So, in case you’ve missed every national news report over the last 24 hours – it’s cold outside. Really cold. The media is calling it Polar Vortex 2014 – because it’s nothing without a catchy name and graphic. Weather reporters are demonstrating how long it takes anything from a wet t-shirt to a hamburger to freeze outside. To the reporter who was stunned that her water froze this morning, I suggest you re-acquaint yourself with what happens in your freezer every day. Social media sites were over loaded with Canadians sending tips to their southern neighbors on how to beat the cold. All this hype over cold weather also prompts anyone over the age of 40 (which means us too) to seem to recall whole winters where the temperature never went above 20 degrees.
The bottom line – it’s winter. Those of us above the Mason-Dixon Line should have the necessary gear to make it through a few days of real cold. For those of you who aren’t used to it dipping below 65 – gloves, scarves, extra socks and let your car warm up for at least 10 minutes before heading out. That about covers it. Cold weather in January just doesn’t seem like something that warrants this much excitement. After all, it’s not like a blogworthy pharmaceutical case out of Idaho. Now that’s news.
The case is Wilson v. Amneal Pharmaceuticals, L.L.C., 2013 U.S. Dist. LEXIS 181953 (D. Idaho Dec. 31, 2013). Plaintiff alleged he developed Stevens-Johnson Syndrome (a severe skin condition) as a result of taking the generic version of the prescription antibiotic Bactrim, manufactured by the defendant. Attached to its answer to the complaint, Defendant included the first FDA approval of Generic Bactrim, the FDA’s acknowledgement of transfer of ownership of the ANDA to the defendant, and three versions of the label for Generic Bactrim. Id. at *4-5. When the defendant moved to dismiss the complaint, it asked the court to take judicial notice of those documents as well as the FDA approval letter for brand name Bactrim and two FDA approvals of label changes for the brand name drug. Id. at *6. Plaintiff objected to the judicial notice request, arguing that defendant’s motion should be converted to a motion for summary judgment and that in turn plaintiff be afforded an opportunity to conduct discovery before the motion was ruled on.
The opinion includes a nice discussion of the standard for judicial notice. See id. at *12-21. While the general rule is that the court is bound by the four corners of the pleadings on a motion to dismiss, it may also consider “material that is properly submitted as part of the complaint” and “matters of public record.” Id. at *12-13. As for public records, the court placed
particular emphasis on material that
is made publicly available by government entities on the internet, and neither party disputes the authenticity of the websites or the accuracy of the information displayed on the website.
Id. at *13. Since the court had “no difficulty” finding all of the FDA approval letters on the FDA website, it granted defendant’s request for judicial notice of those documents as public records. Id. at *15. As for the labels, the court agreed with defendant that they were incorporated by reference in the complaint. Plaintiff’s failure to warn claim “is dependent upon the label, and referenced by [plaintiff’s] statement that [Defendant] failed to give proper notice and instructions.” Id. at *16.
The court also concluded that FDA approvals and drug labels do not contain the type of disputed facts that would warrant against judicial notice:
It is difficult to conceive in this context why the Court is unable to consider the undisputed facts contained in the letters, or the contents of the labels, when the facts under consideration and contained therein are not stating opinions. Moreover, [plaintiff] has not come forward with a persuasive argument or contrary facts disputing the contents of the FDA letters or the authenticity of [defendant]’s labels. Although [plaintiff] argues that the Court may not take judicial notice of the contents of the letters because they reference other events, papers, or documents, the Court is not relying upon the entirety of the letters’ contents. Rather, the Court is being asked to take judicial notice of when certain approvals occurred, and what was being approved–whether it was the transfer of the ANDA for Generic Bactrim, or the labels for Brand Name Bactrim and what those labels stated. These are proper facts not subject to reasonable dispute of which the Court may take judicial notice, and the Court will do so.
Id. at *19-20.
After granting the request for judicial notice, defendant’s motion remained a Rule 12(b)(6) motion to dismiss. And the rest of the opinion is a strong generic preemption decision under Idaho law. Idaho adheres to the Restatement (Second) of Torts §402A. So, plaintiff’s claims essentially boiled down to design defect and failure to warn (the court also tossed out the implied and express warranty claims for lack of privity, see id. at *42-46). And the court found both claims preempted under Mensing and Bartlett.
Preemption of the failure to warn claim is hardly shocking, but we like to see it in print anyway. What also wasn’t shocking was plaintiff’s attempt to re-state his failure to warn claim as a failure to update claim. Admittedly, plaintiffs have had some success getting around preemption by alleging that a generic manufacturer failed to timely update its label after a brand label change. We disagree with those rulings, but this court didn’t have to rely on preemption to dismiss the claim here:
A claim against Amneal for failure to update its warning to reflect labeling changes made by the brand name manufacturer was not sufficiently pleaded. Count Four, for failure to warn, does not specifically state that Amneal failed to update its warnings and instructions, the lag between the updates, how the lag damaged [plaintiff], or any of the specifics required to satisfy Fed. R. Civ. P. 8. Rather, Count Four claims only that Amneal failed to adequately warn consumers of the dangers from taking the drug. As such, Count Four does not satisfy the pleading standard under Rule 8 for pleading a failure to update claim.
Id. at *35-36. Further, the court found that any attempt to amend the complaint to state such a claim would be futile because “all three versions of the drug label submitted by Amneal contain the very warning at issue–the warning that [plaintiff], by taking the drug, could develop a severe and life threatening skin rash, or Stevens-Johnson syndrome. This aspect of the warning label did not change, and was required since 2002.” Id. at *36.
Plaintiff didn’t fare any better trying to avoid Barlett preemption of his design defect claim. In a design defect case, the question is whether the product can be designed “so as to eliminate unreasonable risks of foreseeable injuries.” Id. at *23. But, in Bartlett, “the Supreme Court held redesign is not possible because of the FDCA’s requirement that generic drugs be chemically equivalent to the brand-name drug.” Id. at *38. Therefore, the only way for a generic manufacturer to reduce the risk is to strengthen the warning – which they also cannot do. Thus, design defect claims are also preempted.
Good news out of Idaho. More good news – only 165 days until summer.