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April might be the cruelest month according to T.S. Eliot, but the last month hasn’t been very kind to plaintiffs’ expert Nicholas Jewell, Ph.D.  As we posted recently, at the beginning of December, Prof. Jewell was booted from the Zoloft MDL.  See generally In re Zoloft (Sertraline Hydrocloride) Products Liability Litigation, 2015 WL 7776911 (E.D. Pa. Dec. 2, 2015).  Only two weeks earlier, however, he was also given the bum’s rush in In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 7422613 (D.S.C. Nov. 20, 2015).  His being shown the door in two MDLs in two weeks is pretty impressive defense work.  Anybody out there in a position to turn this brace into a hat trick?

Prof. Jewell is a statistician, not a medical doctor.  Lipitor, 2015 WL 7422613, at *14 (“Prof. Jewell is a statistician, not a medical doctor or medical professional.  He has no expertise in diabetes, has never treated participants of any kind, and is not a clinician.”).  As in Zoloft, the Lipitor plaintiffs called him in to second-guess the statistical bona fides of studies involving the drug and condition (diabetes) in question.  As we discussed in detail in the Zoloft post, Prof. Jewell started with the “a priori opinion” needed by his plaintiff-side paymasters and “t[ook] a results-driven approach . . ., molding his methodology and selectively relying upon data so as to confirm his preconceived opinion.”  Zoloft, 2015 WL 7776911, at *16.  Thus, it’s no surprise at all that he committed the same statistical sins in Lipitor:

The Court finds that Prof. Jewell’s analysis of the [statistical] data was results driven, that Prof. Jewell’s methodology and selection of relevant evidence changed based on the results they produced, and that Prof. Jewell chose to ignore and exclude from his report his own analyses that did not support his ultimate opinions.  It is apparent to the Court that rather than conducting statistical analyses of the data and then drawing a conclusion from these various analyses, Prof. Jewell formed an opinion first, sought statistical evidence that would support his opinion and ignored his own analyses and methods that produced contrary results.

Lipitor, 2015 WL 7422613, at *18.

Continue Reading Bookends – Prof. Jewell’s Opinions Also Excluded in Lipitor MDL, and More

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We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes for scientific journals – and what can be done about it.  Dr. Frank has just written a law review article about this problem.  F. Woodside & M. Gray, “Researchers’ Privilege:  Full Disclosure,” 32 Cooley L.R 1 (2015), which is available online here.  Here’s the abstract:

An ever-growing chorus of academicians report that with the expanding number of academic journals there is a concomitant increase in the number of articles based on questionable methodology.  Many published studies contain improper statistical conclusions, flawed methodology, and results that cannot be replicated.  The recent controversy concerning the failure of parents to vaccinate their children because of the recommendations of flawed research exemplifies this crisis. This epidemic of faulty research has been exacerbated recently by the spread of low-quality academic journals and “pay-to-publish” journals, which will publish virtually anything for a fee.  This Article provides an analysis of a growing crisis of reliability in scientific research and how the so-called “researchers’ privilege” allows faulty research to go undetected.  This Article delineates the reasons why it is difficult, if not impossible, to evaluate published research findings without access to the underlying information that researchers have in their possession.  The Article then analyzes the state of the law regarding the ability of researchers to withhold records and data based on the so-called “researchers’ privilege.”  Finally, the Article explains why courts should favor the disclosure of research data and that confidentiality concerns should be addressed by a confidentiality order.

Id. at 1-2.  Here are the articles subheadings, which describe the material in it in more detail:

  • Misunderstanding and Misuse of Statistics and Research Methods
  • An Ever-Growing Number of Journals and “Pay to Play”
  • Fraud and Questionable Research Practices
  • Pre- and Post-Publication Peer Review Does Not Work

Continue Reading What To Do About Junk Science That’s Published?

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We spent the weekend in the Boston area, visiting the Drug and Device Law Rock Climber for “parents’ weekend.” Saturday’s schedule was replete with activities:  a keynote speech by the university president, lectures on topics academic and not, an informative session on the school’s “semester abroad” program (the DDLRC has informed us that she hopes to spend next spring in Australia), and dozens of presentations by student arts groups (theatre, improv, orchestra, a cappella).

