Manufacturers of transvaginal mesh (TVM) have been under intense scrutiny of late. The U.S. Food and Drug Administration (FDA) started out the new year with an order that all current TVM manufacturers have 30 months to submit premarket approval applications for their products, basically reapplying for FDA approval with a strict safety evaluation.
There are tens of thousands of lawsuits against the seven manufacturers already underway, alleging the devices cause serious injuries including erosion of the mesh into the vaginal tissue, organ perforation, pain, infection, painful intercourse, and urinary and fecal incontinence. Often women require surgery to remove the mesh. In some cases, this can require multiple procedures without succesfully removing all the mesh.
C.R. Bard, in the first jury trial in the seven multidistrict litigation (MDL) suits over the use of transvaginal surgical mesh to treat pelvic organ prolapse and stress urinary incontinence, was hit with $2 million verdict in August. The jury in the first case to be tried in Philadelphia’s mass tort program over pelvic mesh products against Johnson and Johnson’s Ethicon division awarded the plaintiff a $12.5 million verdict in December. The claims from these litigations include that the devices caused serious injuries to patients and that manufacturers failed to properly warn doctors and patients of the risks involved.
Last week allegations of another kind were made against manufacturer Boston Scientific Corp. when attorneys filed a class action lawsuit against Boston Scientific Corp. and three other companies under the Racketeering and Corrupt Organizations (RICO) Act.
The RICO Act is usually used to target criminal organizations, but in this groundbreaking lawsuit the U.S. medical company is being accused of smuggling substandard materials from China from a known counterfeiter. The Boston Globe reported: “The lawsuit, filed in federal court in West Virginia, claims the Marlborough company ran ‘an international conspiracy’ and racketeering scheme to sell defective vaginal mesh….”
The suit was filed on behalf of West Virginia resident Theresa Stevens and other plaintiffs who were implanted with Boston Scientific mesh product after 2012. These women have allegedly suffered from severe discomfort, bleeding, infections, painful intercourse, urinary problems and other complications from the plastic mesh implants, according to a statement by the plaintiffs’ attorneys.
According to SETexasRecord.com: “Court documents assert lead plaintiff Theresa Stevens was implanted with the BSC Obtryx-Halo Urethral Sling System on or around Oct. 27, 2014, stating the device in question was ‘made from counterfeit Marlex pellets smuggled out of China and illegally imported into the United States.'”
The plaintiffs’ attorneys’ statement Thursday included allegations that Boston Scientific “ignored explicit warnings” when in 2005 Chevron Phillips Chemical Co. stopped selling its Marlex pellets, polypropylene resin for surgical mesh, saying that it should not be used in medical devices involving permanent implantation in the human body, and instead in 2011 and 2012 purchased 34,000 pounds of resin pellets of questionable origin from EMAI Plastic Raw Materials Inc. in Guangzhou, China.
They then allegedly “orchestrated secretive plans to smuggle it out of China like a drug deal” according to the attorneys’ statement. The suit says that they divided the product into more than 500 bags, shipped on three separate dates, and reported to Chinese authorities that the product was made in China but claimed it was authentic Phillip’s Marlex when getting it into the U.S.
“They knew they could not verify the authenticity of this plastic resin that they found in a warehouse in China from a known counterfeiter,” an attorney for the plaintiffs told the Boston Globe. “They bought it anyway and have been implanting it potentially into tens of thousands of women.”
According to Law360 the suit seeks unspecified damages for thousands of women who have received the mesh product after September 2012 — as many as 55,000 each year, according to the complaint.
Boston Scientific refutes the lawsuit’s claims.