There is an exhibition at the National Museum of the American Indian in Washington DC showing a warrior with eyes on the back of his head and a blank, eyeless face on the front. That odd image reflects the profound truth that we have seen what has already happened but are blind to the future. (We are reminded a bit of Dr. Bunsen Honeydew, the muppet character who has no eyes. But Dr. Honeydew does have glasses. Talk about odd.)
At the start of 2020 we can only guess as to the coming triumphs and indignities. The calendar has turned but we find ourselves still looking backwards at some of the drug and device law developments in 2019. Bexis shared the 2019 top 10 and bottom 10 lists. (Keep alert for the upcoming CLE program.). Even aside from the positive and negative game-changers of 2019, there were other cases with interesting holdings. We did not get to them all. Some are worth retrieving, holding up to the light, and scrutinizing.
For example, Hofer v. Wright Medical Technology, Inc., 2019 WL 3936130 (S.D. Cal. Aug. 20, 2019), takes us back. The date of the decision takes us back to a birthday dinner for the Drug and Device Law Son in Budapest. The location of the decision takes us back to our first years as a practicing attorney, when we worked on transactional matters in San Diego and proved on a daily basis our ineptitude in drafting trust indentures and other triple-tier finance documents. Most important, the substance of the Hofer decision takes us back to the days when courts took seriously the requirement under Fed. R. Civ. P. 9(b) that plaintiffs must plead fraud claims with particularity.
The plaintiff in Hofer claimed injuries from an artificial hip system that broke into pieces. His complaint included causes of action for failure to warn, negligence, and negligent misrepresentation. The defendant moved to dismiss the negligent misrepresentation claim because it flunked the heightened pleading requirement of Rule 9(b). The defendant prevailed, and the court’s reasoning might be a gift to defendants accused of negligent misrepresentation.
The plaintiff first argued that Rule 9(b)does not apply to negligent misrepresentation. Surprisingly, the Ninth Circuit has not addressed this legal issue. It is hard to believe that, as big as the Ninth Circuit is, the issue has not already been resolved. But it has been resolved at the district court level in the Southern District of California several times, and those sun-blessed judges have consistently applied Rule 9(b) to claims of negligent misrepresentation. Maybe the Ninth Circuit will review the question. Unlike some (most?) other commentators, we do not assume that the Ninth Circuit would mangle the law in a pro-plaintiff fashion. Maybe it is because we clerked on the Ninth Circuit in our salad days, but we foresee a solid affirmance. The Ninth Circuit has a lot of smart judges (and, with the recent addition of our old AUSA colleague Dan Collins, maybe the one of the very smartest). Then again, we are like that Native American warrior, gazing into the future with more hope than vision.
The Hofer plaintiff argued that even if Rule 9(b) governed the case, his complaint satisfied it. No, it didn’t. The complaint referred to various marketing materials that hawked the hip implant’s record of success. But the only representation that the plaintiff alleged had been relied upon by the implanting doctor was that the hip implant system “was properly cleared by the FDA and that it had a good clinical history.” It runs out that there would be problems with these representations. It does not matter. The plaintiff “failed to allege who made any of these representations, when and where any of the representations has been made, and how they were made.” Moreover, the not allege whether or how the alleged misrepresentations has affected the doctor’ s “decision regarding his selection of the device.”
Accordingly, the court dismissed the negligent misrepresentation claim for failure to meet the heightened pleading requirement of Rule 9(b). In the midst of exchanging hearty New Year’s wishes, let’s not forget some of the cases that made 2019 as good as it was. Hofer in its own quiet way, was one of them.