Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL

Zofran (ondansetron) has often been used to combat nausea during pregnancy.  It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks – for example, a recent systematic review and meta-analysis concluded that use of ondansetron during pregnancy was associated with a reduced incidence of miscarriage but “was not associated with abnormal pregnancy outcomes,” including a variety of birth defects.  Nevertheless, plaintiffs have alleged that Zofran causes birth defects and that the warnings accompanying the drug should have said so.  Those claims were dismissed in 2021 when the district court held them preempted, and the First Circuit recently affirmed that decision in In re Zofran (Ondansetron) Products Liability Litigation, — F.4th —, 2023 WL 128570 (1st Cir. Jan. 9, 2023).

Plaintiffs in the Zofran MDL alleged, among other things, that the defendants failed to warn of birth defects observed in certain animal studies.  Because such claims implicate the warnings accompanying an FDA-approved drug, they are preempted unless the manufacturer could have unilaterally amended the label through the Changes Being Effected (CBE) regulation.  The CBE regulation permits a manufacturer to amend a product’s labeling without prior FDA approval “to reflect newly acquired information” and thereby “add or strengthen” the warnings where there is “evidence of a causal association” between the drug and the subject on which the warnings are being amended.

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Supreme Court to Resolve Attorney-Client Privilege Split

For the first time in 25 years, the U.S. Supreme Court is considering the scope of the attorney-client privilege in the case In re Grand Jury, No. 21-1397. The Court heard oral arguments earlier this week about when the attorney-client privilege protects communications involving both legal and nonlegal advice (dual-purpose communications).

In re Grand Jury

A grand jury subpoenaed documents from the petitioner, a tax law firm, related to a criminal investigation into the law firm’s client. In re Grand Jury, 23 F.4th 1088, 1090 (9th Cir. 2021). The law firm withheld documents that had dual-purpose communications based on the attorney-client privilege. After the government moved to compel, the district court used the “primary purpose test” to determine whether the dual-purpose communications were privileged. The court used the test to determine “whether the primary purpose of the communication [was] to give or receive legal advice, as opposed to business or tax advice.” Id. at 1091 (citation omitted). In the end, the district court ordered the law firm to produce documents to the government after redacting tax-related legal advice. When the law firm refused, the court held it in contempt, and the Ninth Circuit affirmed the contempt order.

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5 Major Drug and Device Developments of 2022

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

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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The Zantac Rule 702 Order: TLBR (Too Long, But Read)

On opening an opinion, lawyers habitually roll their eyes when they see a table of contents.  Even more so when they learn the opinion is over 300 pages.  The MDL order granting defense motions to exclude experts and for summary judgment in In re Zantac (Ranitidine) Products Liability Litig. (S.D. Fla. Dec. 6, 2022), however, is a worthwhile read.  The court’s analysis and prose is thorough, clearly reasoned, well-supported, … and highly readable.  It reveals a court willing to roll up its judicial sleeves, tackle and explain the fundamental science in detail, and rigorously apply Rule 702 to perform its essential gatekeeping function – to insulate the jury, and the defendants, from flawed advocacy masquerading as scientific evidence and holding retained experts to reasonable standards of intellectual rigor.

The Zantac litigation involves claims that the active ingredient in popular heartburn medication ranitidine breaks down to produce excessive levels of NDMA, a probable human carcinogen, under certain storage and biological conditions.  That sounds scary.  FDA has set a low daily intake limit of NDMA, a byproduct of, among other things, a common diet.

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

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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