We didn’t get to do any of that.  By mid-morning, the DDLRC had tired of being trailed around campus by her parents.  All were shepherded to the “T,” where, several stops down the line, our procession (and its credit cards) descended on the downtown shopping district.  But before we left campus, we insisted on attending one lecture, a sparkling presentation by the head of the theatre department.  The subject was a famous circus mogul who was one of the university’s founding trustees and whose best-remembered donation was the carcass of his equally-famous circus elephant, who has since lent his name to all of the university’s sports teams.  According to legend, the elephant died while pushing a baby elephant out of the way of a speeding train.  The truth was a less-heroic, but equally fatal, elephant vs. train collision. In any event, he was duly stuffed and sent to live in a university museum.  Years later, he was incinerated in a building fire.  Some of his ashes were scooped into a container and displayed in the rebuilt museum, but a grander tribute awaited.  Just this year, a massive bronze statue of the elephant was erected outside the building bearing his patron’s name.  We love this campus attraction, and we wax irrationally sentimental about the whole story.

We are trying to think of a smooth transition to today’s discussion, but this is the best we can do:  like legendary elephants, Daubert and Frye standards for admissibility of expert testimony, as applied by modern courts, frequently defy segregation into discrete containers.  Notwithstanding a hybrid analysis squeezed into a Frye box, the conclusion was clear: plaintiff’s causation experts in a Philadelphia Zoloft case did not meet any relevant admissibility standards, and both were properly excluded.

Continue Reading A Frye Opinion By Any Other Name: Zoloft Plaintiffs’ Experts Excluded in Philadelphia

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Over the weekend, we watched one of our favorite “chick flicks,” a holiday-themed montage entitled “Love, Actually.”  One of our favorite characters, played by the ever-brilliant Bill Nighy, is an over-the-hill former pop star who resorts to superimposing cheesy holiday lyrics on a familiar melody in an (ultimately successful) attempt to manufacture one last comeback.  A disc jockey, hearing this effort for the first time, exclaims, “How the mighty have fallen!”  This crossed our mind as we read today’s case, a decision on Daubert motions in a leftover breast implant case.

Twenty-some years ago, we cut our Drug and Device teeth on breast implant litigation, arguing motions in the infant Mass Tort Program in Philadelphia  Back then, the high-profile litigation, involving claims that breast implants caused serious auto-immune diseases in recipients, commanded high levels of attention and resources and produced some landmark verdicts.  Now, with the vast bulk of the litigation long settled, key defendants in bankruptcy, and many of plaintiff’s claims resoundingly debunked, all that remains are isolated opt-outs, like In re Dow Corning, Corp., Ezra v. DCC Litigation Facility, Inc., 2015 WL 5737997 ( E.D. Mich. Sept. 30, 2015), a primer on Daubert’s raison d’etre.

Plaintiff in Ezra claimed that her silicone gel implants caused

muscle aches and pains all over her body; metallic taste in the mouth; chronic problems with diarrhea; dizziness/vertigo problems; chronic low-grade fevers; frequent yeast infections; chronic fatigue; severe headaches; loss of taste and smell; memory loss and loss of concentration; frequent gastrointestinal problems; sinus problems with ear aches; difficulty swallowing; problems with choking; easily bruised with slow healing of bruises and cuts; spider veins on legs and feet; coldness of hands, fingers, feet, toes and face; muscle spasms; problems with rashes; tingling and numbness in extremities; difficulty breathing; unexplained dental problems; excessive hair loss; as well as emotional, physical and financial losses.

Ezra, 2015 WL 5737997, at *1.   She proffered the testimony of three causation experts, and defendant moved to exclude all three.

Continue Reading Three Strikes and Out of Court for Breast Implant Opt-Out

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“I’m not a doctor, but I play one on TV” – shorthand for “I am pretending to know what I’m talking about, but I really don’t.”  We have blogged frequently about experts inclined to such pretense and about courts’ varying levels of tolerance for experts who lack expertise or who render opinions lacking foundations and reached without reliable methodologies.  Recently, in Hexum v. Eli Lilly & Co., 2015 U.S. Dist. LEXIS 106153 (C.D. Cal. Aug. 10, 2015) – a Cymbalta “discontinuation case” — the United States District Court for the Central District of California did a noteworthy job of precluding two experts from testifying about opinions they had no business rendering.

In Hexum, plaintiff claimed that she suffered severe “discontinuation” symptoms after ceasing to take Cymbalta, an SSRI manufactured by defendant Lilly, because Lilly’s Cymbalta label provided her treating physician with inadequate warnings about such adverse events. Before trial, Lilly moved to exclude the testimony of two of plaintiff’s experts: 1) a psychiatrist, rendering opinions, inter alia, about the adequacy of Cymbalta’s label; and 2) a “social psychologist,” offering opinions about how “a reader” would interpret various portions of the label.

