HARTFORD, Conn. (Legal Newsline) - A woman who sued her doctor as well as Boston Scientific over an unsuccessful pelvic-mesh implant operation properly lost her case against all of the defendants, the Connecticut Supreme Court ruled, upholding the rule that only the doctor performing a procedure must obtain informed consent from the patient.
Lesly Fajardo sued her gynecologist, Lee D. Jacobs and the manufacturer of her Obtryx trans-vaginal mesh sling, Boston Scientific, over the implantation of the device to relieve stress urinary incontinence. Doctors were required to remove the mesh after she complained of continuing pain.
Farjardo accused Jacobs of failing to obtain her informed consent before referring her to urologist Edward Paraiso for surgery, as well as misrepresenting the risks and benefits of the procedure. She also claimed the sling was defective and violated Connecticut’s Product Liability Act.
The trial judge dismissed the case against Jacobs, ruling that a referring physician has no duty to obtain informed consent for a procedure to be performed by another doctor. The judge also dismissed the misrepresentation claims, saying Jacobs didn’t even know which type of device the urologist planned to implant in her. After a trial, the jury ruled for Boston Scientific on the product claims.
On appeal, Fajardo argued the judge misapplied the law on informed consent. She also complained that the judge improperly failed to inform the jury it could decide Obtryx was unsafe because there was a “reasonable alternative design” called tension free vaginal tape or TVT.
The Connecticut Supreme Court, in an opinion by Justice Raheem Mullins published in December, affirmed all of the trial court decisions over a lengthy partial dissent by one justice.
“When a physician refers a patient to a specialist for a consultation, it is the specialist—assuming that the ultimately performs the procedure at issue—who is solely responsible for educating the patient and obtaining her informed consent,” the court ruled.
As for the alternative design claim, the Supreme Court said Fajardo’s expert, Bruce Rosenzweig, criticized the Obtryx device and praised the class of devices known as TVTs, but failed to identify one single reasonable alternative for the jury to compare with Obtryx to determine it failed the risk-utility test.
“The plaintiffs did not point to a specific existing product on the market and demonstrate that its use would have reduced or avoided the risk of harm to Fajardo,” the court ruled. “At best, the plaintiffs took a scattershot approach, pointing to different alternatives to the Obtryx that included surgical options and a class of products known as TVTs.”
Justice Steven D. Ecker, in a partial dissent nearly as long as the majority opinion, disagreed with the majority’s conclusion that Fajardo’s expert failed to provide enough evidence to inform the jury about reasonable alternative designs. The jury should have been allowed to consider the risks and benefits of TVT products and determine whether they were so much safer than Obtryx as to make the Boston Scientific device unreasonably dangerous, Ecker wrote.
The plaintiffs were represented by Brenden P. Leydon and Jacqueline E. Fusco; Boston’s lawyers included Daniel B. Rogers and Proloy K. Das.