November 8, 2012 ~ A required report by Boston Scientific reveals a number of states plan to initiate an investigation about how Boston Scientific sells mesh.
The information is contained in the company’s quarterly regulatory filing with the Securities and Exchange Commission, (here), issued November 6.
In the report, the Natick, Mass.-based medical device company admits it was contacted by the California Attorney General, Kamala Harris, alerting them that California and other state attorneys general offices intend to initiate a civil investigation into the sale of synthetic transvaginal mesh.
Page 35 of the SEC filing under Product Liability Litigation says:
“In addition, in October 2012 we were contacted by the Attorney General for the State of California informing us that their office and certain other state attorneys general offices intend to initiate a civil investigation into our sale of transvaginal surgical mesh products.”
The report does not go into any details about the allegations and Boston Scientific did not respond to email questions by publishing time.
Product Liability Litigation
Boston Scientific says it is facing more than 2,500 product liability lawsuits over transvaginal surgical mesh implants for a defective design and manufacturing, a failure to warn, breach of warranty, fraud, loss of consortium and violations of state consumer protection laws.
Some of these actions are assigned to state court in Massachusetts. On February 7, 2012, the bulk of the cases were transferred to the U.S. District Court for the Southern District of West Virginia (MDL No. 2326).
Boston Scientific says it was served in August 2012, with a federal complaint that Boston Scientific Neuromodulation Corp. (spinal cord stimulator) violated various states’ False Claims Acts by submitting fraudulent bills for implanted devices, off-label promotions, and under-reporting of certain adverse events.
Those charges originated in the U.S. District Court for the District of New Jersey in March 2011.
You’ll recall Bard announced last July it would appeal the jury award of $5.5 million to Bakersfield, California woman, Christine Scott, who has endured eight surgeries to try and remove the Avaulta Plus transvaginal mesh.
Her husband was awarded $500,000 of that amount for loss of consortium. See background story here.
It appears the Urology/Women’s health division of Boston Scientific is doing moderately well with, “worldwide net sales of these products were $125 million in the third quarter of 2012, as compared to $124 million in the third quarter of 2011.”
From the Introduction:
“Boston Scientific Corporation is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. Our mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures. Net sales for the third quarter of 2012 were $1.735 billion, down from $1.874 billion for the third quarter of 2011.”