The Daily Beast reported on the lawsuit involving the deadly antibiotic Levaquin.  Plaintiffs filed the lawsuit against former Federal Drug Administration chief Margaret Hamburg and pharmaceutical giant Johnson & Johnson, accusing them of hiding the dangers of the antibiotic Levaquin to increase profits.  Filed as a federal racketeering lawsuit, the complaint is salacious claiming that while heading the FDA, Hamburg conspired to “cover up” side effects to boost the profits of Johnson & Johnson (the drug’s maker) and her husband (whose firm allegedly owned stock in the company).

The man behind the conspiracy is Larry Klayman, a right-wing activist known as a “pathologically litigious attorney.”  Hamburg’s attorneys called Klayman’s lawsuit “patently false,” “defective,” and lacking in factual evidence. “For nearly six years, Dr. Hamburg served alongside her FDA colleagues to help protect the health and safety of the American public. Mr. Klayman’s accusations concerning that work are reckless and offensive.”

Warnings surrounding the antibiotic Levaquin have been dangerously insufficient. The drug, capable of causing debilitating tendinitis, permanent nerve damage, ruptured tendons, and even psychosis, is meant to be reserved for severe life-threatening infections.  It’s part of a family of antibiotics that, according to the Centers for Disease Control and Prevention (CDC), is the fourth-most prescribed nationwide, given to 33 million Americans in 2013 alone.

Levaquin (or levofloxacin) first entered the market in 1996 as the newest version of an old class of drugs known as fluoroquinolones. Synthetic broad-spectrum antibiotics, they attack bacterial DNA directly in a way that allows them to treat the severest infections.  The strength with which Levaquin operates is a double-edged sword, leading to a host of side effects. These include nausea, vomiting, diarrhea, headaches, and insomnia as well as seizures, tendinitis, nerve damage, aortic aneurysms, cardiac arrhythmia, psychosis, vision loss, and renal failure.

When used for severe infections, the life-saving benefits of the drug far outweigh the risks. When used for uncomplicated urinary tract infections, a condition for which Levaquin is often prescribed, they do not. According to the 200,000 patients who have suffered serious side effects after being prescribed it for mild infections, that message is still not clear to some doctors. Without awareness, patients are prescribed the drug for mild infections, putting them at risk of permanent physical and psychological damage.

Levaquin began causing problems soon after hitting the market. Ten years after it was approved, the nonprofit consumer rights advocacy group Public Citizen released data showing that between November 1997 and December 2005 there were nearly 800 cases of tendon disorders from use of fluoroquinolones—61 percent of them from Levaquin.

In 2006, Public Citizen Research Group’s director, Dr. Sidney Wolfe, petitioned the FDA to add a black box warning to the label. “The numbers are startling,” Wolfe said in 2006. “Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals.”

In July of 2008, the FDA agreed to add a black box warning about the risk of tendinitis, but refused to notify doctors. The black box did little to curb prescriptions and by 2010 Levaquin was the best-selling antibiotic in America.

Patient complaints increased. In 2008, scientists at the National Center for Biotechnology Information studied the case of a healthy 42-year-old woman who suffered from an “acute-onset delirium” with “psychotic features.” Her symptoms dissipated when Levaquin was stopped, leading them to conclude that the drug caused the reaction.

In 2009, three separate plaintiffs from West Virginia who suffered from severe tendon injuries after taking the drug argued that the black box warning alone wasn’t enough. “Physicians will interpret the relative risk of a Levaquin-induced tendon injury inappropriately,” reads the complaint. “Defendants continue to market Levaquin as a first line therapy for the common bronchitis and sinusitis infections, and for which many other, safer antibiotics are available.”

In 2010, Johnson & Johnson settled its first major Levaquin lawsuit, shelling out $1.8 million in damages to a plaintiff who suffered a tendon rupture after taking the drug. By 2012, the company was facing upwards of 3,400 lawsuits from patients arguing that the warnings were not made clear enough to themselves or their doctors. In November of that year, the company settled 845 of them.

Those suffering from fluoroquinolones-related injuries began rallying together, nicknaming themselves “floxies,” and forming support groups across the Web. A Facebook page called Fluoroquinolone Antibiotic Toxicity boasts more than 7,300 members; another called My Quin Story (“Life After Levaquin”) has 3,179.

Dozens of doctors have spoken out against misuse of fluoroquinolones over the years, most while still affirming that the drugs do have benefits. The University of South Carolina’s Dr. Charles Bennett, who runs the Southern Network on Adverse Reactions, has filed two Citizen Petitions to the FDA about Levaquin—the first, asking for warnings about peripheral neuropathy; the other, mitochondrial toxicity.

