Cantrell v. Coloplast Corp.

Background

Angela Dawn Cantrell alleged that the Restorelle L surgical mesh implanted during surgery in January 2018 caused continuing pain and pelvic-floor dysfunction. She later underwent additional surgeries. Cantrell brought eleven claims against Coloplast Corp. and Coloplast Manufacturing US, LLC. Coloplast moved for summary judgment on all claims and moved to exclude testimony from Cantrell’s six experts. Cantrell opposed the expert motions but opposed summary judgment only as to negligent design, design defect, and failure to warn.

Expert-testimony rulings

The court applied Federal Rule of Evidence 702, which requires expert testimony to be relevant, reliable, and helpful to the fact-finder, along with disclosure requirements under Federal Rules of Civil Procedure 26 and 37.

- Dr. Alan Garely: The court granted Coloplast’s motion to exclude his testimony. His report addressed products intended for transvaginal implantation and did not include Restorelle L, which was implanted transabdominally. The court found that the distinction between those implantation methods was material and that his disclosed opinions would not help the jury decide issues involving Restorelle L. - Dr. Jimmy Mays: The court granted the motion in part and denied it in part. Dr. Mays could testify generally about polypropylene degradation and the possibility that the mesh’s surface layer degrades in the body. He could not testify that the body continually releases oxidizing agents, about the specific properties of Coloplast’s mesh, that the mesh’s antioxidants may be toxic, about the effects of stiffening mesh on the human body, or about clinical complications. The court denied exclusion of his general degradation testimony as irrelevant. - Dr. Peggy Pence: The court granted the motion in part and denied it in part. She could not simply summarize Coloplast’s internal documents except as a basis for her opinions. She could not testify about the scientific properties of polypropylene, the clinical background of disorders treated with mesh, informed consent, or Restorelle warnings to the extent she relied on data involving Ethicon devices. The court allowed her testimony about the adequacy of Coloplast’s testing, warnings and instructions for use in other respects, industry standards, clinical testing, and post-market surveillance. The court denied as moot the motion concerning testimony about disclosures to the Food and Drug Administration because Cantrell said she did not intend to offer that testimony. - Dr. Susan K. Theut: The court granted Coloplast’s motion in part and denied it in part. Dr. Theut could not testify that Restorelle L caused Cantrell’s psychological injury because her report did not provide a causation opinion. - Dr. Bruce Rosenzweig: The court granted the motion in part and denied it in part. He could not testify about transvaginal mesh, safer alternatives that were not other medical devices, the safety of a “blind passage” implantation technique, Coloplast’s state of mind or conduct except as a basis for his opinions, or the design and testing of medical devices. The court allowed other testimony, including testimony about mesh characteristics and degradation based on his clinical experience and the relevant literature, and denied exclusion of his safer-alternative opinions insofar as they concerned other medical devices. - Dr. William Gold: The court granted the motion in part and denied it in part. It excluded his specific-causation testimony because his report did not explain how the materials he reviewed supported his conclusion that Restorelle L caused Cantrell’s symptoms. It also excluded his testimony about polypropylene mesh properties, clinical trials, and adverse-event monitoring. The court allowed his testimony in other respects, including testimony about Cantrell’s future medical needs, and denied as moot the motion concerning corporate culture.

Choice of law

The court applied Minnesota’s choice-of-law rules because the case was in federal court based on diversity jurisdiction. It found an actual conflict between California and Minnesota law and concluded that either state’s law could constitutionally apply. California had the more significant contacts because Cantrell resided there and was implanted with Restorelle L there; Minnesota’s main contact was Coloplast’s headquarters. The court therefore applied California law.

Summary judgment

The court granted Coloplast’s motion for summary judgment.

For negligent design, California law required Cantrell to prove that a product defect caused her injury through competent expert testimony establishing causation within a reasonable medical probability. Because Dr. Theut’s and Dr. Gold’s specific-causation testimony was excluded, the court held that Cantrell could not prove causation as a matter of law.

The court granted summary judgment on the strict-liability design-defect claim for the same lack of admissible causation evidence. Independently, the court held that California law does not allow a strict-liability design-defect claim involving an implanted medical device. Cantrell conceded that California law prohibits such claims.

The court also granted summary judgment on failure to warn. Cantrell lacked admissible specific-causation evidence, and the court additionally concluded that Coloplast had shown that a different warning would not have changed the outcome. The surgeon who implanted the mesh testified that he did not recall reading the product’s instructions for use and instead relied on medical literature. Cantrell provided no evidence creating a genuine dispute on that issue.

Disposition

The court granted Coloplast’s motion to exclude Dr. Garely’s opinions and testimony. It granted in part and denied in part the motions to exclude Dr. Mays, Dr. Pence, Dr. Theut, Dr. Rosenzweig, and Dr. Gold. It granted Coloplast’s motion for summary judgment and ordered judgment to be entered accordingly.