CHICAGO — A federal appeals panel has overturned a ruling that ended a lawsuit from a woman who alleged a faulty medical device caused her injury, determining she filed her initial complaint in a reasonable amount of time.
U.S. District Judge Mary Rowland granted summary judgment to Johnson & Johnson and subsidiary Ethicon after determining the plaintiff, Patricia Stark, should have realized well before 2018 that a pelvic mesh device she had implanted in 2007 might have had a manufacturing defect. Stark brought that decision to the U.S. Seventh Circuit Court of Appeals, which issued its opinion Aug. 24.
Seventh Circuit Judge David Hamilton wrote the opinion; Circuit Judges Frank Easterbrook and Diane Wood concurred.
According to Hamilton, Stark’s relevant medical history began in 2006 when her doctor diagnosed stress urinary incontinence and presented as an option the use of a mesh TVT-Obturator, made by Ethicon. Such mesh products have been prescribed to support weakened organs or tissues, often to treat stress incontinence or pelvic organ prolapse.
The implantation took place in February 2007, but it didn’t ameliorate the issue. Stark’s doctor said her Ehlers-Danlos Syndrome might be a factor in poor wound healing and other complications, but did not mention the mesh itself might be defective.
In early 2008 a second doctor recommended a different Ethicon mesh sling. During the May 2008 implementation, eroded mesh from the initial sling had to be removed. The second doctor said the EDS could make Stark’s body prone to erosion and again did not suggest a defective sling.
In 2015, a third doctor discovered mesh in Stark’s urethra but was unable to surgically remove the remainder of the original sling. All three doctors gave depositions in which they “identified EDS as a possible culprit,” Hamilton wrote, because of her weakened connective tissue.
In March 2018 Stark spoke with a friend who is a lawyer. That led to a referral to a pelvic mesh litigation specialist whom Stark retained that June. She filed her lawsuit In September 2018, alleging the initial sling was defective.
According to the panel, claims like Stark’s are subject to a two-year statutory limitation. When Judge Rowland granted summary judgment, she said that window was long closed by the time Stark sued because, at the latest, Stark should have known by November 2015 she could have grounds for legal action.
However, Hamilton wrote, Rowland’s “view of the evidence is one reasonable view but not the only reasonable view.”
A reasonable jury, the panel continued, might determine Stark presumed her surgical complications were caused by EDS and then look no further. The record includes specific discussions in which different doctors raised that possibility and no evidence of a doctor suggesting the mesh could be defective.
“It is possible that mesh erosion did not strike Ms. Stark or her physicians as a potential product defect because erosion was a known risk of pelvic mesh implantation,” Hamilton wrote. “The FDA had approved the use of mesh implants knowing that they are not 100 percent effective. The fact that a known complication or failure occurs could reasonably be interpreted as a sign that such product or procedure-related failures could occur without anyone acting wrongfully.”
The panel also said a jury could find Stark’s reliance on EDS as the sole cause of the problem “increasingly unreasonable” given her detailed medical history, but that possible scenario only underscores that a “genuine dispute of material fact” exists such that summary judgment was improper.
“Stark — like all other patients — should not be penalized for trusting her physicians’ advice and not suspecting too quickly that her poor medical outcome was caused by a negligent actor,” Hamilton wrote. “Medical treatment of human disease can be complex and full of uncertainty. Success is not guaranteed, and a surgery’s ‘failure’ or shortcomings should not necessarily be sufficient to tell a patient that she should start investigating possible claims against her physicians or the manufacturers of the products they used. Although we have made this point repeatedly in medical malpractice cases, it applies with equal force to product liability claims.”
The panel reversed Rowland’s ruling and remanded the complaint for further proceedings.
Stark has been represented in the action by attorneys Karen Enright and Thomas O. Plouff, of the firm of Costello McMahon Gilbreth & Murphy, of Chicago.
Johnson & Johnson has been represented by attorneys Charles A. Byrd, Susanna M. Moldoveanu and Amy M. Pepke, of the firm of Butler Snow,with offices in Memphis, Tennessee, and Ridgeland, Mississippi; and attorney Sherry A. Knutson, of Tucker Ellis, of Chicago.