The family of Joseph Clint Offutt  who died after nine days in Harborside of Madisonville nursing home in Kentucky has been compensated with a $42.75 million verdict.  92-year-old Offutt died because the staff neglected him.  Offutt suffered severe dehydration, malnutrition, bedsores and infections, all of which led to his death in April 2008.  Offutt was a World War II veteran who was still planting crops at age 88. After a stroke in 2007, his wife of 58 years, Pearline, cared for him at home for eight months before he needed professional care.   The facility is now known as the Hillside Villa Care and Rehabilitation Center.

“Offutt became lethally dehydrated despite having a feeding tube…. The facility simply failed to ensure he got enough water to live,” quoted Kentucky.com.  Adult Protective Services officials of the Cabinet for Health and Family Services backed of the neglect.

Court documents confirm that the jury awarded $1 million for Offutt’s pain and suffering, $1.75 million for his wife’s loss, and $40 million for punitive damages, said Kentucky.com.

Offutt was at the nursing home from March 25 to April 3, 2008. He was transferred to a regional medical center and died April 5, 2008, Circeo said.

Offutt’s family filed the wrongful death lawsuit in 2009 against the nursing home and Sunbridge Healthcare Corp., which owns it.  The trial lasted three weeks.

 

 

Lauren Stevens of Durham, N.C., an attorney for a major pharmaceutical company was charged with obstruction and making false statements  She was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA).

The indictment states that in October 2002, the FDA asked for information about the company’s promotion of a prescription drug, as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the FDA. Data demonstrating a drug’s safety and efficacy for a particular use is required for FDA approval. Federal law prohibits the marketing or promotion of drugs for unapproved – or "off-label" – uses.

The indictment alleges that, in response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.
The indictment also alleges that Stevens did not provide the FDA with slide sets used by the physicians who were paid by the company to promote the drug, even though the FDA had asked for the slide sets and Stevens had previously promised to obtain and provide the FDA with such materials. The indictment alleges that a memorandum was prepared for Stevens that set forth the "pros" and "cons" of producing the slide sets to the FDA. One of the "cons" was that the slide sets would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation." Instead of providing the requested slide sets to the government, Stevens represented that the company’s responses to the FDA’s requests was "final" and "complete."

" This indictment demonstrates that those who purposely subvert the regulatory functions of the FDA through false statements and misleading information will be held accountable for their deception," stated Dara Corrigan, FDA’s Associate Commissioner for Regulatory Affairs.

Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison. 
 

Zaleppa v. Seiwell (2010 PA Super 208 November 17, 2010) is a case out of Pennsylvania that recently held:

"After careful consideration, we conclude that there is no legal basis under either federal or Pennsylvania law to assert the interests of the United States government as to the reimbursement of Medicare liens."

 

Background:

Car wreck resulting in $15,000 jury verdict against Seiwell’s insurance company to compensate Phyllis Zaleppa. Seiwell alleges that the trial court erred in denying her post-trial motion, which requested that the court enter an order directing her to pay the verdict either (1) by naming Medicare, along with Zaleppa and her attorneys, as payees on the draft satisfying the verdict or (2) by paying the verdict into court pending notification from Medicare that all outstanding Medicare liens have been satisfied.

Both of Seiwell’s issues address the same legal question, whether the MSPA either requires or allows a private entity to assert the rights of the United States government regarding a potential claim for reimbursement of a Medicare lien.  Seiwell argues that under 42 U.S.C.A. § 1395y(b)(2)(B)(ii) of the MSPA, she and her liability insurer are considered the “primary plan” responsible for reimbursing Medicare for conditional payments made to Zaleppa.

As such, in the event that a private insurer is legally required to pay for the treatment for which
Medicare has already paid, the MSPA provides that Medicare must be reimbursed for the expense. 42 U.S.C.A. § 1395y(b)(2)(B)(i) (stating that “[a]ny such payment […] shall be conditioned on reimbursement to the appropriate Trust Fund”). An entity which receives payment from a primary
plan must reimburse Medicare within 60 days. See 42 C.F.R. § 411.24(h).

The MSPA specifically delineates the obligations of both the recipient and primary insurance plan as follows.
(ii) Primary plans
A primary plan, and an entity that receives payment from a primary plan, shall reimburse the appropriate Trust Fund for any payment made by the Secretary under this subchapter with respect to an item or service if it is demonstrated that such primary plan has or had a responsibility to make payment with respect to such item or service. A primary plan’s responsibility for such payment may be demonstrated by a judgment, a payment conditioned upon the recipient’s compromise, waiver, or release (whether or not there is a determination or admission of liability) of payment for items or services included in a claim against the primary plan or the primary plan’s insured, or by other means.

