Shook, Hardy & Bacon Miami Partner Mihai Vrasmasu and Associate Katherine Mastrucci authored a June 1 article for DRI’s The Voice newsletter, “Can Medical Devices Be Too Complex for Their Own Good?” discussing defense tactics that are helpful against medical device design-defect claims.
Citing recent lawsuits against surgical robotics manufacturer Intuitive Surgical as examples, the authors explain that the company has faced “failure-to-train” claims in recent years. However, a different argument emerged last year where “a claimant alleges that a device is defective in its design because it requires too much training to use safely.”
In light of the medical device design-defect claim, the authors state that Florida law does not require plaintiffs to provide a safer alternative design to prove their design-defect claim. However, “a jury’s finding pertaining to design defect [must] be based on the state of the scientific knowledge available at the time of the product’s manufacture,” which allows for case-specific determination depending on evidence presented during trial.
The authors also note that the outcome of the suits can be different depending on jurisdiction. For instance, they explain that Washington has categorically adopted “comment k” for all prescription drugs and medical devices, which means that “unavoidably unsafe products” are acceptable by law because with the present state of human knowledge, it is not possible to create these products “safe for their intended and ordinary use.” Comment k to Section 402A of the Restatement (Second) or Torts continues: “Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous ….”
Vrasmasu and Mastrucci conclude that medical manufacturers can counter complex design-defect claims; “evidence negating the existence or the feasibility of a safer alternative design can be used to prove the reasonableness of the product’s design,” and “only time will tell just how much traction this novel excessive complexity design-defect theory will gain.”