Admissions Barred at Knoxville Nursing Home

By Walter F. Roche Jr.

New admissions to a Knoxville nursing home have been barred after state inspectors found that a patient there suffered fractures to both knees from an avoidable accident but didn't even get to see a physician for over a week.
Tennessee Health Commissioner John Dreyzehner ordered the admissions freeze and imposed $30,000 in fines on the Westmoreland Health and Rehabilitation Center, a 222 bed facility.
In a 55-page report state surveyors said the woman suffered the fractures on Nov. 11 of last year when a certified nursing assistant attempted to change the patient's sheets without the assistance of a second staffer, as had been ordered.
The patient slid off the bed and landed on her knees crying out in pain, according to the report.
"The fractures were extremely painful," the report states.
After reviewing nursing home records and interviewing staffers, the state inspectors found that despite the patient's repeated complaints of severe pain, X-Rays were not taken until five days after the fall and it was another four days before she was seen by an orthopedic specialist.
The unnamed woman was then hospitalized and treated for the fractures. She died on Dec. 18.
The state surveyors learned that the delay was apparently the result of a note posted at the nurses' station telling staffers they were not to contact the physician or his nurse practitioner "until contact has been made with the on-call nursing manager."
One staffer told the inspectors that the note disappeared after nursing home officials learned they were being sued.
The home's physician told the state surveyors he only learned of the bilateral fractures from their call. He told them he should have been notified about a fracture.
The report states that the physician and the home's director of nursing also never assessed the patient.
Under Dreyzehner's order the home was fined $5,000 each for six violations including failure to notify the physician of a significant change in a patient's condition and "placing a resident in an environment that was detrimental to their health, safety and welfare."
Contact:wfrochejr999@gmail.com
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Another Compounding Recall

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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

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For Immediate Release

July 28, 2018
Contact
Consumers

Jennifer Henry
724-527-2752
Announcement

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level.

These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in a site-specific or systemic infection which in turn may result in hospitalization, significant morbidity, organ damage, or a fatal outcome. The pharmacy has not received any reports of patient complaints or adverse events related to this recall. To date, FDA is not aware of any adverse events associated with the use of compounded drug products from the pharmacy. Nor is there any indication that the compounded sterile drug products being recalled are actually contaminated. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy’s highest priority.

The recall encompasses compounded sterile drug products, within expiry, that were dispensed between January 17, 2018, and July 10, 2018. The sterile drug products subject to this recall were distributed only within the State of Pennsylvania and directly to customers and/or medical facilities. The recall does not affect the pharmacy’s non-sterile compounded products or retail pharmacy operations.

The pharmacy has notified potentially affected customers of the voluntary recall via U.S. Mail and direct outreach. Customers who have received sterile compounded products subject to the recall should stop using and return the product to the pharmacy for a full refund.

Consumers with questions regarding this recall can contact Ranier’s Rx Laboratory by calling Jennifer Henry at 724-527-2752, Monday through Friday between 9:00 a.m. and 5:00 p.m., EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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FDA Moves Against Toxic Drug

By Walter F. Roche Jr.

Citing "significant safety risks," the U.S. Food and Drug Administration today took a first step to bar the use of a toxic chemical currently being used by drug compounders for treatment of cancer patients.
FDA Commissioner Scott Gottlieb said the agency was immediately issuing an alert warning to drug compounders about the serious health risks posed by the use of cesium chloride.
In addition Gottlieb announced that the agency will be placing the chemical on a list of substances that are not authorized for use in drug compounding.
In announcing the action, the FDA also stated that if it determines that a compounder is using cesium chloride "it intends to take regulatory, such as issuing a warning letter or seizing product."
The action comes more than six months after Public Citizen, an advocacy group, filed a formal petition with the FDA seeking immediate action to bar use of the chemical. The petition cited findings by the FDA itself about the health risks associated with the drug.
Gottlieb's action comes under the provisions of a new law, the Drug Quality and Security Act, passed in the wake of the deadly 2012 fungal meningitis outbreak which took the lives of 76 patients. Federal prosecutors have stated that the outbreak, caused by fungus laden compounded drugs, was the worst outbreak in history to be caused by a prescription drug.
In announcing today's action the FDA cited adverse effects from cesium, including abnormal heart rhythms, low potassium, seizures, fainting, cardiac arrest and death.
Public Citizen also had requested that the FDA issue a regulation specifically barring the use of cesium chloride, but Gottlieb said the agency would have to give public notice and go through a formal rule making process before it could issue such a regulation.
The December Public Citizen petition signed by Dr. Sidney M. Wolfe noted that "FDA staff determined more than 18 months ago that cesium chloride presents serious safety concerns and is not safe for human use."
Wolfe noted in his letter that oral cesium chloride is advertised by a number of compounding pharmacies. He also cited testimony before an FDA committee that "very vulnerable" patients who turn to the drug are often facing "end-of-life scenarios"
Contact: wfrochejr999@gmail.com

$11.5 Million Could Go to Outbreak Victims

By Walter F. Roche Jr.