As the express language indicates, the MSPA imposes a duty upon a “primary plan” and “an entity that receives payment from a primary plan” to reimburse Medicare if the primary plan is responsible to pay for the medical treatment provided. Id. Thus, if an outstanding Medicare lien existed, we recognize that the MSPA requires that either Zaleppa, as the “entity that receive[d] payment from [the] primary plan[,]” or Seiwell and her insurer, as the primary plan, must reimburse Medicare. Id. Importantly for our review, the regulations under the MSPA indicate that only a recovery demand letter, which is issued by Medicare and directed specifically to the primary plan, triggers the primary plan’s duty to reimburse the Medicare trust fund. 42 C.F.R. § 411.22(c) (specifying that a primary payer must make payment to either “an entity designed to receive repayments,” such as a plaintiff receiving a judgment in her favor, or “[a]s directed in a recovery demand letter” from Medicare).

"Seiwell, however, contends that the existence of this statutory obligation requires and enables her and her insurer, as a primary plan, to seek post-trial relief which affirmatively asserts the United States government’s interest in reimbursement. We disagree."  

Nothing in § 1395y(b)(2)(B)(ii), or any other provision of the MSPA, expressly authorizes a primary plan to assert Medicare’s right to reimbursement as a preemptive means of guarding against its own risk of liability. The MSPA sets forth only one method for the United States government to recover the funds which it dispersed through conditional Medicare payments. Under the MSPA, only the Unites States government is authorized to pursue its own right to reimbursement. 42 U.S.C.A § 1395y(b)(2)(B)(iii).

As such, we discern from the regulations that the government may only seek recovery
directly from a primary plan after it has issued a recovery demand letter to that primary plan. See 42 C.F.R § 411.22(c).

 A lawsuit has been filed with the Superior Court of California, County of Santa Cruz, against assisted living facility Sunshine Villa by the children of deceased resident Carol Fundingsland. Ms. Fundingsland wandered away from Sunshine Villa on Friday, April 9, 2010 just hours after she was first admitted to the facility. Her body was found on the evening of Monday, April 12 after she had presumably walked at least ten miles through cold and rainy weather for several days.

Sunshine Villa and its employees neglected to fulfill its basic duty to keep Ms. Fundinsgland safe, that the facility fraudulently misrepresented the skill and training of its staff as well as the measures in place to ensure the safety of its residents, and that it should be held responsible for her wrongful death. As Ms. Fundingsland suffered from dementia at the time of her admittance,  Sunshine Villa and its representatives committed elder abuse by failing to adequately care for a dependent adult in its care.

Ms. Fundingsland’s son, Erik Kuentzel, brought her to Sunshine Villa at 1:00pm on Friday, April 9, 2010 to have her admitted to the facility. He was repeatedly reassured by Sunshine Villa’s Director of Community Relations, Barbara Quinton, that Ms. Fundingsland would receive particular care and attention upon her admittance. Mr. Kuentzel notified Sunshine Villa staff at 5:00pm that he would be departing and that his mother required supervision and attention. Surveillance videos later revealed that Ms. Fundingsland walked out through the front door of Sunshine Villa at 5:30pm that evening.

“When I got home late that Friday night, I heard increasingly frantic messages from Sunshine Villa that they did not know where my mother was,” said Erik Kuentzel. “They were unclear as to whether she had even been admitted; they didn’t even try to reach me until almost 9:30 that night. I’m not sure when they realized that she was missing.”

WanderGuard bracelet is designed as a safety measure to notify staff when a resident left the facility grounds. Although Mr. Kuentzel purchased the optional bracelet to ensure his mother’s safety, it was never affixed.

Sunshine Villa did not notify police of Ms. Fundingsland’s disappearance until nearly 9:30pm on April 9.  The extended delay hampered the search for Ms. Fundingsland. After increasingly intensive search efforts were put into place, her body was found on April 12, nearly 72 hours after she wandered off from Sunshine Villa and ten miles away from the facility. The coroner’s report indicated that Ms. Fundingsland died of exposure and hypothermia. Extensive bruising and scratching throughout her body showed that she likely wandered through wooded, brush-filled wildlands.

Sunshine Villa staff was recklessly negligent in its treatment of this new resident. “Ms. Fundingsland was understandably upset and disoriented during her first night in this new facility,” 

“The worst part about this situation is that my mother died a totally preventable traumatic and painful death,” said Mr. Kuentzel. “My mom died because the staff at Sunshine Villa failed to do their job, plain and simple. The only way to ensure that what happened to my mom doesn’t happen to other people’s families is to hold Sunshine Villa accountable.”

 

 

Attached is an Order by a judge from a suburban Philadelphia County refusing to enforce an arbitration agreement in a Manor Care case. There is no written opinion, just the Order. In Pa. the defendants can appeal a denial of an arb itration motion though the plaintiffs cannot if arbitration is granted.

 

 

 

I have seen several media outlets discussing Dr. David Ring……some attacking him for his mistake and others calling him a noble hero.  I think he has provided a great service in explaining his mistakes, and deserves a special thank you on this day of Thanksgiving!  See articles here and here

Dr. David C. Ring, a hand and arm surgeon at Massachusetts General Hospital, described in the latest issue of the New England Journal of Medicine how a series of mistakes led him to operate incorrectly on the hand of a 65-year-old woman.

