Evidence

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The recent magistrate’s decision in Fecho v. Eli Lilly & Co., 2012 WL 6681895 (Mag. D. Mass. Dec. 21, 2012) (“Fecho II”), isn’t good, but it could have been far worse.  While the decision stretches prescription drug warning causation to the breaking point, at least it didn’t do what the plaintiffs sought, which was the wholesale importation of asbestos-style tactics of proving causation into drug litigation.  Still, to escape summary judgment required unprecedented application of both the Federal Rules of Evidence and Pennsylvania law (although not the law ordinarily applied in product liability cases).

Here’s what went on.  Fecho is a testament to old litigation not dying, but spreading to different injury allegations.  Fecho involves DES.  That’s right old-fashioned diethylstilbestrol – prohibited from use in pregnant women by the FDA since 1971.  As everyone in our line of work knows, DES is linked to a rare type of cancer in young women exposed in utero – a cancer that developed around the time of puberty.

That development, of course, brought about a wave of litigation over events that happened – due to the delay in cancer development – between one and three decades earlier.  Because DES was never patented, many DES plaintiffs could not determine who made the drug they were exposed to.  That proof problem led pro-plaintiff courts in the 1980s to invent “market share liability,” which all in all was probably the radical and ill-conceived expansion of tort liability of our legal lifetimes.  Fortunately, most states didn’t adopt it.

But time passes, and with the youngest of the so-called “DES daughters” now over 40, one would expect the statute of limitations finally to put this litigation to bed – NOT!

Rather than finding something else to sue over, plaintiffs (some of them, anyway) are now claiming that the same in utero exposure to DES causes breast cancer.  Unlike the DES litigation of the 1980s and 1990s, the medical causation science for this new theory isn’t very good, being limited to a couple of studies that plaintiffs’ experts have to massage thoroughly in order to discover any statistically significant increase in any “cohort.”  See Fecho v. Eli
Lilly & Co., 2012 WL 194419, at *2 (Mag. D. Mass. Jan. 20, 2012) (expert found statistical significance in one “subset” of first study that “could be characterized as too thin” only after “control[ing] for” unspecified “confounding factors”); id. (second study had an even “smaller hazard ratio,” so the expert “discounted an excess risk calculation in preference for a proportionate hazards model”) (“Fecho I”).  Not only that, but there’s no distinction between purported DES breast cancer and any other breast cancer.  Id. (“temporal relationship between the exposure and the development of the disease . . . tracks the natural age at which breast cancer typically appears”).  In short, DES breast cancer litigation not only has all the causation problems of earlier DES litigation, but junk medical causation science has replaced the prior “signature disease.”Continue Reading Asbestos Causation Tactics And Pharmaceutical Litigation

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We’ve been reading the Keith Richards autobiography, Life, and it made us think about the past. The Rolling Stones were formed 50 years ago, in April 1962. We were Beatles fans in the 1960’s. (Still are). When the Rolling Stones showed up on The Ed Sullivan Show they seemed sort of terrifying. (Still are.)

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Motions in limine were decided (or not) recently in Wolfe v. McNeil-PPC, Inc., 2012 U.S. Dist. Lexis 2160 (E.D. Pa. Jan. 9, 2012).  The defendant did pretty well, so here’s a brief listing of the highlights (this isn’t everything, as some were case specific, not decided, moot, or simply boring).

 
  • Adverse events –

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Most of the opinion in Riley v. Medtronics [sic], Inc., C.A. No. 2:10-01071, slip op. (W.D. Pa. Aug. 8, 2011), is a fact-specific statute of limitations discussion – oddly occurring in the context of a motion to dismiss – about a less-than-diligent plaintiff who did next to nothing until the statute had almost expired…

