James v. Coloplast Corp.

Background

Shawna Lynn James alleged that the Altis Single Incision Sling System, a synthetic mid-urethral sling designed and sold by Coloplast, caused injuries and complications after it was implanted during surgery to treat stress urinary incontinence. She alleged that the product was biologically incompatible with human tissue and that its polypropylene material caused a severe foreign-body reaction and chronic inflammation.

James asserted claims for negligence, defective design, failure to warn, breach of express and implied warranties, unjust enrichment, fraud, negligent misrepresentation, violations of Minnesota and Oklahoma fraud and deceptive-trade-practices laws, violation of Minnesota’s False Statements in Advertising Act, and violation of Minnesota’s Prevention of Consumer Fraud Act. Coloplast moved for summary judgment on all claims and moved to exclude testimony from James’s experts.

Before implantation, James’s medical history included prior vaginal deliveries, vaginal atrophy, a pelvic fracture, ovarian cysts, prior pelvic and abdominal surgeries, osteoarthritis, chronic neck, back, hip, and knee pain, spinal conditions, and sacroiliac joint dysfunction. After implantation, she reported pelvic and lower-back pain, vaginal discharge and bleeding, and other symptoms. A doctor diagnosed a small sling exposure, and the sling was completely removed in October 2019. James continued to report various symptoms after removal.

Expert testimony

The court granted in part and denied in part Coloplast’s motion to exclude Dr. William Gold’s expert testimony. It granted the motion as to his specific-causation opinion—the opinion that the Altis caused James’s individual injuries—because Dr. Gold did not perform a differential diagnosis. A differential diagnosis is a process of considering scientifically plausible causes and ruling out less likely causes until the most likely cause remains.

The court found that Dr. Gold did not explain how he considered or ruled out James’s prior surgeries, injuries, and medical conditions. Because his opinion did not sufficiently connect the medical records and other materials he reviewed to his conclusion, the court found the opinion unreliable under the rules governing expert evidence. The court denied as moot the remaining portions of the motion concerning Dr. Gold and the other expert-exclusion motions.

Summary judgment

Summary judgment is appropriate when there is no genuine dispute about a fact that could affect the outcome and the moving party is entitled to judgment under the law. The court held that James failed to provide evidence creating a triable dispute on any claim.

The court granted summary judgment on James’s negligence and defective-design claims. Under Oklahoma law, a product-liability plaintiff must show that a defect caused the injury, existed when the product left the manufacturer’s control, and made the product unreasonably dangerous. The court held that James needed expert evidence about causation, and Dr. Gold’s specific-causation opinion had been excluded. Alternatively, the court held that James had not shown that the Altis was unreasonably dangerous. The court noted that the record did not establish what an implanting surgeon would expect from the product or that the Altis failed to meet those expectations.

The court granted summary judgment on the failure-to-warn claim. It held that the Altis’s Instructions for Use warned about the symptoms James attributed to the product, including bladder and vaginal pain, painful intercourse, vaginal bleeding, and urinary frequency. The court therefore found the warnings adequate as a matter of law. Alternatively, under Oklahoma’s learned-intermediary rule, James had not shown that a different warning would have caused her implanting surgeon to change the decision to use the Altis.

The court granted summary judgment on James’s Minnesota-law claims because her counsel agreed that Oklahoma law applied. It also granted summary judgment on the fraud claim because counsel stated that James would not continue pursuing it.

The court granted summary judgment on the negligent-misrepresentation, breach-of-express-warranty, and Oklahoma Consumer Protection Act claims because James had not shown reliance on a statement or representation by Coloplast. The record showed that James relied on her doctor’s advice and did not review Coloplast’s materials about the Altis, and she did not provide testimony from her implanting surgeon showing reliance.

The court granted summary judgment on the implied-warranty claim because James did not identify an applicable implied warranty under the Uniform Commercial Code or argue that Coloplast breached one. It also granted summary judgment on the unjust-enrichment claim because product-liability law provided an adequate legal remedy.

Order

The court ordered that:

The court directed that judgment be entered accordingly.