In their years working with life sciences companies – large and small – Medmarc’s risk managers have evaluated numerous medical devices and pharmaceuticals as well as their manufacturing and distribution operations and FDA compliance histories. From these experiences, our team of risk managers has developed a unique perspective on this innovative and growing industry. Life sciences companies operate in a heavily regulated and litigated environment. Through studying these companies’ successes, and their missteps, the authors of this series have discerned common trends that can influence a company’s products liability exposure. This series will discuss these trends and what companies can do to manage the products liability risks they create.
Product Classification: Products Liability Implications
The medical device industry is heavily regulated by the U.S. Food and Drug Administration (FDA), but despite rigorous oversight, adverse outcomes that arise in connection with medical devices remain an inevitability. The goal of FDA regulations—and the agency’s strict requirement of compliance with the regulations—is to ensure that patients receive safe, effective products. However, even the most compliant firm is vulnerable to products liability claims in the event of adverse outcomes. While much of this series will discuss specific techniques for managing products liability risks associated with medical devices, this article will explore how a product’s FDA classification will impact the legal treatment of the product in the event of products liability litigation. Quite simply, differently classified medical devices receive different treatment under products liability law. This article explains why and what manufacturers should expect as a result.
We will also evaluate the current state of products liability litigation in order to establish some best practices for building a record amenable to supporting a strong products liability defense.
Medical Device Classification: What is it and how does it work?
FDA’s product classification system takes a risk-based approach toward managing its competing goals of ensuring public safety while not hindering consumer access to medical devices unnecessarily. The agency has identified three main classes of devices—I, II, and III—with ascending levels of associated risk. Broadly speaking, each class has a unique pathway to commercialization that attempts to reflect the level of the product’s riskiness in the amount of premarket oversight applied by FDA.
- Class I: Lowest risk devices – Given the low-risk nature of these devices—for example, tongue depressors and manual toothbrushes—FDA has determined that basic manufacturing guidelines, referred to as “general controls,” are sufficient to ensure patient safety and product effectiveness. For some products, their risk is deemed sufficiently low that they are exempted from even the majority of the general controls.
- Route to Market: Typically, such devices do not require FDA’s permission for commercialization. Firms are bound by FDA’s general controls as well as labeling and marketing oversight by FDA and the Federal Trade Commission (FTC). Manufacturers must register their physical plants with FDA, after which they become subject to compliance inspections by FDA.
- Class II: Moderate risk devices – This classification has the most variability in premarket obligations for manufacturers, which corresponds with the broad swath of medical products this classification covers. Class II devices can be: (1) exempt from premarket review; (2) subject to premarket review; or (3) subject to premarket review and “special controls”—product-specific performance standards deemed necessary to enhance the safety profile of a product.
- Route to Market: Class II products are typically described in FDA’s regulations (see 21 CFR § 862, et seq.). A product is categorized first by the classification panel responsible for its evaluation (e.g., anesthesiology, cardiovascular, dental, etc.) and again by its intended use (e.g., diagnostic, therapeutic, surgical, prosthetic, miscellaneous, etc.), and again by individual product type. Each listing for a particular product type outlines the characteristics and parameters for the product type and provides the classification—and thus, the premarket requirements
Typically, Class II devices require premarket notification to FDA, in which the device firm establishes the safety and effectiveness of the device for a particular indication by demonstrating that it is “substantially equivalent” to a device already on the market, known as the “predicate.” Substantial equivalence does not require the new product to be a facsimile of the predicate, but rather, that it: (1) has the same intended use as the predicate and (2) either uses (a) similar technology or (b) different technology that does not raise new questions of safety or effectiveness, and it is at least as safe and effective as the predicate. Substantial equivalence is demonstrated through the submission of a 510(k) premarket notification.
- Class III: Highest risk devices – Any products with life-sustaining or life-supporting properties are regulated as Class III, unless the responsible classification panel recommends, and the FDA commissioner accepts, a lower classification. Additionally, products critical in preventing impairment of health, those that raise a significant risk of illness or injury, and unique products entering the market for the first time all are typically regulated as Class III devices as well. In the case of unique products that do not raise substantial risk or serve critical health functions, manufacturers can submit a request for a de novo classification, in which FDA reviews the risk profile of the device and assigns a classification based on the inherent risk rather than automatically assigning a Class III designation because it is a first-to-market product.
