Is there something wrong with the Bacolfen Pump, Model No. 863740 causing overdoses in patients?
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When we are ill or have a medical condition, we generally trust our doctors and medical system to prescribe us treatments which will help us to feel better. However, sometimes, there are dangers in our treatments which may not be readily apparent.
Is there something quirky about the programming mechanism of the Baclofen Pump or is it just a case of the fat finger syndrome?
The drug Baclofen is used as an antispastic agent and also as a muscle relaxer and is often used to treat people with spinal injuries or multiple sclerosis. For some patients, the drug is administered to the patient via an implanted pump.
This pump is designed and programmed to distribute six months worth of medicine in carefully measured doses. However, there have been instances where patients have been overdosed and under-dosed on the Baclofen through their pumps. Baclofen toxicity is very serious and can potentially be life threatening. Acute under-dosing can also be a serious life-threatening condition. A patient suffering from Baclofen toxicity may experience mild symptoms such as nausea or lightheadedness, but some patients have suffered from respiratory distress and in at least one instance, coma. See Tuanli, Intrathecal Baclofen Toxicity and Deep Coma in Minutes, et al. 2006 American Paraplegia Society and What Are the Advantages of the Bacolfen Pump System? Published on MedicineNet.com.
This toxicity occurs when a patient receives too much Baclofen. A malfunctioning pump can cause this to occur. However, there have also been instances reported where the pump has malfunctioned and has not delivered any medicine at all and patients have suffered from severe withdrawal syndrome Mohammed and Hussain, Intrathecal baclofen withdrawal syndrome- a life-threatening complication of baclofen pump: A case report. 2004, BMC Clin. Pharmocol. This withdrawal syndrome can also be life threatening. Why is this happening? Is there something about the Baclofen pump that is causing it to malfunction or is it simply the result of preventable human error in the doctors and surgeons implanting and programming the pumps? In the instance above the cause was noted to be a programming error.
Case Presentation
"A 24-year-old man with a past medical history of cerebral palsy and spastic quadriparesis developed hyperthermia, disseminated intravascular coagulation, rhabdomyolysis, acute renal failure and multisystem organ failure leading to a full-blown intrathecal baclofen withdrawal syndrome. Intrathecal baclofen pump analysis revealed that it was stopped due to some programming error. He was treated effectively with supportive care, high-dose benzodiazepines and reinstitution of baclofen pump."
The FDA has taken note and has concerns that there may in fact be a fatal flaw in the pump itself. In 2002, the FDA changed its warnings of Baclofen pumps and injections to warn about the risk from the withdrawal syndrome; at that time, the FDA had notice of six deaths which were linked to the pumps’ failure and subsequent withdrawal syndrome of the patient. Lioresal Intrathecal (Baclofen Injection): Overview.
In June of this year as reported by the Wall Street Journal, the FDA sent warning letters to Medtronic, the manufacturer of the pumps which are used for the administration of Baclofen. In the letters, the FDA expressed its concern with what it considered to be a lack of reporting with regard to problems the company knew existed with the pumps; the FDA also was concerned about Medtronic’s response to the reported problems as it took them two years to finally recall the products with the reported problems (http://online.wsj.com/article/SB124585661696447913.html).
"A 24-year-old man was admitted to our intensive care unit (ICU) with a possible diagnosis of seizure disorder and sepsis. He had a past medical history of cerebral palsy and spastic quadriparesis. Three years ago, he had an ITB pump implanted for spasticity refractory to the high doses of oral baclofen. He had a significant improvement in spasticity, social and functional capacity in the past three years. Later, he developed some disorientation and increased spasticity. He was taken to a local physician who prescribed oral baclofen (120 mg daily in four divided doses) for his increased spasticity. He also advised him to have his ITB pump checked immediately. The following day, his spasticity increased even after taking oral baclofen. He developed multiple seizures and respiratory distress in the next 24-hour period. Subsequently, he was admitted in a local hospital where he was orally intubated and transferred to our ICU for aggressive management. ....
Next day, his spasticity improved and an ITB specialist investigated his baclofen pump. His baclofen pump analysis revealed that it was stopped due to some programming error, which was restarted at a previously prescribed baclofen rate (260 μg/day)."
What this seems to show us is that it is not doctors who are to blame in most of the cases of Baclofen pump problems but rather it is the pump itself. In our legal system, a company has a legal duty to ensure that the products it is placing on the market do not suffer from any sort of design or manufacturing flaw or defect and that their warnings about the shortcomings of the products are adequate. The Medtronic pump’s warning label was changed once in 2002 in response to the reports of the withdrawal syndrome but to our knowledge no subsequent warnings have been placed or mandated be placed on the packaging. Doctors are advised that they must constantly and vigilantly monitor any patient that has a pump to ensure its continued functionality and proper dosing.
However, if the problem is with the pump, then it is possible that a consumer who has been injured or suffered as a result of the pump’s malfunction may have a claim in a class action if enough others have been hurt as well. Doctors incorrectly charged with malpractice may also be able to join a class suit. As of yet, there is no class litigation pending but as more people come forward with their stories about malfunctioning Baclofen pumps, litigation may be forthcoming.
"The precise mechanism of action of baclofen as a muscle relaxant and anti-spasticity agent is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal cord level [6], possibly by decreasing excitatory neurotransmitter release from primary afferent terminals, although actions at supraspinal sites may also contribute to its clinical effects. Baclofen also causes enhancement of vagal tone and inhibition of mesolimbic and nigrostriatal dopamine neurons (directly or via inhibiting substance P) [7]. Baclofen is a structural analog of the inhibitory neurotransmitter GABA, and may exert its effects by stimulation of the GABAB receptor to cause muscle relaxation. Baclofen reduces increased muscle tone, Babinski sign, tendon reflexes, ankle clonus and sometimes decreases muscle force."
If you or a loved one have been proscribed a Baclofen pump, remain alert. Watch for signs of withdrawal or toxicity which could be warning signs of the pump’s malfunction. Do not be afraid to speak with your doctor if you feel your pump is not working the way it ought. If you or a loved one does begin to experience symptoms of withdrawal or overdose toxicity, get immediate emergency medical treatment and inform the treating emergency room doctor that the patient has a Baclofen pump so that proper procedures can be used. If you or your loved one have been injured or have experienced problems with either withdrawal, toxicity or any other result of a malfunctioning pump, you may have a case against Medtronic. Contact an attorney who specializes in medical malpractice or class action litigation; as with any potential case, always be sure to take notes of what happened and when so that you have a clear record of your experiences. The Lombardi Law Firm has been serving the Iowa community for almost three decades and would welcome a chance to discuss any concerns you may have regarding your malfunctioning pump.
"ITB withdrawal syndrome has been fatal in some cases. Six patients have died out of 27 cases reported to FDA [13]. Most reported episodes of ITB withdrawal were caused by preventable human errors or oversights. However, catheter dislodgement, catheter migration and kinks, and other catheter-related issues might be more common than pump-related malfunctions [1,14]. Close attention to pump refilling and programming procedures may reduce the incidence of ITB withdrawal syndrome."
You are the patient and should not have to worry that the device installed to treat your pain or your symptoms may malfunction and become a risk to your life.