Lewis v Ethicon is Over! Judge Grants Ethicon's Motion to End Trial

Jane Akre
February 18, 2014

Judge Joseph Goodwin

The plaintiff's side in the first Ethicon trial to be heard in this federal court, had six days before it rested its case. One day later, Judge Joseph Goodwin ended the bellwether trial when he granted Ethicon’s (Johnson & Johnson) Motion for Judgment as a Matter of Law.

See attached Carolyn Lewis Doc #291.

Doc #290 both filed February 18, 2014.

The brief filed Tuesday said there was insufficient evidence presented that would prove liability or defective design. The case never went before the jury for deliberations and the directed verdict came on the eve of Ethicon's case before the jury.

Earlier Judge Goodwin had dismissed plaintiffs from both New Zealand and Canada who petitioned to have their cases moved to the Charleston, WV federal court.

Plaintiff Lewis was implanted with a TVT mesh to treat incontinence in November 2009, She told the jury of ten last week that she had had problems ever since and finally found Dr. Philippe Zimmern of Dallas to remove it. He was unable to remove it all and the arms remain behind. She said she felt much better but was still not 100 percent.

Failure to Warn

Judge Goodwin had left the Plaintiff’s with a difficult burden to prove. He had removed from consideration one element of a defective product case, insufficient warnings. He did so because her implanting physician said she had not read the IFU since 2002.

In the first of four bellwether cases chosen against the C.R. Bard Co. Judge Goodwin had disallowed any discussion of the FDA’s 510(k) approval process that does not require clinical trials for the majority of medical devices.

In a case heard before jurors in state court in New Jersey, Ethicon revealed it did no testing on humans before the product was approved for use in the U.S. in 1998.

There are more than 15,000 cases filed against Ethicon and more than 50,000 filed together against all six manufacturers that are consolidated in this one courtroom before Judge Goodwin. The jurors were not allowed to hear about the number of cases amassed in one court.

Judge Goodwin also did not tell jurors about the mishandling of thousands of pages by Johnson & Johnson, evidence that was to be used in this case to prove the TVT was a defective product.

The Plaintiffs had asked the Court for sanctions and for favorable rulings in the pending bellwether or four selected cases to be heard before the jurors. Judge Goodwin did not allow any evidence of the destruction of evidence, also known as spoilation, to be introduced to jurors.

Additionally lawyers for Ethicon, Christy Jones and David Thomas said that Ms Lewis did not file her cause of action July 25, 2010 more than two years after her two-year statute of limitations.

Ethicon's Motion

In it's motion filed February 18, Ethicon said the Plaintiff's did not meet the legal standard for defective. The Plaintiffs filed to provide evidence that proved the TVT is unreasonably dangerous was designed and there"was a safer, feasible and equally efficacious alternative design to the TVT that was available at the time of Plaintiff's implantation in 2009. "

Attorneys for Lewis showed the jurors the small pore TVT mesh made of polypropylene was too heave a weight to be placed in the pelvis and with small pores caused an overgrowth of fibrotic scar tissue that contracted and entrapped nerves. Attorneys also showed jurors that a larger pore mesh existed at the time that showed less scarring and bridging.

Lewis should have filed her case sooner as any "reasonable person" would have done knowing she was not healing properly said attorneys for Ethicon. Instead she waited two years and six months before filing an action.

Jurors never learned what Ms. Lewis was told by her implanting physician Dr. Muriel Boreham and whether she even knew she had a polypropylene mesh medical device that would be a permanent implant. That information was not allowed into the case. Often women are told the pain they are experiencing is just part of the ongoing healing process and they should be patient,. Mesh News Desk has found it is common for a woman to realize her symptoms may be mesh related.

Earlier attorneys for Ethicon had suggested Ms. Lewis filed her lawsuit only after seeing advertisements by law firms for clients in transvaginal mesh litigation.

The entire issue of any punitive damages is off the table with this ruling.


Attorneys for Ethicon say the Plaintiff's claims are preempted because the Prolene (commercial name for Ethicon's polypropylene) is used in suture filament which is classified under the Food and Drug Administration as a Class III medical device. Regardless, a Class III medical device is not "approved" in the way drug's are which is the basis for a federal preemption of a defective product action.

In the classic case of Riegel v. Metronics, the family of Charles Riegel sued medical device maker Medtronics over his faulty heart implant. In that case, the implant did receive explicit FDA premarket (PMA) approval. The Riegel case was dismissed because federal approval trumps any state court action.

In the case of polypropylene mesh, there is no explicit FDA approval for safety. The 510(k) approval is an exchange of paperwork where the manufacturer notifies the FDA it plans to sell the product. No requirements for safety and efficacy are required. Since there was no PMA approval by the FDA, the preemption argument here does not appear to be directly applicable.

Evidence entered in the case also showed the amount of polypropylene that makes up a suture is miniscule in comparison to a transvaginal mesh implant, therefore making a comparison inaccurate.

More Litigation Ahead

Attorney Adam Slater who secured an $11.1 million verdict in favor of plaintiff Linda Gross in her defective product case against Ethicon told MND this afternoon "I look forward to the next trial against Johnson & Johnson."

Slater's Ethicon trial schedule is here.

The upcoming bellwether trial schedule for Judge Goodwin's court is here.

Bellwether cases are selected to test legal theories before juries. More than 50,000 cases have been consolidated in one courtroom. As of today, there are 16,471 lawsuits filed against Ethicon and its family of Gynecare products, some of which have been taken off the market allegedly for business reasons. The Gynecare TVT remains on the market.

Here is the schedule for the rest of the three Ethicon scheduled trials in this federal court.

Updated 1/29/2014

The third bellwether trial is scheduled for December 4, 2014 at 8:30 a.m. in Bellew v. Ethicon, Inc., et al.,2:13-cv-22473. If the Bellew case has settled or is otherwise not ready for trial, the Lehrer v. Ethicon, Inc., et al., 2:12-cv-08157, case will proceed to trial instead.

Updated 10/08/2013

The first bellwether trial in Lewis, et al. v. Johnson & Johnson, et al., 2:12-cv-04301, will commence on February 10, 2014 at 8:30 a.m.

The second bellwether trial is scheduled for June 23, 2014 at 8:30 a.m. in Huskey, et al. v. Ethicon, Inc., et al.,2:12-cv-05201. If the Huskey case has settled or is otherwise not ready for trial, Edwards, et al. v. Ethicon, Inc., et al., 2:12-cv-09972, case will proceed to trial instead.

Mesh News Desk

Mesh Medical Device News Desk was the only news resource in the courtroom during the Plaintiff's case. Here are the stories what were filed.

Pre Trial - J&J Faces First Defective Transvaginal Mesh

Day One - Lawyers, Liars and Bridging Fibrosis

Day Two - Ethicon Defends TVT Transvaginal Tape Science

Day Three - Polypropylene Under the Microscope

Day Four - When Did Ethicon Know it had Problems

Day Five - Ticking Time Bomb

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