Health Law Daily Post-cataract surgical lens case certified back to state court for clarification on federal law preemption questions
Wednesday, July 21, 2021

Post-cataract surgical lens case certified back to state court for clarification on federal law preemption questions

By Joe Cox, J.D.

The court found unsettled questions as to preemption and certified those questions to the state supreme court.

The Second Circuit Court of Appeals reviewed a tort case against Bausch & Lomb for defective post-cataract surgery lenses. It ultimately reversed the lower court dismissal of the patient’s claims before certifying two pivotal questions to the state supreme court on issues of federal law preemption (Glover v. Bausch & Lomb Incorporated, July 20, 2021, Lynch, G. and Nardini, W.).

The patient in this case underwent cataract surgery and then had Bausch & Lomb’s Trulign Toric intraocular lenses surgically implanted into her eyes. Subsequently, she had pain and suffered loss of vision due to Z Syndrome, a post-surgical complication which has left her vision permanently impaired, as 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, as supported by the Connecticut Product Liability Act (CPLA). Specifically, the patient alleged that Bausch and Lomb 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. Bausch and Lomb sought dismissal on the grounds that the claims were preempted by the federal Food, Drug, and Cosmetic Act (FDCA). The district court granted that motion to dismiss, and also denied the patient’s motion to amend the 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 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 a device in question. The 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 (5th, 7th, and 9th) have in fact 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 (8th, 10th, and 11th) had found that claims like those in this case could not proceed, essentially showing 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.

The court determined that a lack of precedent made it unclear whether Connecticut law imposes a duty on a manufacturer, enforceable in tort, to warn the relevant regulator (the FDA) of potential damages from its products. Such question was certified to the Supreme Court of Connecticut, because if there is not such a duty, the court indicated that the patient’s claims were indeed preempted and should be dismissed.

Meanwhile, on the question of whether the CUTPA would allow claims against Bausch & Lomb for suppressing known safety risks, or whether that too would be preempted, the 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. Bausch & Lomb countered that the claim arose from an allegedly defective product, and that it was thus barred by the CPLA’s exclusivity provision and/or the FDCA. Once again without binding precedent, the court certified another question to the Supreme Court of Connecticut—whether the CPLA bars a claim under the CUTPA based on allegations that a manufacturer deceptively and aggressively marketed and promoted a product despite knowing that it presented substantial risk of injury. Of course, if the CPLA does bar the claim, that the patient’s attempted amendment would indeed be futile.

The court reversed the lower court and reserved decision, retaining jurisdiction over the case pending the response to the two certified questions.

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 CaseDecisions MDeviceNews PreemptionNews PLDeviceNews ConnecticutNews NewYorkNews VermontNews

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