http://www.yourlawyer.com/topics/overview/boston_scientific_enteryx_device Sat, 21 Nov 2009 22:45:09 -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.

]]> http://www.yourlawyer.com/articles/read/10832 Tue, 18 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10832
Prescribed for gastroesophageal reflux disease (GERD), ENTERYX® is injected by a physician into the inside muscle wall of the patient’s esophagus.

The liquid then thickens into a sponge-like substance helping to block stomach acids and prevent them from entering the esophagus and throat.

There have been reports that in rare cases, physicians may have mistakenly injected the drug into areas close to the esophagus, including other vital organs, resulting in serious health complications for the patient, including reduced kidney function, internal bleeding, and even death.

Despite extreme care by doctors to avoid such incidents, it is difficult to discern whether or not the liquid has been injected improperly.

Patients who have been given an inaccurate injection may experience the following symptoms:
·    Pain in the chest or side
·    Cough
·    Shortness of breath
·    Difficulty swallowing
·    Significant weight loss
·    Fever
·    “Flu-like” symptoms
·    Fainting
·    Weakness
·    Fatigue

Even when ENTERYX® is injected properly, it is still possible that long-term complications will occur.
In at least two of the reported cases, patients experienced some of the above symptoms up to a month and a half after their procedure and even though ENTERYX® was injected properly.

The FDA advised patients who have had the ENTERYX® procedure within the last seven weeks, to contact their physicians immediately in the event that they experience any of the above symptoms, even if they have already been treated in the emergency room.

Doctors may order a follow-up procedure to confirm or rule out improper injection of the ENTERYX® product.

FDA and Boston Scientific are working to make sure that physicians treating patients with ENTERYX® products are notified of the reported problems and receive accurate, up-to-date information. Additional information on this recall is available at http://www.fda.gov/cdrh/safety/101405-enteryx.html.]]> http://www.yourlawyer.com/articles/read/10829 Mon, 17 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10829
The serious adverse events involve unrecognized transmural injections of ENTERYX(r) into structures surrounding the esophagus. On September 23, 2005, Boston Scientific issued a recall of all ENTERYX Procedure Kits and ENTERYX Injector Single Packs from commercial distribution.

Physicians should stop injecting ENTERYX immediately and follow the manufacturer's procedures for returning unused product. FDA also provided recommendations on avoiding future occurrences and advice for patients.

Advice for Patients: with ENTERYX® for Gastroesophageal Reflux Disease

Boston Scientific Corporation has recalled all ENTERYX® Procedure Kits and ENTERYX® Single Pack Injectors, because of reports that improper injection procedures can lead to serious patient injury and death.

ENTERYX® is used to treat patients with gastroesophageal reflux disease (GERD). A physician injects the ENTERYX® liquid into the inside muscle wall of the esophagus, close to where it joins the stomach (i.e., the lower esophageal sphincter). The liquid then thickens into a sponge-like substance within the muscle where it helps the sphincter act as a barrier to stomach acids, preventing the acids from entering the esophagus and eventually the throat.

The company has received reports that in rare cases, physicians may inadvertently inject the ENTERYX® liquid into areas close to the esophagus, including other vital organs. This can result in serious health complications for the patient, including internal bleeding, reduced kidney function, and death. Even though doctors monitor patients during and immediately after the procedure to make sure they inject ENTERYX® in the right location, they may not detect some cases of improper injection right away.

Symptoms that patients may experience if ENTERYX® is improperly injected include:

    * Pain in the chest or side
    * Cough
    * Shortness of breath
    * Difficulty swallowing
    * Significant weight loss
    * Fever
    * “Flu-like” symptoms
    * Fainting
    * Weakness
    * Fatigue

To date, all known cases of improper injection of ENTERYX® were discovered within three weeks of the procedure in patients experiencing these symptoms.

It is important for patients to know that even when ENTERYX® is injected properly, long-term complications are still possible. In at least two cases, patients experienced some of the above symptoms up to seven weeks after their procedure, even though ENTERYX® was injected properly.

Advice for Patients

    * Go to the nearest emergency room if you experience chest pain or fainting.
       
    * If you have had the ENTERYX® procedure within the last seven weeks, contact your doctor immediately if you experience any of the following symptoms, even if you have already been treated in the emergency room:
          o Pain in chest or side
          o Shortness of breath
          o Difficulty swallowing
          o Significant weight loss
          o Cough
          o Fever
          o “Flu-like” symptoms
          o Fainting
          o Weakness
          o Fatigue
      Your doctor may order a follow-up procedure such as chest x-rays, barium swallows or chest and abdominal scans to confirm or rule out improper injection of the ENTERYX® product.
       
    * Continue to see your doctor for regularly-scheduled follow-up appointments, even if you experience no symptoms.

