Faegre Drinker on Products

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In Case You Missed It – Summer 2023

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Catch up on the latest developments of interest for product manufacturers. Here’s a quarterly compilation of the most popular blog posts on Faegre Drinker on Products.


Experts Who Cannot Articulate a Standard Cannot Opine That a Defendant Failed to Meet the Standard

By Eric M. Friedman

Burns v. Sherwin-Williams Co. is the latest in a line of cases that apply variations on a simple, common-sense theme — an expert who cannot articulate the applicable standard should not be allowed to opine that a defendant failed to meet the applicable standard. Such testimony is not a “shaky but admissible” opinion to be attacked on cross-examination; it is internally inconsistent, is inherently unreliable, and should be excluded under Rule 702.

Courts Are Citing the Rule 702 Amendments — And Litigants Should, Too

By Christin Jaye Eaton and Eric M. Friedman

Though the pending amendments to Federal Rule of Evidence 702 have not officially taken effect yet, courts already have begun to cite them, echoing the Advisory Committee’s sentiment that the amendments will not change the substance of the law as it was meant to be applied, but that many courts have not been applying it correctly. Litigants should follow suit, citing both the amendments and the Advisory Committee’s notes to alert courts that old precedent — particularly “weight, not admissibility” cases — may not be consistent with newly amended Rule 702.

Can a Treating Physician Opine on Causation? Eleventh Circuit Says It’s About Intent, Not Content

By Eric M. Friedman and Ross W. Johnson

Rule 26(a)(2)(B) requires witnesses who are “retained or specially employed to provide expert testimony in the case” — i.e., “retained” experts — to prepare and sign a report that discloses “a complete statement of all opinions the witness will express and the basis and reasons for them.” In contrast, Rule 26(a)(2)(C) imposes less arduous disclosure requirements on non-retained experts and calls on the party, not the expert, to make those disclosures. As the Eleventh Circuit recently noted in Cedant v. United States, “an expert’s status as a retained witness depends on the original purpose of his retention.” As was the case before Cedant, litigants would be wise to support critical elements of their claims and defenses with testimony from a retained expert and not assume a court will allow a non-retained expert to supply what is needed.

Supreme Court to Resolve Attorney-Client Privilege Split

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

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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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District of New Jersey Finds Amazon to be “Seller” of Hoverboard under NJ Product Liability Act

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The District of New Jersey has held that Amazon may be sued under New Jersey law for defective products sold by third-party sellers through its online marketplace.

The dispute in New Jersey Manufacturers Insurance Group v. Amazon.com Inc., Civil Action No. 16-cv-9014, involved an allegedly defective hoverboard purchased from a third-party seller by an insured of plaintiff New Jersey Manufacturers Insurance Group (“NJM”) via Amazon.com.  NJM filed suit as subrogee of the insured, asserting a strict lability claim under the New Jersey Product Liability Act (NJPLA), in addition to claims for breach of implied warranty and negligence.

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Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy

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Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA recently published revised guidance on its “Refuse to Accept Policy for 510(k)s” that reinforces and clarifies that the regulatory path may be analyzed multiple times by FDA before it clears a 510(k) device. This clarification underscores the reality that the type of application submitted is largely dictated by the agency, not the applicant. This post discusses some key takeaways from this new guidance before briefly discussing how this guidance may be implicated in medical device litigation.

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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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