Tennessee Injury Lawyer Blog

A little over a week has passed since the medical device manufacturer Medtronic issued its Class 1 Recall for its automated external defibrillators (AEDs), this AED recall following a number of dangerous Medtronic medical device recalls Tennessee Law Blog has reported. Now news has broken of yet another dangerous medical device Medtronic manufactured and the FDA considers life-threatening: Sutureless Intrathecal Catheters.

These sutureless connector intrathecal catheters (also called SC catheters) are part of implantable drug infusion systems for administering drugs to the spine, and their defectiveness makes these Medtronic infusion systems unsafe and dangerous medical devices. The affected Medtronic models are

INDURA 1P Intrathecal Catheter, Model 8709SC

Intrathecal Catheter, Model 8731SC

Sutureless Pump Connector Revision Kit, Model 8578

Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC

Over 25,000 of these SC catheter pumps are being used by patients since the came on market in May 2007. Most patients who use the SC catheter pumps have constant spasms from traumatic brain injury, multiple sclerosis, or other causes and need the steady supply of heavy medication these SC infusion pumps deliver.

In June, Medtronic told FDA and doctors worldwide that it had reports of problems with its infusion pumps--83 reports to be exact. The Medtronic SC catheters subject to recall clogged or came loose from the pump, which in both cases makes it difficult to deliver the necessary, sometimes vital, medications these defective medical devices were designed to deliver.

Symptoms of the defective Medtronic medical device include overdose and withdrawal symptoms in the patient. For those patients receiving intrathecal baclofen therapy, symptoms can include death, as baclofen withdrawal leads to life-threatening conditions if not cared for properly. This was the case for the one confirmed death attributed to a defective SC catheter pump.

The recalled Medtronic intrathecal drug delivery systems use pump implanted in the intrathecal space in the spine, which is the area around the spinal cord. Powerful drugs (e.g. baclofen, morphine, and ziconotide) are administered here to make them even more power as they can enter the spinal fluid without crossing the blood-brain barrier and go directly to the brain.

If your Tennessee loved one was injured by a malfunctioning Medtronic Intrathecal Catheter Pump, the Nashville law offices of Higgins, Himmelberg & Piliponis wants to help. Call (615) 353-0930 or fill out our Tennessee medical device injury attorney form for a free initial consultation with a defective medical device lawyer.

It has been five years since 16 people died in a nursing home fire at the NHC home in Nashville. The fire brought to the forefront the need for facilities to have mandatory fire evacuation plans and better systems to get residents to a safe place in case of a fire. According to the Tennessee Department of Health every nursing home is in compliance when it comes to fire safety.

Unfortunately, problems with basic care still exists. These quality problems led to admission suspensions in 24 facilities in 2007. The number stands at 19 for this year. So often the care issues are a result of simply not having enough quality staff at the homes. Without enough staff at these homes the basic needs of the residents can't be meet and our loved ones suffer.

Maybe this year the Tennessee legislature and the nursing home industry can work on cutting these quality of care problems. We only ask that our loved ones be treated with dignity. My office sees to many neglect cases they could have been easily avoided if the nursing home would have worried less about profits and more about caring for the residents.

FDA has issued a Class I recall for LIFEPAK CR Plus automated external defibrillators (AEDs) produced by Medtronic’s subsidiary Physio-Control, Inc. This urgent medical device recall was issued for 249 LIFEPAK CR Plus units manufactured between 4/2004 and 8/2007 and distributed until the end of 2007.

Class I FDA recalls of medical devices are the most serious form of recall reserved for medical equipment that can cause catastrophic injury. As the FDA states:

Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.

The recalled Medtronic automated external defibrillators (AEDs) were configured with software intended for a different Medtronic product, resulting in a medical device that may not work or work accurately in emergency situations. Automatic external defibrillators deliver an electrical shock to restore heart rhythm in persons suffering potentially fatal heart irregularities (cardiac arrhythmia or ventricular tachycardia).

The Medtronic LIFEPAK CR Plus defibrillators, by design, is a fully automated medical device. In actuality, the Medtronic device was programmed with software intended for a semi-automated device that includes voice prompts to push buttons that are not accessible to emergency personnel. These battery-powered units are located in public places for potable emergency usage.

It is reported Medtronic has received at least one case of a problem associated with this defective medical device.

Replacements LIFEPAK defibrillator devices were shipped at the beginning of September with a warning from the Medtronic subsidy that the defective CR Plus devices should not be used or have the covering over the shock buttons be removed. There is no report of how many defective LIFEPAK AED devices are still in use.

