Source: JD Supra
Photo Source: Unsplash, Phillippe Spitalier
Key Takeaways
After two years of consideration, the FDA has restricted the sale of breast implants to healthcare providers that use an FDA-approved patient-decision checklist to discuss the benefits and risks of the implants with patients.
This is the second time the FDA has required the use of a checklist before implanting a medical device and another example of the FDA’s increasing interest in broader disclosure in medical-device labeling.
For many types of devices, implementing a patient-decision checklist raises several considerations for manufacturers in product-liability litigation. In lawsuits where the manufacturer implements a checklist after the plaintiff’s device is implanted, the manufacturer could argue that the checklist is an inadmissible subsequent remedial measure, or argue that any failure-to-warn claims based on the FDA-approved checklist are preempted by federal law. In actions where the checklist was implemented before the device was implanted in the plaintiff, the checklist could strengthen a manufacturer’s arguments that adequate warnings were provided.
The FDA announced on October 27, 2021, that it will restrict the sale of breast implants to healthcare providers and facilities that use a “patient-decision checklist” to provide information to patients about the risks and benefits of breast-implant surgery.1 The FDA subsequently released a consumer update explaining that the checklist, among other items, is aimed at helping people make informed decisions about whether or not to use breast implants.2 This checklist is a new and somewhat novel labeling requirement that could have ramifications for breast-implant litigation as well as product-liability litigation more broadly if the FDA adopts this model for other devices or medications.
The patient-decision checklist is an outgrowth of the 2019 public FDA General and Plastic Surgery Devices Advisory Panel of the Medical Devices Advisory Committee Meeting.3 Some meeting participants (including patients, doctors, and patient advocates)4 expressed concerns that then-approved labeling for breast implants—which included patient information booklets that sometimes spanned more than 40 pages—was too long and made it difficult for patients to make well-informed decisions.5
Following the 2019 meeting, the FDA issued a final guidance for breast implants, recommending the use of a boxed warning, a patient-decision checklist, screening recommendations, a description of materials, and patient device cards.6 The FDA’s 2020 guidance recommends the patient-decision checklist address:
Situations in which the device should not be used or implanted;
Considerations for a successful breast implant candidate;
Risks of undergoing breast implant surgery;
Importance of appropriate physician education, training and experience;
Risk of breast implant-associated anaplastic large cell lymphoma;
Risk of systemic symptoms; and
Discussion of options other than breast implants, as appropriate.7
The patient-decision checklist is significantly shorter than the current patient information booklets and is intended to be reviewed together by the patient and physician. The patient must be given an opportunity to sign and initial throughout the checklist, and the checklist must be signed by the implanting surgeon. 8 The checklist does not displace pre-existing labeling obligations and other new requirements for breast implants, including disclosure of component materials and a boxed warning.
Litigation Considerations for Manufacturers The patient-decision checklist is a somewhat novel requirement that, where adopted, could have a broad impact on failure-to-warn claims in product-liability litigation. The FDA has required patient checklists for medical devices once before: In 2016, the FDA approved a patient-decision checklist for Essure—a permanent birth-control device for women, which has been the subject of litigation.9 The FDA instituted that checklist two years before Bayer voluntarily discontinued distribution for commercial reasons and well after litigation had begun. No Essure case has gone to trial, so the impact of a patient-decision checklist on medical-device litigation is still largely unchartered territory. How a patient-decision checklist is litigated will depend in part on the timing of a plaintiff’s alleged injury, as discussed below.
Warning Claims Based on Alleged Injury Post-Dating Checklist In product-liability actions based on devices implanted after the checklist is implemented, the patient-decision checklist may help the manufacturer’s defense. For example, according to the FDA’s 2020 guidance, the breast-implant patient-decision checklist should address many of the specific risks that are commonly raised in breast-implant litigation (e.g., systemic symptoms and breast-implant-associated anaplastic large cell lymphoma). The checklist is designed to require patients to review and initial sections covering these risks, and to sign at the end, acknowledging that they read the information booklet, discussed benefits and risks with their physician, and considered alternatives prior to their surgery.10 The checklist will make it more difficult for patients to argue that they were not adequately warned of risks.
Second, for jurisdictions that recognize the learned-intermediary doctrine, a patient checklist also may provide additional evidence that doctors were adequately notified of the risks associated with the implants and implant surgery. Like patients, implanting physicians must sign the breast-implant checklist to indicate that they reviewed both the information booklet and checklist, and discussed the benefits and risks with the patient.
Third, patient-decision checklists could be grounds for preemption. Breast implants are Class III medical devices and thus subject to strict regulation. Manufacturers cannot “make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.”11 Because the checklist “is part of the approved labeling” for breast implants,12 allegations that the checklist is inadequate and should have included more or different warnings may be preempted by federal law.13 Moreover, breast-implant manufacturers may still benefit from any additional warnings provided in the other parts of their FDA-approved labeling. Indeed, the FDA’s new requirements are in addition to, not in lieu of, the product insert given to doctors, and the FDA has repeatedly emphasized that the checklist is “intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of breast implants that uniquely pertain to individual patients.”14
Finally, it is conceivable that patient-decision checklists may reduce the number of product-liability claims filed. If patient-decision checklists achieve their objective of “help[ing] [to] ensure that a patient receives and understands the benefits and risks of these devices,”15 patients may be less inclined to file suit in the event they do experience a complication. For the reasons described above, any post-checklist claims may be more difficult to prosecute and less attractive to the plaintiffs’ bar. Warning Claims Based on Alleged Injury Pre-Dating Checklist
For claims based on pre-checklist implants, plaintiffs may argue that the checklist should have been implemented sooner and that warnings were inadequate without it. Manufacturers may be able to argue that such claims are preempted because they would effectively require manufacturers to provide the checklist without first obtaining FDA approval, which would constitute an impermissible change to the FDA-approved labeling. In analogous cases where plaintiffs alleged that breast-implant manufacturers failed to adequately warn of risks, courts have held that such claims are preempted when the warnings are approved by the FDA.16
Additionally, to the extent such claims cannot be dismissed as preempted, manufacturers should consider moving to exclude a patient-decision checklist as inadmissible under Federal Rule of Evidence 407, which prohibits the admission of subsequent remedial measures. Some courts have held that changes to FDA-approved labeling that took place after the plaintiff was prescribed the product are inadmissible subsequent remedial measures. For example, in Chlopek v. Federal Insurance Co., the Seventh Circuit held that a post-injury label change was inadmissible under Rule 407 due to the improper inference that the device manufacturer “added the warning because the product was unsafe without it."17
The Future of Medical Device Warnings The FDA has become increasingly interested in labeling changes that require broader disclosure from manufacturers. As we recently reported, the FDA has proposed requiring the labeling of long-term medical devices to identify all constituent materials that might reasonably be expected to come into contact with human tissue. The new requirements for breast implants further that trend. Thus far, the FDA has required patient-decision checklists for Essure and breast implants, which both involve elective procedures related to women’s health. Although the FDA has yet to indicate that patient-decision checklists will become commonplace, it is possible that this could become a template for future regulation of other medical devices or even medications. As this checklist goes into effect for breast implants, Dechert will continue monitoring how it impacts existing and future litigation.
Do you use such implants? How could such implants impact your health? Was informed consent enough information? What could be the true risks?
If this article was helpful to you, donate to the Shidonna Raven Garden and Cook E-Magazine Today. Thank you in advance.