http://www.yourlawyer.com/topics/overview/medisystems_baxter_dialysis Sat, 21 Nov 2009 00:57:48 -0800 pixel-app en http://www.yourlawyer.com/articles/read/16753 Thu, 16 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16753 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.

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Medtronic Inc., the nation's biggest maker of pacemakers and defibrillators, said it had received a subpoena from the U.S. attorney in Boston seeking information related to the provision of payments or other benefits to people like doctors who help decide which company's products to use.

Additionally, federal prosecutors have subpoenaed rival heart device makers St. Jude Medical Inc. and Guidant Corp., seeking documents related to implanted pacemakers and defibrillators, the companies said Tuesday.

The three medical device makers, all of which have a strong presence in the Twin Cities, said the civil subpoenas came from the U.S. attorney's office in Boston. Additionally, Guidant, in a statement, said it received a subpoena from the Minneapolis U.S. attorney's office.

Medtronic said it was asked for documents about products such as pacemakers and compliance materials related to fraud and anti-kickback statutes, the Fridley-based company said in a statement Tuesday. Little Canada-based St. Jude, ranked No. 3, said it was subpoenaed for documents on general industry practices since January 2000, according to a U.S. Securities and Exchange Commission filing earlier Tuesday.

Guidant's release said the Minneapolis subpoena requests documents relating to the company's Ventak Prizm 2 defibrillator and Contak Renewal pacemaker. Guidant is based in Indianapolis, but it develops its heart devices in Arden Hills. Guidant, the second-largest maker of heart devices, said its subpoena from the Boston U.S. Attorney's office requested documents on pacemakers and related products.

All three companies said they would cooperate with the requests. Medtronic spokesman Rob Clark and Guidant spokesman Steven Tragash didn't return phone messages to their offices after business hours. St. Jude spokeswoman Angela Craig declined to say which documents were sought. She said the subpoena was "a broad request."

Pacemakers use a mild electrical current to speed a slow heartbeat, while defibrillators jolt hearts that have life-threatening irregular beats.

In news releases, none of the companies said what prompted the subpoena, but heart devices have come under increasing scrutiny in recent months.

Dhulsini De Zoysa, an analyst with S.G. Cowen & Co., citing company management, said last month that criminal investigators for the Food and Drug Administration questioned two former Guidant employees.

Guidant recalled some of its cardiac defibrillators June 17 because of reported failures and at least two deaths. The recall involved 50,000 devices, including a model that developed flaws the company fixed in 2002. A week later, Guidant told doctors to stop using five models with another defect. No injuries or deaths were reported in that case.

On Aug. 25, the Food and Drug Administration said it was conducting comprehensive inspections of Guidant's factories. The agency said it couldn't reveal how extensive the inspections would be or how long they may take.

Last week, Medtronic said its Endeavor drug-coated stent failed to keep heart arteries open as effectively as Johnson & Johnson's Cypher in the first head-to-head U.S. study comparing the devices.

Johnson & Johnson has signaled it may seek to reduce its December offer to buy Guidant for $25.4 billion. J&J, the world's biggest maker of medical devices, has said it's considering "alternatives."]]> http://www.yourlawyer.com/articles/read/1663 Thu, 12 Sep 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/1663
The deaths occurred in late August in dialysis centers in Indiana and Michigan using certain Medisystems tubing in connection with Baxter Healthcare Corp.'s Meridian dialysis machine, the FDA said.

The FDA said it is working with Baxter, based in Roundtop, Ill., and Medisystems Corp. of Seattle to determine the cause of the problem.

Meanwhile, Baxter has notified dialysis centers to stop using the tubing in question and use other available blood tubing instead. Blood tubing that may be associated with the deaths or injuries is Medisystems product code D3-9694/9793 or K3-9694/9793, Baxter product code 5M9694, the agency said.

The FDA said the incidents occurred at Nephrology Inc. in Mishawaka, Ind., and Physicians Dialysis Inc. in Grand Rapids, Mich.

"FDA is alerting the public and the medical community to this problem in an effort to prevent other deaths and injuries," FDA Deputy Commissioner Lester M. Crawford said in a statement. ]]> http://www.yourlawyer.com/topics/overview/medisystems_baxter_dialysis Thu, 12 Sep 2002 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/medisystems_baxter_dialysis Medisystems Baxter Dialysis Dialysis centers are being warned not to use certain blood tubing because it may be linked with five deaths and two injuries, the Food and Drug Administration. The deaths occurred in late August in dialysis centers in Indiana and Michigan using certain Medisystems tubing in connection with Baxter Healthcare Corp.'s Meridian dialysis machine, the FDA said.
 
The FDA said it is working with Baxter, based in Roundtop, Ill., and Medisystems Corp. of Seattle to determine the cause of the problem.

Meanwhile, Baxter has notified dialysis centers to stop using the tubing in question and use other available blood tubing instead. Blood tubing that may be associated with the deaths or injuries is Medisystems product code D3-9694/9793 or K3-9694/9793, Baxter product code 5M9694, the agency said.

The FDA said the incidents occurred at Nephrology Inc. in Mishawaka, Ind., and Physicians Dialysis Inc. in Grand Rapids, Mich.  "FDA is alerting the public and the medical community to this problem in an effort to prevent other deaths and injuries," FDA Deputy Commissioner Lester M. Crawford said."

If you or a loved one suffered injuries from a Baxter Dialysis machine, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>