Mesh Medical Device News Desk, February 24, 2017 ~ One needs a scorecard to track the court happenings in transvaginal mesh litigation. While the March 6th trial of Mullins has been continued, the Huskey case appeal has concluded. March 13th is a Boston Sci trial in Philadelphia.
Judge Joseph Goodwin who is overseeing multidistrict litigation (MDL) in his West Virginia court has been busy. With tens of thousands of transvaginal mesh cases filed before him, he has vowed to move them along and out of the MDL.
This week has been very busy for the Mullins v. Ethicon et al case (Case No. 2:12-cv-02952), a trial of 24 or so women who live in West Virginia who were all implanted with the Ethicon TVT. It was to be the largest trial so far of mesh-injured women consolidating the proceeds into one large trial.
It has been continued and has not yet been rescheduled, according to the court. Mullins Order Doc.#1884 Continuing case, Feb 23 2017
Ed Wallace of Wexler Wallace law firm, who had three women in the Mullins MDL, is not aware why the case was continued. “We were ready to go and looking forward to proceeding, but we respect the court order,” he told Mesh News Desk.
Judge Goodwin, has sealed under court order the juror list and qualifying juror questionnaires and supplemental juror questionnaires for the Mullins trial. That court order is dated February 23, 2017. Mullins Doc # 1882, Juror Questions, Feb 23 2017
IS THERE A SAFER TVT?
Judge Goodwin was busy Thursday issuing an Order, this one on alternative designs. Under West Virginia law, the plaintiffs must show there were alternatives to the transvaginal mesh treatment for incontinence. Mullins Doc #1881, Memo and Opinion, Feb. 23, 2017, Alternative Design
“Evidence that a surgical procedure should have been used in place of a device is not an alternative, feasible design in relation to the TVT,” writes Judge Goodwin.
Logically if polypropylene is a huge component of defective design, as many contend, changing the shape of the mesh or detanging its edges would not make any difference. But a non-mesh repair does nothing to inform the jury on a feasible design for the TVT, according to the judge. The jury must be informed how TVT’s design could have been made safer to eliminate the risks that caused the plaintiffs injuries under the West Virginia theory of product liability.
(Both Prolene suture and the tension-free tape (TVT) are made from polypropylene. The average Prolene suture is a few inches long, the TVT measures one-half inches by 16 inches containing much more woven material made from knitted Prolene filaments. The more mesh the more mess, according to mesh removal expert M. Tom Margolis. Also Prolene suture is not intended to adhere to human tissue, while the TVT is designed to adhere to human tissue, making its removal difficult, if not impossible.)
Plaintiffs have argued polypropylene sutures should be considered an alternative, feasible design for the TVT, in other words, a non-mesh repair. The defense too has relied on suture argument, informing the court that sutures underwent premarket approval, therefore Ethicon is immune from prosecution under federal preemption. (See Riegel v Medtronic)
Judge Goodwin finds both arguments lack merit.
And that “polypropylene suture is not an alternative, feasible design for the TVT device as a matter of law.” The plaintiff have to provide evidence of an alternative, feasible design for the TVT, a comparable product or design concept that was in existence at the time of TVT’s manufacture. That then becomes the factual question that can be submitted to the jury.
Any other argument about alternative surgeries concerns the medical judgment of the doctors using the TVT device not on design defect.
In a lawsuit against the product manufacturer, the jury must decide on product liability under strict liability, negligence and warranty, each element must be proven by the plaintiffs.
The plaintiffs do not need to prove an alternative design to prove the product malfunctioned under West Virginia law, or to find negligence.
DO JURORS GET TO HEAR ABOUT THE FDA?
What role the FDA plays in clearing medical devise for market under the 510(k) process will not be presented to jurors.
On one hand, the FDA clears most medical devices with an exchange of paperwork relying on the honesty and integrity of the manufacturer that it’s done its due diligence on safety and effectiveness testing. On the other hand, the defense contends the FDA clearance implies safety.
Since the clearance of medical devices for market does not speak to safety or efficacy, A Motion in Limine, granted by Judge Goodwin means neither side can interject any discussion of the FDA and its role in regulating medical devices. Mullins Motion in Limine Doc. #1880, Feb. 23, 2017
HUSKEY V ETHICON
The Fourth Circuit Court of Appeals on February 22, 2017 issued an order denying Ethicon’s petition for rehearing and rehearing en banc. No judge requested a poll on the petition for rehearing.
Now Ethicon can petition the U.S. Supreme Court to take up the case, however, the nation’s highest court historically hears cases where there are conflicted lower court rulings, which is not the case with Huskey. Appeal 15-2118.
SULLIVAN V BOSTON SCIENTIFIC
The trial of Sullivan v. Boston Scientific (Case No. 2:14-CV-18000)has been moved to March 13th in the Philadelphia Court of Common Please. Lee Balefsky of Kline Specter is the attorney for Ms. Sullivan. ###