Personal jurisdiction seems to be the defense tool du jour in mass torts. The Bauman and BMS SCOTUS cases brought a new dawn. But let's not forget the biggest hammer in the defense toolbox: preemption. How nice to lay eyes on a case that applies both of these defenses.
Doe v. Bausch & Lomb, Inc., 2020 WL 1164189 (D. Conn. March 11, 2020), is a products liability action involving the Trulign Toric intraocular lens. Those lenses are manufactured by Bausch & Lomb ("B&L") and are used to treat cataracts. They are Class III medical devices approved for sale by the FDA. The patient had the Trulin lenses implanted in her eyes. She and her husband sued B&L and various corporate B&L affiliates/holding companies/etc, alleging that the lenses malfunctioned, causing her to suffer loss of visual acuity in both eyes, complete loss of depth perception, extreme photosensitivity, limited ability to see at night, and double vision. She also claims that she suffers continuously from the loss of balance, vertigo, headaches, extreme eye pain, eye fatigue, and tearing. Some of the defendants moved to dismiss for lack of personal jurisdiction, and all moved to dismiss on substantive grounds, including preemption.
The allegations as to any contacts the various corporate affiliates had with Connecticut were “at best, vague." The plaintiffs said these defendants transacted business "in the United States, including in the District of Connecticut; have substantial aggregate contacts with the United States, including within this District; engaged and are engaging in conduct that has and had a direct, substantial, reasonably foreseeable, and intended effect of causing injury to persons throughout the United States, and specifically in this District where the devices were sold to Plaintiff's doctor; and, Defendants purposely availed themselves of the laws of the United States." Such vague allegations simply don't cut it. Nor was it enough to allege that "Although Defendants have recently acknowledged some of the risks and dangers of Z Syndrome and some related complications resulting from the Lenses in the 2016 Instructions for Use, Defendants did not disclose and still have not fully disclosed the seriousness of the issue." These are less than minimal pleadings of minimal contacts.
The inevitable back-up maneuver by the plaintiffs was to try to impute contacts via "alter ego." The plaintiffs summarily asserted that "there existed a unity of interest in ownership between certain Defendants and other certain Defendants such that any individuality and separateness between the certain Defendants has ceased and these Defendants are the alter ego of the other certain Defendants and exerted control over those Defendants." There were competing affidavits.
Under Connecticut law, "a court will disregard the corporate structure and pierce the corporate veil only under exceptional circumstances, for example, where the corporation is a mere shell, serving no legitimate purpose, and used primarily as an intermediary to perpetuate fraud or promote injustice." That is a high hurdle. The plaintiffs could not get over that hurdle. The plaintiffs' conclusory allegations, even coupled with an affidavit, provided no basis for the Doe court to disregard the corporate structure of any defendant. That took care of personal jurisdiction for most of the corporate affiliates. Ba-bye.
Note that we said "most." One affiliate was kept in because it had been part of the case transferred from another jurisdiction pursuant to § 1404(a). It was necessary for the transferor court to find that defendants are subject to personal jurisdiction in the transferee district for a case to be transferred there pursuant to § 1404(a). According to the Doe court, a fair reading of the transfer decision makes clear that the transferring court held the view that the case could have been (and perhaps should have been) brought in Connecticut. Therefore, that defendant was stuck in the case courtesy of the law-of-the-case.
On to the substantive defenses. Connecticut is one of those enlightened states that passed a product liability statute: the Connecticut Product Liability Act ("CPLA"). (Why doesn't Pennsylvania, with its mish-mosh of incoherent product liability doctrine, follow suit?) The defendants sought to dismiss the claims purportedly brought pursuant to Connecticut common law because those claims are barred by the CPLA, which is the "exclusive remedy for claims falling within its scope." A plaintiff cannot assert a common law claim for product liability under Connecticut law. The claims at issue — strict liability in tort; negligence; breach of warranty, express or implied; breach of or failure to discharge a duty to warn or instruct, whether negligent or innocent; and misrepresentation or nondisclosure, whether negligent or innocent— were obviously product liability claims. Moreover, "the CPLA excludes all claims for personal injury caused by the warnings, instructions, marketing, packaging or labeling of any product." Ba-bye, common law claims.
