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Delaware is having something of a moment in the sun.  Although the state’s license plates have long announced it as “The First State,” that refers to being the first to ratify the U.S. Constitution.  It is the second smallest in size and sixth smallest in population of the current fifty states.  The casual peruser of a map of the U.S. might miss it.  Even its state fish, the weakfish, is, well, weak.  (Disclaimer:  A few of us grew up and/or live in Delaware’s neighboring states.)  Now, though, Delaware is home to the President of the United States.  It also continues to be the preferred state of incorporation for publically traded companies, with about 300 of the Fortune 500 incorporated there.  That has led to a bit of a surge in product liability litigation in Delaware state courts.  Why now?  Well, the tightening of the rules on personal jurisdiction over the last several years means that many plaintiff lawyers have to choose between federal court, and possibly a slow MDL, or state court in Delaware, where the defendant is incorporated and/or based.  Before Bauman, it did not seem that Delaware was a popular choice for the plaintiff lawyers, certainly if proceeding in the state court where the plaintiff lived or where the plaintiff lawyer liked to bring many litigation tourism cases was an option.  Now, Delaware is getting more cases and Delaware courts are increasingly deciding cases under the law of another state, somewhat like a federal court sitting in diversity and hopefully practicing some Erie restraint.

In Pope v. Astrazeneca AB, No. N20C-06-116 FAR, 2021 Del. Super. LEXIS 281 (Del. Super. Ct. Apr. 5, 2021), we have just such a case.  The case involves a claim of Fournier’s gangrene, a nasty perineal infection, in connection with the use of a particular diabetes medication.  We have previously posted on decisions from the MDL and from the same Delaware state court about this same medication.  Like this case, the prior Delaware case even involved Texas law, which almost invariably means consideration of the second most famous “007,” § 82.007 of the Texas Code, which provides a presumption of adequacy for FDA-approved drug labels (like a license to kill warnings claims).  We have posted quite a bit on this provision, like here and here, and we can say it has been a key provision in some pretty effective tort reform.  There was a time when the suggestion that a Texan would chose to sue a Delaware drug company in its backyard would have drawn a hearty guffaw.  Times have changed.

In Pope, the plaintiffs brought claims relating to warnings, design, negligence, warranty, loss of consortium, and punitive damages, the defendants moved to dismiss, and the court addressed everything in a no-nonsense and sensible fashion.  The wrinkle in this case was that the plaintiff—the one who took the medication—claimed to have been prescribed it for weight loss as well as his diabetes.  The latter was on-label, but the former was off.  This might matter under § 82.007 because it provides an exception to the presumption of adequacy that would otherwise have applied if “the manufacturer promoted the product for a use not approved by the FDA.”  Id. at *4.  We note that the court did not get caught up in questions about how to deal with FDA approval—a fact often omitted from complaints and necessary for the presumption, which is arguably a defense—on a motion to dismiss.  Instead, it identified that the exception required pleading not just of promotion and reliance on it, but of a causal relationship between the off-label promotion and the plaintiff’s injuries.  Id. at *5.  Here, plaintiff admitted to being prescribed the medication on-label, but with the hope that it would also help him lose weight.  Common sense indicates that the alleged off-label promotion could not be the cause of plaintiff’s injuries in that situation.  Texas federal courts had addressed this in at least two cases, one of which we discussed here.  With its own Delaware version of Erie restraint (Rehoboth restraint or Appoquinimink restraint?), the court held that the exception did not apply:

Pope was using Farxiga for both an indicated and non-indicated use.  And Plaintiffs cannot establish, nor have they even pled, that Pope’s injuries were caused by his off-label use of Farxiga for weight loss, as opposed to his FDA approved use of Farxiga to treat his Type 2 diabetes.

Id. at *8.  The presumption of adequacy held and the warnings claim was dismissed.

Next up was the design defect claim.  As the court had held previously, an adequate warning defeats a design defect claim under Texas law.  Id. at *9.  As an added measure, the court looked at whether plaintiffs could carry their burden of showing a safer alternative design.  Noting that a manufacturer cannot change the design of an approved drug, “[t]o establish that a safer alternative design exists would invoke a state duty to change the design of the drug,” which meant the design claim was preempted.  Plaintiffs, however, attempted to parse the design claim into pre- and post-approval halves, the former of which they claimed was not preempted.  Relying on one of our favorites, Yates, the court rejected plaintiffs’ argument:

In order to find for Plaintiffs on such a claim, the Court would be required to engage in multiple levels of supposition. For instance, the Court would have to speculate about whether a pre-approval design change would have fixed the problem; whether the FDA would have approved such changes; whether Pope’s physician would have recommended and prescribed the differently designed drug, if it was FDA approved; and whether Pope would have taken the drug after such changes and processes were executed. The Court would be required to make unfounded inferences as to each of these questions to find for Plaintiffs, and thus is unable to countenance Plaintiffs’ pre-approval design defect argument.

Id. at *11.  Therefore, the design claim was also dismissed.

As to plaintiffs’ negligence claims, the court did not fall for the argument that merely asserted negligence is enough.  With the exception of negligent failure to test, the negligence claim was really duplicative of the warnings and design claims already dismissed.  Id. at *12.  The same went for express and implied warranty.  Id. at **13-14.  As to failure to test, this is where we have a gripe.  The statement that “[c]ourts in Texas have recognized an independent cause of action based on negligent failure to test” was based on the Murthy decision panned here for, among other problems, not making a proper Erie prediction.  Another case following Murthy (and discussed in not-so-glowing terms here) was cited, but is clearly part of a minority.  In any event, the assertions supporting a purported failure to tests were conclusory boilerplate and held to be inadequate.  Id. at *13.  Because this part of the dismissal was without prejudice, plaintiffs will get another shot at trying to plead negligent failure to test if they choose.  Should they try again, we hope the court will take a deeper dive into whether Texas really has adopted such a claim, which is logically just another version of failure to warn.