Massachusetts Federal Court Rules that Heightened Pleading Requirements Apply in Product Liability Design Defect Cases


By: Kevin Kenneally and William Gildea

The United States District Court, District of Massachusetts (Hillman, J.), recently held that Plaintiffs must affirmatively plead and prove that there is a safer alternative product design in order to maintain defect claims against the product manufacturer. Ducat v. Ethicon, Inc., 2021 U.S. Dist. LEXIS 72793 (D. Mass., April 14, 2021) (“Ducat”). The Plaintiff in Ducat brought claims for: (1) negligent design; (2) violation of implied warranty of merchantability; and (3) loss of consortium alleging the Defendant’s vaginal mesh product was defective in its design, caused physical injury to the plaintiff and diminished her quality of life.  The manufacturer moved for judgment on the pleadings on the grounds the Plaintiff did not allege any facts “showing how the design of the mesh was unsafe, what purported design defect caused Plaintiff’s injuries, and failed to plead the existence of a safer alternative design.”  Ducat, 2021 U.S. Dist. LEXIS 72793 at * 5-6.  The District Judge explored prior design defect case law and held “[b]ecause a reasonable alternative design is a required element of design defect, and Plaintiffs have not pled that an alternative design exists in their Complaint, they have not stated a plausible claim for relief[.]”  Ducat, supra at *14-15.  Ultimately, the Court granted leave for the Plaintiff to amend her Complaint to allege, if possible, the existence of a safer alternative design to revive her deficiently pled design defect and implied warranty of merchantability claims.

U.S. District Judge Hillman’s ruling is consistent with Restatement (Third) of Torts, Product Liability (1997 ed.) §2(b), which adopted the risk-utility test to determine if a product is unreasonably unsafe. The Court contrasted earlier case law and authority -including the Restatement (Second) of Torts § 402A, official comment B—which favored the “consumer expectations test.” That test no longer governs Massachusetts design defect cases.

Restatement (Third) Torts, Products Liability, §2(b) states, in part,

“A product is defective when, at the time of sale or distribution…is defective in design. A product is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe.”

The Ducat decision confirms that a reasonable alternative design is a required element of design defect litigation. The products liability defense bar should take note of the heightened pleading requirement and demand at the outset that plaintiffs show proof of an actual feasible alternative—which is in existence and use– to proceed against a manufacturer.  As the Court noted: “the plaintiff must prove the availability of a technologically feasible and practical alternative design that would have reduced or prevented the plaintiff’s harm” in order for the case to survive a motion to dismiss for failure to state a claim.

For more information, please contact Kevin Kenneally at or William Gildea at