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The new case, Williams v. Mast Biosurgery USA Inc., ___ F.3d ___, 2011 WL 2566426 (11th Cir. June 30, 2011), raises two fascinating issues, but we only offer our opinions about one of them. The facts in Williams are unfortunate, as is true with most of the cases we handle.
The plaintiff, a young lady, was being evaluated for possible infertility.  Her treating gynecologist (doctor #1) found an ovarian cyst and drained it.  During that procedure, he also found “significant dense adhesions that had resulted from a prior surgery some years before,” 2011 WL 2566426, at *1 – surgery that, oddly in our view, was not further described or discussed.
More on that later.
More significant surgery, to remove these adhesions, soon followed.  To prevent adhesions from recurring, doctor #1 inserted the medical device in question, a “bioresorbable” (that is, designed to break down and gradually be destroyed by the body’s biological processes) barrier manufactured by the defendant.
Anyway, since we’re describing a product liability suit, things necessarily went awry.  Within a month after this surgery, the plaintiff returned, in bad shape.  A colonoscopy (performed by doctor #2 in a different medical specialty) revealed “several stiff, hard and brittle pieces of plastic” perforating the plaintiff’s colon.  Id.  This required a second surgery – by a doctor #3 – which “cleaned out” the material and a significant accompanying infection.  Doctor #3 “suspected” the material was from the barrier that had been implanted in the second surgery.
A pathologist (doctor #4), also examined the material.  He echoed doctor #3’s suspicions, but his testimony turned out to be incompetently based solely on a product label he had been given.Continue Reading Of Treating Physicians And Manufacturing Defects

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Returning from the ALI meeting, Bexis had sitting in his inbox the final hard copies of update 14 for his Drug/Device products liability book.  For those of you that use Bexis’ book, that means there’s more to use, but for Bexis that means that it’s time to start on update 15.  A legal author’s work is never done.  This time he’s planning to update the chapter on evidence.
It’s also time for our Thursday long post – time to kill two birds with one stone.
Right now the book has a short subsection on corporate intent evidence in drug and device cases.  That section states simply that corporate motive and intent evidence (usually offered by some purported “expert”) has generally been found inadmissible by courts trying drug and medical device product liability cases.  There’s one footnote, citing four cases from three jurisdictions:  Smith v. Wyeth-Ayerst Laboratories Co., 278 F. Supp.2d 684, 700 (W.D.N.C. 2003); Figueroa v. Boston Scientific Corp., 2003 WL 21488012, at *4 (S.D.N.Y. June 27, 2003); In re Diet Drugs Products Liability Litigation, 2001 WL 454586, at *2 (E.D. Pa. Feb. 1, 2001); In re Diet Drugs Products Liability Litigation, 2000 WL 876900, at *9 (E.D. Pa. June 20, 2000).
We think Bexis can do better than that with this update – and we think we can make a blog post out of it as well.  So let’s take a look.  What have courts held about corporate motive and intent evidence lately?
Probably the best treatment of the subject, of the cases coming down since this part of the book was updated, is in In re Rezulin Products Liability Litigation, 309 F. Supp.2d 531 (S.D.N.Y. 2004). There, three purported corporate ethics “experts” were excluded for a variety of reasons.  First, their ethics opinions were “speculative” in the sense that they were based upon “subjective belief.”  Id. at 543-44.  Second, ethical matters were not relevant to product liability litigation, as it was unrelated to the alleged defects being claimed.  “While the defendants may be liable in the court of public opinion, or before a divine authority . . ., expert opinion as to the ethical character of their actions simply is not relevant to these lawsuits.”  Id. at 544.  Third, ethics evidence was argumentative and prejudicial.  Id. at 545.  Fourth, expert witnesses aren’t really qualified at divining corporate intent, which is something that lay jurors are equally competent to judge, should it be relevant to anything.  Id. at 546-47.Continue Reading Experts Offering Evidence of Corporate Intent, Ethics, And The Like

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A couple of weeks ago we posted about the recently enacted Wisconsin tort reform statute, which, among a bunch of other things, included a “rebuttable” presumption that a product compliant with federal or state standards isn’t defective. Specifically, the statute provides:

Evidence that the product, at the time of sale, complied in material respects with relevant

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First of all, yeah, we know about Wyeth v. Rowatt, ___ P.3d ___, 2010 WL 4812919 (Nev. 2010).  We’re just extremely limited in what we can say, since here on the East Coast, Dechert handles similar hormone therapy litigation for the same client.  Rowatt is one of those times when we most miss Herrmann. …

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In putting together yesterday’s post on second-guessing the FDA, we took a look at the Bartlett litigation in New Hampshire.  Lo and behold, we discovered that, in the past couple of weeks the ever-thorough Judge Laplante has issued a slew of other opinions on in limine motions.

Scads of issues got decided (the trial’s probably…

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A lot of things about that recent Gadolinium opinion ticked us off.  But one of the lowest of many low points was when the court ruled a causation opinion based upon FDA adverse event reports (“AERs”) was admissible in a civil trial because the FDA used AERs to assess causation administratively.  In re Gadolinium-Based …

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn more about this book