[Drug and Device Law] A Collection of Ethicon Mesh Rulings
We’ve reported on multiple sets of in limine and summary judgment rulings coming out of the Pelvic Mesh MDLs (see here, here, here and here for example). And there is a new batch just in. Like the other rulings coming out of this litigation, they are a mixed bag. As is our usual procedure, we are going to primarily focus on the positive and we’ll skip over a lot of the redundant and more mundane rulings. It should make for a short, but hopefully informative post.
All of the rulings were entered in Bellew v. Ethicon, Inc., No. 2:13-cv-22473 (S.D. W. Va.), a bellwether case in the Ethicon Pelvic Mesh MDL. We’ll start with the in limine rulings which can be found at Bellew, 2014 U.S. Dist. LEXIS 165709. Many of the motions were standard – by defendant to exclude evidence of other allegedly bad acts (denied without prejudice); by plaintiff to exclude evidence of other allegedly good acts (denied in part (granted only as to things defendant agreed they would not introduce at trial)); by defendant to exclude that it no longer sells the product at issue (granted); by plaintiff to exclude evidence of 510k clearance (granted).
There was one motion in limine, however, that caught our attention as one we see more commonly brought by defendants. Although, this issue can cut both ways, so we aren’t going to offer much commentary here. Plaintiff moved to exclude “opinion testimony from treating physicians.” Id. at *24. The reason this is more often a defense motion is the unlevel playing field we’ve railed against for years. Plaintiffs have unfettered, ex parte access to the treaters. So, they often use that time to show the doctor things like medical literature the doctor had never read, corporate documents the doctor would never have otherwise seen, or information that post-dates the doctor’s treatment of the plaintiff. All of this is done in an attempt to secure opinion testimony on causation. Now, if the treater is retained by plaintiff as an expert and prepares an expert report, his opinions, like those of any other properly disclosed expert, are scrutinized under Daubert. The problem comes when plaintiff tries to proffer the causation opinion without the expert report.
In Bellew, however, it appears the defendant elicited some favorable testimony from plaintiffs’ treaters – we assume without the “prep” time afforded plaintiffs – that plaintiff wanted to exclude. It also seems that at least some of the testimony that bothered plaintiff, such as smoking history and history of pre-existing injuries – was information the treaters obtained during their treatment of the plaintiff. While the court’s decision doesn’t parse through all of the opinions plaintiff tried to exclude, it made a general ruling that “absent an expert designation, a treating physician may only offer testimony that addresses knowledge gained and opinions formed during the course and treatment.” Id. at *26. It sounds like any dispute on a specific opinion will be hashed out at trial. But the court did go on to say that opinion testimony about pre-existing injuries, for example, was clearly relevant to plaintiff’s “pre-implant quality of life and pain management; breaking the chain of proximate causation; and establishing damages, or the lack thereof.” Id. at *27. So, that’s a good sign.
Moving next to the summary judgment decisions, of which there are two. In the first, plaintiff moved for summary judgment on her design defect claim and all her fraud-based claims. The design defect motion was denied. Bellew, 2014 U.S. Dist. LEXIS 164428, at *10-12. But defendant prevailed on the fraud-based claims (fraud, fraudulent concealment, negligent misrepresentation, breach of warranty and Arizona Consumer Fraud Act claim) when the court agreed that Arizona’s learned intermediary doctrine extended to these claims as well as failure to warn. Id. at *12. Under the learned intermediary doctrine, pharmaceutical manufacturers are not required to warn end-users of their product. If that doctrine didn’t apply to fraud claims, “plaintiffs could simply plead around the learned intermediary doctrine by characterizing failure-to-warn claims as fraud claims.” Id. at *13. The court refused to allow that type of re-packaging.
Finally, defendant also brought a preemption summary judgment motion. Bellew, 2014 U.S. Dist. LEXIS 164621. The defendant had tried this argument without success on two prior occasions in this litigation (See Lewis v. Johnson & Johnson, 991 F.Supp. 2d 748 (S.D. W. Va. 2014) and Huskey v. Ethicon, Inc., 2014 U.S. Dist. LEXIS 92315 (S.D. W. Va. July 8, 2014). In both cases the court denied summary judgment on the ground that the pelvic mesh system that had one component that was PMA approved did not support preemption where the system as a whole was cleared as substantially equivalent under §510k. The court was unpersuaded by any of the new arguments advanced by defendants on this issue and similarly denied summary judgment in Bellew. However, in its rejection of one of defendant’s arguments, the court provides some precedent which could prove useful in other settings.
Defendant in Bellew argued that the FDA considers the 510k process as a “safety and effectiveness analysis.” Id. at *15. To support that argument, defendant relied, in part, on the FDA’s most recent guidance on the 510k process. As plaintiffs often try to rely on FDA guidances, the court’s trouncing of this one is our silver lining in an otherwise dark cloud of a preemption decision. The court found that FDA guidances are not “interpretations” of the FDCA, but are simply “descriptions” of the FDA’s current thinking and “should be viewed only as recommendations.” Id. at *16. The court rejected relying on the FDA Guidance in favor of the Code of Federal Regulations and the Supreme Court.
There are a lot of lemons in those three decisions, but we managed to squeeze out just enough juice for a glass of lemonade (or a single blog post). Enjoy.
--
Posted By Michelle Yeary to Drug and Device Law at 12/09/2014 12:39:00 PM --
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
---
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.
No comments:
Post a Comment