Last week when we posted about some motion in limine rulings coming out of the IVC Filters MDL, most of our blogging team were enjoying a calm week after being hit by two nasty Nor’easters. We were turning our thoughts to spring. Birds chirping, flowers blooming, sunshine and rainbows. Now a week later as we officially head into spring, bam. Here we go again. The predictions vary and it may only be a few more inches of snow, but March has pretty been all lion and we really hoping to see a little lamb in our future. Mother Nature has decided she's not quite ready to let go of her grasp on winter. Much like the court in the IVC Filter MDL wasn't quite ready to let go of the bellwether case Jones v. C.R. Bard, Inc, 2018 U.S. Dist. LEXIS 40020 (D. Ariz. Mar. 12, 2018).
At the heart of the Bard IVC Filters Litigation is an allegation that defendant's filters have a higher comparative risk rate than other filters and that defendant failed to warn physicians about the higher risk. Id. at *319-20. In the context of this bellwether case set for trial in May, defendant moved for summary judgment on failure to warn, misrepresentation, negligence per se, and punitive damages and won on misrepresentation and negligence per se.
The court was applying Georgia law and therefore the learned intermediary doctrine. Id. at *322-23. Defendant's first argument was that plaintiff lacked proof of proximate cause on her failure to warn claim because her surgeon testified that he did not read the Eclipse filter label. You all know this argument – even if the defendant had included the very warning plaintiff contends should have been made, it doesn't matter if the physician wouldn't have seen it. If the doctor's testimony is clear, this should shut the door on failure to warn. The court here, however, found a way to prop that door back open by holding that a defendant can breach its duty to warn not only by having a deficient warning but also "by failing to adequately communicate the warning." Id. at *324. The court looked beyond the label to "dear doctor letters, product pamphlets, and statements by company sales representatives." Id. at *325. If this is an escape hatch for plaintiffs on failure to warn, then we have more questions for doctors at their depositions.
Defendant's second argument on failure to warn causation was that the physician was already aware of the very risk which occurred in this case, device fracture – which was also a well-known risk in the medical community. Id. at *326-27. Plaintiff's countered that the lack warning wasn't about the general risks of filters but that this particular filter had a higher risk of complication than other filters. On this point, plaintiff's surgeon testified that higher complication rates is something "he would have wanted to know" before plaintiff's surgery. That was enough for the court to find a jury question as to prior surgeon knowledge. Id. at *328.
Taking these two rulings together serves to emphasize the critical importance of the physician's deposition. This court wanted "unequivocal" evidence that the doctor would have made the same prescribing or surgical decision even in the face of different warning information. Id. at *328-29. Only such a response would have cutoff causation with regard to any avenue by which the defendant could have communicated warnings to the surgeon. It's a risk to ask the ultimate question – would a different warning have mattered – but without it, the risk is a disputed fact issue for the jury.
The court turned next to the adequacy of the warning provided, which it was undisputed did contain a warning regarding fractures. But as noted above, did not contain information about the comparative risk rates for this filter as against other filters. Id. at *330-31. We had the same gut reaction that defendant in this case appears to have had – 1) how can you possibly provide reliable information comparing risks among products and 2) is this even allowed by the FDA. Id. at *334. It's not for prescription drugs. See 21 C.F.R. §201.57(c)(7)(iii) ("For drug products . . . any claim comparing the drug . . .with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies."). But the same logic should apply. Unless the adverse reactions or complications being discussed have been studied side-by-side to account for variables and assorted other unknowns, the comparison is meaningless and potentially more harmful than helpful. It's one thing to suggest that the label warning of the risk of fractures was insufficient given the state of knowledge defendant had or should have had at the time, but finding that a defendant could be liable for breaching its duty to warn for failing to provide comparative risk rates that are unverified, unapproved, and inherently unreliable puts a defendant in a really precarious position. Don't include and face tort liability; include a face FDA violations for misbranding and misleading information.
Moving on to the two claims that were dismissed – misrepresentation and negligence per se. The court found that Georgia does not recognize an independent claim for misrepresentation in a products liability case. It is subsumed in failure to warn. Id. at *336-37. Similarly, plaintiffs could not maintain a negligence per se claim based on alleged FDCA violations because there is no private right of action to enforce the Act. The court's preemption analysis is emphatic and strongly reasoned. Id. at *338-40. Plaintiff's attempt to sidetrack the court with talk of the difference between PMA and 510(k) devices falls on deaf ears, as it should when talking about Buckman implied preemption. Id. at *340-41. As did plaintiff's attempt to argue that Georgia allows negligence per se claims based on laws that do not create a private right of action. The difference between those laws and the FDCA is "the plain language of §337(a) and the Buckman decision indicate that, where the FDCA is concerned, such [a] claim fails." Id. at *341.
Finally, the court also allowed plaintiff to keep her punitive damages claim based on a design claim that was not otherwise part of the motion. The discussion focuses on the state of the evidence regarding what defendant knew and when and what actions it took regarding the design of the device at issue. It is fairly case specific and so we won't delve into the details here.
Not a banner decision and frankly it raises more questions than it answers about warnings based on comparative risk rates. Hmm, perhaps a deeper dive and a subsequent post is in order. Something for the next snowy day.
This article is presented for informational purposes only and is not intended to constitute legal advice.
