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Pinnacle Pelvic Floor Repair kit
After a two week trial, Boston Scientific won its first product liability trial over transvaginal mesh. The jurors returned the verdict around 5 pm Tuesday, July 29.
On March 9, 2010, Diane Albright received the implant made by Boston Scientific – the Pinnacle Pelvic Floor Repair Kit. According to her complaint, Albright suffered mesh complications including mesh erosion, infection, and chronic pain, among other complications.
She alleged the polypropylene mesh implant was defective in its design, manufacture and construction, the warnings were defective and that the Pinnacle did not conform to the warranty promise by Boston Scientific.
The trial went to the jury Monday after closing arguments. The jury rejected the defective product argument and decided that users received adequate informed consent. Eleven of the 13 jurors had to agree to the questions in the Boston Science Verdict Questions.
There are currently 12,804 similar cases filed in federal court in Charleston, West Virginia and almost 63,000 product liability lawsuits filed in the same federal court against six other manufacturers.
This state action was filed in Middlesex Co in Massachusetts, where Boston Scientific is headquartered.
The defense reportedly brought two witnesses forward - a scientist who did animal studies on the mesh and an ob-gyn. The plaintiffs survived a directed verdict motion on design defect and failure to warn.
Albright was represented by Fidelma l. Fitzpatrick and Jonathan D. Orent of Motley Rice.
Bloomberg reports (here) a Boston Scientific spokesman said:
"We are pleased with the outcome,” Denise Kaigler, a spokeswoman for Boston Scientific, said in an e-mail. “Patient safety is of utmost importance to Boston Scientific and we dedicate significant resources to deliver safe, high-quality products.”
The news source says the next vaginal mesh trial for Boston Scientific will be held in state court in Wilmington, Delaware.
The Pinnacle Pelvic Floor Repair Kit is no longer on the market in the U.S.
On May 10, 2011, Boston Scientific sent an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED” letter to all affected customers concerning its Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because ‘the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”
First Lost Action
This represents the first transvaginal mesh trial that has been decided in favor of the defendant.
In February 2013, nurse Linda Gross was awarded $11.1 million in her product liability case filed against Ethicon, a division of Johnson & Johnson. See background here.
C.R. Bard lost its case in a Bakersfield, California state court to Christine Scott who alleged permanent mesh-related injuries.
In the same Charleston, WV court, Donna Cisson won a $2 million jury award against Ethicon and in Dallas
Judge Joseph R. Goodwin
earlier this year, Linda Batiste was awarded $1.2 million in her case against Ethicon. See background here.
Last year, the Queen case against C.R. Bard settled on the day trial was to begin. See background here.
The Lewis case (Ethicon) did not survive a directed verdict motion filed by Johnson & Johnson and granted by federal Judge Joseph Goodwin. (background here).
The Complaint
Albright did not, according to her complaint, receive any informed consent about what could go wrong or mesh injuries which was “negligently designed and manufactured,” according to her complaint.
Neither Albright or her doctor were warned about the dangers of pelvic mesh or that there were safer alternatives to address her pelvic organ prolapse. She was diagnosed with a recurrent cystocele.
The complaint said Boston Scientific should have known about the complications associated with its product, according to the Albright Stamped Complaint
Those complications include the design and manufacture of the mesh, the raw plastic edges made of polypropylene, a polymer plastic that incites immune and foreign body reaction. The transvaginal placement introduces bacteria into the body; the biomechanical issues that result from the bio incompatibility of plastic mesh and delicate tissue; the pelvic mesh anchors placed too near major nerve routes; and the degradation of mesh over time.
*New- Still Ahead
August 11, the same court will be the setting of the next pelvic mesh trial, Cardenas v. Boston Scientific.
The plaintiff attorney is Michal Appel of Sugarman Rogers of Boston. Here is his link
