Expert Witnesses

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Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison v. Biogen Idec Inc., No. 2:11-CV-01140-DN-DBP, slip op. (D. Utah Aug. 5, 2016).  With respect to preemption and innovator drug warnings, these cases provide further support to an emerging, common-sense bright line in the otherwise all-too-murky world of “clear evidence” – that a warning change rejected by the FDA for lack of scientific evidence must be “clear evidence” that this change would have also been rejected at any earlier date.  The logic is inescapable that, if there was insufficient scientific evidence at moment X, there is no more, and usually less, evidence on the same issue at any time before X.

Looking at our cheat sheet, the first case to so hold appears to be In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. 2013). Fosamax involved the FDA’s partial rejection of a prior approval supplement after the date of the plaintiff’s injury.  Id. at 703 (FDA rejection occurred “approximately one month after” plaintiff’s injury).  The label change failed because “the data that FDA has reviewed have not shown a clear connection” between the drug and the risk at issue.  Id. at 699.

[C]lear evidence exists that the FDA would not have approved a label change to the Precautions section of the [drug] label prior to [plaintiff’s] fracture because Defendant submitted a label change and the FDA rejected it, and the FDA never required Defendant to submit new language or change the label, which demonstrates that the FDA did not think that the label should have been changed at that time.

Id. at 703-04. See In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994, at *11 (D.N.J. March 26, 2014) (applying this ruling “to those Plaintiffs’ whose injuries occurred prior to [the FDA rejection date], without allowing additional discovery”).Continue Reading Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

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If you read the decision in Rossitto v. Hoffmann-LaRoche Inc., 2016 N.J. Super. Unpub. LEXIS 1714 (N.J. App. Div. Jul 22, 2016), we think you’ll agree with our calling it “strong” criticism of two trial rulings that the appellate court firmly believed led to undue prejudice of the defendant.  The $18 million verdict awarded to two of four plaintiffs in a joint trial was vacated and the case is being remanded for a new trial.  This is not the first Accutane plaintiff’s verdict to be vacated by New Jersey’s appellate division, but rather another notch in the demise of this litigation which has seen a turn in favor of defendant since coming under new management.  Indeed, a quick search of the DDL blog for Accutane will show how the tide has turned.

The Accutane litigation is primarily comprised of claims alleging that the manufacturer failed to adequately warn about the risk of inflammatory bowel disease (“IBD”).  Therefore, the drug’s label takes center stage.  Here, the plaintiffs both used the drug with its 1984 label that included a warning that “Accutane has been temporally associated with IBD.”  Id. at *8.  In May 2000, after plaintiffs had stopped using Accutane, the label was revised to remove the word “temporally” and to add information about persistent IBD symptoms.  Id. at *18.

Although only one of the plaintiffs was a New Jersey resident, the parties agreed that New Jersey law would apply to both.  Id. at *34.  So, New Jersey’s “super-presumption” applies – that is if the warning given has been approved by the FDA, there is a rebuttable presumption of adequacy.  Id. at *37.  Called a “super-presumption” because it is “virtually dispositive” on failure to warn, it can be overcome with evidence of intentional concealment of a known risk or “substantial evidence of economically-driven manipulation of the post-market regulatory process.”  Id. at *37-38.  Plaintiffs got to trial in these cases because the New Jersey courts have found that as to the 1984 label plaintiffs have put forth enough evidence from which a reasonable jury could conclude they had rebutted the presumption.  Id.  at *55-56 (citing prior Accutane decisions addressing this issue).   But it’s a strong presumption so we decided to take the time to remind you about it.Continue Reading New Jersey Accutane Plaintiff Verdict Vacated – Appellate Division Strongly Criticizes Evidentiary Rulings

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Today’s decision is that simple. Actually, it’s that simple and it’s that surprising that plaintiffs tried to side-step this golden rule of complex drug/device products liability litigation. You must have expert testimony.

