Monday, June 17, 2013

The MDL Court Has Begun Issuing Pre-Trial Decisions on Bellwether Cases in the Pelvic Mesh Litigation



Four bellwether cases have been prepared for trial in the pelvic mesh MDL, and so the court has begun issuing pre-trial rulings.  Over the coming days (and later if further decisions come out), we’ll discuss a number of those rulings.  All of these posts, however, come solely from the Dechert side of the blog.

Today, we have the court’s summary judgment decision in a bellwether case that originated in Mississippi.  In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 78059 (S.D.W.V. June 4, 2013).  The plaintiff’s doctor had implanted the defendant’s Avaulta Plus Biosynthetic Support System into plaintiff during her pelvic organ prolapse surgery.  The court’s summary judgment decision addressed all, or almost all, of plaintiff’s claims and five of defendants’ affirmative defenses.

By far, the most interesting issue, and the main reason that the opinion merits discussion, is the court’s decision on plaintiff’s failure to warn claim.  The defendant’s first argument was that Avaulta’s label, called the Instructions for Use (“IFU”), warned of the precise risks that the plaintiff was suing about.  Id. at *15.  But, while plaintiff conceded that the IFU warned about a list of possible complications, she claimed that the defendant failed to warn doctors about a particular resin used in the Avaulta product.  Id.  The material safety data sheet for the polypropylene resin, she claims, disclosed that the resin was not proper for permanent implantation in humans, and the defendant didn’t disclose that to doctors.  Id.  The court accepted this argument.  It held that, while defendant disclosed potential adverse events, it was a fact issue for the jury to decide whether its warnings were adequate overall.  Id. at *16-17. 

Now, that ruling may read like a loss for the defendant.  But it didn’t matter.  Enter the learned intermediary doctrine and proximate causation.  No matter what defendant’s warnings said, things wouldn’t have changed because the treating doctor testified that he did not read the IFU for Avaulta:

Q. . . . You've gotten medical devices in the past, have you not, and they've got these instructions with them; is that correct? Just medical devices in general. They generally have a set of instructions with them, don't they?
A. In general, yes, sir.
Q. Do you recall the Avaulta Plus -- this is the Avaulta Plus Biosynthetic Support System -- do you recall ever having seen [the IFU] with the product? Glanced at it? Looked at it?
A. No.

*          *          *          *          *

Q. And do you recall what those products -- devices and what we call an IFU or information for use coming with those devices?
A. I never, you know, read that. I mean, the Cook, I probably did, but that's been 10 years. And the other was just I want to sample my product. Basically, the same mechanism or operative maneuvers. It was just a different  [*19] sling. So I didn't feel like I had to read the fine print in the package insert.

*          *          *          *          *

Q. . . .  And I just want to make sure I'm clear. Do you recall ever reading the Instructions For Use for the Avaulta Plus product?
A. No.

Id. at *18-19 (emphasis added).  That’s what we call a “game-changer,” and that was the end of plaintiff’s failure to warn claim. 

Remember, the learned intermediary doctrine is not a defense.  Plaintiffs have burden to show proximate causation – in other words, that the doctor wouldn’t have used the Avaulta product if it contained a different warning.  Here, plaintiff couldn’t do that.  The only evidence in the case said that, to the contrary, a different warning wouldn’t have changed the doctor’s behavior because he wouldn’t have read it:

[T]he plaintiff never directly responds to Bard's argument that Dr. Williams simply never read the IFU. Dr. Williams's testimony essentially suggests that he felt he knew enough about the risks of implanting meshes such that he did not need to read the IFU. Accordingly, even drawing the facts and inferences in the light most favorable to the plaintiff, as the standard for a motion for summary judgment requires, I cannot find that the plaintiff  has offered sufficient evidence to meet her burden of showing that additional or different warnings would have prevented Dr. Williams from implanting the Avaulta product into her. Simply put, because Dr. Williams did not review the IFU, no amount of warnings contained in it would have caused Dr. Williams to act any differently.

Id. at *19-20.

The court’s “no amount of warnings” language had real power.  The treater had actually testified at his deposition that he was not provided certain risk information that, if he had known about it, would have changed his decision to use the product.  Id. at *19.  That didn’t matter.  If the defendant had put that information in the IFU, the doctor wouldn’t have read it.  This is a useful example of the potential power of testimony from a treater or prescriber that she or he didn’t read the product’s label.
We should mention that the opinion has other, less-interesting decisions.  The court, for instance, granted the defendant judgment on plaintiff’s manufacturing defect claim.  While plaintiff presented some evidence that parts of defendant’s manufacturing process may have been faulty, such allegations about a defendant’s ordinary production process can only be relevant to design defect, not manufacturing defect.  Id. at *13.  The court also granted defendant summary judgment on a host of other claims – warranty, consumer protection laws, and negligent inspection, marketing, packaging and selling – because plaintiff didn’t oppose the motions on those claims.
The decisions on defendant’s affirmative defenses were also relatively uneventful.  The plaintiff won on contributory negligence because there is no such defense in Mississippi.  And she won on defendant’s Buckman preemption defense because plaintiff disavowed that she would claim fraud on the FDA.  Id. at *22, *29-31.  But the court found that the defendant could present other defenses to the jury, if it so chose, because it had sufficient evidence on (i) plaintiff’s treater’s actions as well as inaction by the plaintiff in seeking treatment for other medical conditions (comparative negligence), (ii) plaintiff signing consent forms related to the implant of the Avaulta product (assumption of the risk), and (iii) plaintiff failing to pursue medical follow-up for her injury (failure to mitigate).  Id. at *22-29.
But the real headline for this decision is the  summary judgment win on the failure to warn claim.  If the doctor didn’t read the label, get that testimony.  It can put an end to a failure to warn claim. 

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