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We aren’t going to beat around the bush today – the facts of Paulsen v. Abbott Laboratories, 2021 WL 4439408 (N.D. Ill. Sept. 28, 2021) are straightforward and so too will we be.  This case is largely about the chronology, so here it is:

  • Plaintiff gets injections of the drug in February and March 2004
  • Plaintiff begins experiencing side effects, including bone and joint pain and a diagnosis of osteoarthritis in 2010.
  • Plaintiff files suit in April 2010 against the drug’s NDA holder, manufacturer, and distributor
  • Plaintiff voluntarily dismisses her complaint in May 2014
  • After a request to reopen the case is denied, plaintiff files a new action against the same defendants in May 2015.

Id. at *1-2.  But by then it was simply too late.  We don’t know why plaintiff voluntarily dismissed her lawsuit in 2014, but when she did it was like starting over with a clean slate.  Her voluntary dismissal erased the first lawsuit and with it any benefit of the date of the original filing.  And that was important in this case because plaintiff’s only use of the drug was in 2004 and Georgia, her home state, has a ten-year statute of repose.

By the time of the current motion, only two claims – strict liability failure to warn and negligent misrepresentation remained.  Georgia’s statute of repose bars any strict liability action brought more than “ten years from the date of the first sale for use or consumption” of the product alleged to have caused injury.  That meant plaintiff had until March 2014 to bring her strict liability failure to warn claim.  So, when she filed anew in May 2015 – she was one year and two months late.  Id. at *2.  Plaintiff tried to rely on a carve out in the statute for failure to warn claims, but that exception only applies to negligent failure to warn, not strict liability.  Id.

The court went on to address a few other challenges raised by defendants to plaintiff’s failure to warn claim.  The distributor, for instance, asserted that it was a product seller rather than a manufacturer and as such was exempt from strict liability.  The facts, however, were unclear, regarding whether the distributor engaged in enough activities that it could be considered a manufacturer, so the court reject defendant’s argument on that point.  But the claim was still dismissed under statute of repose.   Id. at *3-4.

Whatever activities the distributor did or did not engage in, the facts were clear that it was not the NDA holder.  For failure to warn, that means the claim against the distributor was not only barred by the statute of repose but also preempted.  The court found the distributor here to be in the same position as the generic manufacturer in Mensing or Bartlett.  Those cases do not turn on whether the product was generic or brand, but rather on whether the defendant was a someone the FDA allowed to make changes to the drug’s labeling.

A drug company that does not hold an NDA, no matter how closely affiliated with the NDA holder, is powerless to submit label changes to the FDA.

Id. at *6 (citation omitted).   So even if not time barred, the claim would have been preempted as to the non-NDA holder defendant.

That left plaintiff’s negligent misrepresentation claim which Georgia does not recognize in claims for products liability.  A negligent misrepresentation claims requires a direct communication with a defendant and reliance by the plaintiff.  Georgia courts have ruled that in products cases, that is simply too similar to a failure to warn claim to stand on its own.  In other words, the misrepresentation claim collapses into the failure to warn claim – which in this case is time barred.  Id. at *7.

Further, even if the claim was permitted, plaintiff presented no evidence of any representation made to her or her prescribing physician, let alone a false representation.  Plaintiff’s complaint alleged that defendant’s sales representatives contacted her prescriber and made statements about the drug’s safety and effectiveness.  Id. at *8.  But defendant’s records produced in discovery show that none of its representatives called on the prescriber before plaintiff received her injections.  Id.  Therefore, plaintiff’s misrepresentation claim was also dismissed for lack of proof on a key element.

Seventeen years after the drug was prescribed, judgement for the defendant on all claims has finally been entered.