The Committee Notes to the newly implemented amendments to Federal Rule of Evidence 702 make clear that the “[j]udicial gatekeeping” of expert evidence is “essential.” Federal courts in New York have played an important role in pioneering and developing this concept. Indeed, the idea of courts as gatekeepers in the expert context finds its roots in the Eastern District of New York, with the late Chief Judge Weinstein coining the term in a 1985 opinion in In re Agent Orange Product Liability Litigation. Three decades later, the Southern District of New York offered one of the most thorough illustrations of careful judicial gatekeeping in In re Mirena IUS Levonorgestrel-Related Prod. Liab. Litig. (No. II). Now, New York can also call itself home to the first MDL-wide decision to exclude experts under Rule 702’s new formulation.
Blake T. Lehr
Articles by Blake T. Lehr:
Failure to Comply with Lone Pine Order Results in Dismissal of Over 1,000 Cases in Zostavax MDL
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).
“Alternative Avenues” Argument in Failure-to-Warn Cases Adding an Additional Wrinkle to Medical Device Litigation
A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims. While a treating physician’s failure to read or rely on the manufacturer’s warnings has historically been fatal to a failure-to-warn claim in many jurisdictions (at least those without a “read and heed” presumption), plaintiffs have tried novel “alternative avenues” arguments to make summary disposition of the claim more difficult.
There are two theories under which a failure-to-warn claim may be brought in the products liability context: a manufacturer with a duty to warn may breach its duty by either (1) failing to provide an adequate warning of the product’s potential risks (the “content theory”) or (2) failing to adequately communicate the warning to the ultimate consumer (the “communication theory”). Plaintiffs have traditionally pursued failure-to-warn claims in prescription medical device cases under the content theory, with most courts holding that a treating physician’s failure to read or rely on the manufacturer’s warnings in the product’s instruction for use (“IFU”) is fatal to the claim. See, e.g., Foster v. Ethicon, Inc., 2021 WL 1169473, at *7 (D.S.D. Mar. 26, 2021).
Latest “Right to Repair” Bill Could Signal Changes for Consumers and Manufacturers
On March 14, 2022, a bipartisan trio of U.S. Senators introduced a bill (S.3830) that would require manufacturers to provide the tools and documentation necessary for consumers and third parties to repair electronic equipment. Dubbed the Fair Repair Act of 2022, the bill is the Senate version of a similar bill (H.R.4006) introduced in the House last June. The proposed legislation covers products ranging from agricultural equipment to consumer electronics and is the latest in a series of federal and state proposed laws seeking to codify the “right to repair.” If the bill becomes law, manufacturers will not only have to comply with the Act’s requirements, but they will also need to prepare for potential liability implications.
Attempts at codifying a right to repair are not new in the United States. Calls for automotive right-to-repair legislation go back to the 1970s. But the movement has hit its stride in the last decade. In 2013, Massachusetts became the first state to pass a right-to-repair law requiring vehicle manufacturers to sell their proprietary diagnostic tools and software to third-party repair shops, spurring a flurry of similar bills across the nation and bringing attention to the right-to-repair movement. Though the movement has had little success in codifying a right to repair so far, the tides may be shifting. Indeed, in July 2021, President Joe Biden signed a sweeping executive order that, among other things, encourages the Federal Trade Commission (“FTC”) to enact regulations prohibiting manufacturers from barring the repair of equipment and devices by consumers and independent repair shops.
Seventh Circuit Holds that State Court Limit on Medical Expert Testimony Does Not Apply to FTCA Claim in Federal Court
Although product liability actions are governed by state tort law, they frequently find their way into federal court on diversity jurisdiction. In such actions, federal law provides the procedural rules and state law provides the rule of decision. Although the distinction between procedure and substance is often clear, it can sometimes be nuanced and unintuitive; for example, statutes of limitations are typically viewed as procedural, whereas statutes of repose are viewed as substantive. In Love v. United States, — F.4th — (7th Cir. 2021), 2021 WL 5119342, the Seventh Circuit Court of Appeals provides another such illustration of this nuanced distinction and further guidance on the subject in the context of the admissibility of expert opinions.
The Plaintiff in Love brought suit under the Federal Tort Claims Act (FTCA), alleging that a nurse employed by the Veterans Administration negligently failed to order additional tests after receiving the results of a urinalysis. Plaintiff alleged that the lack of testing allowed an infection to go undiagnosed and untreated, leading to a heart attack and extended hospitalization.