In cases of defective medical devices, I rely heavily as a pharmaceutical liability lawyer on the testimony of experts who can explain the medical events and causes behind my clients’ injuries. So I was interested to see an 11th U.S. Circuit Court of Appeals ruling excluding certain testimony from one victim’s treating doctors, which ended her case. In Williams v. Mast Biosurgery USA, Wanda Williams of Georgia sued the maker of SurgiWrap, a surgical barrier used on her reproductive system. She alleged that SurgiWrap tore holes in her colon, requiring doctors to remove part of it and giving her a serious infection.
Williams’ gynecologist, Dr. Adcock, wanted to remove adhesions (buildup of tissue between organs, often from surgery) from her abdomen to increase her chances of conceiving. After surgically removing the adhesions, Adcock put SurgiWrap on the area to prevent more adhesions. A month later, Williams came back to the office with pain, fever, diarrhea and other problems. Adcock admitted her to the hospital, where another doctor found hard pieces of plastic inside her colon, some embedded in the walls of the organ. Surgery to repair the damage found more pieces of plastic in her colon, ultimately requiring part of it to be removed and doctors to give Williams a colostomy (opening in the abdomen for removing feces).
Williams sued, alleging SurgiWrap had a manufacturing defect that caused her injuries. She asked all of the doctors who treated the problem to testify as experts, but Mast challenged their testimony. After their depositions, the court ruled that the doctors had offered a mix of lay, expert and inadmissible testimony. Importantly, their testimony that SurgiWrap was the foreign body was ruled inadmissible. Because there was no admitted testimony establishing that SurgiWrap was defective, the court granted summary judgment to Mast.
Williams appealed, arguing first that the court should have admitted testimony that SurgiWrap was defective. The Eleventh disagreed. Treating physicians like these are not always experts, the court wrote. When they offer a hypothesis rather than an account of how they treated the patient, they are experts, and thus subject to the test of Daubert v. Merrill Dow Pharmaceuticals. Because the doctors fail this test, their testimony was correctly excluded, the court wrote. Williams also cannot use lay testimony from Adcock as evidence for her claim, it said. Adcock’s admissible testimony said the only substance left in her body was the SurgiWrap, but the court said it does not necessarily follow that SurgiWrap was defective. No admissible evidence explained whether it was performing as intended or whether it caused the injury. Thus, the Eleventh upheld the trial court’s ruling ending the case.
As a defective medical device attorney, I am disappointed that Williams did not get a chance to present her claim after such a serious injury. Expert witnesses are usually not treating physicians, and this ruling showcases some of the reasons why. These doctors have personal experience with the patient and the problem, but not always the expertise necessary to identify the product and explain how it is supposed to work. As a result, plaintiffs who rely on their treating physicians to be experts can suffer the same fate Williams did — having the case dismissed entirely. Those patients may still call their doctors as witnesses, but as a dangerous medical device lawyer, I prefer to use separate experts to establish vital evidence.
If you or someone in your family suffered a serious injury because of a medical device you thought you could trust, Carey, Danis & Lowe can help. For a free, confidential evaluation of your case, contact us through the Internet or call 1-877-678-3400 today.
Similar blog posts:
Artificial Hip Manufacturer Gets Second FDA Warning Letter for Sterilization Problems
FDA System for Tracking and Announcing Medical Device Recalls Faulted as Recalls Soar
Transvaginal Surgical Mesh is the Subject of a FDA Public Health Notification