This post is from the Reed Smith (and now we should add Cozen) side of the blog only, as Dechert is involved in the litigation to be discussed.
You’ll have to forgive us – we’re weird that way – but we found the opinion in Carter v. APP Pharmaceuticals, LLC, 2013 WL 5532767 (D. Ariz. Aug. 13, 2013), fascinating. Also mysterious: why did Carter take two months to show up on Lexis or Westlaw? We can’t answer that, but we can tell you about the rest of the opinion. Carter deals with a new application of preemption, at least as far as we know. The product, a solution used to keep catheters unobstructed while in use on trauma patients (and perhaps others), contained the long-approved drug heparin – an anticoagulant. For about as long, heparin has been known to cause, in some people, a serious, potentially fatal condition: heparin-induced thrombocytopenia and/or thrombosis (“HITT”). Heparin’s label contained a lengthy and detailed warning about HITT, but plaintiff alleged that the nurses using the product missed the symptoms and as a result his arm had to be amputated. 2013 WL 5532767, at *1.
Yeah, we know. The facts sound rather like Wyeth v. Levine, 555 U.S. 555 (2009) – right down to the plaintiff bringing a product liability action on allegations that sound more like medical malpractice.
The defendant’s product was approved by the FDA in a procedure we don’t think has ever come up in a preemption situation in a product liability case – the so-called “paper NDA.” As described in Carter
[Defendant’s] heparin product was approved by the Food and Drug Administration (“FDA”) under a New Drug Application (“NDA”) filed pursuant to 21 U.S.C. §355(b)(2). [Defendant] submitted an NDA because the drug’s container was a new mechanism for delivery but the heparin sodium incorporated into [defendant’s] heparin flush is the same as that contained in the product of the reference listed drug (“RLD”) holder [Defendant] states it was not required to, and did not, conduct additional clinical, safety and efficacy studies of the heparin sodium drug to acquire FDA approval. According to [defendant], its reliance on the RLD required that it use a label identical to the RLD holder’s label approved by the FDA. The RLD identified for heparin sodium . . . is a heparin product manufactured by [another company], not [defendant]. According to [defendant], it was required to match its warnings with [that other company’s label, including any updates.
* * * *
The third kind of [prescription drug] application is based on 21 U.S.C. §355(b (2). This kind of application has been referred to as a “paper NDA.” Under [this], a drug manufacturer may file an NDA for a drug that is not entirely new but is not simply a generic version of a branded drug. The applicant provides certain information that allows it to avoid preclinical and human studies necessary to achieve a full NDA and shows the drug’s approval will not infringe a valid patent.
2013 WL 5532767, at *2, 5 (citations, quotation marks, and footnotes omitted).This “paper NDA” sounds a lot, to our non-FDA-regulatory-trained minds, like a cross between the (preempted – see PLIVA v. Mensing, 131 S. Ct. 2567 (2011)) generic and (unpreempted – see Wyeth v. Levine, 555 U.S. 555 (2009)) innovator drug processes. Being intrigued, we Googled “paper NDA” for more background. It turns out (at least according to Wikipedia) that the “paper NDA” actually was a shortcut devised by the FDA for generic drugs before there was any Hatch-Waxman Act.
Apparently, that process wasn’t very user-friendly – with only 15 paper NDAs between 1962 and 1984, when it was essentially superseded by H-W. An FDA Guidance from 1984 seems to confirm this, stating that for all approvable paper NDAs in the pipeline, current procedures will apply, but anything new (or unapprovable) will be converted to H-W ANDAs. So, from everything...
