The U.S Food and Drug Administration has been in the news lately for action taken – against antimicrobial soap!
The final rule on antimicrobial soaps was not a recall but a regulation establishing that over-the-counter antiseptic products intended for use with water are not generally recognized as safe and effective (GRAS/GRAE) and are considered misbranded. See the final rule on antiseptic soap.
While we can wash our hands of that problem, there are still a half dozen transvaginal pelvic meshes that remain on the market that have been found to be "defective" by impartial juries in a court of law.
It's not that the FDA can't issue a recall.
Statutorily it has the authority if, “There is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death,” Health and Human Services (FDA) can issue a recall. See (21 U.S.C. § 360h(e)(1));
The problem with the regulation of transvaginal surgical pelvic mesh is that the FDA has never issued a recall even though it claims it will take action, “When a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.”
In civil litigation, juries have found seven pelvic meshes to be “defective” in their design and or manufacture.
But the jury standard for “defective” may not be the FDAs.
Deborah KIotz, FDA media relations, tells MND, “defective” is not determined in civil litigation.
“I don’t think there’s a specific definition for the term “defective,” in the regulations, but in practice, a medical device is defective if it fails to meet all required specifications.”
The thinking is reflected in this guidance, Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements
It’s just that the government, whether the FDA or the Consumer Product Safety Commission (CPSC) finds protracted litigation doesn’t get the job done, it’s better to work cooperatively with the very industries it’s is regulating.
Two that have been found defective have been removed voluntarily and quietly by the companies - Prolift by Ethicon, and Avaulta by C.R. Bard.
With little fanfare, they went away.
Pinnacle was removed from the market voluntarily by Boston Scientific in May 2011 three years after it was launched. The company told the FDA “The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.”
So aside from the disappearing act of a number of pelvic meshes, at least four pelvic meshes that have been found to be defective in a court of law remain on the market.
Carlino v Ethicon – TVT made by Ethicon- February 10, 2016. A Philadelphia jury found Johnson & Johnson made a defective pelvic mesh and awarded Sharon Carlino $13.5 million, which includes $10 million in punitive damages. Philadelphia Court of Common Pleas, Case No. 1306-03470 before Judge Kenneth J. Powell Jr.
Outcome: TVT, made by Ethicon, a division of Johnson & Johnson, remains on the market and is referred to as the “standard of care” or the “gold standard.”
Stevens v. Boston Scientific Corp – all mesh made after 2012. A complaint filed in January in federal court in Charleston WV by the Mostyn Law firm accused the Massachusetts-based company of smuggling polypropylene resin in from China under regulators eyes in both countries. The material has already been tested to be substandard, yet earlier this year, the FDA indicated it would let Boston Scientific investigate its own products to see if they were substantially similar to pelvic mesh made from its older Marlex.
Stevens v. Boston Scientific Corp., et. al., 2:16-0265, U.S. District Court, Southern District of West Virginia (Charleston).
Outcome: Boston Scientific still sells polypropylene mesh, made from the substandard raw resin from China. The company confirmed to Scottish reporter, Marion Scott, that all mesh products they have made in the past three years contain the Chinese resin. If you consider the requirement to “meet required specifications,” Boston Scientific’s pelvic mesh made after 2012 could all be recalled. The FDA is letting Boston Scientific determine if its own mesh is substandard.
Hammons v. Ethicon, Prolift made by Ethicon. In December 2015 a Philadelphia jury ruled in favor of Patricia Hammons and awarded her $5.5 million in damages over its defectively designed Prolift pelvic mesh. The jury later added $7 million in punitive damages to bring her total jury award to $12.5 million. Patricia L. Hammons v Secant Medical, Ethicon, in the Philadelphia Court of Common Pleas, Case No. 2:13-cv-04086.
Outcome- Prolift was quietly removed from the market voluntarily in mid-2012 along with three other meshes that were giving the company problems in terms of consumer complaints.
Linda Batiste v. Ethicon, April 3, 2014, TVT-O. In this Dallas trial, the jury found the TVT-O (transvaginal tape obturator) made by Johnson & Johnson was defective and awarded Ms. Batiste $1.2 million. Batiste v. McNabb, case number. 12-14350, District Court for the 95th Judicial District, Dallas County Texas.
Outcome – Ms. Batiste has since died of cancer. In November 2015, a Texas appellate court reversed her win arguing she didn’t adequately prove an alleged defect in the product caused her injuries. Ethicon still markets the TVT-O.
