For many years, even before the Supreme Court picked up the ball, we have been arguing that “stop selling” theories of liability for alleged injuries from prescription drugs should not be viable.  This is not just a preemption issue.  Basic product liability principles do not square easily with liability contingent on developing one drug instead of another or no other.  See here and here for two of many posts.  Over the same general time period, we have been similarly put off by the idea that a company that develops a drug that the plaintiff valued so much that she brought a suit to keep taking could be subject to liability (or equitable relief) if it stopped selling/providing the drug.  This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) (en banc), and CareToLive v. von Eschenbach, 525 F. Supp.2d 952 (S.D. Ohio 2007), but has generally failed to expand that foothold since.  In particular, plaintiffs trying to force clinical trial sponsors to continue providing free drug after the end of the trial—something clinical trial participants are told is not a guaranty—have floundered.

Instead of highlighting the cognitive dissonance of the possibility that both of these theories of liability could be viable, we could be touting the creativity of the plaintiff lawyers trying different approaches to force pharmaceutical companies to play an unfun version of Simon Says.  (Don’t get us started on the ridiculous decisions involving tenofovir and the supposed duty to innovate.)  The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view.  We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

This is not the first time we have written about litigation related to this shortage.  Back in 2015, the District of Massachusetts determined that there was no duty to keep supplying a drug that a company marketed, at least under the law of the twenty-two states where the plaintiffs resided and with a healthy appreciation of Erie restraint.  Presumably to help patients taking the drug, the manufacturer took measures to minimize the impact of the Fabrazyme shortage occasioned by contamination at its production facility.  It could have just let market forces do their thing with the drug that had been made already or even discontinued the drug entirely, but its efforts to keep some of the drug on the market for on-going use while it worked to bring full manufacturing back on-line were met with lawsuits.  Only one of the plaintiffs claimed that use of a reduced dosage of the drug had somehow “sensitized” him to a worsening of his Fabry’s disease.  On appeal, the First Circuit found that the “sensitization” plaintiff had pleaded an injury in fact, giving him standing, but all the others lacked standing to complain about how much of the drug was available to them.    Even though the focus on appeal had switched from duty to standing, the First Circuit’s Hochendoner decision drew honorable mention honors for the year.  For some reason, with its win on almost all the claims in hand, the manufacturer still engaged in settlement discussions with plaintiffs and potential plaintiffs.

About five years later—more than nine after the shortage ended—a number of the prior plaintiffs and potential plaintiffs were back in the District of Massachusetts with revamped claims over the same old general facts.  The claims were all dismissed, most without prejudice based on lack of standing under Hochendoner and four (who had standing) with prejudice on statute of limitations.   The plaintiffs appealed, but the defendant did not appeal the denial of its statute of limitations challenges as to the plaintiffs without standing.  If that history was not confusing enough, the First Circuit affirmed the statute cases and reversed on the standing cases, but provided a roadmap for the district court to get rid of all of them on statute after remand.  Wilkins v. Genzyme Corp., — F.4th –, 2024 WL 636990 (1st Cir. Feb. 15, 2024), does not have our preferred result, but it is worth discussing.  Clearly, for the overall state of the law in this area, a finding of no duty/claim is best, followed by no standing, with statute of limitations in third.  Wilkins did not address whether the plaintiffs’ claims as pleaded were viable under their respective states’ substantive law, only whether an injury in fact had been pleaded.  This is a fairly technical distinction, but nothing compared to the technical and fact-specific nature of the statute of limitations analysis.

Of interest to us is how some of the Wilkins plaintiffs changed their story over time to get around the standing ruling in Hochendoner.  It is of some solace that this change doomed some of them on statute, but the gamesmanship should not have worked on standing either.  We will explain as briefly as we can.  The standards for pleading an injury in fact for the purposes of standing are spelled out in a number of our recent posts, including the one on the district court decision in this case.  Whereas one of the plaintiffs in Hochendoner had claimed “sensitization” as a mechanism for injury, now all the plaintiffs made the same claim.  The First Circuit credited the convenient “specific allegations about the particular injuries suffered by each plaintiff,” rejecting the district court’s analysis that these conclusory allegations failed to distinguish what allegedly happened to them from typical disease progression.  2024 WL 636990, *4-5.  Twenty one of the plaintiffs added the claim that they had actually received contaminated drug, which hurt them.  This is really a manufacturing defect claim, not a claim based on an alleged duty to continue providing a drug, so it probably does support standing; it just almost never ends up having support beyond general allegations that should not pass TwIqbal.  The court also agreed that economic claims based on “paying for ineffective and medically worthless doses of Fabrazyme” conferred standing.  Id. at *5.  We agree with the court’s implication that the defendant will have strong defenses on the merits that do not go to standing as long as plaintiffs pled that they paid for the drugs they took.  However, there would be no claim had the manufacturer pulled the drug from the market, something that these same plaintiffs would have sued to stop.

For the four plaintiffs dismissed on statute below, to have their claims considered timely required filling a gap from cases originally filed in 2011 and 2013 to a case filed in 2021.  First, the plaintiffs who filed in 2013 tried to rely on class action tolling under American Pipe, which we have said before does not work well with product liability claims.  One of the cases dismissed in Hochendoner had a class allegation that might have covered these plaintiffs.  Unfortunately for them, Indiana law governed statute and Indiana does not recognize class action tolling.  Id. at *8.  Moreover, the plaintiffs whose original claims were filed in 2011, and thus timely back then, tried to rely on Indiana’s three-year savings clause.  There were a number of problems with this argument, the most ironic of which is that the original case did not allege individual injuries and sensitization.  Those allegations in the new case were key to standing, but their absence in the original case meant that the plaintiffs were essentially asserting new claims not trying to continue the ones dismissed without prejudice back in 2016.  Id. at *9.  There is some more to the statute analysis, but we will stop here.  The plaintiffs should have stopped long ago.  Trying to convert a claim without standing because of no injury in fact into a viable claim years later based not on a new injury, but on a new approach to pleading, should not work.