Yourlawyer.com (Boston Scientific NexStent 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.

NexStent Carotid Artery Stents Recalled by Boston Scientific

Fri, 15 Aug 2008 00:00:00 -0700

Boston Scientific said yesterday that it has recalled its NexStent products because of a defective stent delivery system. The Food & Drug Administration (FDA) has deemed the NexStent recall a Class I recall. Such recalls are for dangerous or defective products that predictably could cause serious health problems or death.

NexStent products are used in patients to treat a blockage (stenosis) in the carotid artery, known as carotid artery disease. The two carotid arteries (located on either side of the neck) supply blood to the brain. The device is used in a procedure called carotid artery stenting (CAS), in which the physician places the self-expanding stent in the carotid artery to keep the artery open and to help prevent future narrowing of the artery.

The stent uses one of two delivery systems called the Monorail and Over the Wire, according to the FDA. The recall applies to the Monorail system as well as the stent itself.

The NexStent recall was initiated because the tip of the device used to implant the stent can break off and may damage the blood vessel wall or lead to stroke. If the device malfunctions, emergency surgery could be required to remove the tip. The recall includes NexStent products made from June 2007 to May 2008.

Nearly 2700 NexStent products are involved in this recall. The recall does not affect stents that have already been implanted. That is because the problem caused by the defect only occurs during implantation.

Boston Scientific first made its customers aware of the NexStent products recall via a letter dated June 6, 2008. The FDA said that healthcare professionals and consumers may report any problems with the NexStent system to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. Patients with questions about recalled NexStent products should contact their doctors.

"All U.S. hospitals have responded to Boston Scientific, and a significant number of the distributed devices have been returned," Boston Scientific said in a statement.

NexStent Lawyer Monorail Lawsuit Recall

Fri, 15 Aug 2008 00:00:00 -0700

NexStent Injury Lawyers

Keywords: NexStent Lawyer Monorail Lawsuit Recall

The lawyers and attorneys at our firm are offering free case evaluations to individuals injured by Boston Scientific's NexStent products. Boston Scientific recalled its NexStent carotid artery products in June 2008 because the defective devices could lead to blood vessel damage, stroke or emergency surgery. If you or someone you know were injured by Boston Scientific's NexStent Monorail, NexStent Carotid Stent or Monorail Delivery System, we urge you to contact one of our NexStent injury lawyers as soon as possible to protect your rights.

Boston Scientific first made its customers aware of the NexStent products recall in June 2008. This was done via a letter sent to customers on June 6, 2008. However, the recall was not made public until August 2008. For that reason, many victims of NexStent injuries might not even realize that the device was to blame. Our NexStent injury lawyers are committed to making sure that Boston Scientific treats victims of this defective device fairly.

Boston Scientific NexStent Recall

NexStent was approved by the Food & Drug Administration (FDA) in October 2006 to help keep the neck's carotid arteries propped open after they have been cleared of fatty blockages. The stent uses one of two delivery systems called the Monorail and Over the Wire, according to the FDA. The recall applies to the Monorail system as well as the stent itself.

The NexStent recall was initiated because the tip of the device used to implant the stent can break off and may damage the blood vessel wall or lead to stroke. If the device malfunctions, emergency surgery could be required to remove the tip. Such devastating injuries can take a horrible toll on victims and their families. Our NexStent injury lawyers will work hard to make sure those suffering because of this defective device receive the compensation they deserve.

The recall, which includes NexStent products made from June 2007 to May 2008, did not affect stents that have already been implanted, the FDA said. However, the NexStent injury lawyers know that these defective devices have been implanted in hundreds of people. Because most adverse events are never reported to the FDA, there is no way to know how many patients might have been injured by NexStent products.

The FDA deemed the NexStent recall a Class I recall. Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.

The FDA said that healthcare professionals and consumers may report any problems with the NexStent system to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. Patients with questions about recalled NexStent products should contact their doctors.

NexStent Products

The NexStent Carotid Stent is a laser-cut, nitinol stent with a rolled sheet design that enables one stent size to adapt to multiple diameters in tapered or non-tapered vessel configurations. Its self-sizing feature is designed to provide adaptability when treating lesions in the carotid arteries, and its closed-cell configuration is designed to increase lesion coverage and provide a smooth inner lumen to help facilitate delivery and retrieval of ancillary devices.

NexStent products are used in patients to treat a blockage (stenosis) in the carotid artery, known as carotid artery disease. The two carotid arteries (located on either side of the neck) supply blood to the brain. The device is used in a procedure called carotid artery stenting (CAS), in which the physician places the self-expanding stent in the carotid artery to keep the artery open and to help prevent future narrowing of the artery.

Legal Help for Victims of NexStent Injuries

If your or a loved one suffered a stroke, damage to blood vessel walls, or had to undergo emergency surgery because of a defective NexStent product, you have valuable legal rights. Please fill out our online form or call 1-800 LAW INFO (1-800-529-4636) to discuss your case with an experienced NexStent injury lawyer.