Sometimes there’s a little something for everyone.  Today’s case has personal jurisdiction, corporate veil piercing, PMA preemption, statute of limitations, and learned intermediary.  Not every decision on these issues goes the way we think it should, and perhaps the thorns outnumber the roses, but it caught our attention nonetheless.

The case is Franks v. Coopersurgical, Inc., 2024 WL 1109055 (D.R.I. Mar. 14, 2024).  It involves allegations against the manufacturer and distributor of surgical clips used in tubal ligation surgery—Class III Pre-Market Approved (“PMA”) medical devices.  Plaintiff had surgery in 2014 in which the clips were used.  Shortly thereafter she began experiencing several adverse symptoms, including pain.  In 2021, a CT scan revealed the clips had migrated.  Id. at *1-2.  Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. 

The first issue the court tackled were personal jurisdiction challenges.  The manufacturer argued that it did not purposefully avail itself of the privilege of conducting business in Rhode Island because it manufactured a global product that it delivered to distributors who were responsible for marketing and selling the clips in the United States.  And while the court agreed that placing a product into the stream of commerce is not enough to be “purposeful availment,” the manufacturer here did more.  The court found all of the following persuasive:  over 3000 clips had been sold in Rhode Island, the manufacturer was responsible for ensuring FDA compliance; the manufacturer was obligated to provide marketing materials and samples to the distributor and retained the right to “have its hand in” how the device was marketed in the United States; and the manufacturer was responsible for tracking distribution within the United States.  Id. at *5.  All of that added up to “something more” making the court’s exercise of jurisdiction “voluntary and foreseeable.”  Id. at *6.

Two affiliated companies, however, were dismissed for lack of personal jurisdiction.  First, at least one of the companies did not become involved with the product until well after plaintiff’s surgery.  Therefore, plaintiff’s claims could not possible “arise out of or relate to” that defendant’s contacts with Rhode Island.  Id. at *7.   So, plaintiff tried to argue that the affiliates were “alter egos” of the manufacturer and distributor.  However, a “blurred” line of separation between two companies or crossover by means of shared officers and employees is not enough to pierce the corporate veil.  Plaintiff was missing any “indicia of fraud, wrongdoing, domination, misuse, or subversion of corporate formalities.  Id. at *9. 

The court then turned to the motion to dismiss plaintiff’s claims as preempted under the Riegel two-part test.  Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements.  So, the court moved onto to prong two which it summed up as “whether the plaintiff’s allegations, if true, would impose liability on a manufacturer defendant even though it complied with the FDA requirements.”  Id. at *13.  The court answered that question affirmatively for plaintiff’s design defect and manufacturing defect claims.  Plaintiff did not allege that the design of the clips deviated from the FDA approved design.  Nor did plaintiff allege that the clips were manufactured in a way not approved by the FDA.  So, both claims were expressly preempted.  Id. at *13-14.

On failure to warn, this case simply compounds an error made by In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 537 F. Supp.3d 679 (D.N.J. 2021) (“TBI”).  TBI was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state law, a “warning”-based cause of action against a manufacturer of an FDA-regulated prescription drug or medical device for allegedly failing to report adverse events to the FDA.  See id. at 729-34.  TBI  listed Rhode Island as a state that allowed FDCA-based failure-to-report claims, id. at 731, based on a pre-Riegel decision, Hodges v. Brannon, 707 A.2d 1225, 1228 (R.I. 1998).  Hodges doesn’t stand for that at all, since the case had nothing to do with failure to report.  Hodges was about the evidentiary use of actual adverse event reports for “notice” – not failure to report.  Moreover, the defense prevailed in Hodges:

The plaintiffs next argue that the trial justice erred in restricting the jury’s use of the evidence it introduced concerning certain government reports filed by [defendant] that detailed patients’ negative experiences after taking [the drug].  [Defendant] had submitted these reports to the FDA, but the trial justice limited their evidentiary use to the duty-to-warn and notice issues. . . .  We do not believe that the trial justice abused her discretion in so ruling.  The trial justice was entitled to conclude that the various patients mentioned in these reports were not necessarily similarly situated to each other or to [the decedent].

Id. at 1228 (emphasis added).  Hodges simply doesn’t stand for the proposition for which TBI cited it.  However, without any independent analysis, Franks follows it.  2024 WL 1109055, at *14-15.  Having made up a new state-law duty, the court found no express or implied preemption of plaintiff’s failure to warn/failure to report claims – both strict liability and negligence.  Id. at *15-16. 

The court also disagreed with defendants’ argument that plaintiff’s claims should be time barred because she alleges that she began experiencing symptoms soon after her surgery in 2014 and therefore, she should have discovered her injury before the statute of limitations ran in 2017.  Plaintiff countered that she and her doctors took many steps to try to identify the source of her symptoms, but that defendants’ failure to report the higher migration rates prevented them from exploring that as a cause.  The court agreed with plaintiff.  Id. at *17.

The last issue to be decided was whether plaintiff’s claims were barred by the learned intermediary doctrine.  The good news here is that the court predicted that even though the Rhode Island Supreme Court has not decided the issues, because Rhode Island’s product liability law is based on the Second and Third Restatement of Torts, the state would adopt the learned intermediary rule.  Id.  However, relying again on her allegation of a failure to report to the FDA, plaintiff argued that her physician was not adequately warned about the migration rate.  At the pleadings stage, that was enough for her claim to survive.  Id.

So, Franks has a couple of blooms, but you’ll get a little bloodied plucking them out.