We have expressed our opinion on "failure to update" claims and have not hidden that we don't think much of them. Failure to update claims were manufactured by plaintiffs in response to PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) which basically took the legs out from under products liability suits against generic drug manufacturers. You know what we mean. Federal law requires that generic drug manufacturers' products have the same drug labeling and the same design as their innovator (brand) counterparts—the so-called "duty of sameness." Therefore, any claims for failure to warn or design defect are preempted by impossibility.
A "failure to update" claim is where a plaintiff alleges that a generic manufacturer did not update its labeling to match the most current FDA-approved changes to innovator labeling and that the failure caused an injury. Because that involves an FDA-imposed duty, it is easy to conclude that it looks a lot like a disguised form of FDCA enforcement barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). A few courts, however, disagree and have held such claims are not preempted. In In re: Fluoroquinolone Prods. Liab. Litig., MDL 2642, 2020 WL 6489186 (D. Minn. Nov. 4, 2020), the court said maybe.
The relevant facts are simple. On August 15, 2013, the FDA issued a Drug Safety Announcement requiring the warnings for all drugs containing fluoroquinolone be updated to "better describe the serious side effect of peripheral neuropathy." See https://www.fda.gov/media/86575/download. In November 2013, plaintiff ingested generic ciprofloxacin and suffered an adverse reaction. Plaintiff alleges that the generic manufacturer had not updated its label with the warning set forth in the FDA safety announcement at the time she used the drug. Id. at *1.
The court started its analysis by finding that the failure to update claim differs from Mensing because unlike the issue before the Supreme Court, here plaintiff is not asking the court to require generic manufacturers to provide additional warnings beyond those required of their brand counterpart. Because the claim is not about a stronger warning, it does not violate the duty of sameness and therefore does not implicate impossibility preemption. Id. at *3. For that reason, plaintiff's failure to warn claim is limited. She essentially must concede that the brand warning is adequate and therefore, if provided by the generic manufacturer, would have prevented her injuries. Id. at *4.
As noted above, implied preemption is another obstacle to the failure to update claim. Afterall, the requirement to update the warning label is one imposed by the FDCA. Under Buckman, a private citizen does not have the right to enforce a federal labeling requirement. But the court was willing to entertain a scenario where plaintiff could demonstrate that the failure to update is based on state law as well as a being a violation of the FDCA. In that case, the claim could thread the preemption needle. Id.
In sum, the court concluded that if a generic manufacturer failed to update its label to match the brand label, and the claim is limited to the "inadequacies of the non-updated label compared to the updated label," and there is a state law basis for the claim – it is "not conclusively preempted." Id. In this case, plaintiff did not sufficiently plead any of those elements to survive a motion a dismiss. Plaintiff did not limit her liability allegations only to the failure to update. In other words, all failure to warn claims except failure to update must go. Plaintiff also failed to allege how her failure to update claim is based in state law. Id. Because the court was saying "maybe" as opposed to "never," plaintiff is getting a chance to re-plead her failure to update claim.
Perhaps most importantly, however, the amendment is going to need to address causation. It is on this ground that other courts in the Eighth Circuit, and elsewhere, have dismissed failure to update claims. See id. at *6n.3. Where the learned intermediary has independent knowledge of the risk, the failure to update cannot be the proximate cause of plaintiff's injury. As the court noted, "even though failure to update claims are not necessarily preempted, they may be difficult to prove on the merits, particularly in terms of causation between the label and injury." Id. Here the generic and brand labeling already including warnings about peripheral neuropathy. Based on our own digging, we believe the brand manufacturer added the strengthened warning in July 2013. The FDA then made its safety announcement for all brand and generic drugs in the class to strengthen their warnings in August 2013. Regardless of whether it took the generic manufacturer had not updated its label by November, the information was out there. It was in the medical community. Further, we know from experience that physicians tend to rely on the brand labeling, not the generic. Often, the prescribing physician would never have seen the generic label – updated or not. So, "maybe" may get you over the first preemption hurdle, but causation looms large on the horizon.
Originally Published By Reed Smith, November 2020
This article is presented for informational purposes only and is not intended to constitute legal advice.