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# PhRMA Backs Changes to Evidence Rule 702
- URL: https://www.fdaweb.com/phrma-backs-changes-to-evidence-rule-702/
- Published: 2022-01-26T12:00:00.000Z
- Updated: 2026-09-14T17:30:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151010

Pharmaceutical Research and Manufacturers of America (PhRMA) is urging the Judicial Conference Committee on Evidence Rules to adopt a proposed amendment to Federal Rule of Evidence 702 that governs courts’ role as gatekeepers deciding whether to allow expert testimony. The PhRMA 1/25 comment [letter](https://downloads.regulations.gov/USC-RULES-EV-2021-0005-0038/attachment%5F1.pdf?ref=fdaweb.com) says its members are interested in how the rule is applied because pharmaceutical product liability cases are an enormous and growing proportion of the federal civil case docket.

“Too many of these cases are filed before the scientific community has had the opportunity to study and evaluate the alleged injury and end up being supported only by speculative testimony from plaintiff experts claiming a causal link between a product and an injury,” PhRMA says. “All too often, the plaintiff experts’ speculative opinions lack any sound basis in the scientific community (and contradict the thorough findings of federal regulators like FDA)….” PhRMA says that in practice, the cases often turn on questions of expert admissibility.

When courts have properly applied the gatekeeping requirements of Rule 702, it says, thousands of unmeritorious cases have appropriately faced rapid disposition. “Too often, however, courts have misapplied their gatekeeping obligation, instead waving proffered experts through with the rote and incorrect conception that Rule 702’s core requirements — sufficient facts or data and reliable application of a reliable methodology — go to the weight of the testimony rather than its admissibility,” PhRMA says.

The letter says the growth in product liability suits does not suggest that medicines are somehow becoming less safe or that FDA has become deficient in its oversight. “To the contrary,” it says, “more than four out of every five federal product liability cases resolved on the merits between 2015 and 2019 were resolved in the defendant’s favor, including because there is no reliable science to support the plaintiff’s claims.”

The comment says that too often mass tort lawsuits seek to second-guess FDA’s thorough scientific judgments about regulated products.

PhRMA says that appropriate expert gatekeeping can filter out mass tort lawsuits at an early stage and gives three examples of cases in which it says courts got it right.

“The proposed amendment to Rule 702 provides much-needed direction that courts cannot simply pass along questions of expert admissibility to the jury,” PhRMA concludes. “Indeed, the committee might even consider a modest wording adjustment to the proposed amendment or adding a specific mention in the notes to underscore that it is the court’s obligation to affirmatively determine, based on the preponderance standard, whether or not an expert’s opinion ‘reflects a reliable application of the principles and methods to the facts of the case.’”