The surgically implanted medical device industry is highly regulated by the Food and Drug Administration (FDA). Because federal law so prevalently occupies this arena, most state-law based tort actions are preempted.
In an effort to circumvent this preemption, however, state law plaintiffs are now making false advertising claims against medical device manufacturers based on alleged violation of California’s Unfair Competition Law. This article examines whether these creative theories survive preemption.
What is Federal Preemption?
According the United States Constitution, federal law is the “supreme law of the land.” If a state and federal law conflict, the federal law will “preempt” the state law. When federal preemption occurs, the state law has no effect. (Altria Group, Inc. v. Good (2008) 555 U.S. 70, 76 [relying on Maryland v. Louisiana (1981) 451 U.S. 725, 746].)
When determining whether federal preemption exists, courts look to Congress’s purpose in drafting the legislation in question. (Medtronic v. Lohr (1996) 518 U.S. 470, 485.) Congress may communicate its intent to preempt state law explicitly or impliedly. Even if Congress explicitly indicates a preemptive intent, however, the ultimate inquiry is whether there is an actual conflict between state and federal law. (Freightliner Corp. v. Myrick (1995) 514 U.S. 280, 287.) An actual conflict arises when: 1) compliance with both the state and federal law would be impossible, or 2) state law obstructs the congressional purpose. (Id. at 286.)
Federal Preemption for Medical Devices
In 1906, the U.S. Congress passed the Food and Drug Act prohibiting interstate transport of “adulterated” food and drugs. Congress vested the Food and Drug Administration (FDA) with the authority to regulate prescription and nonprescription drugs. (See generally the Federal Food, Drug and Cosmetic Act [FDCA], 21 U.S.C. § 301 et seq.) The FDCA prohibits states from establishing any drug requirements “different from or in addition to, or that is otherwise not identical with” its requirements. (21 U.S.C. § 379r(a)(2).)
The Medical Device Amendments of 1976 (MDA) extended federal preemption to any state law requirements “different from, or in addition to” medical device regulations established by the FDA. (21 U.S.C. § 360k(a)(1).) Notably, the MDA limits federal preemption to state laws relating to the ”safety,” “effectiveness,” or “any other matter included in a requirement applicable to the device.” (21 U.S.C. § 360k(a)(2).)
Medical devices are divided into three categories based on the amount of regulatory control the device receives. Class I devices (e.g. tongue depressors and examination gloves) pose little threat to public health and safety, and are subject only to general manufacturing controls and labeling requirements. (21 U.S.C. § 360(a)(1)(A).) Class 2 devices (e.g. oxygen masks and powered wheelchairs) are also subject to performance standards and post-market surveillance measures. (21 U.S.C. § 360c(a)(1)(B).) Class 3 devices (e.g. pacemakers and most implants) undergo a stringent premarket approval process and must adhere to FDA requirements governing nearly every aspect of the device’s production and sale. (See Stengel v. Medtronic (9th Cir. 2013) 704 F.3d 1224, 1226-1227.)
Medical device preemption occurs when: 1) the FDA has established specific requirements applicable to a particular device, and 2) state requirements impose a conflicting or additional requirement on the device. (Medtronic v. Lohr (1996) 518 U.S. 470, 498-499.) Any Class 3 device receiving premarketing approval by the FDA automatically satisfies the first prong of the test. (Riegel v. Medtronic (2008) 552 U.S. 312, 322.) Thus, the primary inquiry for preemption of surgically-implanted devices is whether the state requirement imposes a conflicting or different requirement. (Medtronic, supra.)
Which State-Based Causes of Action Are Preempted?
Class 3 medical devices (i.e. most surgical implants) undergo a rigorous approval process focusing on safety and effectiveness. A state tort claim requiring the device to be safer, more effective, or less effective than the mode approved by the FDA is preempted. (McGuan v. Endovascular Technologies (2010) 182 Cal.App. 4th 974, 983.)
Federal preemption of Class 3 devices defeats common law causes of action for strict liability, breach of implied warranty, negligence in design, negligence in testing, negligence in distribution, negligence in labeling, negligence in marketing, and negligence in sale. (Riegel v. Medtronic (2008) 552 U.S. 312, 320; and see McGuan v. Endovascular Tech. (2012) 182 Cal.App.4th 974 [preempting fraud and failure to warn claims].) Preemption has also been extended to tort claims for manufacturing defect, failure to warn, negligent misrepresentation, fraudulent misrepresentation, and fraudulent concealment. (De La Paz v. Bayer Healthcare (2016) 2016 WL 392972.)
The De La Paz case involved personal injury stemming from surgical insertion of a female contraceptive device in plaintiff’s fallopian tubes. The device was categorized as Class 3, and so underwent premarket approval of its design, manufacturing process, and labelling requirements. (Id. at 1-2.) Pursuant to this process, the device’s safety and effectiveness was determined, in part by “weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” (Id. at 1-2 citing 21 U.S.C. § 360c.)