In the petition, Bennett noted that more than 80,000 complaints about the drug had been filed to the FDA between 1997 and 2011 and that—due to the FDA’s weak reporting system—there were likely tens of thousands more. “We are talking about going into the physician’s office, having a little sniffle, walking out with an antibiotic and shortly after having these kinds of problems,” Dr. Bennett said.

A pharmacological epidemiologist named Mahyar Etminan told The New York Times that “lazy doctors” prescribing them for minor infections were “trying to kill a fly with an automatic weapon.” In July, a team at ABC acquired FDA documents showing that the number of serious adverse reactions to Levaquin has soared to 200,000—including at least 3,000 deaths.

This past November, in one of the biggest hearings on the drug to date, 30 patients suffering serious side effects went before a panel of experts at the FDA.  The group urged the FDA to take make clear on the label that Levaquin is not appropriate for minor infections, which it has not done.  Since its release, Levaquin has been prescribed over 300 million times.

One of the members of the November panel was Dr. Tobias Gerhard, a researcher at Rutgers University and pharmacoepidemiologist who looks at the effects and safety of drugs in populations. “What became clear in the advisory committee hearing is that the patients weren’t aware of these risks,” says Gerhard. “It wasn’t a conscious decision and a risk they knowingly agreed to take.” Gerhard says that if quinolones were prescribed less frequently as first-line treatments for mild conditions, as they should be, the serious side effects would occur more rarely. “

Michael Carome, the new director of Public Citizen’s Research Group, takes a less measured approach at Levaquin, calling it one of the most overused antibiotics in the country. “It’s overprescribed for uncomplicated things,” he said. “There are much safer antibiotics that people should use.”

Carome is not shy about implicating the pharmaceutical industry.

“Too often the reason the drugs are overprescribed is because of aggressive marketing by drug reps and other people who push the newest drugs to physicians,” he said. “That’s one contributing factor; the other is that physicians and other prescribers aren’t well informed.”

The Sentinel reported two separate lawsuits filed in the last few months against Golden LivingCenter-West Shore.  The families of two residents accuse the facility of causing their premature and wrongful deaths in 2014.  The accusations include that management of the facility, in an effort to drive up profits, accepted too many residents in need of complex medical care while “recklessly” reducing staffing levels, which led to the deaths of their loved ones.

Golden LivingCenter has been under since the state Attorney General’s Office announced last year a lawsuit against 25 of its 36 facilities, including the West Shore location, for negligence that left residents thirsty, hungry and living in filth. Abc27 reported that there have been hundreds of complaints since the lawsuit was filed, and the Pennsylvania Department of Health late last year continued to find problems at the West Shore facility on Poplar Church Road in East Pennsboro Township.

One of the lawsuits, filed on March 24, alleges that there was negligent care of a woman who was at the West Shore facility from May 9, 2014 to June 9, 2014. The civil suit says that within four days of her residency, she was admitted to the hospital, where she was diagnosed with dehydration, pneumonia and hypokalemia, or low potassium in the bloodstream.

The resident was readmitted to the facility a few days after the trip to the hospital, and later that month she was found to be suffering from a C. diff bacterial infection. A day after that, she suffered a fall, the lawsuit said.  She was discharged to her daughter a little more than a week after that, and she later died on June 26, 2014.

The lawsuit in this case alleges that her chart had missing or incomplete documentation, and that Golden Living had deprived her of adequate care, treatment, food, water and medicine.

The other lawsuit, which was filed on May 31, covered another resident who was at the Golden LivingCenter-West Shore facility from July 28, 2014 until her death on Nov. 6, 2014.

The lawsuit alleges that the resident was admitted to the facility with the management knowing full well her serious risk for falls. However, she suffered six falls in August alone, as well as another fall in October at an eye doctor’s office.   In that October case, the lawsuit said Golden Living dropped the resident off at the curb instead of walking her in, and she was found in the bathroom, having fallen and soiled herself.

During the three months she was at Golden Living, the resident also was diagnosed with an upper respiratory tract infection, urinary tract infection and had lost 38 pounds, or about 24 percent of her body weight. In September, she was hospitalized for dehydration and malnutrition, and on Nov. 6, she was found unresponsive in her room. She was admitted to the hospital that day with acute renal failure and likely sepsis.

Both lawsuits claimed the negligence on the part of the staff and the physical and mental trauma that resulted accelerated the worsening condition of both women and ultimately led to their deaths.