A total of $11.5 million in additional relief to victims of the 2012 fungal meningitis outbreak is being held in escrow pending possible appeals by the IRS but none of the money can be released until 2020.
Paul D. Moore, the former trustee in the bankruptcy of the New England Compounding Center said in an email response to questions that while some of the $11.5 million can be released in 2020, the bulk of the funds won't be ready for release until 2021.
The additional funding comes from a provision in the bankruptcy settlement agreement with the former owners of NECC, the now defunct firm blamed for the deadly outbreak. The owners agreed to pay a portion of any income tax refunds they received into a victims' fund.
The funds are being held in an escrow account because the IRS can still dispute the refunds and claim some or all of it back.
Additional refunds could also be added to the victims fund in the future.
The $11.5 million is in addition to some $144.6 million that has already been distributed to victims under the settlement agreement. According to an annual report filed recently in U.S. District Court in Boston, Mass. that total includes some but not all of the payments made by clinics and healthcare providers who injected victims with steroids loaded with deadly fungi.
Lynne Riley, the administrator of the national settlement fund, reported that $95.8 million has been approved for payment to qualified victims from the national settlement while an additional $48.8 million obtained from settlements with healthcare providers has been approved for payment to the victims injected at those three clinics.
The figure does not include some clinic settlements which are being administered separately. The estimated $20 million from the settlement with a Nashville, Tenn. clinic, for instance, has been distributed separately.
The $11.5 million from the IRS refunds is somewhat below initial estimates of $20 million, but that number could increase.
The national settlement fund includes some $50 million paid by NECC's owners plus settlements with insurance companies and firmsd providing testing, cleaning and other services to NECC.
Victims also have collected payments from a $40 million fund being administered by the Massachusetts Attorney General. In the latest report from that agency a total of $18 million has been distributed to victims who filed valid claims. The deadline for filing from that fund has been extended to Sept. 30.
Contact: wfrochejr999@gmail.com

New Charges in Outbreak Probe

By Walter F. Roche Jr.

A former pharmacy technician at an unnamed Boston hospital has been charged with making false statements to federal agents in connection with payments of $355,000 he received from the now defunct firm blamed for a deadly fungal meningitis outbreak.
In a three-page information filed in U.S. District Court in Boston, Mass. federal prosecutors charged that Claudio Pontoriero, 40, lied about the payments he received between 2006 and 2012 from the New England Compounding Center in Framingham, Mass. The payments were made in $5,000 monthly installments.
While Pontoriero told federal agents the payments were made in return for consulting work he performed for NECC,in fact he was being paid for using his influence to get his employer to buy drugs from NECC. In addition to purchases from NECC, Pontoriero was involved in drugs purchased from NECC's sister company Ameridose, located in Westborough, Mass.
Like NECC, Ameridose closed its doors in 2012 and never re-opened.
State licensing records show Pontoriero has a currently valid license as a pharmacy technician.
The information, which generally means the defendant has agreed to plead guilty to the charges, comes as the final trial date in the original outbreak indictment is approaching. Assistant U.S. Attorneys in the case are Amanda Strachan and George Varghese.
The 10 remaining defendants are set to go on trial Oct.2. Two defendants, Barry J. Cadden and Glenn A. Chin, already are serving prison sentences after their conviction on racketeering, mail fraud and related charges. Chin is serving an eight year sentence while Cadden has begun a nine year sentence. Cadden was president and part owner of NECC while Chin was a supervising pharmacist.
The hospital that employed Pontoriero was not disclosed in the three-page information and was described only as Hospital A.
Other records show Pontoriero was in charge of drug purchases at Massachusetts General Hospital in 2014. In 2007 Ponteroriero posted an entry on a pharmacy related web site highly praising both NECC and Ameridose. He listed himself as a drug purchaser for Mass. General.
NECC has been blamed as the source for thousands of vials of contaminated drugs which were shipped to hospitals and clinics in 23 states. The outbreak sickened 778 patients killing 76 of them. The indictments of Chin, Cadden and 12 others came in late 2014.
In a related development Wednesday one of the NECC defendants awaiting trial filed a motion to have the court authorize the issuance of a subpoena, but to keep secret the details of that subpoena along with a series of filings in support of the motion.
The filing for Joseph Evanosky, a former NECC employee, states that it wants the information also kept secret from federal prosecutors. It states that if Evanosky decides to use the information as part of his defense he will then disclose it to prosecutors.
Contact: wfrochejr999@gmail.com

Six Years Later Outbreak Suits Linger

By Walter F. Roche Jr.

