Category: Civil Procedure

5 Major Drug and Device Developments of 2022

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As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.

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Failure to Comply with Lone Pine Order Results in Dismissal of Over 1,000 Cases in Zostavax MDL

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Earlier this year, we discussed the Eastern District of Pennsylvania’s decision to enter a Lone Pine order – that is, a case management order that requires all plaintiffs to produce evidence establishing specific elements of their claim – in the Zostavax MDL. That post can be viewed here. We lauded that Lone Pine order’s potential to save the parties considerable time and expense while advancing the purposes of the MDL by weeding out meritless cases. That potential recently came to fruition: the court in the Zostavax MDL dismissed 1,189 cases for failure to comply with the Lone Pine order. In re: Zostavax (Zoster Vaccine Live) Prods. Liab. Litig., 2022 WL 17477553 (E.D. Pa. Dec. 6, 2022).

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Listen Up Class: The Role of Daubert at the Class Certification Stage in the Ninth Circuit

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Class certification is the feature fight of any putative class action lawsuit. If granted, it can multiply the stakes of a case several hundred- or thousand-fold. If denied, it can signal the end of the litigation. Because of its importance, parties often invest heavily in the class certification fight, including by offering – and challenging – expert testimony.

As this trend has become more common, more focus has been devoted to answering a key question – to what extent should Rule 702 apply at this critical juncture? A number of circuits have held that Rule 702 applies in full force and that opinions deemed inadmissible under Rule 702 should not be considered in regard to class certification; others, such as the Ninth Circuit, have taken a somewhat different approach. Recently, the Southern District of California, in Stewart v. Quest Diagnostics Clinical Labs., Inc., 2022 WL 5236821 (S.D. Cal. Oct. 5, 2022), weighed in on this question.

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It’s an MDL World: Agreement is enough, or is it?

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The JPML held its second hearing of 2022 at the end of March. We addressed the results of the first hearing recently here, and further observed the JPML’s trend over the course of the last several years in forming fewer MDL proceedings each year. As we move further into 2022, it is clear this trend has continued.

In April, the JPML formed two new MDLs out of four total petitions, bringing the cumulative total of new MDLs in 2022 to four (out of seven petitions considered)—well below the typical quarterly pace for new MDLs, including that of 2021. Through its orders, the JPML provided insights into the circumstances that justify MDL formation, and those that do not. We briefly discuss these orders below:

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It’s not what happened, but why: First Circuit rejects conclusory, unsupported expert opinions

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It is not uncommon for an opposing expert to opine that the existence of injury alone implies negligence, nor is it unusual to find that such opinions are supported only by general reliance on “literature” with no discernible connection to the issue at hand. Certainly, Federal Rule of Civil Procedure 26(a)(2)(B) requires an expert’s report to contain “a complete statement of all opinions the witness will express and the basis and reasons for them.” And, Federal Rule of Evidence 702 requires that an expert not only base an opinion on sufficient facts or data but also reliably apply his or her methodology to those facts or data. Yet all too often, courts decline to hold an expert to task and instead find that these deficiencies go to the weight, but not the admissibility, of an expert’s opinion. But, as recently observed by the First Circuit, an expert must do more than merely cite the existence of an injury if a res ipsa loquitur argument is not available. And regardless, an expert’s failure to link the literature cited to the opinions offered is not a matter of insufficiency, but rather of unreliability.

In López-Ramírez v. Toledo-González, — F.4th —, 2022 WL 1261299 (1st Cir. 2022), Plaintiff experienced hearing loss, facial paralysis and loss of balance following a neurosurgical procedure performed by the defendant neurosurgeon. Plaintiff sued the physician and the hospital, alleging that the defendant neurosurgeon’s failure to properly evaluate, treat and monitor her condition during the surgery amounted to medical malpractice. In support of that claim, Plaintiff disclosed a neurology expert who opined that the defendant neurosurgeon deviated from the standard of care and included with his report articles from the medical literature that he felt “may be helpful” in understanding his opinions.

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District of Delaware Chief Judge’s New Standing Order Requires Disclosure of Third-Party Litigation Funding

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The District of Delaware is the latest in a series of courts to require disclosure of third-party funding arrangements, a subject we have previously explored. The Chief Judge in the District of Delaware now joins other courts like the District of New Jersey and the Northern District of California in requiring these disclosures.

On April 18, 2022, Chief District Judge Colm F. Connolly of the United States District Court for the District of Delaware issued a standing order requiring litigants to disclose whether their cases are being financed by third parties. The standing order requires that, “where a party has made arrangements to receive from a person or entity that is not a party (a ‘Third-Party Funder’) funding for some or all of the party’s attorney fees and/or expenses to litigate th[e] action on a non-recourse basis,” either for “a financial interest that is contingent upon the results of the litigation” or “a non-monetary result that is not in the nature of a personal loan, bank loan, or insurance,” the party must disclose certain details of the funding relationship within 45 days of the entry of the standing order (i.e., by June 2, 2022) for existing cases, or within 30 days of the filing of an initial pleading or transfer of a new matter into the District.

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