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The opening line of Daley v. Mira, Inc., 2023 U.S. Dist. LEXIS 193926 (D. Mass. Oct. 30, 2023), is eye-catching: “Nancy Daley has sued two defendants, alleging claims arising from an eye surgery she underwent in 1986.”  Wow.  In 1986, we were clerking for Judge Norris out in Los Angeles.  Ronald Reagan was President. Chernobyl happened.  So did the Challenger explosion.  The original Top Gun movie hit the screens.  Len Bias died.  Fox Broadcasting launched as the fourth television network.  The Bears were the Super Bowl champions, and the Mets won the World Series against the Red Sox.  Lady Gaga was born.  The Drug and Device Law Heirs were not yet, er, conceived. 1986 was a long time ago.  Could there really be a live summary judgment motion in 2023 about a medical event that happened 37 years ago?  Yes, indeedy.

In 1986 the plaintiff had a medical product implanted in her eye to repair a retinal detachment. Despite the device’s initial success, the implant began to swell and decay over time. It wasn’t until the 1990’s that the plaintiff’s doctor began to learn of possible complications with such implants.  Even so, that doctor did not recommend surgical removal of the eye implant until 2016, two decades after the product had been withdrawn from the market.  The surgical removal proved difficult.  The plaintiff filed her lawsuit in 2018.  Her complaint originally contained six causes of action, but by the time of the summary judgment motion they had been winnowed down to one: strict liability design defect. That claim largely rested on the plaintiff’s expert’s opinion that, based on medical literature published years after the 1986 surgery, the product had an “unacceptable” removal rate due to complications.   

Talk about hindsight.  The plaintiff had no evidence that anybody knew or could have known about the alleged defect at the time of the plaintiff’s surgery.  The plaintiff could “point to no evidence suggesting the tests SERI performed when developing MIRAgel were flawed or inadequate.”  Indeed, the plaintiff withdrew her claim asserting negligent pre-market testing, admitting “It does not appear that technology existed in 1984 to determine that MIRAgel would swell after five or more years after having been implanted into the eye.” 

In Daley, we see a rare, straight-forward application of the state of the art defense under New York law.  To prove liability for a design defect under New York law, a plaintiff must prove that the defendant had knowledge that the design of its product was potentially dangerous and that other, safer designs were available and feasible.  Importantly, the “inquiry focuses on the moment of production or the time of the injury.”  There is a “temporal limitation” on the scope of inquiry.  What did the defendant know about the design risks, and when did it know it?  A defendant’s liability depends on what, with the exercise of reasonable care, was knowable about the product when the plaintiff used or was injured by the product.  In Daley, even the plaintiff’s expert admitted that his defect opinion was made “in retrospect” and not based on any information that existed at the time of the implant. 

The plaintiff simply could not backfill regarding knowledge in the relevant time period.  There was no genuine factual dispute as to what was knowable at the time of the plaintiff’s surgery.  The plaintiff attempted to rely on certain pre- and post-surgery materials,  but none of them supported an inference that the defendant could have discovered the defect alleged by the plaintiff.  The court entered judgment in favor of the defendant.  To borrow a song title from 1986, the Daley case was no longer “Alive and Kicking.”