People supplement a lot of things. You can supplement your diet with a multivitamin. You can supplement your income with a part-time side job. On the DDL Blog, we are always supplementing our scorecards and cheat sheets. Generally speaking, supplement is a pretty common word and has a fairly universally accepted definition. A supplement is an add-on. Something you do to make something more complete. Does the food you eat contain vitamins and minerals? Sure. But that multivitamin adds to it. It’s a boost.

In litigation too, we do a lot of supplementing. In fact, we are required to do so. Federal Rule 26(e) requires a party to supplement its discovery responses if it “learns that in some material respect the disclosure or response is incomplete or incorrect.” This duty to supplement extends to expert reports as well. Fed.R.Civ.P. 26(e)(2). But what does it mean to “supplement” an expert report? And when does supplementing to make a correction or completion go too far?

Plaintiffs got the answer to that question in U.S. ex. rel. Brown v. Celgene Corp., 2016 U.S. Dist. LEXIS 156826 (C.D. Cal. Aug. 23, 2016). Plaintiff-Relators brought a False Claims Act and Medicare Anti-Kickback Statute case against defendant alleging it illegally marketed Thalomid and Revlimid off-label and paid kick-backs to physicians for prescribing off-label. Id. at *6. The court set a deadline for the expert reports and relators timely served a report from their damages expert. Shortly thereafter, however, relators sought leave to supplement that expert report based on late produced Medicare data. Id. at *6-8. Relators wanted to time to analyze the data and supplement the report with that analysis. Relators also represented that while the supplement would be based on new data, the opinions were not expected to differ significantly. Id. at *8. The court granted the leave requested. Defendant was likewise given an opportunity to amend its expert reports in rebuttal and relators’ expert was deposed after his supplemental report was served. Id. at *11.

Continue Reading Plaintiffs Learn Supplementing Isn’t a Second Bite at the Apple

Remember Frye v. United States, the case from 1922 that created the “general acceptance” standard for expert testimony?  In the federal system it’s been replaced by Daubert and Federal Rules of Evidence 702 and 703.  But Frye was technically a decision under DC law (1922 was before Erie v. Tompkins). So, while the rest of the federal courts have been applying Daubert for the last 23 years, DC has remained a Frye jurisdiction. Until now.

In Motorola v. Murray, No. CAB-8479-01 (D.C. App. Ct. Oct. 20, 2016), the District of Columbia Court of Appeals (successor to the DC Cir. as DC’s highest court) inters Frye for good.

Following extensive expert evidentiary hearings, the trial court found that certain of the expert testimony would be admissible under Frye but that most would be inadmissible under Daubert. So, the trial court certified for interlocutory appeal the question of “whether the District of Columbia should adopt Federal Rule of Evidence 702 (or a revised Frye standard) for admissibility of expert evidence. Motorola, slip op. at 3.

The appellate court first examined both evidentiary standards. Under Frye, the entire inquiry is limited to whether “there is general acceptance of a particular scientific methodology.” Id. at 6. The Frye standard equated general acceptance with reliability and looked no further. Id. The standard announced in Daubert viewed general acceptance as one possible factor for the court to consider in its role as a gatekeeper for the admission of expert testimony. Under Daubert, the trial court must “perform a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.” Id. at 7-8.

As subsequent courts refined Daubert, it also became clear that “conclusions and methodology are not entirely distinct from one another.” Id. at 10, citing General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997). This was yet another step away from the rigid Frye focus on methodology only. After Joiner, as part of the gatekeeping function, a court could “conclude that there is simply too great an analytical gap between the data and the opinion proffered.” Id. Application of a particular methodology was something else for courts to consider in determining if the expert testimony was both relevant and reliable.

The Motorola decision includes a quote from the trial court’s own examination of the competing standards that we think fairly clearly demonstrates the superiority of Daubert:

[A]t the risk of over-simplification[,] if a reliable, but not yet generally accepted, methodology produces good science, Daubert will let it in, and if an accepted methodology produces bad science, Daubert will keep it out; conversely under Frye, as applied in this jurisdiction, even if a new methodology produces good science, it will usually be excluded, but if an accepted methodology produced bad science, it is likely to be admitted.

Id. at 14.

Most recently in the history of expert evidence admissibility, Rule 702 was amended to reflect Daubert and its progeny. Id. at 12-13. It is Rule 702 that the DC Court of Appeals decides to adopt over Frye. Rule 702(c) admits expert testimony if it “is the product of reliable principles and methods” – similar to the Frye general acceptance standard. Id. at 15. But, Rule 702 (d) further provides that to be admissible the expert must also have “reliably applied the principles and methods to the facts of the case.”

We conclude that Rule 702, with its expanded focus on whether reliable principles and methods have been reliably applied, states a rule that is preferable to the [Frye] test. The ability to focus on the reliability of principles and methods, and their application, is a decided advantage that will lead to better decision-making by juries and trial judges alike.

Id.

The remainder of the opinion is focused on providing guidance to the DC courts which now must switch to applying Rule 702 and Daubert and become expert evidence gatekeepers. Id. at 16-19. The Court of Appeals specifically admonishes DC trial courts not to “reflexively admit expert testimony because it has become accustomed to doing so under the [Frye] test.” Id. at 18-19. A concurring opinion reiterates this warning and provides some additional resources and guidance for courts faced with applying Daubert for the first time. Id. at 20-23.

Frye is dead; long live Daubert.

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

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

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

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

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

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 Daubert 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