pesticide labels.

While the court ultimately held plaintiffs’ claims were not preempted by FIFRA, its preemption analysis is not necessarily inconsistent with the majority view on preemption for PMA-approved medical devices.

Nevertheless, Bates has been worth watching because plaintiffs will likely try to use it against medical device manufacturers who raise preemption as a defense.

The Impact of Bates on the Lower Courts. Although the result in Bates ultimately may not be that surprising given the relatively limited control exercised by the EPA over pesticide labeling, some observers have been concerned that it might be interpreted as a signal to the lower courts that they should be somewhat more reluctant to find preemption. Indeed, since April, some courts have cited Bates to support findings of no preemption. Three cases have relied on Bates for the proposition that a "labeling requirement" does not extend to all state law claims that might induce a manufacturer to change its label. While none of these cases has involved medical devices, two did involve prescription drugs.

In Rite Aid Corp. v. Levy-Gray (876 A.2d. 115 (Md.App. June 3, 2005)), the Court of Special Appeals of Maryland, citing to Bates, held that the labeling provisions of the FDCA (21 U.S.C. § 301 et. seq.) did not preempt state law claims alleging that a prescription drug’s label was not adequate. 876 A.2d at 133-34. There, a customer sued a pharmacy for allegedly indicating in a patient package insert that she could take an antibiotic for Lyme disease with dairy products. The customer alleged, however, that dairy products interfered with the drug’s effectiveness and caused her to suffer post-Lyme syndrome. The pharmacy argued that, because the package insert it prepared complied with FDA-approved language, the FDCA preempted the customer’s claim. The court, however, held that: first, FDA regulations applied to the drug manufacturer and not the pharmacy; and second, the FDA regulations imposed a minimum standard and, citing to Bates, did not preempt state tort claims that did not directly involve a labeling requirement. Id. at 131–32.

In Gougler v. Sirius Products, Inc. 370 F. Supp. 2d 1185 (S.D. Ala., 2005), the U.S. District Court for the Southern District of Alabama similarly cited to Bates and held that the Federal Hazardous Substances Act ("FHSA") did not preempt a design defect claim. In that case, the widower of a consumer who died shortly after using a certain cleaning product sued the distributor and retailer of the cleaning product, asserting state law claims for negligence, wanton and wrongful failure to warn, and design defect claims in Alabama state court. Plaintiff asserted that the cleaning product was defectively designed because it had high concentrations of strong acids. The defendants argued that the FHSA’s express preemption clause, which is nearly identical to the express preemption clause in FIFRA, preempted plaintiff’s claims. The court, using the analysis outlined in Bates, held that the FHSA expressly preempted state "requirements," but that the state tort claims at issue did not constitute "requirements" for purposes of preemption under the FHSA. Id. at 1194-96.

Finally, the U.S. District Court for the District of Minnesota on July 20, 2005 cited to Bates briefly and held that the labeling provisions of the FDCA did not preempt plaintiff’s state law failure-to-warn claim. Witczak v. Pfizer, Inc., 377 F. Supp. 2d 726 (D. Minn. 2005). Echoing the court’s rationale in Rite Aid v. Levy-Gray (discussed above), and citing to Bates, the district noted: "If Congress had intended to deprive injured parties of a long available form of compensation, it surely would have expressed that intent more clearly."

Fortunately for medical device manufacturers, lower courts generally have accepted that Bates is consistent with the majority view of preemption.

For example, in Baker v. St. Jude Medical ___ S.W. 3d ___, 2005 WL 1539252 (Tex.App.—Houston, 2005), attorneys from Reed Smith and Beck, Redden & Seacrest successfully argued that the state law tort claims (negligence, product liability, and breach of warranty) of more than 50 plaintiffs were preempted, because those claims deviated from the federal requirements imposed through the FDA’s PMA-approval for the device. The Texas appellate court cited Bates to support the position that the Medical Device Amendments expressly preempt state law "requirements," and that requirements "can reach beyond positive enactments, such as statutes and regulations, to embrace common-law duties." Id. at *5.

In addition, in McMullen (discussed in more detail above), the Seventh Circuit also cited Bates for its recognition that common law duties can amount to state requirements. In addition, it used Bates to signal that caution should be taken with plaintiffs’ claims that state requirements parallel federal requirements, echoing that the requirements must be "genuinely equivalent" and explaining that such equivalence is missing "if a manufacturer could be held liable under the state law without having violated the federal law."

