[Drug and Device Law] MDL Court Agrees - Tincher Doesn't Change Pennsylvania Drug/Device Law
Several months ago we responded with some disdain to recent plaintiff-side arguments we had seen claiming that the strict liability decision in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), somehow altered Pennsylvania’s negligence-only standard for prescription medical product litigation that has been unquestioned since Hahn v. Richter, 673 A.2d 888 (Pa. 1996). Hahn, of course, expressly applied comment k to all prescription medical product cases, with the effect of eliminating strict liability in such litigation. 673 A.2d at 890-91. We thought the other side’s Tincher arguments were disingenuous, to say the least, since Tincher expressly recognized Hahn’s exception to the general rule of strict liability in Pennsylvania. 104 A.3d at 382 (listing Tincher as a “but see” exception to proposition that “no product” is exempt from strict liability.
Well, now returns are starting to come in, and courts agree with us. Most notably, the issue received a thorough airing before an MDL judge in In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2015 WL 3669933 (N.D. Ill. June 12, 2015). The same result was also reached (albeit without citing Tincher) in Runner v. C.R. Bard, ___ F. Supp.3d ___, 2015 WL 3513424, at *3-4 (E.D. Pa. June 3, 2015). Of the two, the Nexgen decision was dicier, because a court in Illinois can’t be expected to be as intimately familiar with Pennsylvania law as a Pennsylvania judge, so there’s always a chance….
Didn’t happen. The MDL court saw through plaintiffs’ sophistry and recognized that Tincher didn’t do anything that dislodged comment k from its existing position under Pennsylvania §402A jurisprudence. For purposes of this discussion, we’ll skip the first three-quarters of the Nexgen decision, which dealt with (very thoroughly) a host of litigation-specific Daubert points. If issues such as “posterior edge loading,” “two-millimeter bone cut,” “tibial loosening,” and “polyethylene lift-off” are your thing, you probably can skip this post anyway, since you know already more about this litigation than we do. Since several of us practice in the Keystone State (technically it’s a commonwealth), it’s the Pennsylvania law rulings that interest us here.
As it should have (and as occurred in Runner), the court followed established Pennsylvania law and granted summary judgment against all claims that smacked of strict liability. “The court agrees with [defendant] that the Supreme Court of Pennsylvania, if presented with the issue, would dismiss Plaintiff’s strict liability claim, and summary judgment is granted as it relates to this claim.” Nexgen, 2015 WL 3669933, at *34. One question was whether Pennsylvania’s negligence-only rule applied to design defect claims. Nexgen, 2015 WL 3513424, at *34, n.37 (citing Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), for proposition that negligence is the only allowed design-related product liability theory). Since Tincher did not address this issue, and Lance did, Nexgen rejected the plaintiff’s position:
Lance’s recognition that negligent design claims are available in a pharmaceutical products liability case does nothing to upset Hahn’s rule precluding strict liability claims against pharmaceutical drug manufacturers. Indeed, the Lance court noted Pennsylvania’s “refusal to extend strict liability to prescription drug manufacturers, consistent with the treatment for ‘unavoidably unsafe products’ reflected in comment k to Section 402A,” and observed that Pennsylvania uses a “blanket approach applying comment k to preclude strict-liability design defect claims for all prescription drugs.”
2015 WL 3669933, at *35 (quoting Lance).
The next issue is whether the negligence-only rule should apply to prescription medical devices, as well as prescription drugs. Joining every other case to have addressed the issue under Pennsylvania law, Nexgen held that it did. Nexgen, 2015 WL 3669933, at *34. There are a lot of such decisions. Nexgen marks at least the sixth time that this defendant (Zimmer) alone has won the issue. See also Kline v. Zimmer Holdings, Inc., 2013 WL 3279797, at *4-5 (E.D. Pa. June 27, 2013); Key v. Zimmer, Inc., 871 F. Supp.2d 405, 408 (E.D. Pa. 2012); Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *2 (W.D. Pa. Nov. 10, 2011); Kester Zimmer Holdings, 2010 WL 2696467, at *9 (W.D. Pa. June 16, 2010); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 749-50 (E.D. Pa. 2007). We cited a number of others in our post.
