Bergman v. Johnson & Johnson

Background

The plaintiffs brought a personal-injury products-liability action concerning Ethicon pelvic mesh devices. Sarah Bergman was implanted with Gynecare TVT and Gynemesh PS devices, and Patricia Budnik was implanted with a Gynecare Prolift device. Both plaintiffs later developed medical complications that required removal of their devices.

The plaintiffs’ first amended complaint asserted fourteen claims. In an earlier order, Chief Judge John R. Tunheim dismissed eleven claims entirely and part of one claim without prejudice, leaving negligence based on failure to warn, strict liability based on failure to warn, and loss of consortium. The plaintiffs then sought permission to file a second amended complaint. They proposed adding factual allegations supporting negligent design, negligent failure to warn, and strict-liability design-defect theories. They also sought to revive three fraud-related claims: fraudulent concealment, constructive fraud, and common-law fraud. The plaintiffs expressly withdrew claims for strict-liability manufacturing defect, gross negligence, negligent infliction of emotional distress, breach of warranty, negligent misrepresentation, unjust enrichment, and punitive damages.

Legal standard

Under Federal Rule of Civil Procedure 15(a)(2), a court should freely allow an amended pleading when justice requires, but it may deny leave for reasons including repeated failure to correct deficiencies, undue prejudice, bad faith, or futility. An amendment is futile if the proposed complaint could not survive a motion to dismiss for failure to state a plausible claim under Rule 12(b)(6).

Federal Rule of Civil Procedure 9(b) imposes a heightened pleading requirement for fraud. A party alleging fraud must state the circumstances with particularity, including the relevant details about who acted, what was said or done, where and when it occurred, how it was fraudulent, and what resulted.

Negligence and design-defect amendments

The defendants argued that the proposed negligence amendments improperly repeated a previously dismissed negligent-manufacturing theory and included other negligence allegations that were not independent causes of action under Minnesota law. The plaintiffs confirmed at the hearing that they were not pursuing negligent manufacturing and that the challenged allegations supported only negligent design, negligent failure to warn, and strict-liability design-defect claims.

The court concluded that the alleged actions—such as inspecting, testing, labeling, monitoring, and conducting post-market activities—could be considered as part of the negligent design or failure-to-warn theories at the pleading stage. The court therefore found no basis to deny the amendments as to Count I or Count II. It granted the plaintiffs’ motion to amend as to the negligence and strict-liability design-defect amendments proposed in those counts.

Fraud-based amendments

The court found that the proposed second amended complaint still did not satisfy Rule 9(b). Although the complaint added allegations about employees’ emails concerning problems with the devices and added detailed allegations about the plaintiffs’ injuries and device-removal surgeries, it did not connect the alleged suppression of information to the specific information the plaintiffs or their physicians received and relied on.

The complaint also alleged that Chris Hofschild, identified as a defendants’ sales representative, and Dr. Dennis Miller, identified as a retained preceptor or key opinion leader, provided Dr. Michael Valley with false or inaccurate information about the Prolift device on or about July 25, 2005. The court found that this allegation supplied some information about who was involved and what information was at issue, but did not explain where the interaction occurred, why the information was provided, how it was provided, or how Dr. Valley relied on it. The court also noted that the allegation concerned only Budnik and the Prolift device and did not include a similar allegation concerning Bergman or her devices.

Because the proposed amendments did not cure the fraud pleadings’ lack of specificity or adequately connect the alleged fraud to the plaintiffs’ injuries, the court found those amendments futile. It therefore denied leave to amend as to the fraud-based amendments in Counts VIII, IX, and X. The court did not reach the defendants’ argument about the special relationship required for a constructive-fraud claim.

Disposition

The court ordered that the plaintiffs’ Motion for Leave to File Their Second Amended Complaint was GRANTED as to the negligence and strict-liability design-defect amendments proposed in Counts I and II, and DENIED as to the fraud-based amendments proposed in Counts VIII, IX, and X. The plaintiffs were directed to file an amended pleading consistent with this order and the forthcoming order on the defendants’ pending motion to sever.