Unlike medical device manufacturers, prescription drug manufacturers have not fared as well with the preemption defense recently. For instance, as noted above in Witczak v. Pfizer, Inc., 377 F. Supp. 2d 726 (D. Minn. 2005), the court denied defendant drug manufacturer’s summary judgment motion on plaintiff’s failure-to-warn claim, holding that the labeling provisions of the FDCA did not preempt plaintiff’s claims. Witczak v. Pfizer, Inc., Minn. Dist. Ct., case number 04-CV-2819. See also Cartwright v. Pfizer, 2005 WL1155201 (E.D. Tex. March 31, 2005) (rejecting implied preemption argument because there was no conflict as no FDA approval was needed to add/strengthen warnings on Zoloft); Zikis v. Pfizer, 2005 WL 1126909 (N.D. Ill. May 9, 2005) (same); Gerdts v. SmithKline Beecham Corp., Civil No. 04-3500 (D. Ct. Minn. May 4, 2005) (court rejected implied preemption defense finding plaintiff’s claims were based on misrepresentations to consumers and physicians, not the FDA).

However, the pharmaceutical manufacturers have prevailed with the defense before in failure-to-warn cases, particularly where the regulatory history demonstrates FDA consideration of the specific label warning being attacked by plaintiffs in litigation. Two consolidated appeals before the Fifth Circuit, Dusek v. Pfizer (5th Circuit Case No. 04-11088) and Needleman v. Pfizer (5th Circuit Case No. 04-11088) on these issues thus bear monitoring. In addition, the FDA is expected to file an amicus brief in another pharmaceutical preemption case in the District of Utah, Kallas v. Pfizer, Case No. 04-CV-998. Judge Paul Cassell requested the amicus brief, which currently is due September 1, 2005; and if recent FDA filings are any guide, the amicus brief should provide support for the manufacturer’s position.

And other recent cases bode well for medical device manufacturers. A California District Court in Morton v. Centerpulse Orthopedics, Inc., 2005 WL 1366494 (E.D. Cal., 2005) considered preemption in a case involving an orthopedic knee device that underwent the PMA process. In part because the device underwent the rigorous PMA process, the court held that the MDA (21 USC § 360k) preempted plaintiff’s strict liability claims for design defect and manufacturing defect. The court therefore granted defendants’ summary judgment motion.

More recently, a California trial court in Neal v. Medtronic, Inc. et al., Case No. NC035236, Los Angeles Superior Court (August 30, 2005), granted Medtronic’s motion for summary judgment on preemption grounds. The court held that plaintiff’s claims for strict product liability, negligence and breach of warranty arising out of an allegedly defective PMA-approved pacemaker were expressly preempted by the MDA because they would impose requirements "different from" or "in addition to" the design, manufacturer and labeling requirements imposed by the PMA process. In reaching its decision and consistent with other preemption decisions, the court recognized that devices approved subject to a PMA-Supplement are entitled to the same preemption analysis as an original PMA device. In addition, the court also considered Medtronic’s alternate argument that principles of implied preemption required the dismissal of plaintiff’s claims and concluded they did. Reed Smith’s Michael K. Brown and Mildred Segura prepared Medtronic’s brief and represented Medtronic at oral argument.

Another case in the medical device context worth mentioning is the Sixth Circuit’s decision in Cupek v. Medtronic, 405 F.3d 421 (6th Cir. 2005). The court there rejected plaintiff’s post-sale failure-to-warn and failure-to-recall claims against defendant, finding that such state law claims were "different from" or "in addition to" federal requirements governing the labeling of defendant’s devices. The court also rejected plaintiff’s negligence per se claim based on Medtronic’s alleged failure to comply with the FDA’s conditions of approval because it amounted to a fraud-on-the-FDA claim barred by Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 351 (2001).

A petition for certiorari was filed in Cupek before the United States Supreme Court earlier this summer under the title Knisley v. Medtronic, Inc. (U.S. Sup. Ct. Case No. 05-22), with the opposition to the petition due very shortly. Whether the court will have any interest in wading back into the preemption thicket in the medical device context remains to be seen.

As can be seen by the preemption cases decided in the past several months, the defense of federal preemption continues to evolve, and is an issue that is being heavily litigated and merits close monitoring.

^{* The Supreme Court granted review of the Bates decision after a split developed among the Circuits on whether FIFRA preempted state law tort claims. A majority of the Circuits (including the First, Seventh, and Eighth), California’s Supreme Court, and an amicus brief the EPA filed in Bates held that certain state law tort claims were preempted by the FIFRA-mandated EPA registration process—including the EPA’s review and approval of pesticide label language. Specifically, these courts and the EPA reasoned that any state law tort claim premised on a liability theory that would have faulted a pesticide manufacturer for employing safety or efficacy label language different from what the EPA approved would impose state requirements in conflict with federal requirements. Other courts, including the Texas Supreme Court, and the EPA itself in an amicus brief filed five years ago, took a contrary position on the preemptive effect of the EPA’s review of pesticide warning labels.}

This article is presented for informational purposes only and is not intended to constitute legal advice.