Nichols v. Covidien LP
- Edward Chen
- 3:20-cv-06836
- U.S. District Court · Northern District of California
- 9
In Nichols v. Covidien LP, Judge Chen granted in part and denied in part the defendants’ motion to dismiss product-liability claims.
Donald Nichols and the defendant entities involved in manufacturing and distributing the surgical stapler; Nichols’s manufacturing-defect and failure-to-warn claims were allowed to proceed, while his negligent-design claim was dismissed without prejudice.
What happened
Nichols v. Covidien LP concerns Donald Nichols’s allegations that a surgical stapler used during his rectal-cancer surgery malfunctioned because it lacked components and caused serious complications. He sued the companies involved in making and distributing the stapler.
The court dismissed the negligent-design claim without prejudice because the complaint did not clearly explain why the stapler’s design was defective. The court denied dismissal of Nichols’s manufacturing-defect and failure-to-warn claims, allowing those claims to continue.
Judge Edward Chen therefore granted in part and denied in part the defendants’ motion to dismiss under the rule governing whether a complaint states a legally sufficient claim.
The detailed version
- Nichols v. Covidien LP · No. 3:20-cv-06836
- Edward Chen
- Feb. 26, 2021
Background
Donald Nichols alleges that an Endo GIA surgical stapler used during his September 2018 surgery at St. Joseph Hospital malfunctioned repeatedly. He alleges that the stapler lacked a sled component and one of two pin components, causing it to form an improper staple line. He further alleges that he suffered an anastomotic leak, peritonitis, prolonged hospitalization, and significant scarring.
Nichols sued the entities responsible for the stapler’s manufacture and distribution. His Second Amended Complaint asserted strict products liability for a manufacturing defect, common-law negligence, and strict products liability for failure to warn. The defendants moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), which tests whether a complaint adequately states a legally sufficient claim.
Manufacturing-Defect Claim
The court held that Nichols plausibly alleged a strict-products-liability manufacturing defect. Such a claim requires allegations that the plaintiff was injured, that the product was defective, and that the defect existed when the product left the defendant’s control.
The court found sufficient Nichols’s allegations that the stapler lacked the sled and pin components, differed from its intended design and other units, was defective when it left the defendants’ control, and caused his injuries. The court therefore denied the defendants’ motion to dismiss this claim.
Negligent-Design Claim
Nichols alleged that the stapler’s manual operation made it defectively designed because it could fail to fire staples properly even when used correctly. The court found this theory too broad and insufficiently specific to give the defendants fair notice of why the Covidien Endo GIA stapler was defectively designed. The court granted the defendants’ motion to dismiss the negligent-design claim without prejudice.
Failure-to-Warn Claim
Nichols alleged that the defendants knew the stapler malfunctioned frequently but failed to provide adequate warnings. He also alleged that the defendants used the Alternative Summary Reporting system to keep information about stapler incidents out of the publicly accessible Manufacturer and User Facility Device Experience database.
The court concluded that this database-related failure-to-warn theory was plausible. It reasoned that public reporting could have provided feasible warnings to doctors and patients about the stapler’s dangers, including the possibility that sled and pin components were missing. The court therefore denied the defendants’ motion to dismiss the strict-products-liability failure-to-warn claim.
Disposition
The court granted in part and denied in part the defendants’ motion to dismiss. It granted the motion to dismiss the negligent-design claim without prejudice and denied the motion to dismiss the strict-products-liability manufacturing-defect and failure-to-warn claims. Judge Edward Chen’s order disposed of Docket No. 27.
Read the full 9-page opinion on CourtListener, the free public archive maintained by the Free Law Project.