- Route to Market: Class III products are subject to the most stringent premarket review. They must submit an application for premarket approval, or PMA, that establishes the safety and effectiveness of the device for a particular intended use through scientific data.
Medical Device Classification and the Preemption Doctrine
Products liability lawsuits allege that a defendant caused a plaintiff to suffer a loss in violation of state tort law by offering a defective product for sale. However, in the case of products liability lawsuits against medical device firms, there is potential for a conflict of laws between the state and federal governments because of the strict federal oversight of this industry by FDA. Such conflicts are settled pursuant to the Supremacy Clause of the U.S. Constitution (see U.S. Const. art. VI, cl. 2), which has been interpreted to mean that federal law is the supreme law of the land and that all state judges shall be bound by federal law, regardless of contrary state laws. In effect, federal law preempts conflicting state law. Preemption is an incredibly valuable defense strategy for device firms defending against product liability lawsuits; not surprisingly, the preemption doctrine is also a hotly-debated topic between the plaintiffs’ and defense bars.
The practical application of preemption is quite complicated, and it is a dynamic area of the law. We can break it down by looking at the different types of preemption.
- Express preemption: This type of preemption is derived from the express language of a federal statute, which reserves authority on this matter for the federal government.
- The Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug and Cosmetic Act (FDCA) contain an express preemption against state laws that differ from FDA requirements relating to human medical device safety and effectiveness. 21 U.S.C. § 360k(a).
- Implied preemption: Implied preemption is much broader, as it is derived from the Supremacy Clause rather than a specific statute. Implied preemption can arise when the federal government has implemented a regulatory scheme that essentially corners the market on a particular field; one example is the regulation of foreign affairs. Implied preemption also arises from conflicts of law, where it is impossible to simultaneously comply with both the federal and state regulations.
- Implied conflict preemption drove the Supreme Court decision in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), in which a state law design-defect claim against a generic drug manufacturer, based on the adequacy of product warnings, was found to be preempted by FDA regulations. FDA requires generic drug labeling to follow that of the equivalent legend drug. If the state law were allowed to stand, the only way for the drug manufacturer to have complied with both laws in this case would have been to cease selling this FDA-approved drug, which the court rejected as a valid solution.
Changing Application of Preemption in Life Sciences
Since the passage of the MDA, the vast majority of medical devices entering the market have done so through the 510(k) process.1 However, the 510(k) process itself has undergone an evolution in its own right, most significantly with the passage of the Safe Medical Devices Act of 1990 (SMDA). There was significant consternation over the “substantial equivalence” designation in the 1980s, to the extent that the Subcommittee on Health and the Environment of the U.S. House of Representatives Committee on Energy and Commerce sought assistance from the Government Accounting Office (GAO) on the 510(k) process. The GAO reported on the challenges FDA experienced in implementing a new regulatory scheme for existing products and the slow progress in requiring existing products to meet the new statutory obligations to demonstrate safety and effectiveness. This compliance challenge was particularly evident in the number of Class III devices allowed to enter the market through a demonstration of substantial equivalence to pre-1976 devices, even after newer, superior products had entered the market. The SMDA ended this “me-too” market access for high-risk devices and enhanced the standards for substantial equivalence, allowing FDA to require data to demonstrate both the safety and effectiveness of the new device as well as quality system enhancements that support design quality. The SMDA also enhanced FDA’s ability to enforce the law by authorizing several new penalties, including mandatory recalls and fines.2
Incongruously, one of the foundational cases regarding the application of preemption to medical devices remains Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). In Lohr, the court evaluated whether the plaintiff’s state law tort claims were preempted by the MDA. The court held that they were not, because the medical device in question entered the market via the 510(k) clearance process, which the court stated focused on the equivalence of the device to its predicate rather than an assessment of device safety. However, the device in this case was a Class III pacemaker that was reviewed by FDA in 1982 – the very early days of device regulation. It is an example of precisely the concern addressed in the GAO report, that a patient would be injured because a high-risk device entered the market with only a demonstration of equivalence to a pre-amendment device, and thus, precisely the concern that led to the legislative course correction in the SMDA.
