Yourlawyer.com (Boston Scientific Infusion Ports 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 Shares Dip on Letter News

Tue, 23 Aug 2005 00:00:00 -0700

Federal regulators sent Boston Scientific Corp. a warning letter identifying "serious regulatory problems" in medical devices shipped from a Quincy, Mass., distribution plant, including heart stents sent to hospitals despite a quality control problem.

The U.S.Food and Drug Administration's disclosure of the letter on Tuesday sent shares of Boston Scientific down nearly 5 percent in morning trading to a new 52-week low.

A letter to the company dated Aug. 10 said FDA inspectors found "serious regulatory problems" during a nearly two-month inspection in Quincy that ended May 20. The letter cited problems in shipments of the Natick, Mass.-based company's Taxus drug-coated stents Boston Scientific's top-selling product as well as Vaxcel implantable infusion ports used to administer drugs and Symmetry catheters that insert medical devices.

Boston Scientific spokesman Charles Rudnick said on Tuesday the company "is actively working on every point raised in the FDA letter. We've completed corrective action in many areas."

While the company acknowledges shipping products that should not have left the Quincy distribution center, Rudnick said, "It's important to note that in every case pointed out by the FDA we had previously identified the problems discussed by the FDA through our quality control and taken appropriate action."

Rudnick said none of the problems with shipments cited in the FDA letter harmed patients. Eight Taxus stents that were shipped to five hospitals in January, even though they were in a batch that had previously failed to meet quality standards, were returned to the company before they were used, Rudnick said. The drug-coated stents failed to pass a test involving their release of drugs to prevent scar tissue from forming new blockages after artery-clearing surgery.

However, the FDA's letter, posted on the agency's Web site Tuesday, said the problems it cited "may be symptomatic of serious underlying problems in your establishment's quality system."

The letter said "these serious violations of the law may result in FDA taking regulatory action without further notice to you," including such possible steps as seizing product inventory, obtaining a court order to halt marketing of devices, or fining the company.

The FDA said Boston Scientific's response to the inspection findings "fails to address specific system-wide corrective actions that are necessary to bring your facility into compliance."

Rudnick said the Quincy center distributes most of the company's medical devices, which are produced at various manufacturing sites. He said the FDA highlighted only problems at the distribution center, not systemic problems in the company's manufacturing.

Boston Scientific last summer recalled nearly 100,000 units of the Taxus stent and another model not coated with drugs because of a manufacturing defect that the company has since fixed.

Stents are metal-mesh devices that prop open coronary arteries after surgeries to clear blockages.

Boston Scientific shares declined $1.31, or 4.8 percent, to $25.84 in morning trading on the New York Stock Exchange, where the shares had traded in a 52-week range of $26.50 to $40.20.

Boston Scientific Recalls Device After FDA Warning

Wed, 01 Jun 2005 00:00:00 -0700

Hundreds of patients may need surgery to remove an implanted drug-injection device made by Boston Scientific Corp., the company said yesterday after federal regulators cited it for quality-control problems.

A spokesman for the Natick medical-devices giant said it has been advising doctors to consider surgery if their patients have one of the 1,000 drug-infusion ports it recalled in March. In addition, the company said it will recall another 1,000 ports this week, in response to a warning letter it received May 18 from the Food and Drug Administration about quality-control standards.

The letter, which was posted yesterday on the FDA's website, said Boston Scientific failed to establish manufacturing controls for the quality of the devices and did not properly track quality concerns.

The problems could cause the ports to leak drugs into unintended parts of the body, though the company said it knew of only one possible report of a patient injury. Boston Scientific said the company would take charges totaling $2 million to resolve the issues. The amount is financially insignificant for the company which had 2004 sales of $5.6 billion but company spokesman Charles Rudnick declined to say whether that was the reason the company didn't publicly disclose the problems to investors earlier. He said the company ''fully complied with all requirements regarding notification."

The FDA's letter directed the company to fix problems it called ''serious violations of the law" that could result in fines, product seizures, or other penalties. The language was stronger than any communication Boston Scientific received from the agency last year when the company launched three recalls to fix manufacturing flaws in its most important product, a cardiac stent.

Boston Scientific shares fell 86 cents yesterday to close at $27.09, their lowest close in a year, though several financial analysts said other factors may be driving the stock's decline. Last week, the company lowered its earnings expectations for the year.

Infusion ports make it easier to treat cancer patients and others who need frequent drug injections by avoiding repeated needle-sticks directly into a blood vessel.

