Dechert Re:Torts is a monthly newsletter covering news and developments related to product liability and mass torts litigation.
Inside this issue:
- Delaware Supreme Court Rejects No-Injury Medical Monitoring Claims
- Continued Spotlight on PFAS: EPA’s New Enforcement Priorities for 2024
- Treated as an Expert: When Treaters Must Submit an Expert Report
- Computer Software: It’s Still Everywhere, Even in Medical Devices
- FDA Issues Three Draft Guidance Documents for the 510(k) Program for Medical Devices
Delaware Supreme Court Rejects No-Injury Medical Monitoring Claims
As part of our ongoing coverage of issues in Medical Monitoring, we noted that the Delaware Supreme Court received a certified question from the U.S. Court of Appeals for the Third Circuit about whether no-injury medical monitoring was a viable claim under Delaware law. On August 24, 2023, the Delaware Supreme Court held that it is not. The Court explained that in Delaware “claims in tort require an actual or imminent injury.” Baker v. Croda Inc., 2023 WL 5517797, at *3 (Del. Aug. 24, 2023). The Supreme Court emphasized that “recognizing an increased risk of illness, without more, as a cognizable injury could open the floodgates to ‘endless and limitless’ litigation” and “diminish resources that are presently used for those who have suffered physical injury.” Id. Including Delaware, twenty-eight states now oppose the viability of no-injury medical monitoring claims.
Continued Spotlight on PFAS: EPA’s New Enforcement Priorities for 2024
Last month, EPA announced its National Enforcement and Compliance Initiatives that are released every four years. These initiatives are intended to guide EPA’s Office of Enforcement and Compliance Assurance (“OECA”) and state agencies to prioritize resources to address environmental issues. For 2024, among other environmental priorities, EPA will focus on addressing exposure to per- and polyfluoroalkyl substances (“PFAS”).
EPA plans to ramp up enforcement efforts as to PFAS, particularly with respect to drinking water supplies. EPA’s goals for the initiatives include identifying and characterizing PFAS near manufacturing facilities and performing oversight at federal facilities that may have used PFAS. Furthermore, if EPA designates perfluorooctanoic acid (“PFOA”) and perfluorooctanesulfonic acid (“PFOS”) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act—which is currently under review by EPA—then EPA’s OECA would focus enforcement actions against entities with significant releases of these PFAS. According to EPA, these entities are likely to include major manufacturers and users of PFAS, federal facilities that are significant sources of PFAS, and other industrial parties. OECA states that it does not intend to pursue other entities where “equitable factors” do not support assigning responsibility to them; this includes farmers, water utilities, airports, or local fire departments.
Important questions about EPA’s announcement remain. EPA has not identified what equitable factors will be considered or how they may apply. For instance, a trade and professional association supporting the waste handling industry urged EPA to differentiate its approach to PFAS enforcement activities as to “passive receivers” of PFAS, which include landfills and composting facilities. Other than pointing to “equitable factors,” it is uncertain how OECA will approach PFAS enforcement in the waste industry, among others.
EPA has been strengthening PFAS regulations in other respects, as well. In addition to issuing a gatekeeping framework for new PFAS and new uses of existing PFAS, EPA has also requested public comment on whether it should include PFAS as a required pollutant under its Air Emissions Reporting Requirements, which would require reporting of PFAS air emissions over 100 pounds. This reporting would be different from prior reporting requirements because it would cover cumulative PFAS emissions, rather than emissions of one type of PFAS. Public comments will be accepted on this proposed rule until October 18, 2023.
Takeaway: EPA’s regulatory focus on PFAS continues to intensify, as reflected by its recently announced enforcement priorities and its newly proposed air emissions regulations. Questions remain about the nature of the enforcement and the specific industries that may be impacted.
Treated as an Expert: When Treaters Must Submit an Expert Report
The Court of Appeals for the Eighth Circuit recently clarified the disclosure requirements for a treating physician who provides expert testimony on causation in a personal injury action. In Johnson v. Friesen, plaintiff sought damages for multiple medical conditions resulting from a car accident. No. 22-3335, 2023 WL 5317123, at *1 (8th Cir. Aug. 18, 2023). To support his claims, plaintiff disclosed thirteen medical treatment providers as non-retained experts and stated that each would provide testimony regarding his treatment consistent with plaintiff’s medical records. Id. However, for one treating physician, the disclosure noted that the physician opined “within a reasonable degree of medical certainty” that plaintiff suffered a lower back injury caused by the car crash. Id. The doctor’s opinion, which was not reached while treating plaintiff, was offered in a letter at the request of plaintiff’s counsel. Id. at *3.
Defendant filed a motion to exclude or limit the testimony of all plaintiff’s experts for deficient disclosures but raised specific arguments regarding the doctor that offered a causation opinion. Id. at *2. Defendant argued that because the doctor sought to offer a causation opinion that was not formed during his treatment of plaintiff, Federal Rule of Civil Procedure 26(a)(2)(B) required a written report beyond the limited disclosures required by Rule 26(a)(2)(C). Id. The district court agreed, and Plaintiff appealed. Id.
The Eighth Circuit affirmed the ruling of the district court and held that a treating physician who wishes to provide expert testimony as to the cause of an injury but did not form that causation opinion in the course of providing treatment must provide a written report. Id. at *3. The Court noted that the doctor’s causation opinion was formed only after he was asked to opine on causation by plaintiff’s counsel and after he was provided medical records and photos related to the accident for review. Id. The Court reasoned that this method of obtaining the doctor’s opinion meant he was an expert “retained or specially employed to provide expert testimony in the case” and subject to the reporting requirements of Rule 26(a)(2)(B). Id.