The plaintiff in De La Plaz argued her manufacturing defect claim should survive preemption because manufacturing irregularities noted in the FDA’s premarket analysis caused her injuries. The court, however, determined any such state claim based on adulteration of defendant’s medical devices would exist solely by virtue of the MDA requirements, and so were preempted. (Id. at 7.) The court preempted plaintiff’s design defect claim on similar grounds. (Id.) The court dismissed plaintiff’s breach of implied warranty of merchantability claim as preempted because “merchantability’ addressed whether the device was fit for ordinary use, which bears directly on its safety and effectiveness. (Id. at 10.) Plaintiff’s claim for violation of express warranty of merchantability was preempted because the FDA required all express claims asserted by the manufacturer. (Id. at 10.) Finally, claims for misrepresentation and fraud were preempted based on identical reasoning. (Id. at 11.) In short, federal law preempts the vast majority of state-related surgical implant tort claims.
Does Federal Law Preempt a Claim for Violation of California’s Unfair Competition Law (UCL, Bus. & Prof. C. §§ 17200 et seq.)?
In an effort to circumvent preemption, creative plaintiffs have alleged causes of action beyond the standard products liability theories discussed above. For example, plaintiffs have filed suit under California’s Unfair Competition Law (UCL) (codified at Bus. & Prof. C. § 7200 et seq). To establish a UCL claim, plaintiffs must demonstrate a deceptive or unlawful business practice – this includes untrue or misleading advertising. (Id.) As a result, products liability UCL claims are based on alleged false representations related to the safety and efficacy of the device.
In the California case of McGuan v. Endovascular Tech., supra, the court examined whether a plaintiff’s claim for fraudulent concealment was preempted. Specifically, plaintiff alleged the manufacturer actively concealed its knowledge of design flaws from the public. The court determined that, in order for the plaintiff to prevail on this cause, a jury would have to find the warnings (which were required by the FDA) were inadequate. Because this finding would impose “requirements” “different from, or in addition to” those imposed by the FDA, such a claim would be preempted. (Id. at 984 citing to Riegel, supra, 552 U.S. at p. 329.) Similarly, a UCL false advertising claim would require a jury to determine that the FDA labelling/advertising requirements were inadequate. Arguably then, the UCL claim would be preempted for the same reason fraudulent concealment is preempted.
The U.S. District Court for the Southern District of Texas addressed this issue and made a similar finding. In Deleon v. Johnson & Johnson (2011) 2011 WL 2618957, plaintiff made standard products liability claims, as well as a “deceptive trade practices” claim against a manufacturer based on injuries sustained from a medical implant that had received FDA premarket approval. (Id. at 1.) Plaintiff’s deceptive trade practice claim was based on Texas’s Deceptive Trade Practices Act (DTPA). Texas’s DTPA, like California’s UCL, prohibits false, misleading, or deceptive acts in advertisement. (See generally TX Bus & Com § 17.41 et seq.) Since a finding of violation of the DTPA would effectively impose requirements “different or in addition to” FDA requirements, the court held this cause of action was preempted. By the same reasoning, California UCL theories should be preempted.
Enterprising plaintiffs might also try to skirt preemption by alleging a cause of action for violation of the false advertising section of the UCL (i.e. Bus. & Prof. C. § 17500 et seq). Violation of this code section, however, is also based on alleged false representations related to the safety and efficacy of the medical device. As a result, it would be preempted for the same reason violation of the UCL would be.
Who Enforces the MDA?
The FDA has exclusive authority to enforce the Medical Devices Act (MDA). (Buckman v. Plaintiff’s Legal Committee (N.D. Tex. 2001) 531 U.S. 341, 349, fn. 4.) Class 3 medical device defendants have successfully relied on this fact to argue the FDA impliedly (as opposed to explicitly) preempts this area. (See e.g. De La Paz, supra.)
What Claims May Private Plaintiffs Bring?
The U.S. Supreme Court in Riegel, supra, held that medical device preemption occurs when a state law imposes requirements “different from, or in addition to” FDA premarket approval. Courts have acknowledged a very narrow exception may exist when the plaintiff makes a state law claim imposing a duty “parallel” to the federal requirements.
To be “parallel,” the imposed duties must be “identical” to those imposed by federal law. (Medtronic, supra, at 495.) For the duties to be genuinely equivalent, a manufacturer must not be able to be held liable under the state law without having violated the federal law as well. (McGuan, supra, at 983.) The complaint must allege a specific and pre-existing state-law tort theory that makes the predicate federal regulatory violation actionable while imposing no different or additional duties on the manufacturer. Further, the actionable violation must be the causally linked to the alleged deviation from a federal requirement. (De La Paz, supra, at 6.) In light of these stringent requirements, there are very few “parallel requirement” exceptions to federal preemption.
Federal law preempts the vast majority of products liability claims based on surgical medical devices. Admittedly, there are limited preemption exceptions for “parallel” state claims. False advertising claims, however, do not survive preemption.