Sharon M. Porcellio

This quarter Chief Judge Frank P. Geraci Jr. conducted what was likely the first in-person federal court jury trial since the onset of the COVID-19 pandemic in June. Meanwhile, Senior Judge David G. Larimer addressed express and implied preemption arguments in dismissing a case against the manufacturer and marketer of a medical device by former users of the device  in English v. Bayer, No. 19-CV-6615L, 2020 U.S. Dist. LEXIS 111465, at *1 (W.D.N.Y. June 25, 2020).

Defendants, manufacturers/marketers of the medical device, brought a motion to dismiss arguing that plaintiffs' claims were preempted by federal law. In addition to analyzing preemption and whether to impose sanctions on one of the plaintiffs for a previously filed and duplicitous case, Larimer also considered whether to allow plaintiffs to amend their complaint. In an interesting post-script, despite one of the plaintiffs escaping the imposition of sanctions under Rule 41 of the Federal Rules of Civil Procedure because she established her financial inability to pay, that plaintiff along with the other two, filed a notice of appeal.

A Jury Trial in the COVID Era

Taking the lead to test the new waters, the chief judge held an in-person two-day jury trial beginning June 15. It was a First Amendment civil rights case, thus requiring a smaller jury than a criminal trial. The district used a consultant from the University of Rochester to assist with safety precautions and used a separate courtroom as a jury deliberation room for not only the safety but the comfort of the jurors. The court summoned 140 jurors, and 100 responded that they were willing to serve. Fifty were called to report at staggered times but only 25 were needed to seat the jury. Geraci reports that he regularly canvassed those who served and those who reported to make sure they felt safe. They did and would serve again.

Medical Device Case-Factual Background

Plaintiffs are three former users of a birth control medical device (the device(s)). Between 2009 and 2011, each of the three plaintiffs were implanted with a device and now allege that the devices have the potential to migrate, damaging internal organs and causing mental health issues and autoimmune diseases. Although the plaintiffs fail to specify their injuries individually, they do claim that "as a result of the defendants' acts and omissions, one or more of them suffered from a laundry list of alleged maladies …" The plaintiffs bring their actions against the defendants, as manufacturers and marketers of the subject devices.

Specifically, the complaint asserts state law causes of action for: negligent training of physicians; breach of express warranty; negligent misrepresentation (in the form of advertising concerning safety and effectiveness at preventing pregnancy, and qualifications of implanting physicians); negligent risk management (failing to report adverse events to the FDA); and negligent failure to warn.

In response, the defendants moved to dismiss the complaint pursuant to Rule. 12(b)(6) of the Federal Rules of Civil Procedure for failure to state a cause of action, and requested an award of sanctions and fees against one of the plaintiffs pursuant to Rule 41, not Rule 11, of the Federal Rules of Civil Procedure. The plaintiffs opposed both motions, and cross moved to amend the complaint.

Preemption

In their motion to dismiss, the defendants argued that the plaintiffs' claims were entirely preempted by the Medical Device Amendments (MDA) to the federal Food Drug and Cosmetic Act (FDCA). "The MDAs grant exclusive authority to the FDA to regulate medical devices, and create a regime of detailed federal oversight which expressly preempts any state-law claim or private party lawsuit that would impose safety or effectiveness requirements beyond those imposed by the FDA though its premarket approval (PMA) process."

Larimer thus examined the plaintiffs' state law claims under the Supreme Court's analysis defining "'the contours of federal preemption'" and its progeny, (citing Barone v. Bausch & Lomb, 372 F.Supp.3d 141, 147 (W.D.N.Y. 2019)). Taken together, these cases hold that a state law claim is impliedly preempted under the FDCA if the claim is based solely on a violation of the FDCA rather than on some independent state law duty, and the state law requirements and related causes of action are preempted under the MDA only to the extent that they are different from, or in addition to the requirements imposed by federal law. In other words, the claim must be based upon an independent state law duty, and that duty must parallel, rather than add to, federal requirements.