If you or a loved one in Tennessee has suffered injury from this recalled Medtronic device or personal injury from another defective medical device, the law offices of Higgins, Himmelberg & Piliponis would like to help. Contact our downtown Nashville law office at (615) 353-0930 or fill out our Tennessee personal injury attorney form for a free initial consultation with a defective medical device lawyer.

A Nashville, Tennessee grand jury has issued a second-degree murder indictment against security guard Jeremy Holmes in the death of Adam Villegas. This unfortunate case began when Holmes got into an argument outside the Marathon Sports Bar in Nipper's Corner. Holmes, who was working security in the parking lot at the time.

This case emphasis the drastic need for more stringent training requirements to become an armed security guard in Tennessee. Currently, Tennessee only requires an additional 8 hours of training to become an certified armed security guard. Once this limited training is completed the officer can be placed in the most dangerous of situations and given the duty to protect us. This is both unfair to the security guard and the public. To give someone the ability and to use deadly force with such limited instructions is asking for tragedy. My office has handled to many cases where unnecessary force was used by a security guard and the results where devastating.
We can only hope that some good can come from tragic cases like the one involving the death of Villegas. Hopefully, security companies will provide more training, be more selective on their hiring and our legislature will increase the minimum training requirements.

Medtronic, the medical device giant best known for its heart and diabetes technologies, has recently released a flurry of press releases regarding the FDA’s approval of its software to detect cracks in potential defective Medtronic defibrillator leads. These defective components in their Medtronic's medical devices the company had manufactured were subject to an October 2007 recall. While the risk for serious injury from system failure persists for some patients with the Sprint Fidelis lead in their implanted defibrillator, what these Medtronic press releases have effectively done is bury reports of serious injury caused by off-label use of Medtronic’s Infuse Bone Graft system.

Continue reading "Spinal Injuries from Off-Label Use of Medtronic's Infuse Bone Graft Drowned by Medtronic's Recent Defibrillator Coverage" »

Last Friday, Minnesota shocked the world of nursing home abuse with a report of 15 residents who had been sexually and emotionally abused in heinous and humiliating ways by four nursing assistants. While abusive nursing home staff working in collusion is not unknown in nursing home abuse cases, what was most shocking was who these four abusers were: teenage girls.

The typical profile of a nursing home sexual abuser remains male and a person working alone, though coworkers at the nursing home may be made accomplices in his depraved abuse of the elderly for whom he cares. Physical abuse and emotional abuse is slightly more common among both sexes as stress and mental disorder can lead to resident abuse. Four teenage girls is unheard of. And, unfortunately for the nursing home residents at Good Samaritan Society in Albert Lea, MN, went unheard for months.

What saved the day was the confession of a fifth girl who knew of, but was not party to, the abuse. And she spoke out only after she was fired, explaining during her exit interview how the four abusers operated.

Their targets under their charge, like many sexual predators, were residents with severe Alzheimer’s or dementia. Allegedly to make work more fun, according to newspapers, these four teenage girls fondled the nursing home residents’ breasts, buttocks, and genitals, inserted foreign objects in their anuses and mouths, simulated sexual acts, spit into their mouths, stuck fingers in their mouths and noses to keep them from screaming, and exposed themselves and otherwise sexually abused and teased them, many times while physically restraining the abused nursing home resident.

The adolescent (three juveniles, one an adult) girls would laugh when residents became upset, according to news reports. The four bragged about what they did, according to one employee. Though staff was told to report suspect situations right away, they were not trained to and failed to report. Some at the nursing home stated they knew of what the four were doing but did not know what to do. The four abusers reportedly treated their abuse as a joke and openly talked about what they were doing with other nursing home employees.

Minnesota Department of Health officials have told local reporters that the nursing home will keep its license because it addressed the abuse issues and contacted the proper authorities. The criminal case is awaiting the county attorney's bringing charges against these four nursing home aides. The four abusers have since been terminated by the nursing home.

The nonprofit Good Samaritan Society maintains 230 care locations across the country, including one in Fairfield Glade, Tennessee, west of Knoxville.

Not all nursing home sexual abuse is as blatant as what these four teenage girls did to those under their care, though many times it is even worse, much worse. I urge anyone who suspects their loved one of suffering sexual abuse at a Tennessee nursing home to contact the Nashville law offices of Higgins, Himmelberg & Piliponis at (615) 353-0930 or fill out our suspected TN nursing home abuse form to speak with me or another of our nursing home attorneys.

Too often these abuse cases remain quieted by the Tennessee nursing home and are only brought into the open, and victims given justice, when a nursing home attorney begins the process of discovery. If you're reading this because you suspect your loved one in a Tennessee nursing home has suffered some form of abuse or neglect, let us know so our attorneys can take a look. Our initial consultations are always free of charge.