Boston Sci Hit with Restraining Order Over Vaginal Mesh

The company would have likely disposed of potential evidence without the temporary restraining order, said Judge Jaclanel McFarland in Texas. A Boston Scientific spokesperson says that order is an unnecessary legal maneuver.

Qmed Staff

A judge in Harris County, TX has granted a temporary restraining order filed against Boston Scientific, prohibiting the company from disposing or altering evidence related to the allegedly counterfeit resin the company used in its vaginal mesh products. The order was filed ex parte, without notifying Boston Scientific.

Maria Teresa Saldierna from Pasadena, TX, who is suing Boston Sci, would have been irreparably injured in the likely circumstance that Boston Sci destroyed Marlex that was potential evidence in the case, Judge Jaclanel McFarland wrote in the restraining order, which is set to expire on February 13.

Such disposing or altering of the Marlex would "interfere completely" with the investigation being conducted by Saldierna's lawyers and experts, McFarland said.

The order forbids Boston Scientific from altering or disposing storage containers, shipping containers, packaging, bags, or over-bags of the Marlex resin in question.

"This is an unnecessary legal maneuver," says Tom Keppeler, senior manager, global media relations at Boston Scientific. "As with any active litigation, any potential evidence would be preserved. Boston Scientific did not, and does not, have any intention to destroy or alter its supply of Marlex or any material evidence, regardless of this ruling."

Keppeler says that Boston Scientific officials believe that this case has no merit and that the company plans to vigorously defend Saldierna's claims.

In a separate federal RICO case filed by Teresa Stevens of West Virginia against Boston Scientific, the plaintiff alleged that the company used a counterfeit polypropylene resin in its transvaginal mesh products. McFarland's order in Texas is now prohibiting Boston Sci from destroying its reserves of polypropylene for surgical mesh, which the firm Mostyn Law argues has injured tens of thousands of women.  The reportedly counterfeit mesh also contains high levels of "toxic selenium," according to Mostyn Law, which is handling both Saldierna and Steven's cases.    

McFarland also ordered to avoid destroying or altering "records, invoices, shipping data, customs forms, communications with suppliers" that may serve as evidence that the company procured counterfeit mesh from China.

Mostyn Law has alleged that Boston Scientific decided to procure counterfeit resin from Chinaafter Chevron Phillips, the manufacturer of the resin stopped selling the resin to Boston Scientific in 2005.

In the federal case filed in West Virginia, U.S. District Judge Joseph Goodwin ordered the plaintiff in the federal case to ask the FDA to determine whether the mesh products are safe.

"The FDA is aware of allegations that Boston Scientific used counterfeit materials in its vaginal mesh device products. We are looking into those allegations to determine appropriate next steps," says FDA spokesperson Deborah Kotz.

The allegations against Boston Scientific are similar to those filed against CR Bard, which had been accused of creating a dummy company to buy counterfeit resin for mesh in a trial brought by plaintiff Donna Cisson, who was awarded $250,000 in compensatory damages and $1.75 million in punitive damages against that company in August 2014. Bard appealed the case.

Bloomberg recently reported that Johnson & Johnson is working towards settling thousands of its own mesh vaginal mesh lawsuits in a settlement that has it paying $120 million to settle the first of 2000-3000 lawsuits. More than 40,000 lawsuits are still pending against J&J.

Meanwhile, a jury in Jackson County, MO, recently found that Boston Scientific and C.R. Bard were not liable for plaintiff Eve Sherrer's injuries--a legal win for the two companies in vaginal mesh cases, according to Law.com.

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA.

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