On March 19, 2021, Judge Martinotti found that the majority of plaintiffs’ claims are not preempted in the Allergan Biocell Textured Breast Implant Products Liability Litigation.
First, Judge Martinotti considered the plaintiffs’ failure to warn claims premised on both 1) Allergan’s failure to submitted PMA supplements to update product labeling and 2) Allergan’s failure to make adverse event reports to the FDA. (Ex. A, at p. 17.) On the former, the court determined that the “requirement that a PMA supplement be submitted when unanticipated adverse effects . . . only requires a submission to the FDA, which, depending on the FDA’s decision, may or may not translate into a mandatory label change.” (Id. at 21.) The court therefore concluded the label-based failure to warn claim was expressly preempted. (Id.) With respect to failure to report, applying the Restatement (Second) of Torts § 388, the court concluded device manufacturer’s state law duty to warn included reporting adverse safety events to the FDA. Accordingly, this claim was not preempted. (Id. at 23-25.)
Second, Judge Martinotti concluded that the manufacturing defect claim “constitutes a deviation from the design in violation of the PMAs” and was not preempted. (Id. at 27.) The court rejected Allergan’s contention that the plaintiff’s allegations were “disguised in manufacturing defect clothing,” but are “actually aimed at the PMA-approved processes.” (Id. at 25.) Alternatively, the court found that the current good manufacturing practices regulations and the FDCA’s adulteration provisions could also serve as parallel federal requirements. (Id. at 27.) In particular, the court found Allergan allegedly “violated state law and parallel federal requirements set forth at 21 C.F.R. § 820.30 by failing to,” among other things, “test production units under actual or simulated use conditions.” (Id. at 28.) Thus, “the Court finds Plaintiffs’ manufacturing defect claims are not preempted.” (Id. at 29.)
Third, Judge Martinotti concluded that “Plaintiffs’ claims concerning Allergan’s investigational devices used in an approved clinical trial are preempted.” (Id. at 30.) However, “Plaintiffs’ claims concerning Allergan’s tissue expanders and implants sold before the 2000 PMA are not preempted.” (Id. at 37.) Likewise, implants sold through the 510(k) process did not “trigger preemption.” (Id.)
Fourth, regarding implied warranty, Judge Martinotti agreed “implied warranty claims are not preempted, because they parallel violations of federal law: the BIOCELL implants are not merchantable due to the violations of federal requirements regarding manufacturing and labeling.” (Id. at 33.) Accordingly, “the Court concludes Plaintiffs’ implied warranty claims are not preempted.” (Id. at 34.)
Fifth, Judge Martinotti considered the claims for Negligent Misrepresentation and Breach of Express Warranty. The court held that “[t]o the extent these claims are based on Allergan’s statements not approved by the FDA, they are not preempted.” (Id. at 36.) Moreover, he found these claims to be “supported by adequate factual allegations.” (Id.)
Finally, the preemption section of the opinion ends with the following summarization:
In conclusion, the Court finds the following Plaintiffs’ claims are preempted and therefore dismissed: (1) label-based failure to warn claims; (2) claims challenging the safety or effectiveness of Allergan’s investigational devices used in an approved clinical trial; and (3) negligent failure to warn claims based on Allergan’s alleged failure to conduct post-PMA clinical studies. The above preemptions, however, do not apply to Plaintiffs’ claims concerning Allergan’s tissue expanders and implants sold before the 2000 PMA.(Id. at 37.)
Moze Cowper and Cowper Law LLP sit on the Plaintiff Steering Committee before Judge Martinotti in the federal MDL. Moze Cowper is also co-lead of the Allergan textured breast implant litigation JCCP in California before Judge Hogue. If you are implanted with Allergan textured breast implants, call Cowper Law now at 877.529.3707 for a free consultation.