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 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