Nursing Home COVID-19 Procedures Put Patients At Risk

Nursing Home Procedures Put Patients at Risk

Elderly residents in long-term care facilities face the greatest danger with the COVID-19 pandemic. Viruses have decimated care centers for years due to poor infection control and lax oversight. These persistent problems were compounded by the fast-spreading COVID-19 pandemic leading to about one-third of U.S. COVID-19 deaths having occurred in nursing homes. Individuals living in long-term care facilities are particularly vulnerable to poor outcomes of the COVID-19 virus by living in shared living quarters and communal spaces which make social distancing or isolation difficult. 

Many of the deaths that have occurred at long-term care facilities could have been prevented if state regulators, the federal government, and nursing home operators had responded to early warnings and taken basic safety steps to improve safety procedures as the outbreak began. 

Professor of Health Policy at Harvard Medical School, David Grabowski told the Star Tribune, “The warning bells were loud and clear. From the beginning, there was evidence that once COVID-19 really gets going in these huge care facilities, there’s just no way to protect residents.” 

In February 2020, the World Health Organization (WHO) reported that 22% of COVID-19 patients in China over the age of 80 were dying of COVID-19. That is nearly 6 times the death rate for the population as a whole. 

As Europe imposed strict lockdown measures in spring 2020, the COVID-19 virus soon infiltrated a large nursing home in suburban Seattle. This set off a deadly chain reaction at the Life Care Center in late February that eventually took 46 lives and infected at least 60% of its patients. The Federal Centers for Medicare and Medicaid Services (CMS) issued changing guidelines on testing and when to limit visitors to nursing homes; however, states were left on their own to implement those recommendations. The Department of Health and the State Emergency Operations Center informed providers in April 2020 that its emergency stockpile of N95 masks was reserved for “hospital settings only” and that they should wait until their supplies had decreased to “zero to three days” before requesting more gear. 

Stories of residents dying alone in their rooms from COVID-19 have horrified senior citizens and shaken the public’s belief in the government’s ability to defend them from the pandemic. The long-term care facility residents leave behind family such as children, grandchildren, and great-grandchildren who are angry and guilty after trusting the long-term care facilities to care for their aging loved ones. 

Prior to the pandemic, 8 in 10 nursing homes were cited for infection control problems. In May 2020, the U.S. Government Accountability Office reported that infection control deficiencies in nursing homes were “widespread” and “persistent.” It determined that 82% of nursing homes surveyed between 2013 and 2017 were cited for infection prevention and control deficiencies in one or more years. Around half of those nursing homes were cited for the same deficiencies in multiple inspections over a 5-year period.

One of the largest COVID-19 outbreaks in the nation occurred at North Ridge Health and Rehab in New Hope, Minnesota which had been cited for multiple safety violations prior to the pandemic. 

‘Death Ridge’ Long-Term Care Facility In Minnesota

The North Ridge Health and Rehab long-term care facility in New Hope, Minnesota has become known as “Death Ridge” due to the horrifyingly high COVID-19 infection rate and the staggering numbers of deaths at the facility–likely due to the facility’s inadequate safety procedures. 

Within weeks, the facility became the site of the deadliest outbreak in Minnesota and one of the largest nursing home outbreaks in the nation. As a result, North Ridge employees began to refer to the three-building brick complex with 320 beds as “Death Ridge.” A Minnesota Health Department investigator noted that the new virus cases “have blossomed” at North Ridge and the facility “seemed very overwhelmed” by regulatory oversight calls from the agency. 

At North Ridge, about one third of the rooms are double occupancy rooms. This means that a mesh curtain serves as the only barrier between residents. The shared rooms allow people to sleep close enough for each person to hear. In some of the facility’s oldest rooms, four residents share a single toilet and gathering area. 

North Ridge staff members move throughout the facility providing intimate care that includes bathing, dressing, and toileting–all of which require constant physical contact. Doorways are kept open to bustling hallways which allow understaffed nurses to move about at all hours. The facility was so understaffed that it would take up to three hours for workers to respond to residents’ requests for assistance. 

By April 20, North Ridge was pleading for assistance from the Department of Health for help. The facility said that it would “not make it the next 72 hours” without more staff. Staff raised alarms about being asked to work while sick and not having enough protective gear. They also complained of being asked to work in both the COVID and the non-COVID areas of the facility. 

