By Joe Cox, J.D.
The Second Circuit panel found there were unsettled preemption questions relating to failure to report adverse events to a regulator following a product’s approval and to claims that a manufacturer deceptively marketed a product despite knowing that it presented a substantial risk of injury.
The U.S. Court of Appeals for the Second Circuit has certified two questions to the Connecticut Supreme Court on the scope of federal preemption of that state’s tort law and has retained jurisdiction for purposes of resolving an appeal by a cataract surgery patient who alleged post-operative injuries she claims were caused by implanted artificial lenses. The appellate panel found that the patient’s claims raised unresolved issues of state law that were appropriate for certification (Glover v. Bausch & Lomb Inc., July 20, 2021, Lynch, G.).
The patient in this case underwent two successive cataract surgeries and had Bausch & Lomb’s Trulign Toric intraocular lenses surgically implanted in both her eyes to correct her vision. After the surgeries, she experienced eye pain and significant loss of vision. She was diagnosed with Z Syndrome, a post-surgical complication which has left her vision permanently impaired. Subsequent procedures have left doctors unable to remove some components of the Trulign lenses from her eyes. The patient filed suit on the grounds of negligence and failure to warn under the Connecticut Product Liability Act (CPLA). Specifically, the patient alleged that Bausch & Lomb (B&L) downplayed risks of the lenses and failed to alert the FDA in the post-approval device review process to the extent of the risk of Z Syndrome.
B&L sought dismissal on the grounds that the claims were preempted by the federal Food, Drug, and Cosmetic Act (FDCA). The district court granted the lens maker’s motion to dismiss the patient’s claims with prejudice, concluding that the patient’s failure-to-warn claim was both expressly and impliedly preempted by federal law. The court determined that, to the extent the claim alleged that B&L failed to warn the patient and her physicians, it was expressly preempted by §360k of the FDCA because federal law imposes no duty to warn patients and physicians of risks presented by medical devices, apart from those warnings included on FDA-approved labels. To the extent the claim alleged that B&L failed to warn the FDA of post-approval adverse events, the district court concluded that it was impliedly preempted because any such claim was "wholly derivative of the FDCA" and the patient failed to identify a corresponding duty to warn the FDA under Connecticut law. Further, the district court concluded that the patient’s negligence claim, which it understood as based on failure to report adverse events to the FDA, while "likely not expressly preempted," was impliedly preempted for much the same reason as the failure-to-warn claim. In addition, the district court denied the patient’s motion to amend her complaint to add a claim for wrongful marketing under the Connecticut Unfair Trade Practices Act (CUTPA), finding that such amendment would be futile on the same grounds. The patient appealed.
Federal preemption. The FDCA contains a provision expressly preempting state law, which provides that a state cannot impose any requirement different from, or in addition to, any requirement provided by that law which relates to the safety or effectiveness of the at-issue Class III device. The appellate court noted that this limitation has created a "narrow gap" for pleadings which do not impose any additional requirements from the federal law, but also rest on state law grounds. Three judicial circuits-the U.S. Courts of Appeals for the Fifth, Seventh, and Ninth Circuits-have found that state tort claims premised on a failure to comply with the FDA’s post-approval requirements are not preempted. However, three other circuits-the U.S. Courts of Appeals for the Eighth, Tenth, and Eleventh Circuits-have found that claims like those in the case at bar could not proceed, essentially indicating doubt that a traditional state-law cause of action existed for failure to report adverse events and believing instead that the aggrieved patients were attempting to enforce the FDCA.
Questions for certification. The Second Circuit determined that a lack of precedent made it unclear whether Connecticut law imposed a duty on a manufacturer, enforceable in tort, to warn the relevant regulator-here, the FDA-of potential damages from its products. The appellate panel certified the following question to the Connecticut Supreme Court: "Whether a cause of action exists under the negligence or failure-to-warn provisions of the Connecticut Product Liability Act, Conn. Gen. Stat. §§ 52-572h, 52-572q, or elsewhere in Connecticut law, based on a manufacturer’s alleged failure to report adverse events to a regulator like the FDA following approval of a product, or to comply with a regulator’s post-approval safety requirements for the product." The appeals court said that if there is not such a duty on a manufacturer to warn the regulator of such potential product dangers, then the patient’s claims would be an effort to enforce the FDCA, which only the FDA may do, and, thus, would be preempted and dismissed.
On the question of whether the CUTPA would allow claims against B&L for suppressing known safety risks, or whether that, too, would be preempted, the appeals court again came to a sticking point. The CPLA included an exclusivity provision that it provided the exclusive remedy "for harm caused by a product." The patient argued that her claim was not preempted because it sounded in wrongful advertising rather than product defects. B&L countered that the claim arose from an allegedly defective product, and, thus, it was barred by the CPLA’s exclusivity provision and/or the FDCA. Without binding precedent, the court certified a second question of Connecticut law to the state’s high court: "Whether the Connecticut Product Liability Act’s exclusivity provision, Conn. Gen. Stat. § 52-572n, bars a claim under the Connecticut Unfair Trade Practices Act, Conn. Gen. Stat. § 42-110a, et seq., based on allegations that a manufacturer deceptively and aggressively marketed and promoted a product despite knowing that it presented a substantial risk of injury." If the state supreme court determined that the CPLA did bar the claim, then the patient’s attempted amendment would indeed be futile.
The appellate panel invited the Connecticut high court "to construe liberally and, if necessary, expand these certified questions to address related or other relevant issues in connection with this appeal." The panel retained jurisdiction over the case once the supreme court either ruled on the certified questions or declined certification.
This case is No. 20-1156-cv.
Attorneys: Wendy R.Fleishman (Lieff Cabraser Heimann & Bernstein, LLP) for Marjorie Glover. Brigid F. Cech Samole (Greenberg Traurig LLP) for Bausch & Lomb Inc. and Bausch Health Companies Inc.
Companies: Bausch & Lomb Inc.; Bausch Health Companies Inc.
MainStory: TopStory WarningsNews PreemptionNews MedicalDevicesNews ConnecticutNews NewYorkNews VermontNews
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