Happy New Year. We are doing that usual January/Janus thing of looking both backwards and forwards. We are gearing up for a massive litigation in 2025, for a couple of trials, and for the January 16 Drug and Device Law webinar on the best and worst cases of 2024. And we’re still finding some 2024 cases that offer interesting doctrinal baubles.

A couple of years ago we attended a bench/bar conference sponsored and run by plaintiff lawyers.  (Whoops – as happens more and more, we belatedly realize that “couple of” should be “more than 10.”  Yikes.) We were among the two or three defense hacks invited for target practice and comedy.  At lunch, one of our favorite plaintiff lawyers, a brilliant and brutal fellow, told us that we’d be missing a bet if we didn’t get into gadolinium litigation.  He said that the science issues were fascinating and, best of all (at least from his predatory perspective), the injuries were ghastly. Prolonged exposure to the gadolinium contrast dye could produce a condition in which organs hardened.  The plaintiff lawyer said that some clients became “living statues” who invariably died painful, prolonged deaths. And then the judge overseeing the federal MDL issued one of the worst, pro-plaintiff Daubert rulings we’ve ever seen.  Bexis called it “spherical error.”

Thus, Langara v. Bayer  Corp.,, 2024 WL 5186723 (D. Conn. Dec. 20, 2024), is a gadolinium contrast dye claim that arrives as a blast from the past.  The court dismissed the case on grounds of both statute of limitations and preemption.  This double-barreled ruling makes the appellate prospect dismal for the plaintiffs. The court also denied leave to amend because of futility. Yogi Berra said “It ain’t over till it’s over.”  Well, the Langara case is over. To quote amusement park ride operators, Langara has come to a “complete and final stop.” That termination comes even though the Langara court bent over backwards to cut the pro se plaintiffs some slack.   

The medical procedure took place back in 2007.  The plaintiffs began their litigation journey by filing suit against the defendants in Massachusetts state court in 2020.  The case was removed to federal court.  The D. Mass. judge dismissed the case for lack of personal jurisdiction.  The plaintiffs appealed but the First Circuit affirmed.  In 2024, the plaintiffs filed a case in Connecticut state court.  The defendants removed to federal court (D. Conn.).  Then the defendants moved to dismiss the entire complaint, which included claims for negligent failure to warn, negligent pharmacovigilance, negligent marketing and design, breach of express warranty, fraudulent, negligent, or innocent misrepresentation, fraudulent concealment and omission, and for the husband, loss of consortium.  If some of those causes of action sound meritless to you just on their face, join the club. It turns out that, facial frailness aside, all the causes of action are precluded by the statute of limitations and federal preemption.

On this blog, we do not typically linger on statute of limitations issues.  Such issues are fact-specific and one can learn only so much from any particular court decision. Here, the plaintiff suffered injuries immediately after receiving the gadolinium contrast dye in 2008, was told that the contrast dye caused her injuries, and then sought treatment for those injuries multiple times in 2008 and 2009.  The Connecticut statute of limitations for product liability claims is three years, so the 2024 complaint is terribly late. But the plaintiff argued that her claims did not accrue until 2017, when her “doctors told her that the sickness, harm and injury from which she has been suffering for years since her MRI in December 2008 was directly related to  her exposure” to the contrast dye. 

But 2017 is still more than three years before 2024, right?  Hold on.  We’ll get there.

In the meantime, the Langara court agreed that the action accrued no later than 2009.  Still, you can see how this factual inquiry could get messy, right?  

Now we are at the most interesting portion of the statute of limitations analysis in Langara, which revolves around the application of the Connecticut saving/tolling statute. That savings provision allows a plaintiff to re-file a dismissed action within one year of dismissal so long as the action was originally commenced within the statute of limitations, and the dismissal was based on one of the specific procedural reasons enumerated in the statute. Under the plaintiff’s reasoning, the action did not accrue until 2017, she beat the statute of limitations by filing the Massachusetts case within three years, and then she filed in Connecticut within one year of the Massachusetts dismissal.  The Connecticut savings clause really would save her case.  Right?  Wrong.

 Lots of states have such savings provisions, but the Connecticut statute did these plaintiffs no good.  The plaintiffs had played forum shopping games with their prior action, bringing it in a state where they did not live.  Too bad.  The Connecticut statute applies only to non-merits dismissal of actions originally filed in Connecticut state or federal court. The earlier Massachusetts case (whether state or federal) was not covered by the savings clause.  (In 1636, the same year that saw the founding of a certain preeminent college in Massachusetts, a group of approximately 100 people left Massachusetts and founded a settlement at Hartford. Ever since then, Massachusetts and Connecticut have been separate.  Sure, some residents of the Nutmeg State (far and away the best state nickname – charming and without the vast pretension of the “Empire,” “Keystone,” “Golden” or “Sunshine” states) call themselves part of Red Sox Nation, but nobody is fooled. Anyway, the Langara court was not fooled, and it held that the plaintiff’s claims were time-barred.   

But it is the alternative preemption holding that supplies the main reason why the Langara case is blogworthy.  The court did not need to reach the issue, but these serial plaintiffs probably needed to hear that their case had no chance. Preemption was the primary reason gadolinium contrast litigation never really took off when plaintiffs tried to make a mass tort out of it in the 2019-2020 time period.  For the design and manufacturing claims, a manufacturer would need prior approval from the Food and Drug Administration (FDA)  for any “major”: changes to the design and manufacturing of already-approved drug products. So those claims are clearly preempted. For the labeling claims, the issue was whether the defendant could have unilaterally added a warning that gadolinium retention could harm patients like the plaintiff who did not have pre-existing renal problems. But at the time of the plaintiff’s procedure, the FDA found that gadolinium did not cause any harm except in patients with pre-existing renal problems.  Because the FDA already determined that the defendant’s product did not cause any serious conditions to people like the plaintiff, the plaintiff could not use the changes being effected (CBE) regulation as a source of power to make a unilateral label change to say something the FDA had already found to the contrary.  The plaintiffs came up with no “new evidence” during the relevant time period that indicated “risks of a different type or greater severity.” Moreover, the FDA’s determination that gadolinium affected only people with pre-existing renal disease constituted “clear evidence” that the FDA would have rejected the plaintiffs’ contrary contention.  In conclusion: “As a result, even accepting as true the allegations in Plaintiff’s Complaint, Defendants could not amend  [the gadolinium product] label through a CBE regulation, nor would the FDA have approved such a change if they had attempted to do so.”

The Langara complaint was not just late; it was a loser.