North Ridge also had a financial incentive to accept patients infected with COVID-19. New patient arrivals filled the financial void left by patients who died from the virus in addition to the beds left empty because fewer people are coming to nursing homes to recover after surgeries. Nursing homes were paid up to $800 a day from Medicare for new patients who required short-term stays. North Ridge continued to accept dozens of COVID-19 cases through the summer and fall of 2020 from hospitals and other long-term care facilities–even while the facility itself reported being severely understaffed and lacking personal protective gear. 

By late June 2020, 73 residents had died from COVID-19 and 350 residents and staff had already tested positive for the virus.

Numerous Prior Safety Violations at North Ridge Before the Pandemic

There had been signs in the months and years prior to the pandemic that the North Ridge facility might be unprepared for the highly contagious and lethal virus. Dozens of government inspection reports dating back to 2017 show that the facility repeatedly puts its residents in harm’s way in addition to the facility being on the federal government’s watch list of 450 troubled nursing homes for three years. Since 2017, the nursing home has accumulated more than 80 violations of federal health and safety standards. 

For instance, residents’ pressure sores were left to fester untreated until they bled. Emergency call buttons were poorly staffed, so residents had to wait for hours or call 911 when they needed help. Bedridden patients went weeks without being bathed due to the lack of staff. Rooms frequently smelled of urine, mildew, and outdated food.

COVID-19 in Minnesota Long-Term Care Facilities

Long before the pandemic, nursing homes in Minnesota had been cited for safety violations. That lack of effective procedures was exacerbated by the pandemic. Minnesota’s StarTribune conducted an analysis of federal health records and determined that nearly 70% of Minnesota’s nearly 370 nursing homes have been cited for lapses in infection control over the past 4 years. 

Across the state of Minnesota, reported resident and worker infection rates in senior care facilities increased from an average of 20 per day at the beginning of April 2020 to more than 130 per day by the end of the month. In total, nearly 70% of Minnesota’s COVID deaths have occurred in long-term care settings.  That is one of the highest such ratios in the entire country. 

GoldenbergLaw Can Help

If you or a loved one was infected with COVID-19 after staying in a nursing home, contact the Personal Injury Attorneys at GoldenbergLaw for a free consultation. Contact us today and leave the sleepless nights to us.

What Does a Successful Thrombectomy Procedure Look Like?

What Is a Thrombectomy Procedure, and Why Is It Done?

A surgical thrombectomy is a procedure to remove a blood clot from inside an artery within the brain. 

Blood clots can form as a result of the blood thickening and clumping within one of the vessels. As a result of the blood clot, the blood flow can be restricted or blocked. Decreased blood flow can damage nearby brain tissues.

How Is a Thrombectomy Procedure Done?

In a surgical thrombectomy, an IV is first put into the patient’s arm or hand to allow for delivery of medications such as a blood thinners and anesthesia during the procedure. If a patient has hair in the area where the incision will be made, the hair will likely be removed. Continuous X-ray imaging is frequently used during the procedure to guide the surgeon to the precise location of the blood clot. The surgeon will then make an incision above the blood clot, open the blood vessel, and remove the blood clot. A stent may be put in the blood vessel to help keep it open so the clot can be removed. 

In catheter aspiration thrombectomies, the surgeon will make an incision in the groin and advance the catheter through the artery or vein to reach the blood clot within the blood vessel. The Penumbra JET 7 Xtra Flex catheter was one of the most widely used catheters in thrombectomy procedures prior to its recall in December 2020. The catheter’s distal tip is then placed next to the clot and negative pressure is applied at the distal tip of the catheter through suction. This is done in order to remove the blood clot through the catheter. Once the blood clot has been completely removed, the incision is closed and bandaged to conclude the surgery.

What Can Happen If a Thrombectomy Procedure Goes Wrong?

There are potentially fatal complications if a surgical thrombectomy goes wrong. The U.S. Food and Drug Administration (FDA) received hundreds of reports of adverse events stemming from the use of Penumbra JET 7 Xtra Flex catheters during thrombectomy procedures. The Jet 7 catheter was recalled due to reported distal tip malfunctions. When the Jet 7 catheter’s distal tip malfunctions, it can quickly expand to become multiple times the size of the blood vessel and create pressure on the vessel which can cause it to weaken. If the blood vessel becomes too weak it can rupture, resulting in substantial bleeding in the surrounding area of the brain. 

Excess blood in the area of the brain surrounding the ruptured blood vessel can overwhelm brain tissue, compress it, and cause significant damage. Additionally, other areas of the brain more distant from the ruptured blood vessel can also be damaged, as those areas receive reduced blood flow due to the large amount of excess blood concentrated in the specific area of the brain where the blood vessel ruptured.

