[Drug and Device Law] MDL Judge Allows Manufacturing Defect Claim to Go to Trial with No Direct Evidence of a Defect in the Device Actually Implanted in Plaintiff
The Judge in the ObTape device litigation has allowed another manufacturing defect claim to go to trial with no direct evidence that the device implanted in the plaintiff had a manufacturing defect. See In re Mentor Corp. ObTape Transobturator Sling Prods. Liability Litig., 2015 U.S. Dist. LEXIS 140263 (M.D. Ga. Oct. 15, 2015). In denying the manufacturer’s motion for summary judgment, the court relied solely on a review conducted by plaintiff’s experts of sample ObTape devices—that is, devices other than the one implanted in the plaintiff. The experts found that the pore sizes of those other samples were at times outside of the alleged manufacturing requirement of 40 to 100 microns. Relying solely on this, the court rejected the manufacturer’s argument that plaintiff had not shown a manufacturing defect in the device implanted in her. The court explained its reasoning, which from our point of view is less than convincing:
One way to prove a manufacturing defect is to test the specific subject product against manufacturing standards. For example, in BIC Pen Corp., the parties tested the cigarette lighter that caused the plaintiff's injuries. 346 S.W.3d at 540-41. But Mentor [the manufacturer of ObTape] did not point the Court to any authority that such testing is the only way to establish a manufacturing defect under Texas law. Here, Mrs. Sanborn relies on the same evidence as the Phase I Georgia Plaintiffs, whose specific ObTape was not tested, either. Rather, their experts tested a number of ObTape samples and concluded that a substantial portion of each ObTape tested had pores smaller than 40 microns. In re Mentor, 711 F. Supp. at 1376. At this time, the Court remains satisfied that this evidence is sufficient to create a genuine fact dispute on Mrs. Sanborn's manufacturing defect claim. Mentor's summary judgment motion on the manufacturing defect claim is thus denied. The Court may reconsider this issue when ruling on any motion for judgment as a matter of law that may be presented at trial.
Id. at *8-9.
We have a number of concerns with this ruling. First, a manufacturing defect claim is, by its nature, specific to the product used by plaintiff. The issue is whether the product used in plaintiff had a manufacturing defect. In this case, however, plaintiff produced no direct evidence that the pores of the ObTape implanted in her were out of spec. Instead, she relied solely on her experts’ sampling, offering no other evidence whatsoever and, in particular, no evidence as to her actual device. We can see why defendant moved for summary judgment.
Second, when the manufacturer pointed the court to cases in which the plaintiff was required to show the defect in her device, the court responded by saying, in essence, that those cases don’t restrict the court from allowing plaintiffs to show a defect with less direct (and, frankly, inferior) evidence. But, as we warn again and again on this blog, federal courts working under the Erie doctrine should not be in the business of establishing new law or standards that have not been authorized and employed by the courts of the state whose law (here, Texas law) the court is interpreting.
Third, after holding that plaintiff’s experts’ samples testing was enough to get to trial, the court hedged, saying that it might “reconsider the issue” on a motion for judgment as a matter of law at trial. But the issue had already been teed-up before the court on the manufacturer’s summary judgment motion and, in fact, according to the court itself, had been teed-up in another case before the same judge by another plaintiff who also relied on samples testing, and the court allowed that case to go to trial too. If the court was suggesting that plaintiff’s evidence might not have actually been enough to support a jury verdict—and it certainly seems that it wasn’t—the court should have pulled the trigger and granted summary judgment for defendant right then and there.
The court’s opinions contained a couple of other decisions, as it dismissed plaintiff’s implied warranty claim as time-barred and allowed her failure to warn claim (based on the pore sizes again) to go forward. And we might quibble with the failure to warn decision.
But we’re not so interested in quibbling on this blog. We’re more interested in the big issues. And it’s big news that a plaintiff, at least in the ObTape litigation, can take a manufacturing defect claim all the way to trial without ever presenting direct evidence that the device that she actually used had the manufacturing defect. That seems like a court, essentially, opening the doors to the court room to any plaintiff who can state even a hint of a manufacturing defect claim. All they need do is point to the experts, not their own product.
Let’s hope that the court sees things differently on the motion for judgment as a matter of law that the defendant will no doubt file at trial. Thereafter, the court might become more comfortable taking care of these evidentiary deficiencies at the summary judgment stage.
(In the meantime, for those following the baseball playoffs and this blog, you can be certain that we will sit back and enjoy the remainder of the playoffs with the knowledge that Chase Utley is now relegated to using his special skills developed in the bush league to, if he so chooses, injury starters and rangers on golf courses. In fact, he’ll likely have another opportunity to show those skills on the golf course during next season while experiencing what are likely to be two unpaid days off.)
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Posted By John J. Sullivan to Drug and Device Law at 10/19/2015 11:22:00 AM --
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