This week, as Drug and Device Law Jews, we are preparing for Passover, which, like most Jewish holidays, begins with a multi-generational dinner at the home of the Drug and Device Law Bubbie (our mother). Although we of the second generation (there are now four) still fancy ourselves to be the “kids’ table” at this dinner – giggling at the solemn points of the reading, singing endless choruses of our favorite Passover song in defiance of the “just one time” edict, and generally disrupting the proceedings as much as possible – the reality is that we are all upper-middle-aged adults. And, as our matriarch ages (at least on paper), we assume more and more of the food preparation for the Seder dinner. And there’s the rub. For, much as we would enjoy the occasional stroke of rogue creativity, we know that nothing unfamiliar will be allowed on the table and that each of the traditional dishes must taste exactly as it has tasted for the past 50-plus (if not 2,000) years. Every ingredient and every step of preparation is subject to scrutiny, and Bubbie is the gatekeeper. (You know where this is going).

As everyone knows, under SCOTUS’s Daubert decision, the trial court is the gatekeeper when it comes to admitting or excluding the testimony of expert witnesses. We who practice in the mass tort space have gratefully experienced judges who take this responsibility seriously and have endured those who “punt” these determinations, nearly always to the benefit of plaintiffs whose dime-store experts – lacking qualifications, methodologies, or both – are permitted to peddle their wares to unsuspecting juries.

The Lipitor MDL judge falls resoundingly into the former camp. In In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices, and Prods. Liab. Litig., 2016 WL 1251828 (D.S. C. Mar. 30, 2016), considered the defendant’s Daubert motions addressed to the plaintiffs’ four causation experts, and wholly or partially excluded all four. But there is backstory. Lipitor is prescribed in four different doses – 10 mg, 20 mg, 40 mg, and 80 mg. This is an MDL, so our readers can guess which doses most of these plaintiffs took. While several studies show a statistically significant association between higher doses and new-onset diabetes, none shows such an association at the lowest dose. After the plaintiffs’ experts submitted their initial reports, the court “was concerned as to whether Plaintiffs’ experts had sufficient facts and data to support their causation opinions at all doses . . . , and even whether the experts would be willing to offer an opinion at low doses, given the available data.” In re Lipitor, 2016 WL 1251828 at *3. Over the defendant’s objections, the court allowed all four of the plaintiffs’ experts to submit supplemental reports addressing whether the drug caused diabetes at particular doses. Id. at *5. The defendant’s Daubert motions followed submission of the supplemental reports.

Continue Reading Gutsy Gatekeeping: Plaintiffs’ Experts Excluded in Lipitor MDL

We spend a large portion of our professional life preparing motions to exclude the testimony of plaintiffs’ experts in mass tort litigation.  Our pleasure in reading today’s decision is no doubt a function of the frequent futility of this effort and the consequent inflation of plaintiffs’ settlement demands.  As such, we offer an enthusiastic tip of the hat to Tarek Ismail for sending us a nearly great (we’ll explain the qualification later) opinion out of the Mirena MDL.  In a voluminous opinion in In re Mirena IUD Prods. Liab. Litig., 2016 WL 890251 (S.D.N.Y. Mar. 8, 2016), the United States District Court for the Southern District of New York considered both sides’ Daubert motions.

Defendant’s Medical Experts

Continue Reading Good Things Sometimes Come in Big Packages: Mirena Rule 702 Rulings Favor the Defense — Big Time

Put quotes around the phrase “litigation science” and Google it.  Go ahead, we’ll wait. . . . . What did you find?  Not good, right.  You found a lot.  Too much. The first Google page alone shows how controversial this subject is.  For instance, you’ll find references to Ninth Circuit Judge Alexi Kozinski’s uncertainly that “what’s going on here is not science at all, but litigation,” in the Daubert case that produced the Supreme Court’s famous Daubert decision.  You’ll find agendas for legal conferences—or are they scientific conferences?—on litigation science, with some scientists suggesting that sparring between experts and lawyers might produce better scientific results than scientific peer review.  Really. If you Google some more, you’ll find that some of the scientists saying that are themselves experts in litigation. You’ll even find a Wikipedia entry on forensic science with a subheading for “Litigation Science.”  That’s disappointing.  Are there those in the scientific community who actually believe that science is better developed in a courtroom than a lab?  Take it from us, it’s not.

Daubert is intended to curtail litigation science, not encourage it.  Judges must be the gatekeepers to the courtroom, closing those gates to unreliable opinions based on methodologies that are neither scientific nor based on appropriate data.  Courts must consider peer review, not lawyer review.

Continue Reading New York Court of Appeals Rejects Specific Causation Expert Opinion under Frye Standard

As a defendant manufacturer in a drug or device product liability case, it is one of the last things you want to see.  The key treating physician concludes that your product was to blame for the plaintiff’s problems and sidles up to the plaintiff’s lawyers.  There are lawyers who reflexively identify every treating physician as a non-retained expert under Rule 26(a)(2)(B) and describe their anticipated testimony so vaguely that it is difficult to determine from the designation if you have the dreaded situation.  The medical records may hint at it.  If you learn that the plaintiff’s lawyer has been providing materials to the doctor and/or meeting with her, then that hint may get stronger.  Once she testifies, however—hopefully before trial—you will know.  You can imagine the plaintiff lawyer advising the jurors that they can trust the “independent” doctor “who has not been hired by either side” and “who has no dog in this fight” (or similar colloquialism).  You know that her testimony can be quite impactful, especially if she slams your product while giving her view on what happened with the plaintiff.