Tincher, which did away with Pennsylvania’s prior over-enthusiastic version of strict liability, could not be read as impliedly expanding strict liability into prescription medical product liability litigation, where eight prior decisions have uniformly refused to allow it. See Lance, 85 A.3d at 453; Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 527 (Pa. 1995); Hahn, 673 A.2d at 891; Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1386-87 (Pa. 1991); Baldino v. Castagna, 478 A.2d 807, 810 (Pa. 1984); Incollingo v. Ewing, 282 A.2d 206, 219-20 (Pa. 1971); DiBelardino v. Lemmon Pharmacal Co., 208 A.2d 283, 285-86 (Pa. 1965); Henderson v. National Drug Co., 23 A.2d 743, 748 (Pa. 1942). Tincher, which did not involve any prescription only product, did “not sway the court.” Nexgen, 2015 WL 3669933, at *35. “Tincher acknowledged Hahn’s holding that strict liability is unavailable for prescription drug claims premised on defective design or inadequate warning, but the Court declined to categorically bar strict liability claims for any other types of products.” Id.
That did not mean that Tincher sub silentio drew a distinction between prescription drugs (which were not before it) and prescription medical devices (which were also not before it).
[T]he court is unwilling to read Tincher’s tea leaves so expansively absent more explicit language from Pennsylvania’s highest court cabining Hahn to prescription drugs only. Tellingly, the product at issue in Tincher was . . . not a prescription drug or medical device. Tincher clarified the standard for imposing strict liability on any products besides prescription drugs, but its analysis reaches prescription medical devices only if the reference to “innovative products” includes them. The court does not believe Tincher, a lengthy opinion that exhaustively details the state of products liability law in Pennsylvania, intended its presumption in favor of strict liability to apply to prescription medical devices, especially when such devices, as discussed above, share so many similarities with prescription drugs.
Nexgen, 2015 WL 3669933, at *35 (emphasis original) (citation omitted). Other than the vague reference in Tincher to “innovative products,” there was nothing in Tincher remotely on point, and that one general reference did not defeat all the precedent analogizing between prescription drugs and prescription medical devices. Id. (“such devices, as discussed above, share so many similarities with prescription drugs”). Nor is it just Pennsylvania, nationwide – according to the footnote in Bexis’ book, §2.02[2] fn.14 – the talley of case-law equating prescription drugs and prescription medical devices for comment k purposes stands (as of about a year ago) stands as a lopsided 61-2 in favor of the position that Nexgen adopted.
One final argument, not based on Tincher, was also rejected. Plaintiffs in Nexgen contended that prescription medical devices should be subject to strict liability even if prescription drugs aren’t, because FDA scrutiny of drugs is greater than that given to devices that are cleared (rather than “approved”) under the §510k “substantial equivalence” process. 2015 WL 3669933, at *36. Noting that the same rationale would imply a difference – never recognized by any court, and certainly not in Pennsylvania – between innovator and generic drugs for comment k purposes, id., the MDL court gave this argument the back of its hand. “Simply put, Plaintiff’s arguments about the level of regulatory scrutiny brought to bear on drugs and medical devices do not satisfy the court that they fare differently under comment k of the Second Restatement.” Id.
We agree with Nexgen’s analysis of these issues of Pennsylvania law. Tincher changed a lot of things about strict liability, but one thing that did not change is Pennsylvania’s reliance on §402A. Comment k is part of §402A, and in accordance with 70 years of unbroken Pennsylvania precedent, comment k (and similar Pennsylvania holdings before comment k existed) has been interpreted as precluding strict liability, in whatever form it might take, against prescription medical products.
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Posted By Bexis to Drug and Device Law at 6/18/2015 04:00:00 PM --
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