Medtronic Settles Whistleblower Allegations over SubQ Stimulation for $2.8 Million

Medtronic Settles Whistleblower Allegations

Medtronic Settles Whistleblower Allegations


Medtronic has reached a $2.8 million settlement with the United States to resolve allegations under the False Claims Act that it caused false claims to be submitted over SubQ stimulation. According to a news release from the Department of Justice (DOJ), the company promoted the procedure despite knowing that its safety and efficacy had not been established by the U.S. Food and Drug Administration (FDA).

“Today’s settlement demonstrates our commitment to ensure that beneficiaries of federal health care plans, including Medicare recipients and military families, receive medical treatments that have been proven safe and effective,” said Acting Assistant Attorney General Joyce R. Branda of the Justice Department’s Civil Division in the release. “Targeting chronic pain patients with a medical procedure that lacks evidence of clinical efficacy wastes the country’s health care resources.” [Read more…]

FDA Issues Safety Warning on Use of Bone Graft Devices in Patients Under 18

FDA Issues Safety Warning on Use of Bone Graft Devices

FDA Issues Safety Warning on Use of Bone Graft Devices


In a safety communication addressed to healthcare providers, patients, and parents and guardians, the Food and Drug Administration is warning that bone graft devices containing recombinant proteins or synthetic peptides can cause serious injury when used in patients under age 18.

Certain recombinant proteins and synthetic peptides mimic natural bone growth substances and these may be added to a device that is surgically implanted in a patient with a bone defect to promote new bone growth or to replace or heal existing bone. The FDA has approved devices such as Medtronic Infuse for orthopedic and dental use only in patients over the age of 18 who have finished growing (skeletal mature). The labeling for each product provides the specific indications for use. The FDA has not evaluated the safety and effectiveness of these devices in patients under age 18, whose skeletons are considered immature. Any product that affects bone growth could negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates, the FDA explains. [Read more…]

Class I recall issued on Medtronic SynchroMed drug infusion pumps

Class I recall issued on Medtronic SynchroMed drug infusion pumpsA Class I recall has been issued on Medtronic’s SynchroMed II drug infusion pumps.

The recall was deemed necessary after the manufacturer admitted that the motor can stall on the devices, especially when they’re used to dispense unapproved drug treatments. The recall includes SynchroMed II infusion pumps manufactured from May 1998 until November 2012. They were distributed from April 1999 until November 2012.

A Class I recall from the Food and Drug Administration means that use of a medical device or drug will likely result in serious injuries or death.

The recall includes the following SynchroMed drug infusion pumps: SynchroMed II, models 8637-40 and 8637-20 (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir sizes.) and the SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. [Read more…]

Judge Dismisses Medtronic’s Preemption Claim in Off-Label Lawsuit

Judge Dismisses Medtronic’s Preemption Claim in Off-Label LawsuitOverview: A California judge has denied Medtronic’s attempt to pursue litigation without a trial based on preemption in a case alleging Medtronic promoted the off-label use of its bone growth product, Infuse. The off-label use and marketing of Infuse has been surrounding the controversial product since 2008.

 

 

 

  • The California Health Department is investigating a Pomona Valley Hospital following accusations of off-label promotion and experimental procedures with Medtronic Infuse and two Stryker products
  • Judge Michael Linfield has denied Medtronic’s motion for summary judgment on the basis of preemption, stating that the plaintiff is suing on the count of federal, not state, violations
  • Medtronic has been faced with a number of lawsuits alleging it promoted the off-label use of Infuse, which has been associated with life-threatening complications

Product: Medtronic Infuse Bone Graft

Manufacturer: Medtronic, Inc.

Side Effects & Complications

  • Cancer
  • Difficulty breathing, swallowing
  • Uncontrolled bone growth
  • Nerve injury
  • Male sterility
  • Retrograde ejaculation

[Read more…]

Medtronic Infuse is Associated with Pain and Nerve Injury

Pain and nerve injury are among the side effects associated with Medtronic Infuse, which is a product used to stimulate bone growth in the spine. The U.S. Food and Drug Administration (FDA) has only approved it for certain regions of the spine (L4 to S1) and certain dental procedures, but the product has been used in an “off-label” manner, meaning that doctors use Infuse in ways not approved by the FDA. While physicians are allowed to do this, it is illegal for companies to promote off-label use.

Allegedly, Medtronic not only promoted Infuse for off-label procedures but reports suggest that the company paid doctors to hide the side effects. Medtronic Infuse has been linked to pain and nerve injury due to the excessive bone growth that occurs when the product is used. Research has also linked the artificial bone graft to male sterility, retrograde ejaculation and cancer.