In 2008’s decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Supreme Court held that state law tort claims against a medical device manufacturer were preempted in the case of Class III devices because these devices are subject to FDA’s rigorous PMA approval process, which establishes a reasonable assurance of the safety and effectiveness of the device for its intended use. This case was significant for the manufacturers of Class III devices because it created a liability “shield” for the manufacturers of these products. Quite simply, Riegel prevents a plaintiff from maintaining a products liability action against the manufacturer when the plaintiff’s injuries arise from an alleged manufacturing or design flaw in the product. However, Riegel also reaffirmed the court’s assessment in Lohr that the 510(k) process is merely focused on equivalence and not safety, despite the significant changes to the 510(k) process between the time addressed in Lohr and the decision in Riegel.
The Medtronic Legacy
More recent cases, which of course lean on the history established in Lohr and Riegel, are beginning to demonstrate that the Medtronic cases have influenced courts’ thinking well beyond the application of the preemption doctrine. These cases are also influencing some courts’ assessment of the relevance of a manufacturer’s compliance with FDA’s 510(k) process in products liability litigation. Specifically, this divide is manifesting in the varying opinions regarding the admissibility of a defendant having complied with FDA’s 510(k) process to support a defendant’s claim that its device is safe, and this difference in opinion can have an impact on litigation outcomes.
In 2013, two separate cases involving DePuy’s metal-on-metal hip implants reached juries within weeks of each other. In one case, the plaintiff received a jury award of $8.3M. Weeks later, DePuy received a full defense verdict from a different jury for the same product and same allegations. The chief difference was simple—venue. In the case where the jury found for the defense, the judge had allowed evidence and testimony regarding the defendant’s compliance with FDA’s 510(k) clearance process while this information was excluded in the other case.3 The result was an incomplete picture for the jury and a finding for the plaintiff.
However, there may be hope on the horizon. The U.S. District Court judge overseeing the bellwether Bard IVC filter MDL recently ruled on a pretrial motion regarding the admissibility of the device’s 510(k) clearance. The 510(k) evidence will be admissible at trial, though the judge noted that he would not permit it to be used as a demonstration of FDA approval.4 This decision, while not a ringing endorsement of the 510(k) process, does appear to be a step back from the inapposite conflation of preemption and relevance in Lohr and beyond. It remains to be seen whether this case is an outlier or the beginning of a shift in trends.
This is a challenging proposition for device firms, as their ability to control their future narratives is limited. They cannot predict how litigation might arise, which judges will hear their cases, or even whether their judges will be familiar with complex FDA regulations. Instead, companies would be wise to remember that the best defense is always a good offense. In this case it means attention to detail with each step of the product design, manufacturing, and distribution processes. While this series will provide an in-depth look at several risk management strategies, there are a few underlying principles to keep in mind throughout.
- Focus on company culture: Empower employees through training not just on the SOPs they encounter each day, but on why those steps are critical to the experience of the end user.
- Focus on quality: Build a robust quality system that fits your operations rather than trying to fit your operations into an off-the-shelf quality system. FDA focuses not just on the adequacy of your quality system, but also on how well you comply with your own policies and procedures.
- Focus on your reputation: Ensure that your company’s policies and procedures are pointing you in the right direction, and support your efforts in building this foundation through a strong documentation program. For FDA, if it is not documented, it did not happen. Build your documents proactively and let them support you in the future.
1 Beck, James, and Vale, Anthony. Drug and Medical Device Product Liability Deskbook, § 4.01(2)(b) (3d ed. 2006).
2 Frank E. Samuel, Jr., Safe Medical Devices Act of 1990, Health Affairs, Vol. 10, No. 1, Spring 1991, at 192. Available at https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.10.1.192.
3 Troy Roberts. The FDA’s 510(k) Approval Process in Medical-Device Litigation, ABA Section of Litigation, Jul. 29, 2013. Link formally available at http://apps.americanbar.org/litigation/committees/products/articles/summer2013-0713-fda510k-approval-process-medical-device-litigation.html.
4 Lexis LegalNews, 510(k) ‘Defense’ Will Be Allowed In Bard IVC Filter Bellwether Trial, Jan. 31, 2018. Available at https://www.lexislegalnews.com/articles/23949/510-k-defense-will-be-allowed-in-bard-ivc-filter-bellwether-trial.
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