But do the Rules of Evidence give the treating physician named as a non-retained expert extra leeway in offering whatever opinions she has by the time of trial?  This was the situation addressed in Alarid v. Biomet, Inc., No. 14-cv-02667-REB-NYW, 2016 U.S. Dist. LEXIS 11496 (D. Colo. Feb. 1, 2016).  The same orthopedic surgeon implanted the defendant’s prosthesis in each of the plaintiff’s shoulders (in separate surgeries) and then removed and replaced them a few years later after devices “fractur[ed] at the joint between the baseplate and the trunnion.”  Id. at **3-4.  Plaintiff named him as a non-retained expert—we can only assume this was correct and he was not getting paid to review materials outside of his own records—and disclosed his anticipated opinion testimony as including blaming the need for reoperation on “bad engineering,” a design with “wrong material and wrong thickness” and a “humeral tray [with] material too thin to withstand pressure,” which he based on claimed “knowledge of medical device development, general safety procedures which should be followed in the development of medical devices, impedance matching and impact techniques and requirements for devices that connect with tapers.”  Id. at *5.  If he really had that experience and could offer those opinions, then plaintiff had quite a free expert.

Continue Reading Res Ipsa Loquitur, Ipse Dixit, And A Non-Retained Expert

Recently, some of the more footloose of the Drug and Device Law Relatives auditioned for the game show Family Feud.  The first step was a mock “round” of the game, played against another auditioning family.   All were instructed that, even if their answers made no logical sense, they should shout them with conviction and applaud them with over-the-top enthusiasm.

While this may be a good audition strategy, it is less appropriate when employed in litigation by witnesses supposedly expert in their fields.  In Sparling v. Doyle, 2016 WL 236266 (W.D. Tex. Jan. 20, 2016), the court considered the plaintiffs’ objections to the magistrate judge’s 72-page opinion striking the testimony of three of plaintiffs’ experts in a dietary supplement death case.  Plaintiffs argued that, contrary to the magistrate’s ruling, their experts’ causation opinions were based on “considerable evidence and reliable methodologies.”  2016 WL 236266 at *4.  Under this general heading, they lodged four specific objections to the magistrate’s opinion.

First, the plaintiffs argued the magistrate had committed error by failing to consider “material scientific admissions” by the defendants’ experts, including the experts’ alleged concessions of “critical causation issues” – namely, the experts’ supposed concession of the mechanism by which the supplement in question allegedly caused hyperthermia and death.  The court responded, “Plaintiffs . . . are conflating evidentiary proof to support their theory of causation with the reliability determination of their experts’ opinions under Daubert. The key issue here is whether the offered testimony by Plaintiffs’ experts is reliable.  Nowhere in Plaintiffs’ experts’ reports do they cite reliance on Defendants’ experts as a basis for their opinions.” Id.  Further, the court explained, a “statement by a defense expert is [at most] an evidentiary admission, and not a judicial admission.”  Id. at 5.  Unlike a binding judicial admission, which is “an intentional waiver, releasing the opponent from proof of a fact,” id. (internal punctuation and citation omitted), “an evidentiary admission is merely a statement of assertion or concession made for some independent purpose,” id., which a party may attempt to contradict and explain.  Because any admissions by the defendants’ experts were not judicial admissions, and were therefore not binding on the court, the court overruled the plaintiffs’ first objection.

Continue Reading Plaintiffs’ Experts Out in Dietary Supplement Death Case

Have you ever seen a superbly qualified expert give an opinion that is utterly unsupported? That is what happened last week in In re Lipitor (Hempstead v. Pfizer), No. 2:14-cv-1879, 2015 WL 9165589 (D.S.C. Dec. 11, 2015), and the district court did an admirably methodical job putting the kibosh on it. The expert was a former Rhodes Scholar, trained at top universities, and was the director of the endocrinology and metabolism division at a prestigious teaching hospital on the west coast. Yet, she seemingly allowed plaintiffs’ lawyers to lure her into placing her reputation at jeopardy by giving a medical causation opinion that was obviously wrong and boiled down to little more than “because I said so.”

Of course, we are oversimplifying, but not by much. The product was Lipitor, a statin, which is one of the most useful and health-promoting drugs in history. Even Consumer Reports, which is run by consumer advocates, has said that statins reduces the risk of heart attack, heart disease, and death and that statins are quite safe overall. But Lipitor is also one of the best selling drugs in history, which has attracted reams of litigation. The allegation du jour against Lipitor is that it causes Type-2 diabetes, which is curious since adult weight gain is a major risk factor both for Type-2 diabetes and high cholesterol. Do you think maybe people taking statins also show an increased prevalence of Type-2 diabetes because they are overweight or obese? Hmm.

Anyway, back to our wayward expert, Dr. Elizabeth Murphy. The plaintiff in Hempstead took Lipitor off and on starting in 1999 and was diagnosed with new-onset diabetes five years later. 2015 WL 9165589, § II (the order was just posted to Westlaw, so there is no star pagination yet.) Naturally, she sued Lipitor’s manufacturer and had the good fortune of being selected as a “bellwether” case.

Continue Reading Lipitor MDL Judge Dissects Plaintiff’s Expert

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

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?

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

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