 

The Sentinel Echo reported on the tragic and preventable death of Dorothy McKnight.  McKnight was a resident of Laurel Village.  The facility failed to supervise her and allowed her to leave the premises during frigid winter temperatures on Jan. 18. Laurel County Coroner Doug Bowling said after the incident that McKnight was “not dressed for the weather” that measured only 6 degrees above 0 the previous night and morning.  She died from exposure.

A lawsuit was filed May 31 by Joseph McKnight, who was appointed executor of the estate of Dorothy McKnight following her death on Jan. 18.  The lawsuit claims that employees at the elderly housing complex were negligent in supervising the 95-year-old woman who is described in the lawsuit as “an adult with physical and mental disabilities.”

That alleged negligence includes claims that the staff at Laurel Village “failed to adequately assess, assist, care for, supervise and monitor” McKnight’s  activities; did not follow its own policies and did not provide adequate staff and adequately trained staff.  It also states the nursing facility did not conduct timely checks on the residents and did not implement a care plan for McKnight.

 

 

“As a result of the Defendant’s negligence, Dorothy McKnight eloped from the premises, was injured and died,” the document reads. “As a result of Dorothy McKnight’s injuries she suffered physical pain and mental anguish until the time of her death….her estate has incurred funeral and burial expenses.”

 

Greenville Online had an article on the national for-profit nursing home chain Covenant Dove attempting to increase their market share in South Carolina. Covenant Dove, which this month became Orianna Health Systems, is a private company with nursing homes in 11 states, including 17 in South Carolina. Thirteen of them are in the Upstate, including a 132-bed facility on Rutherford Road in Greenville.

Greenville Health System is negotiating with Covenant Dove about selling its nursing homes. The arrangement could involve a sale, but it could also be an affiliation or some other kind of deal, said Malcolm Isley, vice president of strategic services for GHS.

“We are in discussion with Covenant Dove regarding an expanded affiliation involving skilled nursing services that could include the sale of The Cottages at Brushy Creek in Greer and some sort of relationship with Lila Doyle in Seneca,” Lisa Stevens, chair of the board of trustees, told The Greenville News.  There are 264 beds between the two nursing homes.

GHS recently announced that it was dealing with a $16 million budget shortfall. It’s made progress in closing the gap by instituting a plan to cut costs through such measures as deferring about $32 million in capital projects and eliminating about 400 clinical and administrative positions – about half through attrition – for a savings of $13.2 million in salaries and benefits.

A voluntary exit program for 66 employees and not filling another 73 positions also saved about $657,000.

GHS employs about 200 employees at The Cottages, Isley said. If the board decides to sell it, they would become Covenant Dove employees, he said. What that would mean to them in terms of pay and benefits is unknown at this time, he said.

 

 

NY1 reported the indictment of 2 caregivers at the Peninsula Nursing and Rehabilitation Center in Far Rockaway, NY for allegedly neglecting a severely disabled patient as he lay bleeding on the floor.  Attorney General Eric Schneiderman says a 51-year-old patient fell and suffered a head wound.

The surveillance video shows the nurses doing nothing to help the disabled man as he crawled on the floor bleeding for about ten minutes.  A Certified Nurse Aide eventually dragged the patient back to his room.  Prosecutors say about 25 minutes later, the man crawled out of his room with blood still running down his head.  They claim the nurses continued to ignore him and he was never treated until paramedics arrived 20 minutes later.

Both nurses, 34-year-old Funmilola Taiwo and 39-year-old Esohe Agbonkpolor, were indicted. They face a felony charge of endangering the welfare of an incompetent or physically disabled person.  Taiwo was also charged with falsifying business records. The Certified Nurse Aide who dragged the patient already pled guilty to neglect.

and  at Wealth Management wrote an article on the recent South Carolina case Thompson v. Pruitt Corp. (S.C. App., 2016).  ” While the enforceability of arbitration agreements in general isn’t a particularly novel topic, there’s often an added twist in this context when admissions paperwork is signed by the patient’s spouse, child, other relative or personal representative bringing the patient to the facility.  In these scenarios, there’s little uniformity regarding whether courts will enforce an arbitration agreement.”

The authors explain the facts behind the Thompson case.  In January 2011, a brother and sister had their mother, who suffered from dementia, admitted to a Pruitt Corp. nursing home facility.  Under South Carolina’s Adult Health Care Consent Act (the Act), her children were authorized to make decisions concerning her health care because she was unable to consent.  Upon arriving at the nursing home, the son was presented with an Admission Agreement, an Arbitration Agreement and several other documents to sign on his mother’s behalf.  The Arbitration Agreement was separate from the Admission Agreement and wasn’t a precondition for admission to the nursing home.  Additionally, the Arbitration Agreement contained a provision allowing the patient to disclaim the agreement within 30 days.

