Evidence Archives - Faegre Drinker on Products

Category: Evidence

Fifth Circuit Clouds Threshold Dose Analysis in Ruffin v. BP

Plaintiffs in toxic tort cases must prove both general and specific causation, generally through the testimony of experts. Experts must establish that a specific chemical exposure can (and did) cause the specific injury at issue. In order to make that showing, the plaintiff’s exposure must at least have exceeded the minimum harmful level of the chemical — the “threshold dose.” As the Eleventh Circuit made clear last year in its handling of In re Deepwater Horizon BELO litigation (which we discussed here), threshold dose is a concept that straddles general and specific causation. A more recent BELO case, Ruffin v. BP Exploration & Production, Inc., — F.4th —, 2025 WL 1367185 (5th Cir. May 12, 2025), shows how isolating an expert’s general causation opinion from its implications on specific causation can cloud the analysis.

In Ruffin, the plaintiff worked for five months as a clean-up worker following the Deepwater Horizon oil spill. He was diagnosed with prostate cancer five years later and sued the defendant, claiming he was exposed to chemicals that caused his cancer. He described two instances of exposure: one when oil splashed onto his face while travelling by boat and another when he fell in the water. The plaintiff had a known genetic risk for prostate cancer, but his expert claimed the oil exposures were a “second and necessary hit to initiate his prostate cancer.” The defendant moved to exclude the plaintiff’s causation expert, a genetic and molecular epidemiologist, under Federal Rule of Evidence 702. The district court had excluded both the expert’s general and specific causation opinions as unreliable, largely for failure to specify a threshold dose, and then granted summary judgment for want of admissible expert evidence.

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Plaintiff’s Half-Baked Attempt to Prove Defect and Causation With Photographs of Moldy Bread Shows the Knead for Expert Testimony

A picture may be worth a thousand words, but that doesn’t make the camera an expert witness. Product liability actions usually require expert testimony to prove defect and causation. Pictures, like other documents, can be central to an expert’s opinion on those points. But as a plaintiff in the Eastern District of Pennsylvania recently learned, pictures alone are insufficient. Defect and causation still require an expert’s testimony — even in cases involving products as simple as a loaf of bread.

In Kovalev v. Lidl US, LLC, 2024 WL 4642982 (E.D. Pa. Oct. 31, 2024), the plaintiff alleged that he became ill after consuming bread sold and/or baked by the defendants. He claimed to have bought eight loaves initially and experienced abdominal pain and difficulty breathing after spending two days eating the first loaf. He claimed to have thereafter discovered that the loaf was “extensively contaminated with dangerous disease-causing toxic mold.” He took pictures. Later, the plaintiff ate from a second loaf and developed nausea, vomiting, abdominal pain/cramps, general malaise, and respiratory issues “for days.” Once again, he allegedly inspected the bread after eating it and “discovered various-colored mold.” And once again, he took pictures. (As an aside, if we became ill after eating a loaf of bread and then discovered “extensive” mold on it, we would spend the foreseeable future carefully checking all our bread for mold before digging in. We might do so simply because we have read this case. But we digress.) Three months later, the plaintiff purchased four more loaves of bread from another of defendants’ stores. He claimed that while eating that bread he discovered “a large piece of black substance” inside it. Once again, he took pictures. Because he did not know what the substance was or whether he had consumed part of it, he claimed to be “severely traumatized” and afraid of developing future “cancer or damage to his organs,” “suffer[ing] a physical impact,” and losing his “enjoyment of life.”