A stroke can occur when the flow of blood to part of the brain is cut off or significantly reduced. Since the blood flow is reduced, the brain cells are deprived of the oxygen from the blood which causes them to die quickly. This can cause a patient’s death or permanent brain damage. The severity of a stroke depends on where the stroke occurs in the brain and how much brain tissue was damaged.  

After the FDA received more than 200 reports of adverse events from thrombectomy procedures where a Penumbra JET 7 Xtra Flex catheter was used, Penumbra Inc. issued a voluntary recall in December 2020 of all its Penumbra JET 7 Xtra Flex catheters. 

To learn more about the dangers of the Penumbra JET 7 Xtra Flex catheter failures, read the blogs from GoldenbergLaw’s Penumbra JET 7 Xtra Flex Cather Resource Center found below: 

Penumbra JET 7 Xtra Flex Catheter Resource Center

GoldenbergLaw Can Help

If you or a loved one was harmed by a thrombectomy procedure where a Penumbra JET 7 Xtra Flex catheter was used, contact the Brain Bleed Attorneys at GoldenbergLaw today. With thirty-four years of experience, the attorneys at GoldenbergLaw will advocate for you so that you can receive the justice you deserve. Contact us today for a free Penumbra catheter lawsuit consultation and leave the sleepless nights to us!

 

Why Was the Penumbra JET 7 Xtra Flex Catheter Recalled?

On December 15, 2020, the U.S. Food and Drug Administration (FDA) announced Penumbra, Inc.’s recall of all Penumbra JET 7 Xtra Flex catheters due to the “risk of unexpected death or serious injury.” Penumbra, Inc.’s recall included a warning that all medical facilities who used the Penumbra JET 7 Xtra Flex catheter should remove them from their inventory.

How the Penumbra JET 7 Xtra Flex Catheter Is Supposed to Work

The Penumbra JET 7 Xtra Flex catheter is part of the Penumbra System which was designed to work in tandem with the Penumbra Aspiration Pump, Penumbra Aspiration Tubing, and the MAX delivery device to restore blood flow by removing blood clots. This intended to be achieved by using continuous aspiration (a method that uses suction to remove a blood clot) in patients who have suffered from an acute ischemic stroke within 8 hours of symptoms appearing. The Penumbra JET 7 catheter series was intended to deliver deeper vacuum aspiration power to allow the practitioner to safely extract blood clots in acute ischemic stroke patients.

During a catheter-based thrombectomy procedure, the surgeon makes an incision in the groin and advances a catheter through an artery all the way to the blood clot. The surgeon uses an X-ray to guide the catheter to the blood clot. The catheter then removes the blood clot from the blood vessel in order to restore blood flow. 

Penumbra JET 7 Xtra Flex Catheter Resource Center

Penumbra JET 7 Xtra Flex Catheter Defects

The FDA has received more than 200 medical device reports associated with the Penumbra JET 7 Xtra Flex catheter. The reports include complications such as death, serious injuries, and malfunctions. The report listed device failure modes as “ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.” 

The distal tip is located at the very top of the catheter and is what makes contact with the blockage within the vessel. However, in the case of the Penumbra JET 7 Xtra Flex catheter, the distal tip may expand to become several times the diameter of the blood vessel. This expansion can put undue pressure on the weakened blood vessel and can lead to an increased risk of rupturing. If the blood vessel ruptures within the brain, the brain tissue can be flooded with excess blood which causes damage to the brain and may result in a serious brain bleed (a hemorrhagic stroke) or even death. 

Penumbra, Inc. conducted testing that confirmed this potentially fatal complication. To come to this conclusion, the manufacturer compared the Penumbra JET 7 Xtra Flex catheter to its other aspiration catheters. It determined that the Penumbra JET 7 Xtra Flex catheter’s distal tip could not withstand as much pressure as the other aspiration catheters before failing–resulting in the distal tip expanding and potentially causing the blood vessel to rupture. This means that the Penumbra JET 7 Xtra Flex catheters have an increased risk of failure compared to other aspiration catheters. The FDA confirmed these concerning findings in its December 15, 2020 announcement of Penumbra, Inc.’s voluntary recall of the Penumbra JET 7 Xtra Flex catheter.

GoldenbergLaw Can Help

If you or a loved one have been harmed by a Penumbra JET 7 Xtra Flex catheter malfunctioning, contact the Hemorrhagic Stroke Attorneys at GoldenbergLaw who have more than thirty years of experience in fighting for justice. Contact us today for a free Penumbra Jet 7 lawsuit consultation and let us give you the Gold standard of advocacy you deserve!