Takeaway: Treating physicians who are offered to provide opinion testimony on causation but form those opinions outside of plaintiff’s course of treatment must submit an expert report pursuant to Federal Rule of Civil Procedure 26(a)(2)(B).
Computer Software: It’s Still Everywhere, Even in Medical Devices
On August 11, 2023, FDA updated its industry guidance on “Off-The-Shelf Software Use in Medical Devices.” See August 2023 Industry Guidance (“Guidance”). FDA first published this Guidance in 1999 and updated it in September 2019. The update clarifies and simplifies the premarket submission recommendations for off-the-shelf (“OTS”) software.
OTS software is defined as “generally available software component[s]” as opposed to purpose-built software. Its benefit is the ability to allow the manufacturer to plug and play. “The use of OTS Software in a medical device allows the manufacturer to concentrate” solely on the “software needed to run device-specific functions.” The manufacturer is in turn generally required to “give up software life cycle control,” but remains responsible for the safety of the overall product.
The FDA remains concerned that a medical device manufacturer could employ inadequate OTS software, rendering the entirety of the device ineffective or unsafe. In the past, the Guidance employed a “safety-based approach to risk management,” estimating risk as “the product of the severity of harm and the probability of occurrence of harm.” The revised Guidance employs “[t]he least burdensome approach . . . to identify the minimum amount of information that, based on [the FDA’s] experience, would generally be needed to support a premarket submission for a device that uses OTS software.”
Previously, the FDA split OTS software into three categories depending on the software’s degree of risk and recommended additional steps depending on the potential degree of risk the OTS software presented. Software that presented only a minor concern needed two steps, with the FDA recommending that the sponsor provide hazard analysis and basic documentation. On the other hand, software that was a major concern required five steps (hazard analysis, basic documentation, hazard mitigations, description and justification of residual risk, and special documentation). Software for which failures or latent design flaws could result in non-serious injuries was considered a moderate level of concern.
The updated Guidance identifies two categories of recommendations, both of which require that a sponsor include a description of the OTS software, a risk assessment of that software, and testing to verify and validate its utility. But the level of information a sponsor should provide to verify and validate its software depends upon the level of risk the OTS software presents, and, where failure of the device could pose a probable risk of death or serious injury, the sponsor should provide enhanced documentation and information about continued maintenance of the device.
Takeaway: Although FDA’s recent update on the use of Off-the-Shelf Software in medical devices clarifies prior recommendations, the Guidance remains complex and manufacturers should ensure that their pre-market submissions provide adequate information related to their product, the requisite risk assessment, and testing data.
FDA Issues Three Draft Guidance Documents for the 510(k) Program for Medical Devices
On September 7, 2023, the FDA issued three draft guidance documents on (1) “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission,” (2) “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions,” and (3) “Evidentiary Expectations for 510(k) Implant Devices.” These guidances are part of FDA’s ongoing efforts to modernize the 510(k) program, and are intended to improve the predictability, consistency, and transparency of the 510(k) premarket review process.
Under the Federal Food, Drug, and Cosmetic Act, and FDA regulations, a Premarket Notification (commonly referred to as a 510(k)) is required for devices intended for human use, for which a Premarket Approval Application (“PMA”) is not required, unless the device meets certain limited exemptions. A 510(k) must be submitted to FDA at least 90 days before initial commercial distribution, and must demonstrate, through safety and effectiveness data, that the new device is substantially equivalent (“SE”) to a legally marketed “predicate device.” FDA’s recommendations in the three draft guidances are as follows:
- Best Practices for Selecting a Predicate Device to Support a 510(k) Submission: When selecting a predicate device to support a 510(k) submission, FDA recommends the following four best practices: Select a predicate device that (1) was cleared by FDA using well-established methods, (2) continues to perform safely and as intended, (3) does not have unmitigated use-related or design-related safety issues, and (4) has not been subject to a design-related recall (According to FDA, design-related recalls can indicate a fundamental flaw with the design of the device.)
- Recommendations for the Use of Clinical Data in 510(k) Submissions: As it concerns the use of clinical data, in most cases, a new device can demonstrate SE to a predicate device based on non-clinical safety and performance data. However, for certain devices, clinical data may be necessary to demonstrate SE. FDA describes the following four most common scenarios when clinical data may be necessary: (1) Differences in the indications for use, (2) differences in the technological characteristics, (3) SE cannot be determined by non-clinical testing, and (4) a newly identified or increased risk for the predicate device.
- Evidentiary Expectations for 510(k) Implant Devices: The draft guidance related to evidentiary expectations for 510(k) implant devices provides recommendations on the design and execution of appropriate performance testing for implants, which are devices “placed into a surgically or naturally formed cavity of the human body” and “is intended to remain implanted continuously for a period of 30 days or more.” 21 C.F.R. § 860.3(d). FDA recommends that submitters consider the following factors regarding performance testing: (1) the indications for use, (2) the intended duration of implantation, and (3) the anticipated patient and physician experience with the implant. In addition, FDA provides specific recommendations on types of Non-Clinical Testing, Human Factors/Useability Testing, Patient Experience Testing, and Proposed Labeling.
Takeaway: These draft guidances are a part of FDA’s ongoing Medical Device “Safety Action Plan,” which is intended to improve the predictability, consistency, and transparency of the 510(k) premarket review process. When finalized, they will help manufacturers meet FDA’s expectations for appropriate device predicates, when clinical data is necessary, and the testing required for implant devices. This may help to accelerate the pre-submission and 510(k) clearance process.