Truly unique cases are, well, unique. Most cases involve variations or combinations of cases we have seen before. Sometimes you get different results between two decisions on basically the same case with a single fact different. In February, we posted on an Eastern District of Pennsylvania decision on a motion to dismiss in a case involving allegations about severe hypophosphatemia (“HPP”) with a prescription injection for iron deficient anemia. The decision applied Pennsylvania law and was a mixed bag. Pennsylvania, of course, does not have strict liability for prescription medical products, so those asserted claims went away. Most of the rest of the decision was not so great for the good guys, though.
In Atkinson v. Luitpold Pharms., Inc., No. 19-277, 2020 WL 1330705 (E.D. Pa. Mar. 23, 2020), the same court ruled on a similar motion to dismiss involving pretty much the same complaint about the same injury with the same prescription drug. The main difference is that Atkinson applied Texas law. Texas really has not been the plaintiffs’ paradise of yore (and lore) for some time. This has been driven in part by the enactment in 2003 of §82.007 of the Texas Civil Practice and Remedies Code. In addition to having a cool number—we leave it to others to suggest a Bond movie marathon to pass the days or offer an appropriate recognition of the passing earlier this week of Honor Blackman—the provision creates a rarely rebuttable presumption on non-liability for failure to warn claims where a drug’s label has been approved by FDA. Among the enumerated bases for rebutting that presumption is where the defendant “withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury”—i.e., committed fraud on the FDA in Buckman parlance. PA has nothing like that. The provision’s relative novelty has led to a fair amount of attention and a bunch of posts over the years.
Briefly, Atkinson involves a complaint alleging a range of design and warnings claims related to the risk of HPP with the drug, which was approved in 2013 after two prior non-approvable letters driven by concerns about HPP. As could be expected, the launch label contained information approved by FDA about HPP in multiple sections. Plaintiff, who was prescribed and administered the drug once in 2016, claimed to have developed HPP and criticized the strength of the HPP information in the label. (She also criticized changes to the label after her prescription, but that is of no matter.) Defendants—the NDA holder and three other companies—moved to dismiss, largely based on preemption given §82.007. Plaintiff’s response included the contention that she could rebut the presumption based on the fraud-on-the-FDA exception. Thus, the issue—the one we care most about—was joined.
The court started its analysis, from our perspective, a little backwards. Rather than starting with what plaintiff asserted and what Texas law said about it—e.g., what claims exist, what is required to prove them—the court started with a discussion of preemption, starting with this curious statement:
Defendants argue that any of Plaintiff’s claims that are premised on a failure to warn are preempted by federal law in that they boil down to the theory that Injectafer should have been labeled and designed differently despite FDA approval of the existing label and design.
Id. at *3. This came with a footnote saying the defendants challenged only pre-approval warnings and design claims, the plaintiff did not claim a post-approval design claim, and defendants did not challenge the post-approval warning claim. We will save our ink on all of that and simply note that the approach here allowed the court to follow its approach in Crockett and conclude a pre-approval design claim was not preempted. Id. As we have said before, if any claim is preempted in a prescription drug product liability case, then it is one premised on the argument that the drug should have had a different design when it was approved. With this issue punted away, the court turned to the Texas statute and, in short order, Buckman.
Plaintiff’s concession that she could avoid the presumption of non-liability for all the warnings claims she asserted only by proving that defendants had “withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury” teed up the precise issue about the Texas statute.
Although a handful and some cases have evaluated whether it (or a substantially similar Michigan statute) is preempted by the Buckman rationale, the Third Circuit has not.
Id. at *5. The court cited Lofton, Garcia, and some lower court cases in the Third and Fifth Circuits on the preemption side and Desiano and some lower court cases in the Third Circuit on the no preemption side. After reviewing the circuit cases in some depth—although with a bit too much on the debunked presumption against preemption for our taste—the court looked primarily to Lofton as the most persuasive and on-point. The “the only federal appellate court to have interpreted the Texas exception at issue here,” happened to be one “conversant in Texas law,” and “it did so in a factually analogous circumstance involving common law tort claims after carefully considering the counter-arguments made in Desiano.” Id. at *7.
Following Lofton and noting that plaintiff’s fraud allegations did not include the claim that FDA had ever determined HPP risk information had been withheld, Buckman precluded plaintiff from trying to fight the presumption against warnings claims. Id. That did away with five of plaintiff’s counts grounded in failure to warn, including a fraud count that was based on “failure-to-warn allegations cast under a different heading.” Id. at *8.
Another domino fell because Texas follows comment k and, as discussed above, the presumption of adequate warnings held. That means plaintiff’s design defect claim was also dismissed. All that was left for the court was the issue of whether plaintiff had pled a failure to test claim, which Texas recognizes as a species of negligence. Her general negligence and “gross negligence” allegations did not come close, but, as with most initial challenges to the adequacy of pleading, plaintiff was permitted another shot to get it right. If she does not come up with enough allegations to revive a gross negligence claim, then her punitive damages claim will also stay dismissed. Even with something of plaintiff’s complaint remaining, there was not enough to support punitive damages. That last bit was a holding under either Texas or Pennsylvania law. The rest was pure Texas.