Typically, the ports feature a circular surface made of silicon-like material about the size of a 50-cent piece that is implanted under the skin, often just below the clavicle. Needles poked through the port's surface deliver drugs that flow through a catheter surgically attached to a vein.

The technology became widely used by the 1990s. Boston Scientific calls its latest versions ''Vaxcel Low Profile Infusion Ports" and says they close more effectively than earlier models, reducing complications.

According to the FDA's letter, Boston Scientific started reviewing its manufacturing procedures Aug. 26 after receiving a complaint that the two plastic pieces that form the port's cover and base had separated, possibly because they weren't correctly welded.

It received at least four more complaints through Feb. 9, and on March 9 launched a voluntary recall of all 1,000 ports it had shipped to date that included valves to stop blood from flowing up from the catheter to the reservoir.

At the time, Boston Scientific said it didn't need to recall ports made without valves because the company hadn't received complaints about those models. But the FDA's letter said it did receive a complaint Jan. 5 about a ''leak in the membrane" of a nonvalved port.

The company was warned for failing to maintain adequate procedures to identify actions ''to correct and prevent the recurrence of nonconforming product and other quality problems."

Rudnick said the cause of the leak reported Jan. 5 was ''inconclusive." But he added the second recall was meant to address all the FDA's concerns, pending another meeting with the agency expected within a week.

Of the 1,000 ports that have already been recalled, Rudnick said the company is working to determine how many have been implanted in patients and that it is only advising doctors to consider removing the devices.

The ports typically are removed after about six months, he said. The company isn't advising doctors whose patients have the other type of port to consider having them removed because it hasn't received any reports of the port's cover and base separating, he said.

Boston Scientific to Recall Infusion Ports

Wed, 01 Jun 2005 00:00:00 -0700

Boston Scientific Corp. said it will recall another 1,000 drug infusion ports in response to a stern warning from the U.S. Food and Drug Administration.

The FDA warning, issued May 18 and posted this week on its Web site, said Boston Scientific failed to establish quality controls for making the infusion ports and failed to properly track quality concerns, including leaking, that the FDA called "serious violations of the law."

Hundreds of patients may need surgery to remove the device, the company told the Boston Globe.

The ports, about the size of a 50-cent piece and implanted under the skin, deliver drugs through a catheter attached to a vein.

They are used often for cancer patients or others who need frequent drug injections.

The second recall would bring to 2,000 the number of Boston Scientific drug infusion ports recalled this year.

Boston Scientific Vaxcel Low Profile Infusion Port Recall Lawyer

Wed, 01 Jun 2005 00:00:00 -0700

Boston Scientific Infusion Ports

Hundreds of patients may need surgery to remove an implanted drug-injection device, the Vaxcel Low Profile Infusion Ports made by Boston Scientific Corp., the company said yesterday after federal regulators cited it for quality-control problems. A spokesman for Boston Scientific said it has been advising doctors to consider surgery if their patients have one of the 1,000 drug-infusion ports it recalled in March. In addition, the company said it will recall another 1,000 ports this week, in response to a warning letter it received May 18 from the Food and Drug Administration about quality-control standards.

The letter, which was posted yesterday on the FDA's website, said Boston Scientific failed to establish manufacturing controls for the quality of the devices and did not properly track quality concerns. The problems could cause the ports to leak drugs into unintended parts of the body, though the company said it knew of only one possible report of a patient injury. The FDA's letter directed the company to fix problems it called ''serious violations of the law" that could result in fines, product seizures, or other penalties.

Infusion ports make it easier to treat cancer patients and others who need frequent drug injections by avoiding repeated needle-sticks directly into a blood vessel. Typically, the ports feature a circular surface made of silicon-like material about the size of a 50-cent piece that is implanted under the skin, often just below the clavicle. Needles poked through the port's surface deliver drugs that flow through a catheter surgically attached to a vein. According to the FDA's letter, Boston Scientific started reviewing its manufacturing procedures Aug. 26 after receiving a complaint that the two plastic pieces that form the port's cover and base had separated, possibly because they weren't correctly welded.

It received at least four more complaints through Feb. 9, and on March 9 launched a voluntary recall of all 1,000 ports it had shipped to date that included valves to stop blood from flowing up from the catheter to the reservoir. At the time, Boston Scientific said it didn't need to recall ports made without valves because the company hadn't received complaints about those models. But the FDA's letter said it did receive a complaint Jan. 5 about a ''leak in the membrane" of a non-valved port.

The company was warned for failing to maintain adequate procedures to identify actions 'to correct and prevent the recurrence of nonconforming product and other quality problems. This technology became widely used by the 1990s.

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