iPump, Inc.

Posts Tagged ‘medtronic’

Legal and Ethical Concerns Over Medtronic’s Business Practices

Medtronic has a court-documented track record of failing to properly notify its customers in a timely fashion of known product defects. Product failure has resulted in deaths, hospitalizations, and both individual and class action lawsuits against the company. Their inexcusable behavior has even prompted new proposed legislation because legal rights for patients who died or were injured by Medtronic products were substantially limited when it came to suing for tort damages.

. ..”Following the 2008 Supreme Court decision Riegel v. Medtronic, (.pdf) patients and families have been prevented from having the right to file a viable Medtronics lawsuit to help cover medical bills, lost wages and pain and suffering based on FDA preemption.

For more information about Medtronic’s legal battles, see the Medtronic Recall Center.

Why We Are Not Accepting Medtronic Insulin Pump Supplies At This Time

Medtronic has most recently recalled another three million infusion sets from their two top-selling product lines. We have received well-intended donations of supplies that have been recalled and may be defective. In order to ensure the safety of our clients we are no longer accepting Medtronic insulin pump supplies. Unfortunately, we do not have the funds to hire staff – iPump is run by one full-time volunteer and we simply do not have the resources to manually track all Medtronic products at this time. Additionally, Medtronic has not returned our calls or letters about exchanging donated items that were recalled.

Why We Are No Longer Accepting Medtronic Insulin Pumps

Medtronic frequently refers their call-in customers to iPump as a place to donate their used insulin pumps. Instead of allowing Medtronic customers to turn them in for a $500 credit towards a new pump, several people have told us that Medtronic suggests they can donate old pumps to iPump and get a tax deduction for several thousand dollars instead of just a $500 credit as their insurance will pay for the pump anyhow.

This may sound like a nice gesture, but Medtronic is diverting pumps that they know are so old they will not upgrade them so really have no value at all. In simplest terms, Medtronic appears to be using iPump as a medical device dumpster. We have contacted Medtronic multiple time via phone, emails and letters – including to Medtronic’s president and board of directors and have not had the courtesy of a reply.

We hope to have a better, more reciprocal business relationship with Medtronic someday, but until such time, we are no longer accepting any Medtronic MiniMed insulin pumps or insulin pump supplies.

We do not wish to alienate or offend Medtronic customers – and we must remind our blog readers that any and all medical device manufacturer is open to lawsuits.  But this recent news only serves to reaffirm our commitment to serving the best interest of our clients and our reason for focusing on working with companies whose business ethics value the safety of consumers.

Medtronic Paid Doctor to Testify Before Lawmakers

A medical professor at the University of Minnesota received $6,000 from medical device maker Medtronic in exchange for testimony that urged lawmakers to continue funding medical research involving a bone growth product called Infuse, according to the New York Times. The newspaper reports that Dr. David W. Polly Jr. failed to disclose that he was working as a consultant for Medtronic when he testified before a Senate panel in 2006. Documents released by Senator Charles E. Grassley show that Polly received $1.14 million in fees and expenses from Medtronic from 2003 to 2007.  Barry Meier, The New York Times 07/29/2009

The following is an excerpt updating the status of proposed legislation prompted by a lawsuit against Medtronic in which consumers lost.

From: Medtronic Lead Recall Center

…”On August 04, 2009 there was a hearing on S. 540: the Medical Device Safety Act of 2009. This legislation would reverse the 2008 Riegel Supreme Court decision and allow patients injured by medical devices the right to bring a claim for compensation. This legislation would also help remove harmful medical products from the market even if they were initially approved by the FDA. Class III medical devices include heart defibrillators, artificial valves, and prosthetic knees and hips.

Note: The 2008 Riegel Supreme Court decision denied patients who died or were injured by medical devices the right to bring a claim for compensation. In particular, Medtronic was not found liable for tort damages (such as pain and suffering, emotional distress, etc.) and therefore has continued to confidently offer a variety of medical devices with known defects – because of the limitations on how people could sue.

Our concern is this: If a client was injured or died as a result of an insulin pump improperly recertified by Medtronic, our client would have very little legal recourse against the company. While this would be true of any insulin pump manufacturers, it is the overall way in which Medtronic conducts business and the number of lawsuits against them for faulty medical devices that causes us concern.

…”Currently, the medical device industry enjoys complete immunity for their class III medical devices, even when the devices are found to be defective and dangerous, and have even been recalled. This benefits all patients by helping make sure that safe medical products are in the marketplace. The Medical Device Safety Act is vitally important for victims of defective Medtronic defibrillator leads who are currently left without any meaningful legal options and patients in general who use FDA approved medical devices.

More Information
Medtronic Class Action Lawsuits

Note: We are not in any way associated with, connected with, or receive any compensation or donations from the Medtronic Lead Recall Center. We merely capture and highlight this law firms news updates.

July 11, 2009
The Wall Street Journal
by Jon Kamp

Medtronic Recalls Insulin Devices

The following is an excerpt from one of many articles relating to the recent Medtronic infusion set recall of approximately 3 million sets.

Late last month, the medical-device maker came under fire from the U.S. Food and Drug Administration, which warned Medtronic about what the agency called a failure to properly report and remedy flaws in the Synchromed drug pump and the MiniMed insulin pump.

In a letter, the FDA said it took Medtronic almost two years to recall Synchromed II pumps after discovering a missing propellant in some versions. The agency also said the company didn’t follow proper reporting procedures involving complaints about the insulin pump.

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Driver’s Insulin Pump Blamed for Fatal Crash
By Jodine Mayberry
Medical Devices Litigation Reporter

A Warren County, Ky., man was killed in a motor vehicle collision after his insulin pump failed to deliver sufficient medication and he lost consciousness behind the wheel, according to a lawsuit filed in a Kentucky federal court.

Plaintiff Paula Kennedy, the administrator of Jeffrey T. Kennedy’s estate, alleges her husband was killed Feb. 17, 2004, when his Paradigm Sof-set Ultimate QR Infusion Set malfunctioned. The pump was attached to his abdomen and sent the insulin into his system subcutaneously.

The plaintiff says manufacturer Medtronic Inc. was preparing to issue a recall of a similar infusion set yet failed to advise or warn consumers, including Kennedy, of the impending recall. Medtronic had not filed an answer to the complaint at press time.

Medtronic recalled more than 160,000 Paradigm Quick-set Plus insulin pumps in June 2004 because the tube that delivers insulin to the body could become dislodged or disconnected, causing an interruption of the insulin flow.

The problem caused some 200 diabetics across the country to be hospitalized for elevated blood sugar levels, according an Associated Press report at the time.

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