Before turning to the merits of the plaintiffs' specific claims, Larimer noted that several other courts had already dismissed similar claims involving the devices on express or implied preemption grounds.

Nevertheless, he proceeded to address each of the plaintiffs' claims. First, Larimer tackled the plaintiffs' negligent training claims, which allege, among other things, that the defendants failed to "properly train physicians in hysteroscopy, sufficiently supervise physicians during placement procedures, and monitor patients thereafter." For these allegations, Larimer stated that the plaintiffs failed to "plausibly allege" that defendants were required to take any of those actions under the FDA-approved training requirements. Therefore, the plaintiffs' allegations would impose different or additional requirements and were expressly preempted.

Further, plaintiffs alleged that defendants "deviate[d] from FDA requirements by failing to ensure that implanting physicians completed preceptoring requirements, read and understood the Physician Training Manual, and successfully completed simulator training  … " Although these claims were not expressly preempted (because they do not impose obligations in addition to those required by federal law), they were impliedly preempted because plaintiffs failed to point to any parallel state law cause of action to support them.

Under similar logic, Larimer went on to hold that the remainder of the plaintiffs' claims were expressly and/or impliedly preempted.

Cross Motion to Amend

In response to the defendants' motion to dismiss, the plaintiffs cross-moved to amend. After reiterating the well-known standard for considering a motion to amend pursuant to Rule 15 of the Federal Rules of Civil Procedure, Larimer noted that the plaintiffs failed to comply with a Western District of New York local rule requiring a redlined proposed amended pleading. Regardless, he considered the proposed amended pleading and found that it was deficient because it was "largely identical" to the original complaint and any new claims would be dismissed as preempted and/or insufficient. In a lengthy footnote, Larimer described the court's "troubling observation" that the 94-page proposed amended complaint contained cut-and-pasted allegations and descriptions of injuries from a differing case. Notably, these unedited allegations did not "meaningfully" correct the deficiencies in the original and conflicted with the facts alleged in the original complaint. For these reasons, Larimer found it "difficult to take the plaintiffs' proposed amended complaint seriously."

Sanctions

The defendants also moved for sanctions against one of the three plaintiffs pursuant to Rule 41(d) of the Federal Rules of Civil Procedure. Rule 41(d) provides that "a plaintiff who previously dismissed an action in any court, who subsequently files an action for the same claim against the same defendant, may be ordered to pay the costs of the prior proceeding, and their subsequent action may be stayed pending their compliance with the order awarding costs."

By way of background, one of the three plaintiffs had previously filed and voluntarily dismissed an action against the defendants in a New York state court based upon the same "nexus of facts" as those presented in instant case. The defendants' counsel had performed substantial work in that case, including the preparation of a motion to dismiss before Plaintiff Scott voluntarily dismissed the action. Accordingly, defendants sought costs and attorney fees from the prior action and requested a stay of the instant action until the plaintiff complied.

In determining whether to impose sanctions, Larimer considered whether the instant action was predicated on the same facts as the first action. He answered this question in the affirmative and found that plaintiff's prior lawsuit constituted the kind of "duplicative litigation" that Rule 41(b) was designed to address. Indeed, the plaintiff conceded that she filed and dismissed the prior suit, suggested that she or her attorney failed to adequately investigate her claims before filing the lawsuit, and that she later decided it would be preferable to litigation in a different forum. Despite this, Larimer, declined to impose sanctions due to the plaintiff's indigent status. He did, however, caution "that the filing of any additional actions against the same parties, based on the same operative facts, could result in reexamination of the above factors, with the potential for imposition of monetary and other sanctions."

Nevertheless, despite that admonition, all three plaintiffs have filed a notice of appeal. (Dkt. #26).

Sharon M. Porcellio is a member of Bond, Schoeneck & King representing businesses and institutions in commercial litigation and employment matters. She can be reached at [email protected]. Alyssa Jones, an associate with the litigation department of the firm, assisted with the preparation of this article.