We are headed to Guitar Town. That’s Nashville to you. Guitars are played and guitars (including the magnificent Gibson ES-335) are made there. We aim to sample plenty of live music and hot chicken. But the reason for our trip is the Defense Research Institute (DRI) Drug and Medical Device Conference. Tomorrow we will be
We are on a DRI panel this September in Nashville discussing challenges to expert testimony, so we are especially vigilant when it comes to new cases on this subject. The rulings on expert admissibility in United States v. Biogen Idec., Inc., 2022 U.S. Dist. LEXIS 120549 (D. Mass. July 8, 2022), are not especially
A very helpful to-be-published opinion from the California Court of Appeal caught our eye this week because it comes out the correct way on an issue that has always bothered us: Does a defendant (not the plaintiff) in a product defect case have to offer evidence on medical causation to a reasonable degree of medical
The “mesh case of the week” — Robinson v. Ethicon, Inc., 2022 U.S. Dist. LEXIS 36441 (S.D. Texas March 2, 2022)— is a veritable mixed bag. We cannot decide whether to carry that bag from the car trunk to the kitchen table or just heave it in the dumpster.
The issue in Robinson was
We posted just the other day about widespread judicial reluctance to follow the expert admissibility standards imposed by Federal Rule of Evidence 702. We called out the Eighth Circuit as a prime example of that problem, and we discussed the committee-approved amendments to Rule 702 that are intended to reinforce the need for expert opinions
The California Court of Appeal has finally filed its opinion in the much-discussed talc ovarian cancer case, Echeverria v. Johnson & Johnson, No. B286283, 2019 WL 3001626 (Cal. Ct. App. July 9, 2019), and while it is not a complete win for the defense, it was close, and there is much to talk about.
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
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”).
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.