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In re Taxotere (Docetaxel) MDL Court Rejects Plaintiffs’ Argument that Lone Pine Order is Unfair

We think Lone Pine orders are pretty fair. Lone Pine orders are case management orders that require plaintiffs in multidistrict litigation (MDL) to produce specific evidence without which the plaintiffs cannot make a prima facie case. There is nothing unfair about dismissing a case that is fatally flawed for want of critical evidence that cannot be obtained. Yet Lone Pine orders rarely sit well with plaintiffs who cannot (or do not want to have to) make the showing required of them. Rather than accept their fate, these plaintiffs often attack the Lone Pine order in an effort to delay the inevitable. We discussed one such effort in the In re Zostavax MDL in 2022 and earlier this year. The In re Taxotere (Docetaxel) MDL now provides another example, not only of how plaintiffs attack Lone Pine orders but also of how courts should respond to these unmerited attacks. In re Taxotere (Docetaxel) Prods. Liab. Litig., 2024 WL 4362982 (E.D. La. Oct. 1, 2024).

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Can a Treating Physician’s Medical Testimony Be “Lay Opinion”? Divided Sixth Circuit Panel Disagrees on Where to Draw the Line

Federal Rules of Evidence 701 and 702 govern the admissibility of lay and expert opinion testimony, respectively, in federal courts. Rule 701(c) helps paint the line between the two, providing that an opinion “based on scientific, technical, or other specialized knowledge within the scope of Rule 702” cannot be admitted as a lay opinion. This requirement was added in the 2000 Amendments to Rule 701 to address what the Advisory Committee described as a risk “that the reliability requirements set forth in Rule 702 will be evaded through the simple expedient of proffering an expert in lay witness clothing.” Given this history, one might expect courts to err toward applying Rule 702 to any testimony that inherently draws on expertise that laypeople do not possess. But, as illustrated by the Sixth Circuit’s split decision in United States v. Betro, — F.4th —, 2024 WL 3811838 (6th Cir. 2024), some courts use a different approach.

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Third Circuit Affirms Lone Pine Order and Ensuing Dismissals in In re Zostavax MDL

In March 2022, the In re Zostavax MDL court entered a Lone Pine order requiring plaintiffs who claimed to have developed shingles as a result of using the Zostavax vaccine to produce certain test results supporting causation. In December 2022, the court dismissed 1,189 cases for failure to comply with that Lone Pine order. We posted about the Lone Pine order in April 2022 and the dismissal order in December of the same year. Now, on appeal, the Third Circuit has affirmed both the Lone Pine order and the dismissal. In re: Zostavax (Zoster Vaccine Live) Prods. Liab. Litig., 2024 WL 3423709 (3d Cir. July 16, 2024).

Zostavax is a vaccine meant to prevent shingles, a viral infection caused by the varicella-zoster virus (VZV). The vaccine introduces a weakened strain of VZV, triggering an immune response that primes the recipient’s immune system against non-vaccine sources of VZV (i.e., “wild-type strains”). VZV is responsible for both shingles and chickenpox, and it remains in the body for life. As a result, everyone who had chickenpox as a child faces a risk of the virus reactivating and causing shingles in adulthood. A laboratory test (called a “PCR test”) can reliably distinguish between the strain of VZV used in Zostavax and the wild-type strain one would find due to chickenpox infection.

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A KIND Result After Insufficient and Biased Consumer Perception Evidence

Consumer perception evidence is necessary for plaintiffs to survive summary judgment in a false advertising class action, but vacillating and flawed connections between the evidence and the key question of what a reasonable consumer would expect may lead to its exclusion. The Second Circuit, in Bustamante v. KIND, LLC, 2024 WL 1917155 (2d Cir. May 2, 2024), provides an illustrative example of this, affirming the Southern District of New York’s exclusion of plaintiffs’ experts and grant of summary judgment to a snack foods manufacturer in a false advertising class action.

In Bustamante, Plaintiffs alleged they were deceived by the packaging of KIND snack bars as “All Natural” despite the inclusion of certain “non-natural” ingredients, and their lawsuit asserted warranty, unjust enrichment, negligent misrepresentation, and state consumer protection statute claims. Although there were differing elements to Plaintiffs’ various claims, they were narrowed for the purposes of summary judgment to deception, materiality, and injury, with only the element of deception at issue on appeal.

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