Doctors never admit mistakes because of an irrational fear of liability.  Patient safety advocates praised Ring’s seven-page mea culpa as a necessary step to reversing rising numbers of wrong-site surgeries and other errors. “My immediate reaction was ‘Bravo!’” said Dr. Helen Burstin, senior vice president for performance measures at the National Quality Forum, a safety coalition famous for pioneering a list of what were once called “never events,” medical mistakes that should never occur.

Ring, along with colleagues at Massachusetts General and Harvard Medical School, detailed the series of missteps that led to the wrong operation in the patient whose ring finger on her left hand was stiff, painful and sometimes got stuck in a flexed position, a condition known as "trigger finger."

The patient was the last operation on a day that included three major surgeries and three minor surgeries.  Stress was high because several other surgeons were behind schedule.  Time equals money.  As a result, the patient was moved to a different operating room at the last minute, with different staff, including the nurse who had performed the pre-operative assessment.

No “time out” protocal was completed.  A time out is the safety pause for the medical staff aimed at double-checking surgical sites, but no formal check occurred.  In addition, there was a change in nursing staff in the middle of the procedure and a bank of clinical computers that diverted nurses’ gazes away from the patient.

Ring performed a carpal-tunnel-release operation, instead of a trigger-finger-release procedure.

“About 15 minutes later, while I was in my office dictating the report of the operation, I realized I had performed the wrong procedure,” Ring wrote.

Ring notified the staff, the patient and the hospital’s safety team.  Massachusetts General Hospital officials reviewed the error, reemphasized safety protocols and coached Ring and others involved in ways to avoid specific mistakes in the future.  Hospital officials offered her a settlement.

 

/study-treatment-mistakes-for-1-in-7-hospitalized-medicare-patients/

 

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NPR has developed an interactive database that has information about the independence level of residents at nearly 16,000 nursing homes around the country. For each facility it shows the percentage of residents who can do various daily living tasks by themselves, such as dressing, bathing, eating, walking, and using the toilet. It may be useful information when talking about the number of residents the CNAs need to assist to do things like dress, bathe, eat, etc., when presenting claims for understaffing.

 

After this morning’s entry about the nursing home nurse addicted to narcotics and stealing the resident’s medications, I ran across this Crime Round Up in the Salisbury Post :

120 Hydrocodone pills missing from nursing home drug room. Hydrocodone pills were reported missing from the drug room at Liberty Commons Nursing and Rehabilitation Center.  According to the Salisbury Police Department, 120 pills were discovered missing by a nurse at 5:30 Thursday morning. A nurse told police the door to the drug room was supposed to be locked at all times, and after an investigation, officers learned the door was probably unlocked at some point between 3 a.m. and 5:30 a.m. Officers conducted interviews with the employees working at that time, however, no one seemed to know what had gone on, police said.

I hope they drug test all the employees.

 

 

The Times News reported the two year sentence of Summer Brooke Lane, a former nurse at Holston Manor Nursing Home, for stealing painkillers from a patient at the Kingsport nursing home. Lane pleaded guilty to obtaining a controlled substance by fraud, theft $500 or less and abuse of an adult.  Lane deprived a patient of prescribed extended release pain medication for a 24-hour period beginning July 6, 2009. On documents related to the patient’s treatment, Lane indicated that she had administered the drugs as prescribed on July 6, 2009, and July 7, 2009.

Dr. Robert Lee, medical director at Holston Manor, advised investigators that "in his medical opinion she (the patient) would have been in pain" during the time she was deprived of her pain medication. Lee had prescribed the pain medication – to be administered twice a day – for the patient on July 13, 2005.

During an Oct. 13, 2009, interview, Lane told investigators that she began the job at Holston Manor in June 2009, after beating the drug screen with someone else’s urine. At first, Lane said she was supervised and "could not get anything."  Then on July 6, 2009, she was left in charge of a medicine cart. Though she said she did not recall taking any medicine that day, she said she took 10 to 15 tablets before working the "3-11" shift the next day. When she arrived at work, "I knew I had to have something," she said. A Roxicet prescription for one patient had been discontinued, Lane said, so she flushed the narcotics control sheet down the toilet and pocketed tablets from a blister pack.

On that same day, Lane said she recalled having also pocketed a morphine tablet after signing that she had given it to a patient. She was stopped by the Scott County Sheriff’s Office on the way home.

Two years and another job later – this time at Norton Community Hospital – Lane said she was using 20 to 30 Lortabs a day. After having surgery that year, Lane said she obtained prescriptions from two different doctors – one for Lortabs, the other for Percocets.

Near the end of 2008, Lane said she used someone else’s urine to beat a drug test and started working at the Brian Center in Weber City, Va. During that time, she said she had also become involved with a man "mainly because I knew what he could get as far as controlled substances."

At that point, Lane said she was "using Lortab and Percocet very heavily," and that she had to have them "just to get up to go to work." By May 2009, Lane said she was taking "muscle relaxers, Somas" and anything else "that I could get my hands on."

Where is her supervisor?  How could someone not notice?