Whistleblower chirps on medical device makers

"A federal judge has unsealed whistleblower lawsuits alleging that Boston Scientific, Medtronic, St. Jude Medical and four other manufacturers engaged in Medicare fraud by selling medical devices used during a heart procedure called surgical ablation," according to a story by Christopher Snowbeck of the St. Paul Pioneer Press. Further excerpts:

The whistleblower -- whose identity is shielded -- alleges that manufacturers have struggled to sell their surgical ablation products because the devices have not been specifically approved by the government for use in the treatment of a common heart rhythm problem called atrial fibrillation.

As a result, companies initiated a nationwide sales campaign including illegal kickbacks and other improper means to entice physicians and hospitals to use the products for "off-label" purposes, the lawsuit claims.

For most patients, the lawsuit alleges, cardiac ablation can be provided more safely and at a lower cost when performed on an outpatient basis by specialized cardiologists in a catheterization lab. Surgical ablation, on the other hand, is performed on an in-patient basis by surgeons, the whistleblower states.

"Defendants have promoted their products to hospitals by highlighting the high spread between Medicare reimbursement for procedures performed with defendants' products and the relatively low cost of those procedures," the lawsuit claims. ...

Among other allegations, the whistleblower contends the companies offered discounts to hospitals to "lock-in" market share; agreements also allowed them "to confiscate all competitors' products and equipment ... to ensure that the hospitals will only use defendants' products."