Mersilene Mesh, BiotecSA website
August 8, 2012 ~ An appeals court ruling in Mississippi has upheld a lower court dismissal of a $10 million vaginal mesh case against Johnson & Johnson’s Ethicon division.
The United States Court of Appeals Fifth Circuit filed the decision August 2, 2012 in the case against Ethicon by Deborah and Michael Smith.
Deborah Smith had a hysterectomy in 2001 along with pelvic organ prolapse which required additional surgery. Dr. Phillip Barksdale of the Women’s Hospital in Baton Rouge, Louisiana did the abdominal sarcoplexy April 12, 2002 using Mersilene mesh made by Ethicon, a division of Johnson & Johnson (J&J).
The court noted that the mesh had a package insert that said “No significant adverse clinical reactions to MERSILENE mesh have been reported. The use of nonabsorbable MERSILENE mesh in a wound that is contaminated or infected could lead to fistula formation and/or extrusion of the mesh.”
Dr. Barksdale said he was familiar with Mersilene mesh and had used it hundreds of times and was aware of the risks involved.
Deborah Smith experienced pain, vaginal discharge and by July of 2006 she was diagnosed with vaginal mesh erosion, sinus tract formation, pain, adhesions and rectocele. She was admitted to the hospital and stayed for five weeks. Smith became sick with sepsis (infection), renal insufficiency, pneumonia and respiratory failure.
The Smiths filed their complaint on October 16, 2007 in federal court in the Eastern District of New York which was later transferred to the Southern District of Mississippi. They claimed negligence, strict liability, breach of implied warranty of merchantability, breach of express warranty and loss of consortium. They had requested damages in the amount of $10 million.
Strike the Experts
The court noted the Smiths submitted the names of three experts on the day of a deadline. The witnesses included the expert testimony of Drs. Stuart Hart, Kyle Wohlrab, Robert Lloyd Goldstein, and William A. Hyman.
Ethicon argued the names were not sufficient and that the reasons those persons had been chosen needed to be stated under federal law. Ethicon layers filed numerous motions to strike the Smith’s expert witnesses based on lack of timeliness. The court also concluded the expert witnesses did not provide “factual support or reasons for their conclusions.”
Drs. Hart and Wohlrab had stated they believed Mersilene mesh caused vaginal erosion.
“Dr. Hart’s medical report did not address the actual question at issue in this case, which is not whether the Mersilene mesh caused Smith’s injuries, but whether the warning provided by the manufacturer in the Mersilene mesh documentation was sufficient and whether any inadequate warning caused Smith’s injuries.”
The defective product lawsuit was dismissed by the lower court in favor of Ethicon. The Smiths filed an appeal of that order on the basis that certain experts were not allowed to testify on their behalf. In addition, the Smiths also appealed being ordered to pay some legal fees to Ethicon for the alleged late filings.
The appellate court found the lower court’s evidentiary rulings were not an abuse of discretion and the Smiths did not factually state the inadequacy of the Mersilene warning and whether an adequate warning would have prevented the doctor from using Mersilene mesh.
An inadequate warning or a failure to warn can be one additional component of a defective product or product liability case.
The court granted Ethicon's summary judgment dismissing the case based on the “learned intermediary” defense.
The Mississippi court cited the “learned intermediary doctrine” as “a manufacturer of a prescription drug has no duty to warn the end user of the drug’s possible adverse effects.” In other words, the physician is the end user, the “learned intermediary” between the patient and manufacturer and the duty to warn stops with him or her.
The Mississippi rule also applies to medical devices.
Since the product label said there were “No significant adverse clinical reactions to Mersilene mesh,” the Smiths dug into the FDA database and found that was not true. There had been eight adverse event reports prior to 2002 of injuries associated with Mersilene mesh, three of which resulted from tears in the mesh. The Smiths had argued that information should have been on the mesh product warning on the package and if it had been, Dr. Barksdale would not have used Mersilene mesh.
Dr. Barksdale testified that he was aware of the risks of Mersilene but still thought the mesh was the best option for Mrs. Smith. If the doctor is the end user, that ends the argument if he was aware of some of the warnings.
The Smiths were ordered to pay the legal costs of Ethicon’s responses to late paperwork and ordered to pay costs to Ethicon.
Civil Action No. 3:08cv245 HTW-LRA
Mississippi Southern District Court
U.S. Court of Appeals 5th Circuit:
Background on Mesh production, UC Denver: