Mass. Nursing Home Getting Coronavirus Victims

Sunday, March 29, 2020
Mass. Nursing Home to Get Coronavirus Patients

By Walter F. Roche Jr.

Owners and employees of a nursing home chain with a unique arrangement to care for Massachusetts victims of the coronavirus pandemic donated over $20,000 to the campaigns of Massachusetts Gov. Charles Baker and Lieutenant Gov. Karyn Polito.
Under an agreement disclosed Friday coronavirus patients being released from Worcester area hospitals will be cared for at the 164-bed Beaumont Nursing and Rehabilitation Center also in Worcester.
Beaumont disclosed Friday that the 147 patients now at the Worcester facility are being transferred to other Beaumont and Salmon nursing homes, a move which has prompted protests from relatives of some of those patients who are about to be moved.
Campaign finance reports show Matthew Salmon, Beaumont's chief executive officer, and other members of the Salmon family, have been regular contributors to Baker's and Polito's campaign committees.
The Salmon family has been generous contributors to other state officials including Sen. Michael Moore, a Millbury Democrat, and House Speaker Robert A. DeLeo, Democrat of Winthrop.
A spokeswoman for Beaumont and Salmon referred all questions to Beaumont's facebook page which includes a video from Matthew Salmon announcing the impending transfers.
"At this time, we are directing all inquiries to our Facebook page," Maggie Bidwell wrote in an email response to questions.
According to that announcement the 147 current patients are being transferred to other Beaumont facilities or other nursing homes with vacancies in the Worcester area.
Unanswered were questions including how much will be paid for each coronavirus patient and who will pay.
Questions directed to Baker's office also went unanswered.
In the video presentation Salmon said deciding to go forward with the agreement was "a very, very difficult decision" that he anguished over. He said the move was necessary to protect the current residents who would be put at risk when coronavirus patients were admitted.
He said all of the current patients would be moved by Wednesday. He also said the arrangement carried substantial financial risk.
Relatives of those current residents protested the sudden transfers and expressed concern that the disruption could have tragic results.

Covid-19 Virus Outbreak About to get Worse

By Walter F. Roche Jr.

A physician who heads a national research group says the effort of the Trump administration to initially downplay the significance of the now ongoing coronavirus pandemic already has had disastrous results and things are likely to get worse.
Dr. Michael A. Carome, director of the health research group at Public Citizen, said the efforts to downplay the outbreak led to a lack of planning and resulted in a failure to deploy test materials in advance of the virus' arrival in the United States.
"The response has been disastrous," Carome said in an interview. "The failure to deploy testing materials early has left us blindsided. People are going untested."
He said the United States should have followed the example of South Korea where testing materials were immediately available giving the healthcare system time to respond.
Calling the current crisis "one of the greatest public health debacles in the history of the country, Carome cited current Covid-19 hot-spots in New York, California and Washington.
"We have a health care system that is about to be overwhelmed," Carome said adding that the situation is only going to get worse as supply problems with such items as masks just magnify.
Stating that the Centers for Disease Control and Prevention's first attempt at a diagnostic test failed, Carome said that helps "explain why we've reached this state so soon ... and it's going to get worse."
He said the CDC made matters worse by declining to accept diagnostic tests offered by other countries.
He said health care providers in the United States may soon face the dilemma now being faced by their counterparts in Spain; taking ventilators away from the elderly and giving them to younger pandemic victims deemed more likely to survive.
He said his organization has joined with other advocacy groups in calling for accelerated efforts to find a Covid-19 vaccine. They also have called on the federal Occupational Safety and Health Administration to set an emergency standard for proper safety equipment for health care workers.
The organization has also called for paid sick leave for victims of the pandemic.
As for how long the current pandemic will last, Carome said while there has been speculation that warmer weather will bring relief "we just don't know."
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Conigliaro Wants Acquittal Affirmed

By Walter F. Roche Jr.

Charging that to do otherwise would be "unconscionable and unjust," lawyers for the former part owner of a defunct drug compounding company are asking a federal appeals court to uphold a judge's ruling clearing him of federal conspiracy charges.
In a more than 60-page filing in the First Circuit Court of Appeals in Boston, lawyers for Gregory Conigliaro asked the appeals court to affirm the conclusion by a district court judge that it was a legal impossibility for their client to defraud the U.S. Food and Drug Administration.
Citing the court and congressional testimony of two top FDA officials, the brief charges that the FDA didn't believe it had clear regulatory authority over compounding pharmacies like the New England Compounding Center, where Conigliaro was a vice president.
Conigliaro was one of 14 indicted in 2014 following a two year probe of the deadly 2012 fungal meningitis outbreak caused by contaminated drugs shipped by NECC to health providers in more than 20 states.
Conigliaro was convicted of conspiracy to defraud the FDA by a unanimous jury vote, but that was overturned in June of 2019 by U.S. District Judge Richard G. Stearns.
Federal prosecutors have appealed that decision thus prompting the response from Conigliaro's legal team.
Citing Stearns decision, Conigliaro's lawyers argued, "The FDA functions with which Mr. Conigliaro was accused of impeding did not exist."
Citing testimony by Janet Woodcock, a top FDA official, that the agency's authority was "blurry," the brief states that the FDA had "intentionally abdicated enforcement functions concerning compounding pharmacies."
"Acquittal here was mandatory," the brief continues, adding "The government's position here defies common sense and leads to abusive results."
Dismissing arguments that NECC violated a law requiring patient specific prescriptions, the brief contends that during the time of the alleged conspiracy there was no clear legal distinction between a drug compounder and a drug manufacturer.
"For the government to now rest criminal liability on the ambiguous legal foundation of its own making is unconscionable and unjust," the brief concludes.
The same arguments were raised by co-defendant Sharon Carter, who also had her jury conviction overturned by Stearns. An NECC supervisor, Carter faced the same conspiracy charge as Conigliaro.
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Cadden, Chin Michigan Hearing Postponed

By Walter F. Roche Jr.

A scheduled hearing on the second degree murder charges against two former Massachusetts pharmacists has been postponed and a new date has not been set.
A hearing on whether Barry Cadden and Glenn Chin should be bound over for trial on 11 counts of second degree murder had been scheduled for March 27, but it has been postponed due to the ongoing coronavirus crisis.
Kelly Rossman-McKinney, spokeswoman for Michigan Attorney General Dana Nessel, said today that a new hearing date has not yet been set.
Cadden and Chin were charged in the deaths of 11 Michigan residents who died in the 2012 fungal meningitis outbreak, which was caused by drugs produced by the New England Compounding Center. Cadden was president and part owner of NECC, while Chin was a supervising pharmacist at the now defunct Framingham, Mass. company.
The two already have been convicted on federal racketeering, conspiracy and mail fraud charges. Cadden was given a nine year federal sentence, while Chin was sentenced to an eight year term.
Though they have both begun serving their federal sentences, they are currently being held in the Livingston County Jail pending the upcoming hearing before District Judge Shauna Murphy.

Cadden's Wife Due $103,441 Reimbursement

By Walter F. Roche Jr.

Federal prosecutors have moved to reimburse the wife of a convicted drug company owner for expenses incurred prior to the sale of his house under a federal forfeiture order.
In a filing today in U.S. District Court in Boston, Mass, the U.S. Attorney asked for the release of $103,441.37 to the lawyer representing Lisa Cadden, the wife of Barry Cadden, who is now serving a nine year sentence following his conviction on racketeering, conspiracy and mail fraud charges.
Cadden's home at 13 Manchester Drive in Wrentham, Mass. was sold for $1.3 million last December under the terms of a settlement agreement between federal prosecutors and the Caddens.
Under the agreement the proceeds from the sale were split between Lisa Cadden and the U.S. Justice Department.
The final sales price was less than half of the original asking price of nearly $3 million. It remained on the market for 343 days.
Cadden was president and part owner of the New England Compounding Center, the company that caused a nationwide fungal meningitis. The outbreak caused by fungus laden steroids sickened 800 patients. Over 100 ultimately died.
The five bedroom 9,000 square foot home, described as "a magnificent private enclave," includes a six-person bar, a salt water pool and a bocce lawn.

Study Finds Continued Compounding Errors

By Walter F. Roche Jr.

Errors in drug compounding have continued despite a new federal law and regulatory efforts by some state pharmacy boards, according to an updated report from the Pew Charitable Trust.
The report issued Tuesday cites some 335 new adverse reports from compounded drugs since the original report was issued two years ago.
Even in states with strong adverse event reporting requirements, illnesses and deaths are not always recorded, the report states.
A major chunk of the new incidents came from a Texas company, BioTE, which acted as the distributor for hormone pellets produced by two other companies.
Citing testimony by a top official of the U.S. Food and Drug administration, the report states that despite evidence of 4,202 adverse events stemming from BioTE products, the company never reported them to the FDA. The agency was subsequently able to confirm 61 of the adverse incidents.
Concerns with drug compounding surfaced following the 2012 fungal meningitis outbreak. Federal officials say some 800 patients were sickened and over 100 subsequently died after being injected with contaminated steroids produced by the now defunct New England Compounding Center.
The Pew study concludes that contaminated sterile drugs, like NECC's methylprednislone acetate, accounted for most of the adverse events.
Cited were 23 adverse events, two resulting in deaths, from cesium chloride, and 46 adverse events from re-packaged Avastin, a cancer fighting drug also used to treat certain eye conditions.
Several other adverse events cited in the report resulted in blindness or eye injury. Other examples include super-potent morphine produced in Indiana and resulting in adverse events in Indiana and Illinois.
Citing data from the update and the original study, the report cites 1,562 adverse events including 116 deaths from 2001 to 2019.
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For 2012 Outbreak Victims A Frightening Deja Vu

By Walter F. Roche Jr.

Though there are some important differences the ongoing outbreak of the Coronavirus has brought back some frightening memories to victims of another medical nightmare, the 2012 fungal meningitis outbreak.
"This definitely takes Ken and I back to 2012," said Donna Borton, whose husband Ken was one of dozens of Michigan victims of the fungal meningitis outbreak.
Citing daily meetings between doctors and the U.S. Centers for Disease Control and Prevention, Borton remembered "the helplessness we felt when we would ask the doctors and they would reply,'We don't know.'"
"It was uncharted territory with no vaccine or cure," recalled Dawn Elliott, an Indiana outbreak victim.
Elliott noted that one important difference is that there was no risk of contagion in the 2012 outbreak, the victims had been injected with a spinal steroid laden with deadly fungi.
Indeed the ongoing outbreak, officially labeled Covid 19, has spread from continent to continent and is now taking victims from Washington state to Tennessee to Pennsylvania and the northeast. Though it wasn't known at the outset, contagion or person to person spread turned out to not be an issue in 2012. The culprit was a drug compounding firm in Massachusetts that shipped out thousands of vials of contaminated methylprednisolone acetate.
Yet like the 2012 outbreak the unknowns about the Covid 19 outbreak are abundant.
"We had never before experienced anything like that," Borton said."The first time we got that 'We don't know' response we were dumbfounded."
Though several drug companies are now working on a possible Covid 19 vaccine, such a cure is months or years away.
In the 2012 outbreak, experts conceded they were dealing with an unknown. Eventually treatment focused on anti-fungal drugs like Voriconazole which many victims found made them even sicker.
"It was uncharted territory," agreed Joan Peay, a Tennessee victim who suffered not one but two bouts of fungal meningitis.
"I don't know about the after effects of of the Coronavirus, but certainly do of the fungal meningitis," Peay added.
And she noted that in both cases innocent people have become the victims.
As to after effects Peay says she is still feeling them both from the meningitis and the anti-fungal medications.
She said those continuing problems are difficulty in comprehension and arachnoiditis, an extremely painful condition around the site where the tainted drugs were injected.
Elliott noted that another similarity is the fact that both outbreaks were "both man made and could have been totally avoided if it had not been for carelessness."
And the 2012 victims say from their experiences, they certainly sympathize with the victims of Covid 19
"We feel for everyone who has been infected with this disease. We hope that a solution is found soon," Borton concluded.
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Pa. Hospital Faulted in Treating Paraplegic

By Walter F. Roche Jr.

A Scranton hospital has been cited by state health surveyors for multiple errors in the treatment of a paraplegic suffering from a bladder infection.
In a report dated Jan. 23, state health investigators said the patient at the Moses Taylor Hospital was suffering from cystitis of the bladder apparently due to a catheter that needed to be changed.
But it was a full seven days after his admission that the old catheter was removed. At that time a full two liters of urine were collected from the patient.
The hospital failed to ensure "a catheter was changed in a timely manner," the report states.
According to the report errors in the case began when the patient was brought by ambulance to the emergency room on Dec. 19. Nurses at Moses Taylor did draw up a list of the patient's medications, but failed to record when the most recent doses were administered.
In addition to suspected cystitis the patient at admission was suffering from chronic pressure ulcers. He also was diagnosed with pneumonia.
State investigators reviewed the patient's records and reported that on Christmas eve leakage was noted around the catheter. A urology consult was requested the same day and again on Christmas day. On Dec. 27 the records show the patient was still waiting for a urology consult. Noting that the standard of care called for a consult to be made within 24 hours, the report states that a new catheter was finally installed on Dec. 29.
Other deficiencies cited include failing to perform a prescription drug reconciliation and failing to obtain a sterile urine specimen. in addition despite the patient's paraplegia and bed sores, records showed the patient was not turned every two hours. He had two stage pressure sore, records showed.
The 214 bed hospital is part of the Community Health System.
The hospital did file a plan of correction in which it promised to re-educate staffers on drug reconciliation procedures and consultation requirements. The hospital also agreed to perform audits to ensure the plan of correction is being implemented.
Hospital officials did not respond to a series of questions about the state's findings.
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