A little over a year ago, we discussed one of the best decisions we had ever read on why comparative risk claims – premised on a manufacturer’s alleged failure to warn that a competing product was supposedly “safer” – are both statistically invalid and practically impossible. That decision, Nelson v. C.R. Bard, Inc., 553 F. Supp.3d 343 (S.D. Miss. 2021), explained at length both how product “comparisons,” if based on the FDA’s voluntary “MAUDE” adverse event reporting system are inherently suspect due to “informational bias,” id. at 355, and, if based on non-public information, would require access to unavailable information about competitors’ products. Id. at 354-55.Continue Reading More on Comparative Warnings
Earlier this week, we spoke of the impending birth of our soon-to-be standard poodle puppy. We are delighted to report that the puppies are being born as we type this! Eight are expected (e-mail us and we will send you a cool x-ray that shows all eight in utero – count the spines and…
We are watching the post-MDL-remand Bard IVC filter litigation with interest. It bears some resemblance to the Bone Screw litigation of the late 1990s/early 2000s (except in Bone Screw, there was no MDL settlement) in that the targeted defendant is engaged skirmishes across the country. In mass torts, the plaintiffs have the benefit of…
It’s a good day in suburban Philadelphia. The sun is shining, the snow is melting, Covid-19 cases are down nationwide, and we just got a text from the Drug and Device Law Rock Climber heralding a weekend visit (with the Irascible Rescue Pomeranian in tow). We are enjoying a welcome (if cautious) flash of optimism. …
If you have been following along for a while, then you have surely run across our posts making some combination of the following points: 1) design defect claims rarely make sense for a drug because changing the design in some material way will usually make it a different drug, 2) such design defect claims, if recognized by state law, will usually be preempted because FDA approval of a different drug cannot be assumed, and 3) courts really should analyze conflict preemption by first determining that there is an actual state law duty that has been asserted or supported (depending on the procedural posture). One such post walked through why it took so long until a circuit court held that a design defect claim with a prescription drug was preempted. That case, Yates, has been followed a number of times, including on motions to dismiss, but there are still some glitches.
The decision in Young v. Bristol-Myers Squibb Co., No. 4:16-CV-00108-DMB-JMV, 2017 WL 706320 (D. Miss. Feb. 22, 2017), counts as a glitch on the preemption front even though the court dismissed (without prejudice) the design defect claim and eight of the nine other claims asserted. The plaintiff claimed to have suffered ketoacidosis and renal failure from taking a prescription diabetes medication right around the time FDA issued a Public Health Advisory about the risk of ketoacidosis for the class of medications, SGLT-2 inhibitors, to which it belonged. Several months later, the drug’s label was revised to include warnings about ketoacidosis and urosepsis, a blood infection stemming from a urinary tract infection. Plaintiff claimed that the inherent design of the drug, like all SGLT-2 inhibitors, created a risk of ketoacidosis. When plaintiff sued, she asserted a wide range of claims and defendants moved to dismiss on various grounds. We will address only some of them.
Part of our point here is that the order can matter. We do not have the briefs, so all we can go off of here is the opinion. After the preliminary issue of whether common law claims are subsumed by the Mississippi Product Liability Act—the four here were—the court starts off the meat of the analysis with this: “The defendants argue that Young’s claim for defective design must fail because Young has failed to plead a feasible design alternative and because federal law preempts the design defect claims.” Id. at *5. So, what gets analyzed first? Preemption. (Remember, federal courts are supposed to try to resolve disputes on nonconstitutional grounds if they can.) In so doing, the court has to hold out as unresolved whether Mississippi law imposes the very duties that might create the conflict leading to preemption. As the court recognized at the end of its, to us, flawed preemption analysis:
If there is no state law duty, the state law cause of action must certainly fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state law duty is fatal to a claim but not under the doctrine of conflict preemption.
Id. at *8. This logic suggests that the court needs to decide first whether there is a state law duty to do what the plaintiff urges was necessary. Because the court never determined that there was such a duty, the whole discussion of preemption seems like a bunch of dictum to us.Continue Reading Another Court Tackles Prescription Drug Design Defect
Maybe you’ve noticed that many of our recent posts have reported good decisions out of Mississippi. Here, here, and here, for example. It’s as if there has been an outburst of judicial common sense in that fair state. But it has not really been such a sudden thing. Looking back over last year, sound reasoning and clear decision-making seem to be commonplace in Mississippi opinions. You just had to look for these things, and you didn’t have to look all that hard.
Consider Mealer v. 3M Co., 2015 WL 9692735 (Miss. March 28, 2015). That opinion came out ten months ago, and is now available on Westlaw. It isn’t a drug or device case, but its holding on the safer alternative requirement is important for any product liability design defect claim.
The product at issue was a one-use, disposable respirator mask. The plaintiff wore one while wielding a jackhammer in a demolition project. The claim was that the mask did not adequately filter out silica particulates, and that the plaintiff ultimately contracted a fatal lung disease as a result. The plaintiff’s experts opined that there was no design change that could make a disposable respirator mask adequate. Instead, the safer, feasible alternatives included such things as elastomeric respirators with cartridge filters and exhalation and inhalation filters with rubber seals. The court held that those weren’t safer alternatives but were, instead, different products altogether. The disposable mask used by the plaintiff was a simple fiber piece that costs about a dollar. By contrast, the elastomeric respirator costs about $25-30. As the court reasoned, “[t]hey are completely different and their utility is completely different, the variation in longevity of the two products is obvious.”Continue Reading Mississippi Gives Teeth to the Safer Alternative Requirement
Last month, we discussed Estes v. Lanx, Inc., 2015 WL 9462964 (N.D. Miss. Dec. 23, 2015), and mentioned that the court had left a bit of unfinished business behind – having raised sua sponte the question of whether the plaintiff’s assertions that the device lacked proper FDA clearance was preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).
A lot of you were interested. That post has received over 1000 hits.
The other shoe has now dropped.Continue Reading The Other Shoe Drops in Estes