Bexis has just returned from a week’s vacation in Acadia National Park in Maine.  After being rained out for a couple of days due to a stray hurricane, he climbed four mountains in three days – the Precipice Trail up Mt. Champlain; the West Face Cadillac Mountain trail up that mountain, and the Jordan Cliffs/Deer Brook trail up Sargent & Penobscot Mountains, with a stop at Sargent Mtn. Pond (Paradise Pool).  Any Acadia aficionados among our readership will recognize those trails as the three most strenuous in the Park.

That being said, we’re pleased to direct your attention to Haddon v. C.R. Bard, Inc., 2021 WL 3131670 (D. Or. July 23, 2021).  This is the latest of several favorable opinions Bard has won addressing the law of Arizona, where Bard’s vascular device business is headquartered.  Victory, like charity, begins at home.

Haddon built on Peterson v. C. R. Bard, Inc., 2021 WL 799305 (D. Or. March 2, 2021), an earlier decision by the same judge.  Haddon, 2021 WL 799305, at *1.  Peterson ruled, in a case brought by plaintiff transplanted from Pennsylvania to Oregon after surgery, that Oregon choice of law principles required that Pennsylvania law to govern liability and Arizona law to govern punitive damages.  2021 WL 799305, at *5 (liability), *7-8 (punitives).  Thus when Haddon came down the pike, the choice-of-law issue, pointing to Arizona on the issue of punitive damages, had already been resolved.  2021 WL 3131670, at *1.

Plaintiff in Haddon sued despite his IVC filter having worked fine for many years – so many that, while plaintiff “received his filter in 2007, five years before Arizona enacted the statute at issue [Ariz. Rev. Stat. §12-689(A)].  He filed this lawsuit in 2019, seven years after enactment.”  Id.  Thus, the first question was whether applying the Arizona statute barring punitive damages where the defendant complied with governmental regulations was “retroactive.”  Haddon ruled that it was not.   “[T]he operative date for a retroactivity analysis is the date the lawsuit was filed.”  Id.  An Arizona plaintiff has no vested rights before filing suit.  “Arizona courts have “consistently defined statutory changes as retroactive only when they affect cases already in litigation.”  Id. (citations omitted).

The punitive damages statute applied.

Nor could the plaintiff’s punitive damages claim escape the statute via an exception.  Plaintiff waved a 2015 FDA warning letter around.  Id. at *2.  Didn’t help.  The statute only allowed punitive damages for violations occurring:  (1) “at any time before the activity or event that actually caused the harm,” or (2) upon a government finding of that the defendant “knowingly violated applicable regulations requiring the reporting to that government agency of risks of harm and the unreported information was material and relevant to the harm that the claimant allegedly suffered.”  Ariz. Rev. Stat. §12-689(B)(4).  Again, plaintiff lost, for three reasons

First, the “plain language” only applied to alleged violation “after the product was sold but before the activity or event that allegedly caused the harm.”  Haddon, 2021 WL 3131670, at *2.  The FDA warning letter was from 2015 – several years too late, given plaintiff’s implantation date.  Id.

Second, the warning letter did not contain any indication of a “knowing” violation.  “This makes intuitive sense:  the letter was a warning, putting Bard on notice.”  Id. (emphasis original).  Nothing in the record suggested that the conduct continued or was otherwise suggestive of intent.  Id.

Third, the statute required that the violation be “material and relevant” to the injuries claimed in the case.  The warning letter did not even involve the same device, which wasn’t even being sold any longer.  Id.  Nor was plaintiff’s “speculation” any substitute for the statutorily required “government finding.”  Id.  “An after-the-fact, judicial finding of knowing violations that no government agency ever uncovered will not do.”  Id.

Thus, not only does this particular plaintiff’s punitive damages claim fall by the wayside, but Haddon is directly on-point precedent (perhaps the first such precedent, since Haddon didn’t cite any cases) limiting future plaintiffs’ ability to use FDA warning letters to avoid Arizona’s statutory compliance defense to punitive damages.