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  4.  – A Brief Review of The Trial Testimony and Directed Verdict for Ethicon in Carolyn Lewis Mesh Bellwether Case

A Brief Review of The Trial Testimony and Directed Verdict for Ethicon in Carolyn Lewis Mesh Bellwether Case

| Feb 19, 2014 | Drug and Medical Device Litigation, Transvaginal Mesh

On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc. (In Re:  Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.).

What is a Directed Verdict?

Federal Rule 50 provides: “If a party has been fully heard on an issue during a jury trial and the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue, the court may:

(A) resolve the issue against the party;”

A directed verdict is granted where the Judge decides, at the conclusion of the Plaintiff’s case, that there is no evidence to support a verdict for the Plaintiff, and takes the case from the jury who never get to deliberate or make a decision.

Basis of Ethicon’s Motion for Directed Verdict

Ethicon brought its motion on two grounds; first that Plaintiff Carolyn Lewis waited too long to bring her suit and was thus barred by the Statute of limitations.  In November 2009, Lewis, of Texas, was implanted with a Gynecare TVT (tension free tape) pelvic mesh device made by Johnson & Johnson to stop urine leakage (Stress urinary Incontinence SUI).  The medical device was marketed in 1998 by Ethicon, a subsidiary of Johnson & Johnson, for permanent implantation in women to treat stress urinary incontinence (SUI).  She filed her lawsuit in July of 2012 in Texas and Ethicon contended it should have been filed under Texas law by January or February 2010.

The second ground for the motion by Ethicon is that Plaintiff failed to present sufficient evidence of defective design. This is especially important because previously Judge Goodwin threw out Ms. Lewis claim for failure to warn. (see below)

In its brief Ethicon wrote;

  1. On her claim for strict products liability for defective design, Plaintiff has failed establish through competent expert  testimony:

(a)    That the TVT was unreasonably dangerous as designed;

(b)    That a safer and equally efficacious alternative design was available and feasible in November 2009 that would have would have prevented or significantly reduced the risk of Plaintiff’s injury without substantially impairing the product’s utility; or

(c)    That her alleged injuries were caused by the purported defect in the product.

Since the Plaintiff is from Texas, the law of that jurisdiction is applicable.  Part (b) is a requirement of Texas law that is different from the requirements of many other States requiring the Plaintiff to show there was another safer product that would have prevented or reduced the risk of injury.  In its motion, Ethicon argued that Plaintiff failed to meet this requirement and failed to show that there was a feasible alternative that would have prevented or reduced the risk of injury.

According to Ethicon’s motion, none of the Plaintiff’s witnesses testified that a specific defect in Ms. Lewis mesh resulted in degradation or particle loss.  Ethicon’s motion states that the only Plaintiff witness who examined Ms. Lewis did not make any causal connection between her symptoms and alleged defect.  The Court granted the motion verbally and did not yet issue a written opinion.

Failure to Warn Excluded

A failure to warn case often depends largely on what warnings the doctor received from the company.  If the company did not adequately warn the inserting doctor then the patient could not have had adequate warnings and can go forward on the basis of inadequate warnings.  This would open the door to all of the information the company knew about adverse reactions, problems, etc., that it failed to place in its literature or warnings.  An important part of the claim is what the doctor was told, what the doctor read, and what information the doctor received from the company as to warnings.

Earlier, Judge Goodwin removed the failure to warn case on the grounds that her implanting physician, Dr. Muriel Boreham of Dallas, had NOT read the instructions for product use (IFU) since 2002.  This was especially harmful to Ms. Lewis case because the Doctor would receive any warnings on her behalf, could evaluate the adequacy of the warnings and then instruct the patient.  Since the doctor had not read any warnings since 2002, the Court did not allow that portion of the case that would establish what Ethicon knew, when they knew it and how they failed to timely warn thus gutting the case and making it a very technical defective product case with debating scientists.

Trial witnesses who testified live or on videotape included the following;

Dr. Richard Isenberg, a urogynecologist from Philadelphia, who was the first Medical Director of Ethicon for the new division with Johnson & Johnson called Gynecare, which was established to develop and market medical devices for the female population,

Dr. Howard Jordi, a biochemist, whose lab did an analysis of the explants from Carolyn Lewis, testified that as long as the implant remained in situ, it will continue to degrade.

Dr. Bernd Kloserhalfen, surgical pathologist from Germany, has removed approximately 500 meshes from women experiencing complications from transvaginal mesh.

Dr. Uwe Klinge, who has studied mesh implants at Germany’s Aauchen University and testified in the Linda Gross trial

Dr. James Hart, a surgeon from New York who was hired by Johnson & Johnson and worked in medical affairs for Ethicon from 2005 to 2007

Piet Hinoul, former Ethicon Medical Director, who testified in the Linda Gross trial.

Dan Lamont, Director of Post Marketing Surveillance for Ethicon, quality engineer for Ethicon during the time the company began producing laser cut mesh.

David Robinson, M.D. is a worldwide medical director.  He also testified in the Linda Gross case. He is a OBGYN from Kansas who consulted for Ethicon and was an early proponent of the devices, doing approximately 100 insertions annually.

Dan Smith, Ethicon engineer for 36 years whose testimony included his involvement in the Matrix project looking for TVT mesh replacement.

Dr. Bruce Rosenzweig, urogynecologist at Rush University, who did about 20 insertions before stopping and has done approximately 200 removals, whose testimony included there were no studies ever done on TVT with the primary end point as safety; He did not examine Ms. Lewis.

Dr. Axel Arnaud, Medical director for Europe, whose deposition was read to the jury regarding changing out the TVT for an alternative.

Click here to read the full article: Judgment As Matter Of Law Granted In 1st Ethicon Pelvic Mesh Bellwether Trial

Vaginal Mesh Trial History

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R.Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

Our office represents women who have suffered horribly from these mesh products.  We remain committed to representing them to a successful conclusion of their cases.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.