San Diego CA (PRWEB) December 06, 2012
Resource4thePeople is today informing consumers who may have had Medtronic Infusion operations of several recent developments involving litigation and the findings of an investigation into the company’s dealings by the U.S. Senate Finance Committee.
Medtronic recently filed a motion to dismiss a whistleblower suit filed against it in which the company is accused of covering up the fact that the inventor of the Infuse product was paid by the company to write positive articles in prominent medical journals without revealing his relationship with the company.*
Resource4thePeople notes that Medtronic SynchroMed II and SynchroMed El Implantable Infusion Pump and Refill Kits were the subject of a Class 1 Recall issued by the Food and Drug Administration on Jan. 14, 2011.**
Class 1 Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death, according to the FDA.
Resource4thePeople is providing referrals to lawyers for Medtronic Infuse Pump lawsuits for victims of these side effects who may be eligible for compensation for medical costs, loss of wages, pain and suffering and other expenses.
Free consultations are being offered and cases are now being accepted. http://www.resource4thepeople.com/defectivemedicaldevices/medtronic.html
As with most legal cases, there may be legal deadlines for filing a Medtronic Infusion Pump lawsuit so Resource4thePeople recommends that contact be made as soon as possible to preserve all available legal options.
Resource4thePeople also notes that the motion by Medtronic lawyers to dismiss the whistleblower suit against it comes shortly after a bi-partisan study by the Senate Finance Committee on Oct. 21 released the findings of 16-month investigation of Medtronic.
The committee found that the investigation “revealed questionable ties between the medical technology company and the physician consultants tasked with testing and reviewing Medtronic products.”***
The committee found that Medtronic did not publicly disclose the fact that its employees “collaborated with physician authors to edit – and in some cases, write – segments of published studies on its bone-growth product Infuse.”
The committee said Medtronic spent nearly $210 million in payments to physicians in this capacity over a 15-year period and the failure to disclose these relationships undermines the credibility of these publications.
“Medtronic’s actions violate the trust patients have in their medical care. Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has,” said Senator Max Baucus. “Patients everywhere will be better served by a more open, honest system without this kind of collusion.”
“These findings emphasize the value of the Grassley-Kohl Physician Payments Sunshine Act, which will result in public disclosure of industry payments to physicians starting next year. The findings also should prompt medical journals to take a very proactive approach to accounting for the content of the articles along with the authorship of the articles and studies they feature,” said Senator Chuck Grassley.
“These publications are prestigious and influential, and their standing rests on rigorous science and objectivity. It’s in the interest of these journals to take action, and the public will benefit from more transparency and accountability on their part.”
The committee said that in 2002 the Food and Drug Administration (FDA) approved Infuse for use stimulating spinal bone growth in patients with a degenerative disease affecting the lower spine and that, according to Medtronic, Infuse has been used to treat more than 500,000 patients.
The report released by the Finance Committee – which has sole jurisdiction over Medicare and Medicaid – is the product of an investigation they began in June 2011.
Medtronic cooperated with the committee’s inquiry and produced more than 5,000 documents pertaining to 13 different studies of Infuse for the investigation.
Resource4thePeople notes that this is not the first time that the Minnesota-based company has been in hot water over improper physician payments.
In 2011 Medtronic agreed to pay the United States a $23.5 million settlement to resolve allegations that it violated the False Claim Act by using physician payments related to post-market studies and device registries as kickbacks to induce doctors to implant the company’s pacemakers and defibrillators.****
In announcing the settlement, the Justice Department said post-market studies are intended to assess the clinical performance of a medical device or drug after that device or drug has been approved by the Food and Drug Administration.
Registries are collections of data maintained by a device manufacturer concerning its products that have been sold and implanted in patients, the Justice Department said.
The Infuse bone graft device was approved by the FDA in 2002 for use in anterior approach spinal fusions in the lower back, primarily for patients suffering from degenerative discs.
However, as noted in the Senate Finance Committee’s report, off-label, or unapproved uses of the devices have surfaced and come under scrutiny because of Medtronic’s “questionable” use of payments to physicians for positive medical findings.***
The Spine Journal, the official publication of the North American Spine Society in a June, 2011 article reported that it investigated the Medtronic-funded research studies and “found that 13 Medtronic-funded studies downplayed or entirely omitted evidence of safety issues with Infuse.”****
Medtronic’s legal issues also have had an effect on company earnings, according to a Bloomberg News report, which said that legal fees have overwhelmed flat sales of other products.******
“Medtronic said revenue from its spinal division fell 7 percent to $782 million,” Bloomberg reported. “The division has been hurt by ongoing revelations about the company's handling of its protein bone graft Infuse.
Last month a Senate investigation concluded that the company helped write and edit medical journal articles about the graft that downplayed its risks. InFuse contains a genetically engineered protein that can stimulate bone growth.
The Food and Drug Administration approved Infuse in 2002 for use in spinal, oral and dental graft procedures, but most of the time it has been used off-label in neck surgeries and other procedures. Those uses can lead to problems swallowing, breathing and speaking.”
*Case 3:11cv0413 Document #44, U.S. District Court, Southern District of Mississippi