Eric M. Friedman

Eric Friedman guides clients through all stages of product liability litigation, particularly working with expert witnesses to present the science behind clients' products. By leaning on his pre-law history as a biochemist, he is able to identify key arguments for and against clients and craft winning strategies for both motion practice and trial.

View the full bio for Eric M. Friedman at the Faegre Drinker website.

Articles by Eric M. Friedman:


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

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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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Failure to Comply with Lone Pine Order Results in Dismissal of Over 1,000 Cases in Zostavax MDL

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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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Experts’ Disagreement with Medical Literature Leads to Exclusion

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Peer-reviewed literature can be a powerful tool in attacking an opposing expert’s opinions.  A solid, on-point article can do more than merely satisfy several of the so-called Daubert factors for assessing reliability – by showing a court that others in a challenged expert’s field disagree with his or her opinions, literature can remove any expert “aura” that might discourage a lay judge from discharging his or her duty as a gatekeeper.  Presenting literature that directly undermines the expert’s opinion can make the difference between winning and losing a motion to exclude, especially where the expert’s opinion is not supported by other literature accepted in the field.

A recent example is U.G. v. United States, 2022 WL 7426212 (S.D.N.Y. Oct. 13, 2022), a medical malpractice action under the Federal Tort Claims Act in which plaintiff suffered a shoulder injury during his birth and was later diagnosed with permanent Erb’s palsy, or brachial plexus injury.  He alleged that the obstetrician caused the injury by using excessive force on his head and shoulders during delivery.  In support of his claims, he offered two causation experts – an obstetrician/gynecologist and a pediatric neurologist– both of whom claimed the “totality of the circumstances” ruled out several possible alternate causes and thus showed that the defendant caused the injury.

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Ipse Dixit – It’s Not Just for Analytical Gaps Anymore

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There are few legal phrases more fun to say than “ipse dixit.” The phrase is most commonly used in motions to exclude experts who base their opinions on nothing more than their own say so.  As the Court noted in General Electric Co. v. Joiner, 522 U.S. 136 (1997), an ipse dixit – Latin for “he said it himself” – leaves an impermissible “analytical gap” between the expert’s opinion and the facts on which it is based.  But ipse dixit arguments can and should stretch beyond just the “basis” part of the expert argument. Courts should also exclude experts who provide unsupported and self-serving testimony to suggest that their method is accepted generally in the community.

That is precisely what happened in Knepfle v. J-Tech Corporation, 2022 WL 4232598, — F.4th — (11th Cir. 2022).  Plaintiff was injured in a motor vehicle accident when she ran her motorcycle into the side of a vehicle that had turned in front of her, causing her to be thrown from the motorcycle.  Although the helmet she was wearing protected her head during the initial impact with the other vehicle, she alleged that it came off and failed to protect her head when it struck the pavement.  She brought product liability claims against multiple defendants in the manufacturing and distributing chain of the helmet.

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Exclusion of Damages Expert at Class Certification Stage Results in Partial Denial of Certification Motion

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Just a decade ago, it was still an open question whether parties could challenge the admissibility of expert testimony in class certification proceedings.  The United States Supreme Court recognized the issue in Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338 (2011), and suggested that experts should be scrutinized as usual, noting that “The District Court concluded that Daubert did not apply to expert testimony at the certification stage of class-action proceedings.  We doubt that this is so . . .”  Since then, multiple circuits have taken that hint and held that a court must conduct a full Rule 702 analysis before deciding whether to certify a class.  The Fifth Circuit, in Prantil v. Arkema Incorporated, 986 F.3d 570 (5th Cir. 2021), became the fourth federal court of appeal to adopt this rule expressly.  As the district court’s recent decision on remand in Prantil demonstrates, a full Rule 702 analysis can make the difference between certifying or rejecting a class.

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Expert’s Failure to Identify Product Defect in Pressure Cooker or Inadequacy in Warnings Leads to Summary Judgment

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It is axiomatic that a plaintiff must offer evidentiary support for each element of her claim in order to survive summary judgment. And a ubiquitous feature of product liability actions is the use of expert witnesses by both sides. These principles are, of course, related – the plaintiff usually must offer expert testimony in order to make a prima facie case, and the defense then attacks that prima facie case through expert testimony. But sometimes a plaintiff loses sight of the connection and, despite retaining an expert, fails to elicit the opinions she needs to make her case. As a recent decision from the Western District of Wisconsin illustrates, it pays for a defendant to carefully evaluate whether a plaintiff has checked all of the necessary boxes.

In Moore v. National Presto Industries, Inc., 2022 WL 1555875 (W.D. Wis. May 17, 2022), Plaintiff alleged that she was injured when she opened her pressure cooker while it was still pressurized, ejecting its contents onto her arm, causing burns. Plaintiff sued the cooker’s manufacturer, asserting strict liability claims for design defect and failure to warn as well as a claim for negligence. Defendant moved for summary judgment on each of these claims.

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