Updated EPA Analysis on Long-Term Health Effects of Formaldehyde Exposure Could Have Lasting Implications for Manufacturers

On April 14, 2022, the Environmental Protection Agency (EPA) released draft conclusions in a report updating its analysis regarding formaldehyde exposure, suggesting that long-term exposures to small amounts of formaldehyde in the environment can increase the risk of rare head and neck tumors, leukemia, and other threats to health. The conclusions are not final agency action. Still, manufacturers should be aware of the potential for EPA’s analysis to influence both regulation and litigation at both the state and federal levels.

For over a decade, there has been much debate and study on the long-term effects of exposure to formaldehyde. The EPA’s new analysis is an update of a 2010 draft EPA report that was heavily panned by scientists, legislators, and chemical manufacturers and that drove the EPA back to the drawing board. For example, the National Academies of Sciences, Engineering, and Medicine criticized the 2010 draft EPA report for failing to describe the rationale behind its methodology and failing to sufficiently support its conclusions.

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

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

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

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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Third Circuit Confirms That Alleged Defect in “Simple” Component of More Complex System Must Be Proven by Expert Testimony When Facts Surrounding Defect Claim Are Beyond Common Knowledge

A plaintiff who alleges that a product is defective usually has to offer expert testimony in support of that allegation.  This should come as no surprise for complex products – if it took a team of scientists and engineers to bring the product to market, then a lay jury should not be asked to evaluate an alleged defect in that product without the aid of expert testimony.  But what if a plaintiff alleges a defect in the design of a relatively simple, more familiar component of a complex product?  The Third Circuit recently addressed that question in an opinion that, although nonprecedential and in some respects peculiar to New Jersey law, illustrates how a court should approach the issue.

In Kuhar v. Petzl Co., 2022 WL 1101580 (3d Cir. Apr. 13, 2022), Plaintiff fell and injured himself while using a safety harness that he had purchased as part of a kit seven years earlier.  He alleged that the fall occurred because a bolt attached to the carabiner of the safety harness had snapped due to a design and/or “indeterminate” or manufacturing defect.  In support of his claims, Plaintiff proffered a metallurgical and materials sciences expert who identified two alleged design defects – a “sharp profile change” and “sharp threads on the bolt” – and machining grooves that the expert deemed a manufacturing defect, some combination of which he claimed had caused the accident.  But some of the expert’s defect and causation opinions were “net opinions” – New Jersey parlance for “ipse dixit” opinions – and were excluded for lack of supporting data.  Other opinions were excluded because the expert failed to define his terms or explain his reasoning.  The Third Circuit agreed with the district court that the expert’s opinions lacked both reliability and fit, and affirmed its exclusion of all of the expert’s opinions.

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Ninth Circuit Asks California Supreme Court to Clarify the Causation Standard Applicable When the Learned Intermediary Doctrine Applies

How demanding is the causation standard in a California failure to warn claim when a learned intermediary testifies that he would have read and incorporated more stringent warnings if they had been available? Is the plaintiff required to show that the stronger warning would have altered the physician’s decision to prescribe the product? Or may the plaintiff establish causation by showing that the physician would have communicated the stronger warnings to the patient and that a prudent person in the patient’s position would have declined the treatment as a result?

The Ninth Circuit isolated this undefined causation standard in Himes v. Somatics, LLC, and certified the question to the California Supreme Court. After confirming that the learned intermediary doctrine is alive and well in California and that a failure to warn claim cannot survive when the learned intermediary does not read the warnings at all, the Ninth Circuit stopped short of defining the causation standard that applies when a learned intermediary does read the warnings.

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