Byrd Federal Courthouse, Charleston WV

Byrd Federal Courthouse, Charleston WV

On October 14, Johnson & Johnson (J&J) filed a Motion in federal court asking that the Jo Huskey verdict be overturned and that  the company receive a new trial.

See Huskey Doc #438 J&J asks for a new trial October 20142:12-cv-05201.

In September, Mrs. Huskey won a $3.27 million judgment against the medical device maker, alleging the mesh was defectively designed and the warnings to the implanting physician were inadequate.

Before the case went to the jury,  J&J had asked for a directed verdict in its favor.

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph Goodwin denied that motion but also denied the Huskey team the ability to seek punitive damages, which could have resulted in a higher award.

In its motion,  J&J argues that Plaintiff Huskey failed to offer a “legally sufficient evidentiary basis” for her claims.

Transvaginal tape obturator (TVT-O)  is used to treat incontinence with a length of polypropylene that supports the urethra and exits through a woman’s groin area.

J&J says its TVT-O “meets the standard of care” and because of that it cannot be unreasonably dangerous.

Prolene Mesh

Prolene Mesh

Adequate Warning

The implanting physician is the end user of any medical device and it is the company’s responsibility to keep him/her informed about the dangerous potential of a product. J&J argues the product warnings did include pain, dyspareunia and erosion, the complications Mrs. Huskey suffered.

J&J argued that implanting physician, Dr. Byrkit,  still uses TVT-O in her practice and would use it again if a patient presented with the same symptoms.  At trial, the implanting physician also said she would  likely not use TVT-O if  it was contraindicated for athletic women and that information was contained in the product label or Instructions for Use (IFU).  Jo Huskey was an avid kayaker, liked to exercise, walk and work out regularly. At trial, Dr. Byrkit said if the warning was on the label that TVT-O should not be used in athletic women, she would have reconsidered using it on Mrs. Huskey.

Dr. Jerry Blaivas, brought in as the expert to testify for Mrs. Huskey, testified that active women should not be implanted with a TVT-O.

J&J argues Dr. Byrkit did not rely on the TVT-O IFU and in fact hadn’t relied on it for years. Who then informed her about the product’s dangers? Was it the sales rep? Dr. Byrkit said she did not rely on company representatives to make prescribing decisions and pointed to “independent sources of information” including talking to other doctors.

Mrs. Huskey’s lawyers pointed out that Dr. Byrkit never testified the doctor did not rely on the IFU.

Risk-Benefit Test

Since Mrs. Huskey is from Illinois, the federal court must defer to its definition of a design-defect. Under Illinois law a product is unreasonably dangerous if it does not meet the consumer expectation or it fails the risk-utility test, which requires the plaintiff to present overwhelming evidence that the dangers outweigh the use of the product as designed. Plaintiffs failed to do so, said attorneys for J&J.

At most, the opinions of Dr. Blavais and Dr. Bruce Rosenzweig, both presented by the plaintiffs, disagreed with the medical societies (AUA, AUGS) which support the safety of TVT-O. Even though J&J says the “vast majority of the medical community” support its safety, there has been no individual polling of members to substantiate that claim.  Many doctors who belong to those medical societies do not agree with the leadership’s positions.

The plaintiffs alleged there were six defects to the TVT-O – it is made with Prolene mesh that 1- undergoes oxidative degradation; 2- shrinks; 3-deforms; 4-is too heavy and causes a chronic foreign body reaction; 5-is placed in the obturator space; and 6-is laser cut.

Ethicon attny, Christy Jones during Linda Gross trial, Feb. 2013

Ethicon attny, Christy Jones during Linda Gross trial, Feb. 2013

J&J says the plaintiffs presented no evidence that the implant in Mrs. Huskey shrank deformed or degraded. J&J argues that attorneys for Mrs. Huskey did not show by competent expert testimony that her injuries resulted from a specific defect design defect.

J&J has made the argument before and it was rejected by Judge Goodwin but again in this motion defense claims that Prolene filaments cannot be the basis of a lawsuit because the Prolene fibers underwent Food and Drug Administration approval, therefore under federal preemption, J&J cannot be held accountable.

See the Riegel v. Medtronic decision for that definition.

J&J asks Judge Goodwin for a new trial in federal court due to the “erroneous and prejudicial evidentiary rulings.”

The motion was filed by Ethicon attorney Christy Jones (Butler Snow) who represented J&J at the Huskey trail and is listed as Document #438.

Learn More:

Huskey Trial, $3.27 Million Verdict, September 5, 2014

https://www.meshmedicaldevicenewsdesk.com/patient-profiles/awesome-jury-deciedes-for-huskey-3-27-million/

Huskey Case Survives Summary Judgment,  Riegel v. Medtronics,July 24, 2014

https://www.meshmedicaldevicenewsdesk.com/legal-news/huskey-v-ethicon-case-survives-summary-judgment/

 

December 4, 2007 Riegel v. Medtronic, Cornell Law

http://www.law.cornell.edu/supct/html/06-179.ZS.html