Jorden v. Covidien, LP.

Background

Shari Annette Jorden brought a products-liability action against Covidien, LP. and Medtronic, Inc. She alleged that the defendants manufactured the Parietex Optimized Composite Mesh implanted during her December 2014 laparoscopic ventral hernia repair. She alleged that the mesh failed and that she later required surgery in September 2018 to repair a recurrent hernia and partially remove the mesh.

The complaint asserted two claims: strict liability based on failure to warn and negligence. It alleged that the product had a high rate of failure, injury, and complications; that defendants failed to warn about known problems; and that the mesh’s design and manufacture contributed to its failure. Defendants moved to dismiss all claims and moved to dismiss or strike Jorden’s request for restitution or disgorgement. They also asked the court to take judicial notice of an FDA website and the product’s instructions for use.

Statute of Limitations

The court explained that California law applies a two-year statute of limitations to both products-liability claims and negligence claims for personal injury. Defendants argued that Jorden’s claims accrued in June 2017, when she reported concerns that her hernia was recurring.

The court rejected that argument. It treated September 2018 as the earliest accrual date alleged in the complaint because the alleged mesh failure, resulting injury, and surgery occurred then. Jorden filed suit in September 2019, within two years of that date. The court therefore denied defendants’ motion to dismiss all claims as untimely.

Strict-Liability Failure-to-Warn Claim

Under California law, a manufacturer may be strictly liable for injuries caused by failing to warn about known or reasonably knowable dangers. The court concluded that Jorden pleaded more than a general assertion that the warnings were inadequate. The complaint identified alleged risks, including that the mesh could contract over time, increase tension where it was secured, and eventually tear. It also alleged that the mesh tore and that the tear led to her later hernia-repair surgery.

The court denied the motion to dismiss the strict-liability failure-to-warn claim.

Negligence Claims

The court held that Jorden adequately alleged negligent failure to warn. The complaint identified the alleged warning deficiencies, connected them to her injury, and alleged that defendants owed her a duty of care because of their involvement with the product. The court denied the motion to dismiss that claim.

The court also held that the complaint adequately alleged negligent design and manufacturing defects. It cited allegations that defendants knew or should have known that the product’s polyester component was more likely to tear and cause a severe inflammatory response than polypropylene, despite the product’s absorbable collagen barrier. The complaint also connected the alleged tear to Jorden’s subsequent surgery. The court denied the motion to dismiss these negligence theories.

To the extent Jorden attempted to assert fraud as part of her negligence claim by alleging misrepresentations about the product’s safety, effectiveness, and suitability for human use, the court granted defendants’ motion to dismiss. The court found that the complaint did not satisfy fraud’s heightened pleading requirement.

Restitution and Disgorgement

The court granted defendants’ motion to dismiss or strike Jorden’s demand for restitution or disgorgement. It reasoned that restitution may be available when a defendant obtained a benefit through fraud, duress, conversion, or similar conduct, but Jorden alleged only failure to warn and negligence and did not allege such conduct.

Judicial Notice

The court denied as moot defendants’ request for judicial notice. It stated that the FDA website and the product’s instructions for use were not necessary to resolve the motion to dismiss.

Disposition

The court denied defendants’ motion to dismiss all claims. It granted the motion to dismiss the fraud allegations to the extent they were included in the negligence claim. It granted the motion to dismiss or strike Jorden’s demand for restitution or disgorgement, and denied as moot the request for judicial notice. Judge William Alsup signed the order.