Within five hours of admission, their mother fell out of a bed because of a broken side rail.  The mother died as a result of the fall, and her daughter filed a wrongful death and survival action against the nursing home.  The nursing home moved to compel arbitration, but the trial court denied the motion.  The trial court found that there was no valid agreement to arbitrate because the son didn’t have authority to execute the arbitration agreement on his mother’s behalf.  The Court of Appeals of South Carolina affirmed that decision on appeal, for several reasons.

First, the court held that that son didn’t have statutory authority to execute the Arbitration Agreement for his mother.  Because the Arbitration Agreement was a separate document that didn’t deal with health care decisions, the court reasoned that the Act didn’t apply to establish the necessary principal-agent relationship.  Importantly, because the Arbitration Agreement wasn’t a precondition to admission, the court didn’t consider it related in any way to decisions concerning the mother’s health care.  This follows the South Carolina Supreme Court’s decisions in Dean and Coleman Decision.

Second, the court considered whether common law principles of agency could bind the mother’s estate to the Arbitration Agreement.  The court held that the fact that the mother had dementia prior to being admitted to the nursing home meant that she could neither consciously nor impliedly agree to allow her son to enter into the agreement as her agent.

Finally, the court noted in dicta that, even if the mother did have capacity to consent to her son handling her affairs, a standard power of attorney (POA) for property or health care doesn’t convey authority to the agent to bind the principal to an arbitration agreement, thereby waiving the principal’s right to access the courts and to a jury trial. 

Finally, whether the arbitration agreement is a precondition to admission is also a critical factor.  Where an arbitration agreement is purely voluntary, courts typically hold that the agent doesn’t have authority to bind the patient.  In practice, this factor may leave nursing facilities desiring to arbitrate all disputes stuck between a rock and a hard place, in that these agreements may be seen as unconscionable if entered into solely because they’ve been made a prerequisite to the patient receiving critical health care services.

Leading Age website had an article from LeadingAge’s MDS expert consultant, Judy Wilhide-Brant, RN, providing guidance on the 3 new MDS-based quality measures to be added to CMS Nursing Home Compare beginning April, 2016. These measures are calculated using two ADLs in G0110 that have not been used before.  She offers a guide to coding and highlights relevant insights to assist with answering the necessary questions within the section.

 

 

 

The News-Gazette had a very sick and disturbing article on how Channing J. Butler, an employee of Bickford Senior Living facility Bickford Cottage, was caught and arrested for soliciting others to have sex with female residents so that he could videotape them. Butler allegedly wanted the men to perform both oral and vaginal sex on the women.  Bickford is an assisted living and memory care facility for seniors. The victims were ages 88, 90 and 95. One of the women has since died.

“It happened in the middle of the night but at the time it happened, they were awake or conscious. It’s not like there was no reaction,” First Assistant State’s Attorney Steve Ziegler said of the victims, whom he described as having profound memory problems and being unable to be interviewed by police.  It appears that the men Butler hired never consummated sex acts with the three elderly women, but not for lack of trying.  “They tried to do this and the victims kept pushing them away,” he said.

“They were all in the same area and he was an employee who was supposed to be working. He was doing this during his employment hours. There were no other employees around” Ziegler said.

One of the men Butler allegedly hired to perform the sex acts “got a guilty conscience” and turned himself in to the police. Police learned that Butler recruited the men to have sex with the women so that he could videotape the interactions.  Police obtained Butler’s cellphone and retrieved still images and text messages of the crimes.  Ziegler said of the other three men involved in doing Butler’s bidding, two are currently in prison and police have been unable to find the third.

“He’s paying them so he can do the videos, which we believe he may have been reselling. It’s not entirely clear if it was for his own sexual gratification or for reselling or both,” said the prosecutor.

Butler also worked for the Champaign County Nursing Home as a certified nurse assistant from November 2012 to April 2013, according to county records.


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Reuters reported on a new study that found at least one in five nursing home residents may endure verbal or physical abuse from their roommates or other residents, a study found in Annals of Internal Medicine, online June 13, 2016.  Researchers examined data on 2,011 nursing home residents and found 407 of them had been involved in at least once occurrence of abuse involving another resident during the four-week study period. To assess the prevalence of abuse involving residents, researchers examined data from interviews with staff and residents of five urban and five suburban nursing homes in New York, as well as information from medical charts and accident or incident reports.

