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KAY VAN WEY | Medical Malpractice
Defective Pain Pumps: Medtronic Fails to Protect Patients
Ireally feel for chronic pain patients. Over the course of my 32 years in practice, I have seen so many ne
folks who are in pain 24/7/365. e lives of chronic pain patients center around what they can do to get relief. ey o en look to anything that can help reduce or relieve their pain.
Medical technology has entered the pain eld and o ered many solu- tions to pain patients, that are alter- natives to powerful and highly addic- tive narcotics. Medtronic designed an implantable pain pump that would deliver medication directly to the pa- tient at pre-set intervals. is could have several advantages, including providing consistent levels of medica- tion and avoiding the risk of the pa- tient accidentally over-medicating or over-dosing themselves.
e pump was designed to be im- planted directly into the patient’s ab- domen and connected internally by a catheter to the intrathecal space of the spine. In this way, the medica- tion can be directly targeted to the pain receptors in the spine. e pump was only approved for use in certain patient populations and with certain drugs. For example, it could be used to deliver morphine for the treatment of intractable chronic pain or metho- trexate for the treatment of pain as- sociated with primary or metastatic cancer. As well, it was approved for delivery of Baclofen for treatment of severe spasticity.
However, the Medtronic Syn- chromed II Pump has faced many problems, leading up to an FDA re- call. According to the FDA, Medtron-
ic was required to recall the Syn- chroMed II pump, because “a so - ware problem may cause unintended delivery of drugs during a priming bo- lus procedure, used to quickly deliver a large dose of medication from the device to the patient’s spine.” During this time, patients may also “receive the drug unintentionally at a high rate of infusion in the cerebrospinal uid followed by a period of reduced drug delivery a er the priming bolus.
Other problems which have been observed with the pumps include:
• Motor stalls
• Catheter becomes clogged
• Catheter disconnects from the
pump
• Battery dies prematurely
• So ware misdirects the amount of
medication
• Pump short-circuits • Priming bolus fails
Sadly, a malfunctioning pain pump can lead to a host of problems, includ- ing delivery of a fatal drug overdose to the unsuspecting patient!
e FDA, reacting to complaints, conducted multiple inspections of Medtronic’s manufacturing facili- ties between 2006-2013 and revealed many concerns. Part of the problem was the way in which Medtronic dealt with complaints about devices that were reported to have malfunctioned or caused serious injury to a patient. AS the FDA stated, the manufacturer is required to investigate and imple- ment changes under these circum- stances. But, the FDA didn’t stop there. ey asked the Justice Depart-
AttorneyAtLawMagazine.com
ment to get involved. at led to DOJ ling a complaint which alleged that Medtronic and two of its senior exec- utives had been distributing medical devices into interstate commerce that were adulterated because they were not manufactured in accordance with current good manufacturing process- es. e DOJ action led to a consent decree in which Medtronic and its leadership committed to make chang- es in their process that will “bene t the American public by ensuring that their products are safe and e ective for patients.” According to counsel for the DOJ, “ e DOJ will not permit medical device manufacturers to shirk their responsibility to ensure that the devices that patients rely upon are safe.” I say, GO DOJ!
In conclusion, I suppose this isn’t the rst time you’ve heard about a defective medical device and I can al- most promise you it won’t be the last. As patients, we have very little control over what products are put inside our bodies and we therefore, must place extreme trust in corporations who manufacture these products. Unfor- tunately, we see time and time again, that corporations are perfectly willing to put pro ts over patient safety until they are forced to stop and made to pay for the harm they have caused.
Don’t you wish the bad behavior would end so that I would run out of things to write
about? Until then,
friends and col- leagues, stay safe out there!
Kay Van Wey is a plaintiff’s medical malpractice attorney. After more than 30 years in the trenches, her goal is to make herself extinct by helping to eradicate preventable medical errors. Voted Texas Super Lawyer for 14 consecu- tive years, she’s named to D Best Magazine in tort product and medical liability litigation: plaintiff 2016. Kay has also attained membership in the Million and Multimillion Dollar Advocates Forum. Her vast experience in personal injury litigation, combined with her tremendous work ethic and leadership skills, have culminated in her leading an “A” team of committed professionals. Contact Kay online at vanweylaw.com or [email protected].
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