Today’s case is Glover v. Bausch & Lomb, Inc., – A.3d -, 2022 WL 2035805 (Ct. S. Ct. Jun. 7, 2022). And all we can say is Boo! Not a Halloween, Casper-type Boo! But a real Queen of Putrescence-type Boo! Because unfortunately, the Connecticut Supreme Court, responding to a certified question from the Second Circuit, found that Connecticut law allows a common-law claim for liability for failure to report adverse events to the FDA. Muck!
It is hardly a surprise that Glover is a PMA-preemption case. This is where we see plaintiffs push failure to warn based on failure-to-report claims – because their actual failure to warn claims are preempted. If a traditional failure to warn claim cannot survive the Fire Swamp (express preemption), failure-to-report adverse events to the FDA should meet its demise in the Pit of Despair (Buckman implied preemption). How can a duty to report adverse events to the FDA not be wholly derivative of the FDCA, just like a fraud-on-the-FDA claim? In fact, isn’t failure to report just a version of fraud-on-the-FDA? If the claim is that the manufacturer failed to provide the FDA with information (adverse events) which had the FDA received would have caused it to act in a manner that would have prevented plaintiff’s injury – that sounds a lot like fraud-on-the- FDA. Which everyone agrees is preempted. But here we are twenty-one years after Buckman, and just like Inigo Montoya, we are still looking to take down the six-fingered man. We may have bested Vizzini (Stengel), but the Connecticut Supreme Court, like Miracle Max, managed to breathe new life into failure to report.
Plaintiff underwent cataract surgery using artificial lenses manufactured by defendant. She suffered a known complication from the lenses that required additional corrective surgeries. Plaintiff brought a claim for failure to warn under the Connecticut Product Liability Act (CPLA) and sought leave to amend her complaint to bring a deceptive marketing claim under the Connecticut Unfair Trade Practices Act (CUPTA). The district court dismissed plaintiff’s claims as preempted, which brings us to our certified questions.
After examining the provisions of the CPLA, the court acknowledged that the statute does not expressly allow a failure-to-report claim, but that the legislative history of the act shows it was intended to “protect people from harm caused by defective and hazardous products. . ” In the case of a medical device that means making sure it is accompanied by a proper warning. Under the CPLA,
[a] The product seller may not be considered to have provided adequate warnings or instructions unless they were devised to communicate with the person best able to take or recommend precautions against the potential harm.
General Statutes §52-572q (d). This same provision is the foundation of the learned intermediary rule in Connecticut. Afterall, it is the physician who stands “in the best position to evaluate a patient’s needs and [to] assess [the] risks and benefits of a particular course of treatment. ” In fact, the physician is the only person in the unique position of having both the education and training to understand the risks of a treatment and the personal health history of the patient to make an independent medical decision regarding the best course of treatment for the individual. . No member of the FDA, all strangers to the plaintiff, can or should be the one to communicate risks personally to patients or to make recommendations for treatment. The FDA does not govern the practice of medicine.
But the court was not persuaded that the person in the best position to communicate warnings about a medical device is limited to plaintiff’s physician. Where there are “upstream obstructions to the flow of information,” juries should be allowed to look elsewhere. Again, the court’s focus on the withholding of information from the FDA feels like we should be running headfirst into Buckman preemption – which as far as we are concerned is as impenetrable as Fezzik (the Giant). We think the court saw that too, which is why is found a way to allow failure-to-report claims as a preemption dodge.
The way was to read the CPLA “broadly to accomplish its remedial purpose.” If the statute was read plainly, it does not include a failure to report claim. But then, in PMA preemption cases, plaintiffs are left without a remedy. Right, because the only cause of action is for a violation of the FDCA which does not belong to the individual, but to the FDA.
Further, under Connecticut law, a duty of care is triggered when a reasonable person, knowing what he knew or should have known, would anticipate that harm was likely to result from a failure to act. In this case, accepting plaintiff’s allegations as true, the court concluded that defendant should have known that failing to provide information regarding adverse events to the FDA prevented that information from being known by plaintiff and her surgeon. Insert here the enormous causation gap this argument glosses over – the assumption that the FDA would have made the adverse events publicly available and / or taken some action that in turn would have been seen by plaintiff’s surgeon and that he would have changed his course of treatment based on it. In this case plaintiff alleges that eventual reporting by the defendant did lead to a change in the warnings, but a changed warning does not necessarily mean a change in treatment. A change in treatment can only come from the physician, meaning we are once again back to the learned intermediary.
The court next looked at the cases from other jurisdictions and found the cases allowing failure to report claims to be “more persuasive.” The court seems to discount defendant’s cases because they “intertwined” their analyses with preemption, namely Buckman, which the Connecticut Supreme Court said was not an issue before them. Trying to separate any analysis of failure-to-report from a discussion of Buckman, is like trying to keep apart Wesley and Buttercup. It should not and cannot be done. Interestingly, the court is quick to discount preemption when it helps defendants, but quick to embrace it when it helps plaintiff – because of preemption plaintiff would be left without a remedy.
The only thing that saves this opinion from being a complete Humperdinck, is the court’s decision that the CPLA’s exclusivity provision precludes plaintiff from bringing a claim under the state’s consumer protection statute.
Clearly Glover is on the list as a potential bottom ten case for 2022. And we’d like to believe that plaintiff still has a battle ahead of her on causation. So, we end with this farewell.