The defendants also sought dismissal of all claims on the ground that they were preempted by the Medical Device Amendments ("MDA") to the Food, Drug, and Cosmetic Act ("FDCA"). A Class III device, such as the Trulign Toric intraocular lens, is subject to the rigorous pre-market approval process of the FDA. As most of you can probably recite from memory, the MDA contains an express preemption provision:
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 21 U.S.C. § 360k(a).
You doubtless also recall that federal law impliedly preempts state law claims if those claims are based solely on violations of FDCA requirements. Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 353 (2001). In other words, "a litigant's [state law] claim may be impliedly preempted when the state-law claim is in substance (even if not in form) a claim for violating the FDCA—that is, when the state claim would not exist if the FDCA did not exist." And now, as pretty much always, we confront the dreaded "parallel claim" exception. Between those claims that are expressly preempted and those that are impliedly preempted is an "extremely narrow" class of claims that are not preempted. "The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such claim would be impliedly preempted under Buckman)." Plaintiffs must advance a state law claim that parallels federal law "but which … is not wholly derivative of federal law."
That exception did not apply here. It could not save the failure to warn, negligence, or manufacturing defect claims. Why? Under the CPLA, "[a] product seller may be subject to liability for harm caused to a claimant who proves … that the product was defective in that adequate warnings or instructions were not provided." The plaintiffs predicated their failure-to-warn claim on a purported duty to warn owed to the patient or her doctors. But the plaintiffs failed to identify any FDCA requirement directing the defendants to provide warnings to consumers or physicians separate and distinct from their disclosure obligations to the FDA or the use of FDA approved labels. Accordingly, to impose such a duty under the CPLA would be to impose requirements "different from, or in addition to" FDCA requirements and this claim is therefore expressly preempted by § 360k(a).
The plaintiffs also alleged that the defendants failed to abide by their FDA reporting obligations. (To wit, the defendants "ignored and neglected [their] responsibilities to the FDA and the conditional approval [they] had received to market the Trulign Lenses when [they] failed to timely file adverse event reports …."). This claim is impliedly preempted because it is wholly derivative of the FDCA. The plaintiffs never identified any duty under Connecticut law that required the defendants to warn or communicate adverse event reports to the FDA so as to give rise to a parallel claim.
Under the CPLA, product liability claims include actions based on theories of negligence. Here, again, the plaintiffs alleged that the defendants were negligent insofar as they failed to report adverse events to the FDA, and that such failures deprived the patient or her doctors of information that would have stopped their use of the Trulign Lenses. Whatever the FDCA requires with respect to adverse event reporting, under Connecticut law, manufacturers do not have a duty to report adverse events to regulatory entities such as the FDA.
On to the almost always spurious manufacturing defect claim. The plaintiffs alleged that "[t]he Lenses were not manufactured in conformity with the manufacturer's design or in conformity with the FDA approved design that Defendants had submitted to FDA. " The defendants argued that this allegation, and the others surrounding it, were conclusory. The judge agreed. The plaintiffs also alleged that asymmetric vaulting, known as "Z-Syndrome," is a post-operative complication unique to the Trulign and Crystalens lenses, that the plaintiff was diagnosed with Z-Syndrome, and that the Z-Syndrome caused her pain and suffering. That is a consequence, not a defect. The plaintiffs never managed to allege that the plaintiff's lenses suffered from any specific manufacturing defect. Nor did they identify which FDA approved specification was allegedly not met. This, it was not preemption that did in the manufacturing defect; it was the TwIqbal failure to plead specific, plausible facts. Ba-bye.
The plaintiffs also brought three counts alleging violations of California statutes: Deceit by Concealment, California Civil Code §§ 1709, 1710; a violation of Cal. Bus. & Prof. Code §§ 17200, et seq. ; and a violation of Cal. Bus. & Prof. Code §§ 17500, et seq.. Those statutes have long been the bane of corporate defendants doing any business in the Golden State. But not this time. The plaintiffs' brief in opposition to the motion to dismiss “devote[d] exactly six sentences to these causes of action. They cite no authority, provide no analysis and summarily assert that the claims are adequately pled. They do not address the Defendants' preemption argument in the context of these statutes at all." Because those claims derived from the same nucleus of factual allegations—the failure to warn and the failure to report adverse events— the plaintiffs failed to establish the parallel claim exception. Ba-bye to the California claims. And it follows, ba-bye to the loss of consortium claim.
Originally published 22 April, 2020
This article is presented for informational purposes only and is not intended to constitute legal advice.