In Chatman v. Zimmer, Inc., 2016 U.S. Dist. LEXIS 78657 (S.D. Miss. Jun. 16, 2016), plaintiff alleged she suffered injury as a result of implantation and subsequent failure of her knee implant.  The device was implanted in 2006 and in 2013 plaintiff started experiencing pain that led to revision surgery. Id. at *2. Rather than producing an expert to opine regarding product defect or medical causation, plaintiff informed the court she would be relying on “her own accounting of the events, records from her treating physicians, and a recall notice.” Id. at *3. We don’t need to know anything else. There is no way any of those three sources could satisfy the requirement that plaintiff produce expert testimony as to the alleged defect.

The court first threw out the recall notice because it pertained to a different knee replacement device than that implanted in plaintiff. Plaintiff apparently cited to cases involving commercial products to argue the admissibility of substantially similar circumstances. But this wasn’t similar circumstances, it was an entirely different product. Therefore, the recall is irrelevant. Id. at *5.

So plaintiff is down to “her own accounting” and her “medical records.” Plaintiff’s “own accounting” cannot establish product defect or medical causation. Plaintiff did not appear to be either a biomedical engineer or an orthopedic surgeon. The fact that her knee implant eventually failed after seven years and that she experienced pain are facts – but they have no connection to liability without expert testimony on defect and cause.Continue Reading No Experts, No Case

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Last week, we (along with many of you, we assume) attended the DRI Drug and Medical Device conference in Chicago. We re-connected with friends dating to the beginning of our lengthy career (literally – ran into the head of our decades-ago summer associate program), met lots of new people, and attended great parties.  (Perhaps we are biased, but we thought the reception Reed Smith co-sponsored was particularly fabulous – stunning venue, fantastic food, great company and ambiance.)

Squeezed in among the parties was a whole seminar program, covering all manner of hot topics in the mass tort space in which we practice. We were (as we always are) awed by the sheer intellectual firepower the speakers brought to bear and by the depth of their knowledge and the thoroughness of their preparation.  We also enjoyed observing the diversity of presenters’ styles.  Some were earnest and academic, some deceptively casual and colloquial, still others politician-impassioned.  As wordsmiths, we always delight in this, and we count it among the reasons we like today’s case, which follows a mostly serious and measured (albeit dismissive) majority opinion with a snarky and stylized dissent.  (Guess which one was more fun to read.)

Milward v. Rust-Oleum Corp., 2016 U.S. App. LEXIS 7470 (1st Cir. Apr. 25, 2016), is not a drug or device case. It is the First Circuit’s review of the District of Massachusetts’s exclusion of the plaintiffs’ specific causation expert in a benzene-exposure toxic tort case, but the issues are identical to Daubert issues we face in our cases.Continue Reading First Circuit: Plaintiffs’ Specific Causation Expert Fails to Pass Muster in Benzene Case

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In Witt v. Stryker Corp., 2016 WL 1583816 (11th Cir. Apr. 20, 2016), a Daubert decision in a Stryker knee replacement case, even ipse dixit seemed a bit generous. Roughly translated, ipse dixit means “he himself said it.” But it’s not clear that the expert in Witt said “it.” His report didn’t seem to venture an opinion at all, no less one that came from applying a scientific process to true and accurate data. It offered a feeling, seemingly a timid one hoping not to be noticed: “I feel that the mechanical failure of the EIUS [the knee replacement system] Stryker components was the competent producing cause for the need for surgery on 04/17/2009 and for a revision arthroplasty to a total knee replacement.” Id. at *5 (emphasis added). In case you thought this was just careless terminology, he did it again: “I feel that the mechanical failure of the EIUS System installed on 04/18/2008 was a competent cause for the need for subsequent surgeries on 03/30/2011 and on 01/17/2012.” Id. (emphasis added).

We haven’t studied the case law on feelings. But we are confident that, if it exists, it won’t be favorable to this expert.

Things grew more timid from there. At has deposition, it wasn’t even clear what the expert was feeling:

Indeed, he explicitly disclaimed having any expert opinion about why the EIUS design was defective. Besides broadly referencing the likelihood that the device suffered some mechanical failure, Dr. Lubliner offered no explanation for why the defect was one of design and not of manufacture.

Id. (emphasis added). Oof.Continue Reading Not Hooked on a Feeling, the Eleventh Circuit Upholds Exclusion of Expert

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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

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

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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

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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

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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

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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.
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