Yourlawyer.com (Boston Scientific Flextome News)

Lawsuits Allege Medtronic, Other Firms Illegally Marketed Surgical Ablation Products

Thu, 16 Jul 2009 00:00:00 -0700

Medtronic Inc., St. Jude Medical Inc., AtriCure Inc. and Boston Scientific Corp. all allegedly paid kickbacks to doctors in order to convince them to use their surgical ablation products to treat the heart-rhythm defect called atrial fibrillation, according to lawsuits recently unsealed in Texas. According to The Wall Street Journal, the lawsuits were filed by former employees of the companies.

Allegations of kickbacks by medical device makers are nothing new. For example, in 2007 a New Jersey based federal probe found that some orthopedic device makers made lucrative payments to U.S. physicians between 2002 and 2006 as a way to encourage doctors to favor their products. Stryker Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

The lawsuits detailed by The Wall Street Journal, which were filed in federal court in Houston, are related to an inquiry in Texas by the U.S. Justice Department that was previously disclosed by several of the companies in filings with the Securities and Exchange Commission. They were originally filed in 2007, the Journal said.

According to the Journal, the lawsuits allege that a "fraudulent marketing and inducement campaign" involving kickbacks to doctors and hospitals resulted in excessive charges to the Medicare insurance program. For example, several of the suits allege that Boston Scientific, Medtronic and AtriCure marketed surgical ablation equipment as a treatment for atrial fibrillation even though it was not approved by the Food and Drug Administration to treat that condition.

Those charges were made by a former Boston Scientific salesperson, who the Journal says, claimed to have been fired after complaining about the company's allegedly illegal practices.

All of the companies involved in the lawsuits told The Wall Street Journal that they were cooperating with the probe. Boston Scientific is no longer in the ablation business, the Journal said.

Boston Scientific Recalls Flextome Angioplasty Device

Mon, 06 Feb 2006 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) and Boston Scientific Corporation have notified healthcare professionals regarding the class 1 recall of an angioplasty device (Flextome Cutting Balloon Device and Monorail Delivery System), due to the potential for distal catheter shaft separation during device withdrawal.

The device consists of a surgical balloon with microsurgical blades (microtomes) attached to the sides. It is inserted via catheter into the artery, and then expanded to allow the blades to cut through fatty deposits and widen the blocked coronary artery.

Shaft separation may prolong the procedure or necessitate more in-depth surgery to remove the remaining fragment from the artery, according to an alert sent Friday from MedWatch, the FDA's safety information and adverse event reporting program.

According to a company news release, 8 cases of shaft separation have been reported, 3 of which required surgery.

The FDA notes that the recall does not affect patients who have already received treatment, because the problem occurs during the angioplasty procedure.

Healthcare professionals are requested to cease using the product, and to contact the company at 1-800-811-3211 to arrange for returns. The recall affects approximately 40,000 devices worldwide.

Adverse events related to use of the angioplasty device should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Boston Scientific Recalls Balloon Devices

Thu, 08 Dec 2005 00:00:00 -0800

Medical device maker Boston Scientific Corp. said Thursday it is recalling 40,000 implantable devices meant to treat blocked coronary arteries, saying it has received eight complaints that the end of the device became detached as it was inserted in the patient and required more surgery in three cases.

The recall affects all of its Flextome cutting angioplasty balloon devices that the
Food and Drug Administration approved as recently as September.

The device differs from standard angioplasty balloons in that it is lined on the outside with three or four lengthwise microsurgical blades. During angioplasty, a balloon catheter is snaked into a congested artery and inflated to reopen the blood vessel and push back accumulated plaque.

Boston Scientific said it received eight complaints that the device tip separated from the catheter as it was removed from the patient, and said surgery was needed in three cases to remove the tip.

The company said it is working with the FDA on the recall and notifying officials from other countries. The Flextome was approved in Europe in January. Boston Scientific booked $13 million in Flextome sales in 2005.

This is the second recall of a balloon-related device in as many years for Boston Scientific. The company recalled thousands of its Taxus Express2 drug-coated stents last summer after reports that the balloon used to place the stent did not deflate in some instances causing injury to the patient.

The recall marks Boston Scientific's second within a week. On Friday, the company announced the recall of about 18,000 devices that filter and dissolve blood clots from entering the lungs. The recall was triggered by eight complaints that the capsule carrying the filter during implantation became detached from the delivery system, causing one patient death.

Boston Scientific Angioplasty Flextome Recall Lawsuit

Thu, 08 Dec 2005 00:00:00 -0800

Boston Scientific Flextome

Medical device maker Boston Scientific Corp. is recalling 40,000 implantable devices meant to treat blocked coronary arteries, saying they have received eight complaints that the end of the device became detached as it was inserted in the patient and required more surgery in three of the cases.

The recall affects all of its Flextome cutting angioplasty balloon devices that the Food and Drug Administration (FDA) approved as recently as September. The device differs from standard angioplasty balloons in that it is lined on the outside with three or four lengthwise micro-surgical blades. Boston Scientific said it received eight complaints that the device tip separated from the catheter as it was removed from the patient, and said surgery was needed in three cases to remove the tip. The company said it is working with the FDA on the recall and notifying officials from other countries. The Flextome was approved in Europe in January.

Boston Scientific booked $13 million in Flextome sales in 2005. This is the second recall of a balloon-related device in as many years for Boston Scientific.

If you or a loved one suffered injuries from a Boston Scientific Flextome device, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.