Medical devices, which are regulated by the federal Food and Drug Administration (FDA) and governed by the US Federal Food, Drug, and Cosmetic Act (FFDCA), are often the subject of various types of lawsuits. This article examines some of the more common types of litigation that arise in the medical device industry and discusses what practitioners can expect to see in this field.
Typically, two types of cases consume the majority of medical device litigation: patent lawsuits and product liability cases, where an individual or class alleges that a particular device caused an injury.
(1). Patent Lawsuits: The debate over the intellectual property rights of device manufacturers is rife with controversy. Recently, the US Supreme Court held that if a manufacturer’s medical device is refurbished and then re-sold, the original manufacturer loses their patent rights. See, e.g., Greg Stohr & Susan Decker, “U.S. Supreme Court Curbs Patent-Holder Power to Block Resale,” Bloomberg, May 30, 2017, available at https://www.bloomberg.com/news/articles/2017-05-30/u-s-supreme-court-curbs-patent-holders-power-to-block-resale (last visited June 21, 2017). The Court was largely unanimous in its conclusions, and analysts have argued that “[t]he ruling takes away an important tool used by companies to control the marketplace. The biotechnology, drug and agricultural industries backed Lexmark in the dispute, calling for broad patent rights. Medical-device companies like Medtronic Inc. argued that allowing the reuse of devices like cardiac catheters could imperil patients and expose the original manufacturers to lawsuits.” Id.
Interestingly, the case before the Supreme Court arose in the context of printer cartridges, but legal analysts have warned that there may be implications for the medical device industry as well, and that practitioners in the field should be prepared to make arguments as to why the Court’s holding should not apply to medical devices. See, e.g., Joseph Re & Paul Stewart, “Manufacturers May Want to Lease—Not Sell—Their Patented Medical Devices,”MDDI, Jun. 12, 2017, at http://www.mddionline.com/blog/devicetalk/manufacturers-may-want-lease-not-sell-their-patented-medical-devices-06-13-17 (last visited June 21, 2017). In order to determine whether the Supreme Court’s decision will or should extend to medical devices, attorneys should consult expert witnesses in patent law as well as experts in medical devices. The latter group is particularly important because medical devices are often unique, in that they are not intended to be resold or refurbished. See, e.g., id. For example, many devices are not intended to be reused, and the risk of contamination with products that could be dangerous if refurbished and used additional times may cause a number of injuries and give rise to additional litigation. As some analysts have explained, “A patent generally allows its owner to prevent others from making, using, or selling patented products. The law has long been that, when a patent owner sells a product without restrictions, the buyer is free to use and resell that product. But sometimes patented products are sold where the buyer agrees not to resell that product or not to use it in certain ways. Those agreements are commonly used for medical devices, where manufacturers seek to ensure that patient safety is not compromised by the repeated use of single-use medical devices. For example, in a post-AIDS world, manufacturers try to make sure that contaminated products are never reused.” Id. It is unclear whether the Supreme Court’s holding will apply to medical devices, but it is clear that legal professionals in the industry should seek out the advice and guidance of expert witnesses to help clarify the issue for courts.
Some legal commentators have gone so far as to suggest that, with respect to medical devices, patents should be leased rather than sold. This may or may not be a wise choice, but the best way to assess whether such a choice would be best for a given manufacturer would be to consult experts in the field and ask for an analysis of what the best course to protect patent rights would be.
(2). Product Liability: There are untold numbers of cases, often involving class actions, that involve an allegation that a particular medical device was somehow defective and caused a specific injury to a party or group of people. Product liability cases always require expert opinions, as proving issues such as causation requires solid scientific expertise. Experts in product liability, medical professionals, scientists, and medical device specialists will all be called upon to assist in these types of cases. Lawsuits alleging that a particular device caused a given injury are quite common, and they will only increase as new products are put out on the market. Attorneys on both sides of the issue should be prepared to address these matters by relying upon the knowledge and experience of expert witnesses.
Medical device litigation is likely to see increases, as multiple types of cases have been filed and will undoubtedly continue. Other patent questions and issues are currently being litigated, and the main two types of lawsuits, discussed herein, will keep attorneys and experts occupied now and in the years to come.