Your doctor has been notified of the problems associated with ENTERYX®, and has received specific information about how to monitor patients who have had this procedure. FDA will continue to monitor reported problems with ENTERYX®, and we will update this notice as more information becomes available.
]]> http://www.yourlawyer.com/articles/read/10690 Wed, 28 Sep 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10690
The company says it considers its Enteryx injection kit safe, but some patients have been harmed because doctors used it incorrectly.

About 3,800 patients have been treated with Enteryx, which was approved in 2003 by the
Food and Drug Administration. The treatment is a liquid polymer injected directly into the walls of esophagus. It thickens into a permanent spongy lump which is supposed to help block acid from flowing from the stomach toward the throat.

Boston Scientific's recall notice said some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing "adverse events."

The notice was posted on the company's Web site last week.

According to reports filed with the FDA, patients have suffered leakage, swelling, and ulcers in the esophagus. An elderly patient died last year after a doctor accidentally hit the wall of the patient's aorta, the body's largest artery.

The company issued a safety alert in July 2004.

The Enteryx device was touted as one of the companies promising new products and analysts initially projected several hundred million dollars in annual revenues. But the procedure has been dogged by safety questions and uncertainty about whether insurers would reimburse for the injection.

Boston Scientific sold about $5.5 million worth of Enteryx kits last year.

"That basically was touted as a potential $500 million product, and it's turned out to be a zero," Mark Landy, a medical-device analyst for Susquehanna International Group, told The Boston Globe.

Dr. Ram Chuttani, chief of endoscopy at Beth
Israel Deaconess Medical Center, said his hospital has performed 40 to 50 Enteryx procedures. He called process, technically "very demanding."

"It is quite difficult to control even in the best settings even in experienced hands, when you inject, you cannot be absolutely certain where the Enteryx is injected," he said.]]> http://www.yourlawyer.com/articles/read/8386 Sun, 15 Aug 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8386
The FDA is also looking at injuries in six other patients treated with the Enteryx device.

The review comes as Boston Scientific grapples with a month-old recall of its lucrative drug-coated heart stent.

Nearly 100,000 Taxus and Express 2 model stents have been recalled since July 2 because of a manufacturing defect.

In the Enteryx review, the FDA is looking into whether physician technique or the device itself triggered the woman's death, which occurred when her aorta ruptured. The Enteryx device is used to inject a plastic substance into the esophagus. The substance is designed to reduce the symptoms of acid reflux disease.

"At this time there doesn't appear to be a problem with the device," FDA spokeswoman Kathleen Quinn said.

Paul Donovan, a spokesman for Boston Scientific, said the company is recommending that the product's label be changed to stress the importance of closely following directions for use.

"We are going to work closely with the FDA," Donovan said.

Boston Scientific's stock has fallen nearly 25 percent since just before the beginning of July, when the stent recalls began.

Enteryx, which costs about $1,700, has been used in about 2,000 procedures since it was introduced in April 2003.

In acid reflux disease, the contents of the stomach back up into the esophagus. Enteryx is one of a handful of minimally invasive treatments designed to offer relief without daily medication.]]> http://www.yourlawyer.com/topics/overview/boston_scientific_enteryx_device Sun, 15 Aug 2004 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/boston_scientific_enteryx_device Boston Scientific Enteryx Device The FDA & Boston Scientific notified health care professionals and patients about serious adverse events, including death, occurring in patients treated with the Enteryx device. On September 23, 2005, Boston Scientific ordered a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. Additionally, Boston Scientific Corp. recently suspended sales of it's Enteryx Device after more than two dozen reports of problems. The notice was posted on the company's Web site, during  the week of September 19, 2005.

An estimated 3,800 patients have been treated with Enteryx device, which was approved in 2003 by the FDA. The company's recall notice stated some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing adverse events. Boston Scientific sold about $5.5 million worth of Enteryx kits in 2004.

Based upon reports filed with the FDA, patients suffered leakage, swelling, and ulcers in the esophagus. One elderly patient died last year after a doctor accidentally hit the wall of the patients aorta, the body's largest artery. Boston Scientific Corp. said the U.S. Food and Drug Administration is looking into reports of one death and six injuries linked to the use of its treatment for acid-reflux disease. Boston Scientific, said the FDA is looking into its Enteryx device, an injectable treatment for acid reflux, after the death of an elderly woman last month, three weeks after treatment. The agency will try to determine whether the death was linked to the device or to physician technique.

We've reported this to the FDA and we're working cooperatively with them," said Paul Donovan, a Boston Scientific spokesman. FDA spokeswoman Kathleen Quinn confirmed the agency was reviewing the adverse events. The Enteryx treatment, which the company had identified as one of its top products in terms of sales growth potential involves the injection of a plastic substance into the esophagus to help protect patients from acid backing up from the stomach.

In July 2004, the company issued an alert to doctors about the product and is updating the product label. In the case of the patient who died, some of the polymer had been injected into the woman's aorta, which ruptured, causing her to bleed to death.

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