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DEPARTMENT OF JUSTICE AND FDA TAKE ACTION AGAINST MEDTRONIC:
In 2006, 2007, 2011, 2012 and 2013 the FDA inspected Medtronic SynchroMed manufacturing facilities each time finding numerous violations of FDA regulations.  Warning letters were issued after each inspection.  Based upon Medtronic’s failure to appropriately address these violations, the FDA deemed the devices to be ‘adulterated’ because they were not manufactured according to the standards required by law.

On April 27, 2015:
The U.S. Department of Justice filed an injunction against Medtronic in U.S. District Court demanding that Medtronic stop all manufacturing and distribution of the SynchroMed II Infusion System. This injunction followed years of failed attempts by the FDA to force Medtronic to follow those FDA regulations that govern how medical devices are manufactured, packaged and distributed. A copy of the Injunction can be found by clicking here. 
 
Medtronic entered into a Consent Decree with the DOJ and FDA in which Medtronic agreed to not manufacture or distribute any new SynchroMed II devices except under extraordinary circumstances, including where a treating physician certifies that a SynchroMed pump is medically necessary and that the benefits of having this particular pump outweigh the risks. A copy of the Consent Decree can be found by clicking here.  The Consent Decree received judicial approval on April 29, 2015.  The Consent Decree requires Medtronic to undertake extensive corrective measures to be reviewed and approved by the FDA before normal operations can recommence.

 PERSONAL INJURY AND PRODUCT LIABILITY ALLEGATIONS AGAINST MEDTRONIC:

  • That patients have been severely injured by faulty devices manufactured using processes that are in violation of FDA regulations. 
  • That injured patients, the surviving family of deceased injured patients, and those not yet injured but at risk of injury, have not been adequately informed of the risks inherent with having one of these adulterated devices.
  •  That doctors who implanted these devices, or treat patients with these implants, have not been adequately advised of the extent of Medtronic’s FDA violations or the risk to which patients are currently exposed.
  • That other infusion pumps not found to be adulterated by the FDA are available to patients.


IS THIS DEVICE AND WHY IS IT USED?​
The Medtronic Synchromed II is a programmable infusion system implanted in the abdomen to deliver medications to treat chronic pain, severe spasticity, and cancer.  The system consists of a battery-powered pump and catheter.  The medication reservoir is filled by a clinician on average 3 to 4 times a year. The device is manufactured by Medtronic Neuromodulation and has been available since 2004.

The Medtronic Synchromed II System has been approved by the FDA to deliver the following medications:

  • Infumorph (morphine sulfate) for chronic pain
  • Baclofen (Gablofen, Lioresal, Liofen) for severe spasticity, including that caused by cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury and stroke.
  • Prialt (ziconotide) for chronic pain
  • Floxuridine (FUDR) for primary and metastatic cancer
  • Methotrexate (Otrexup) for primary and metastatic cancer


WHAT HAPPENS WHEN THE DEVICE FAILS?

  • Manufacturing defects can cause the system to fail, resulting in:
  • Overdose
  • Underdose
  • Movement of the catheter to a place other than where it was implanted.
  • Separation or loosening of the catheter from the pump.
  • Fragmentation of the catheter tip resulting in migration to other parts of the body.



SYMPTOMS OF THESE INJURIES:
Symptoms that the device is not working properly include:
Appearance of an overdose of the medication.
Sudden worsening symptoms of the condition which the medication delivered by the pump was intended to treat.
Some of the symptoms seen include:
Severe pain
Loss of consciousness
Respiratory failure
Heart attack
Stroke
Cardiac arrest
Coma
Death
Baclofen withdrawal syndrome is potentially life-threatening.  Symptoms include: fever, hallucinations, rebound spasticity, autonomic instability, mental status changes, seizure, and rhabdomyolysis.


WHAT TO DO IF YOU HAVE BEEN AFFECTED BY A FAULTY MEDTRONIC SYNCROMED II INFUSION PUMP:
If you or a loved one received a Medtronic SynchroMed II Infusion Pump implant, and suffered one of the injuries listed above, contact us immediately to receive a free confidential consultation to discuss your legal rights.  You may be entitled to compensation.  Contact us today!

MEDTRONIC SYNCHROMED INFUSION PAIN PUMP LAWSUIT

​​​​​​​​​​​Toll Free: ​866-584-0070

​​​​​​CYNTHIA K. GARRETT

Attorney at Law​

                                      

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Accepting Medtronic SynchroMed Pain Pump injury cases nationwide.  Call today to speak with an attorney about your legal rights. 

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Email:  CKG@CKGLawfirm.com