This post is from the non-Reed Smith side of the blog only.
We are going to break from the traditional communal persona for just a minute because today’s case made me think of something my nine-year old son said just the other day. He was watching a video with me on the evolution of dance music. I take great pride in that his musical likes include the Beatles and Bruce Springsteen and run the gamut to Zac Brown and Imagine Dragons. That said, I wasn’t surprised by his snickering while watching flappers do the Charleston or bobby-soxers do the Twist. But when we arrived at the 1980s, he simply looked at me and said “Yuck.” With a slight cringe at the jab to the music/dance/style of my youth, I tried to look at it through his eyes. That is, with a view not clouded by the fond memories that the songs provoked. And, yep, I had to admit – yuck was pretty accurate.
And yuck is certainly an accurate description for today’s case – Barba v. Carlson, 2014 Del. Super. LEXIS 198 (Del. Super. Apr. 8, 2014). It’s bad on learned intermediary. It’s bad on design defect. It’s bad on breach of warranty. In other words, if we were Dick Clark, we’d say it’s got a lousy beat and you can’t dance to it either.
Plaintiff underwent surgery involving implantation of pelvic mesh medical devices. Id. at *1. She filed products liability claims against the manufacturer and medical malpractice claims against her surgeon. Her surgeon testified, and it was undisputed, that he did not recall reading the warning label or package insert that came with the pelvic mesh devices. Id. at *2. It was also undisputed that plaintiff’s surgeon attended training courses provided by the manufacturer on implanting pelvic mesh. Id.
The court begins its substantive analysis with the learned intermediary doctrine. The court appears to start down the right path, but then gets tripped up by three little letters. There are two steps to a failure to warn analysis at the summary judgment stage. The first question is whether the warning was adequate as a matter of law. Id. at *7. If there is a genuine dispute on adequacy, the next issue is proximate cause -- “whether additional information or warnings would have made a difference to a reasonable learned intermediary.” Id. (emphasis in original). A failure of proof on either issue is sufficient to end plaintiff’s failure to warn claim. Either plaintiff couldn’t establish that the warning was inadequate or plaintiff couldn’t demonstrate that any inadequacy caused her injury.
We’ve seen the necessary causal link broken in many ways, such as by evidence that a physician would not have changed his treatment of plaintiff even if a different warning had been provided. Or, evidence that any additional warning would not have made a difference because the physician would never had seen it. Defendant argued the latter here based on the doctor’s testimony that he doesn’t recall reading the product’s warnings. The court, however, focused on the surgeon’s attendance at the defendant’s training sessions. Since there was a genuine dispute regarding whether the warnings provided at those sessions were adequate, there was also a genuine dispute regarding whether different information provided at the training would have made a difference in such a way as to have prevented plaintiff’ s injury. Id. at *11-12. Since the court was also unwilling to determine that the defendant’s warnings in its labeling were adequate as a matter of law, the whole thing got rolled up in a question of fact for the jury.
While we don’t like the outcome, our real problem is with the court’s statement of the law. When the court put step one and step two together, its analysis changed:
If the warnings and information are found to be adequate, andadditional warnings or information would not have affected the medical decisions of a reasonable physician, then the learned intermediary insulates the manufacturer from liability.
Id. at *7-8. Plaintiff has to fail both prongs of the test? Shouldn’t the “and” have been an “or”? If the warning is found to be adequate, that’s the end of the story. What difference does additional information make? On the flip side, if the warning was allegedly inadequate but plaintiff’s physician opted not to read it, how can the failure to warn have been the cause of plaintiff’s injuries? In application in this case, the court’s use of “and” didn’t matter because it found that there was an issue regarding the adequacy of at least some information which plaintiff’s surgeon did review and apparently rely on. But, in other cases, the seemingly small difference between “and” and “or” could be huge.
Moving on to negligent design defect (no strict liability in Delaware), the court first sets forth the test:
The proper test is whether the design has created a risk of harm which is so probable that an ordinarily prudent person, acting as a manufacturer, would pursue a different available design which would substantially lessen the probability of harm.
Id. at *13 (emphasis added). Then, the court strips out the alternative design element of the claim. Without citation to any legal support, the court finds that evidence of an alternative design while relevant, is not necessary to prove a design defect claim. But, it’s right in the test itself. Based on the language cited by the court, we consider Delaware a state that has adopted alternative design as a prerequisite to a design defect claim. We’ve been wrong before, but this one seems obvious to us.
The example given by the court demonstrates the nonsensicality of its position:
For example, if a mask designed to protect miners from coal dust did not filter out any harmful particles, then the design would be defective, even if the alternative would be for the miners to work without any protective apparatus.
Id. at *15. Not only is the court’s example based on an absurd extreme – a filter that doesn’t filter anything – it bears no connection to an FDA approved medical device which does in fact provide a medical benefit. Moreover, it is simply a different way of articulating the “stop selling” argument that the Supreme Court shot down in Mutual Pharmaceutical Co. v. Bartlett.
Finally, the court essentially nullifies Delaware’s warranty notice requirement. Under Delaware law, “the buyer must notify the seller of the breach within a reasonable time after discovery of the breach.” Id. In this case, plaintiff didn’t provide notice before filing her lawsuit. The court determined it was a question for the jury. Id. at *16. There is no analysis, no discussion. Just a straight forward punt, which to us reads like if you timely file a lawsuit, you’ve timely given notice. The two are not the same and courts should at a minimum have to conduct the appropriate analysis.
The court also punted on plaintiff’s fraud claims finding that because “the evidence is so intertwined with other claims, it does not appear that permitting fraud to remain as an issue for trial will prolong or complicate the proceedings unnecessarily.” Id.at *19. We thought the relevant inquiry was whether plaintiff had met her burden on the elements of her claim, not whether tacking on a few additional claims would protract the trial. Under that rationale, once any claim survives is there much justification for dismissing the others? We don’t have a lot of confidence that a full blown analysis would have resulted in a dismissal, but it would have been better than the “sure, why not” we got here. Oh, and the court allowed the punitive damages claim too. Why not?
Distance, time and perspective may make you look back on times gone by with a changed attitude. Cool may become lame. Boring may become inspiring. Exciting may become foolish. But we don’t think any amount of time will allow us to look on this case as anything but yucky.