Continue Reading Central District of California “Discontinues” Much of Plaintiffs’ Experts’ Testimony in Cymbalta “Discontinuation Symptoms” Case

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When we read the opinion in Kline v. Zimmer Holdings, 2015 WL 4077495 (W.D. Pa. July 6, 2015), it felt like driving back from the mountains (or the Jersey Shore) after a holiday weekend, listening to classic rock radio playing last half-hour or so of some “countdown” of the top 500 (1000, whatever) songs of all time.  Kline granted summary judgment to the defendant, ending a lot of bobbing and weaving by the plaintiff, who claimed injury from a hip implant that broke.  It’s a two-part opinion, with the judge adopting and supplementing an earlier magistrate’s recommendation.

The design claims were dismissed because plaintiff ultimately couldn’t coax the necessary design defect opinions out of his experts – and non-experts.  The most interesting witness was the plaintiff’s treater, who was also alleged to have “involvement with the design team of the device at issue.”  Kline, 2015 WL 4077495, at *2.  However, that “unique” status fell rather hard by the wayside because plaintiff played fast and loose with the rules, sandbagging the defendant by failing to file any expert report.  Id. at *3.  Yes, he was a treater, so that’s allowed – but only to the extent that the physician “give[s] opinion testimony based upon the physician’s examination, diagnosis, and treatment of a patient.”  Id.  The opinions that the treater offered about his interactions with the defendant’s design team could not be considered:

[The witness] was not identified as an expert witness to testify about the design of the device at issue. While [he] may have been a consultant to [defendant] about the device at issue, there is no record that he is an expert in the design of or warning about the product or that his consulting services enabled him to give an opinion as a design or warnings expert. . . .  There was no identification of his qualifications to be a design or warnings expert, he was not designated as such, and he did not submit an expert report about design defects or warnings.

Id. at *3.  Oops.  That’s what happens when a plaintiff tries to be too cute.

Continue Reading Medical Device Decision Plays PA’s Greatest Hits

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Many of the more senior among the current prescription medical product liability defense bar cut our teeth during the vaccine wars of the 1980s/1990s.  Thus, we noted with grim satisfaction when the junk science progenitor of the purported “link” between vaccines and autism lost his medical license.  A decision we recently came across suggests that

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A couple of days ago, we watched the lovely “St. Vincent.”  The film stars a spot-on Bill Murray as Vincent, an unemployed curmudgeon living alone in an otherwise tidy residential neighborhood.  Disrepair has turned Vincent’s house into an eyesore.

Vincent is eluding his threatening bookie, who is seeking repayment for money Vincent has lost on the horses. Vincent is unkempt and rude, and we are led to believe that his only “soft spot” is reserved for his white Persian cat.

Enter a subdued and quietly effective Melissa McCarthy (compare “Bridesmaids”), as a newly-single mother moving next-door to Vincent with her (flat-out adorable) young son in tow.   We’ve recently been the victims of spoilers ourselves (see McDreamy), so we won’t reveal more except to note that Vincent is not quite the unredeemed ne’er-do-well he seems to be.  The movie reminds us to reserve judgment and not to allow initial impressions to obscure nuance.  Sometimes, there is good buried among the bad.

Such is not the case for Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015).  There are few, if any, silver linings in this Massachusetts Supreme Court decision affirming an eye-popping jury award of $50 million in compensatory damages to a child whose devastating toxic epidermal necrolysis (“TEN”) was allegedly caused by Children’s Motrin.  The Court also affirmed loss-of-consortium awards of $6.5 million to each of the child’s parents.

Continue Reading Freehand Line-Drawing in Affirmance of Huge Verdict in Children’s Motrin/TEN Case

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This post comes only from the Cozen O’Connor side of the blog.

The Vioxx MDL is still alive.  But not really kicking.  The master settlement agreement ended the mass tort portion of this litigation, leaving behind a vastly smaller number of cases filed by plaintiffs who chose not to “opt in” to the settlement.  The MDL court is still managing some of those cases.  But, if Levitt v. Merck Sharp & Dohme Corp., 2015 U.S. Dist. LEXIS 52756 (E.D. La. Apr. 21, 2015), is any indication, it won’t be for much longer.

In Levitt, the MDL court denied Merck’s motion for summary judgment, instead ordering that discovery be reopened.  While that might not sound like the decision of a court looking to end its involvement in the Vioxx litigation, remanding the case to the original transferor court for further proceedings sure does.  And the MDL court did that too.  Id. at * 30.

Continue Reading Yes, There Is Still Vioxx Litigation