Huskey v. Ethicon, September 2014, TVT-O. Jo and Allen Huskey were awarded $3.27 million in September 2014 due to her injuries from the Ethicon TVT-O. There were no punitive damages. It was the first bellwether jury trial naming Ethicon in the MDL in Charleston, WV and the first time a jury decided TVT-O was defectively designed. Huskey et al, v. Ethicon (2:12-cv-05201), in the U.S. District Court for the Southern District of West Virginia.
Outcome – J&J asked for a new trial and in August 2015 Judge Goodwin denied a Motion for Judgment or for a new trial. TVT-O remains on the market.
Perry v. Ethicon, March 5, 2015, TVT Abbrevo Midurethral Sling. Coleen Perry won her product liability trial against Ethicon and was awarded $5.7 million. She had been implanted with J&J’s Abbrevo mini-sling as a treatment for incontinence. The award includes $5 million in punitive damages. Abbrevo mini-sling was found defective in its design and in its instructions to doctors.
California case is Perry v. Luu, 1500-CV-279123-LHB, Superior Court of California, Kern County (Bakersfield).
Outcome – The Abbrevo sling which was an improvement over previous treatments, was introduced in 2010 and expected to bring $1.7 billion a year by 2017. Abbrevo remains on the market. J&J announced at the time of the verdict that it planned an appeal.
Cisson v C.R. Bard, June 2013, Avaulta Pelvic Support System, Avaulta Plus. Donna Cisson was awarded $2 million in her claim against mesh manufacturer C.R. Bard over the Avaulta Plus surgical mesh she had implanted.
Outcome – The Cisson $2 million in compensatory and punitive verdict against C.R. Bard was upheld by an Appellate court in January 2016. Avaulta was taken off the market by Bard in July 2012.
Christine Scott v C.R. Bard, Bard Avaulta. July 2012. The jury was instructed on negligence theories, specifically negligent design.
The jury found Bard was negligent in the design of the Avaulta Plus and that the defect caused Scotts’ injury. Christine Scott et al. v. C.R. Bard Inc.,
case number F066039, in the Court of Appeal of the State of California, Fifth Appellate District.
Outcome- In November 2014, a California Appeals Court affirmed the $5.5 million verdict against C.R. Bard and the gynecologist. This was the first case to reach a verdict and after exhausting all appeals, Bard had to pay Scott and her husband $3.6 million since the jury assigned 40% of the blame on her physician.
Eghnayem et al v Boston Scientific, November 2014, Pinnacle Pelvic Mesh Repair Kit. A Miami jury decided November 13, that the Pinnacle was defectively designed and its instructions to physicians were also defective and the company had failed to warn adequately about the dangers of the Pinnacle. Four women were plaintiffs in this case who were awarded $26.7 million or about $6.7 to $6.7 million each. No punitive damages were awarded. (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 14-24061, S.D. Fla.).
Outcome – Pinnacle was removed from the market by Boston Scientific May 2011 three years after it was launched after a growing body of adverse events or complications were reported. It was a Class 2 or moderate risk Device Recall under FDA rules. The reason for the recall – “The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.”
Tyree v Boston Scientific, November 2014, Obtryx midurethral sling. In November 2014, four plaintiffs proved theircase against Boston Scientific and were awarded a total of $18.5 million over damages suffered after they were implanted with the Obtryx midurethral sling used to treat incontinence. This was the second federal case in multidistrict litigation. Jurors decided the OBtryx was defectively designed and the company was negligent in its manufacture and design of Obtryx. The case is Tyree v Boston Scientific (2:12-cv-08633)
Outcome – Obtryx II remains on the market. Boston Scientific continues to train doctors on the use of its mesh products through its Pelvic Floor Institute. http://www.bostonscientific.com/en-US/medical-specialties/female-pelvic-medicine/pelvic-floor-institute.html
Salazar v Boston Scientific, September 2014. Obtryx Transobturator Midurethral sling system. A new record was reached in this $73.5 million award over her defective Obtryx TVT-O midurethral sling. Dallas District Court Judge Ken Molberg oversaw the trial (#DC 12 14349).
Outcome – At the time, the Salazar case was the highest award ever in transvaginal mesh litigation even after it was slashed in half in October 2014 due to tort reform. Now the highest jury award is $100 million.