Verbal taunts were the most common, accounting for about 45 percent of these cases, followed by physical assaults, which made up 26 percent of incidents.  While verbal and physical abuse was the most commonly reported type of abuse residents suffered from other residents, about 20 percent of incidents involved invasion of privacy, researchers report.

In about 4 percent of cases, one resident directed menacing gestures or facial expressions at another resident. Slightly less than 3 percent of cases involved some form of sexual abuse.  The most common types of verbal aggression were screaming at another resident and using inappropriate words. With physical aggression, the most common cases involved hitting or pushing another resident.

Most nursing homes do not have adequate staff and training to deal with older adults with cognitive and psychiatric issues like dementia, depression, and delirium.   Incidents were more common in units with fewer certified nursing assistants — the staff who are responsible for residents’ daily care.  The study also found that incidents were more common in nursing homes’ dementia units. On the other hand, one-quarter of residents with no dementia symptoms were involved in at least one incident.

Families should look for nursing homes with rooms or units set aside for dementia patients or residents prone to aggressive behaviors,” said Dr. Janice Du Mont, a public health researcher at the University of Toronto who wasn’t involved in the study.

“During a tour, see if there is adequate open space or if the facility feels overcrowded,” Du Mont added by email. “Assess how many residents are in each room, if there are separated recreational areas, and how many staff you see on duty.”

See another article about this topic from Health Day.

 

Health Day had an interesting article about a recent study about urinary tract infections (UTIs).   A team from New York City’s Columbia University School of Nursing surveyed 955 nursing homes in 2014. The researchers also analyzed data from the Centers for Medicare and Medicaid Services.

They found that in any given month, for over 88,000 nursing home residents in the study, an average of 5.4 percent of them — more than 4,700 people — had suffered a UTI.  This research finds the infections are common in nursing homes, often due to a lack of proper prevention and use of catheters. In fact, in the Columbia study, nursing home residents with catheters were four times more likely to get a UTI than those without catheters.  UTIs in nursing home residents can often have serious effects, including delirium, debilitating falls and even fatal blood infections.

“It is obvious, based on this random survey of nursing homes, that there is a lack of education and inconsistent practices that can raise the risk for infection,” Donna Armellino, a nurse and vice president of infection prevention at Northwell Health, in Lake Success, N.Y said.  UTIs often occur “when bacteria enters the urinary tract through the urethra and move up the tract to infect the bladder or kidneys,” she explained. “This infection is often related to an inserted device referred to as an indwelling urinary catheter.”

“UTIs in the elderly can have a significant health impact by leading to a confused delirious state or — if undiagnosed — leading to dehydration or infection in the bloodstream,” explained Dr. Paula Lester, a geriatrician at Winthrop-University Hospital, in Mineola, N.Y.

Many nursing home residents suffer from dementia, or have conditions that rob them of their ability to communicate, therefore caregivers must be properly educated and trained to prevent UTIs, and recognize the signs and symptoms such as painful urination, foul odor of urine or increased frequency of urination of a UTI.

The findings were presented this month at the annual meeting of the Association for Professionals in Infection Control and Epidemiology (APIC), in Charlotte, N.C.  Read more about APIC at Eureka Alert.

Nursing homes typically have four main ways of lowering UTI rates.

  1. Nursing homes that used portable bladder ultrasound scanners to confirm that a patient had voided all urine were 10 percent less likely to have high rates of UTIs not associated with catheter use.  Unfortunately, only about one in every five facilities surveyed had this policy, the researchers found.
  2. Regularly cleaning the urine collection bag attached to the resident’s leg. That step cut catheter-linked UTI rates by 20 percent.  However, only 44 percent of facilities had this policy in place.
  3. Nursing homes with “infection preventionists” on staff — who also took a national course through APIC — were also 20 percent less likely to have high rates of UTIs, the study found.  But again, only 9 percent of the nursing homes in the study had such staff.
  4.  Prevent UTIs by make sure the patient is mobile when possible, has “regular toileting” and is kept clean and dry.

According to Armellino, other things to look for if you visit an infirm loved one in a nursing home include:

  • Making sure that urinary catheters are inserted “only when clinically needed,” assessed daily and removed when no longer necessary.
  • Urine collection bags are kept below the bladder.
  • Urine flows freely in the drainage tube.
  • The device is “secured to the leg to minimize movement.”
  • Patients are washed frequently with soap and water.
  • Staff members use proper hand hygiene before and after touching the catheter device.