McMillian v. Sanofi S.A.

Background

This case was transferred to the Northern District of California from the Eastern District of Louisiana, where it had been part of multi-district litigation concerning Taxotere, also known as Docetaxel, and alleged permanent hair loss. Regina McMillian used Taxotere from approximately October 3, 2013, through December 5, 2013, as part of breast-cancer treatment. Her proposed amended complaint alleged negligence based on failure to warn and strict products liability based on failure to warn.

McMillian filed the case in 2017 using the standard short-form complaint used in the multi-district litigation. The complaint incorporated the master complaint and included claims under California law. In 2019, the multi-district litigation court denied a request to remove the prior definition of the alleged injury as hair loss that became permanent six months after chemotherapy. In 2020, that court issued an order allowing certain plaintiff-specific factual amendments, including facts about medical care and communications with medical professionals. McMillian did not amend her short-form complaint under that process.

After the case was transferred back to this district, the court set a deadline for amendment of the pleadings. McMillian then moved for leave to file a proposed First Amended Complaint. The proposed complaint sought to remove the six-month injury definition, add allegations that she learned about the risk and suspected Sanofi’s conduct in late 2015 or early 2016, and add further punitive-damages allegations. Sanofi opposed the motion.

Legal standards

The parties disagreed about whether the court should apply Federal Rule of Civil Procedure 15(a)(2), which generally says courts should freely allow amendments when justice requires, or Rule 16(b)(4), which requires good cause to modify a scheduling order. The court did not resolve that dispute because it concluded that McMillian could not satisfy either rule.

Under Rule 15(a)(2), courts consider factors including undue delay, bad faith, repeated failure to correct deficiencies, prejudice to the opposing party, and whether the proposed amendment would be futile. Under Rule 16(b)(4), the central consideration is the diligence of the party seeking to change the schedule.

Court’s analysis

The court viewed the proposed amendment as resembling a request to reconsider earlier rulings by the multi-district litigation court. It concluded that the prior rulings and McMillian’s failure to use the amendment process established in that litigation weighed heavily against allowing the new motion. The court also stated that it could not approve what it characterized as an attempt to circumvent those rulings, including prior decisions rejecting similar allegations about when individual plaintiffs saw advertisements linking Taxotere to permanent hair loss.

Applying Rule 15(a)(2), the court found that allowing the amendment at that stage would prejudice the defendants by undoing years of litigation and discovery, requiring discovery to be reopened, and causing additional delay. The court also found undue delay because McMillian had not amended her complaint during the earlier period allowed for plaintiff-specific allegations and had not explained why she failed to do so.

The court separately rejected the proposed additional punitive-damages allegations as unnecessary. The operative complaint already incorporated allegations from the Second Amended Master Complaint, which sought both compensatory and punitive damages. The court therefore found no need to amend the complaint to add a punitive-damages claim.

Disposition

Judge Susan Illston denied McMillian’s motion for leave to file an amended complaint. The opinion did not rule on the underlying failure-to-warn claims.