As the sixth anniversary of a deadly fungal meningitis approaches dozens of victims are still waiting for a final verdict in suits brought against the clinics where they were injected with a highly contaminated steroid.
In Indiana alone some 77 victims await the outcome of suits which already made their way to that state's highest court.
"I'm sick of it," said Jack Pavlekovich of South Bend, one of the 77 represented by Indiana attorney Doug Small.
Pavlekovich, whose 35 year career in law enforcement ended when he was stricken with fungal meningitis in 2012, said the ordeal already has "taken six years out of my life."
"They ruined me. They ruined my family. I can't walk more than five yards at a time," he added.
Small, who has suits pending against two Indiana clinics, said he just filed a motion seeking summary judgment on some of the issues in the case of one clinic. He said a parallel motion is being prepared in the suit against the other clinic.
Indiana was one of the hardest hit states in the outbreak which eventually sickened some 778 patients, killing at least 76 of them.
Indiana had 93 victims sickened and 11 deaths. Neighboring Michigan had 204 cases and 19 deaths. Other hard hit states included Tennessee, Virginia and New Jersey.
In Michigan victims won a $10.5 million victory from one clinic, but another suit brought in behalf of 170 victims against three physicians resulted in a not guilty verdict.
Victims also have won substantial settlements against health care providers in Virginia, New Jersey and Tennessee.
But even those awards and the settlement in a related bankruptcy case have often provided too little too late.
Pavlelovich said he was forced to file for bankruptcy following an avalanche of medical bills.
The awards or settlements have been reduced by claims from Medicare, Medicaid and insurance companies along with attorneys fees and expenses. Depending on the state where the cases are filed, attorneys fees can eat up as much as 45 percent of any award.
Small said his cases ended up in the state Supreme Court which decided that the claims would be considered under the state's medical malpractice law and not as negligence cases.
He said that while the malpractice law generally favors medical providers, it could ultimately provide for a greater recovery "for the group of all plaintiffs."
Attorneys for the two health providers, the South Bend Clinic and OMSC (Orthopedic and Sports Medicine Center of Northern Indiana), did not respond to requests for comment.
Pavlekovich, meanwhile, despite needing to use a walker, is getting ready for a move to Wisconsin. But he already has learned that having filed for bankruptcy created yet another headache.
"It was hard to get a mortgage," he said.
Contact: wfrochejr999@gmail.com










Walter,

We represent 77 individuals who have asserted claims against two clinics here in northern Indiana, OSMC and the South Bend Clinic.

A big part of our delay has been the need to determine whether these cases were to be governed under Indiana general negligence law or medical malpractice statute. That issue went all the way up on appeal to our Indiana Supreme Court. The court affirmed the decision of the trial court that these cases are governed by our malpractice statute.

We just filed a motion for partial summary judgment against OSMC and will be doing the same on a motion against the South Bend Clinic yet this month. A copy of the motion filed against OSMC is attached.

The clinics or their insurers have rejected settlement overtures to date.

I have been taking the lead on these cases, though there are other attorneys in Indiana with claims. They include Rick Morgan and Vincent Campiti here in South bend. Attorneys in Indianapolis handling some of the cases here in the North and cases against clinics in southern Indiana include James Piatt, Robert Dassow and Ned Mulligan.

Doug Small
Foley & Small
1002 E. Jefferson Blvd.







There is both good and bad. The procedures under our medical malpractice act favor the healthcare provider typically. On the other hand, we have the opportunity for a greater recovery under the Act for the group of all plaintiffs. The defendant, OSMC/ASC, had general liability insurance coverage of only $5 million for coverage year 2012, when the outbreak occurred. Under the Act, each of our clients has a possible available recovery of up to $1,250,000, the liability claim limit for each claim under the Act, and would not be subject to the $5 M limit for all claims paid under OSMC’s gen liab insurance coverage.

Pa. Hospital Hit With Compounding Deficiencies

By Walter F. Roche Jr.

In a scathing report that eerily echoed details of a five-year-old deadly national outbreak, a Pennsylvania hospital has been cited with multiple violations of drug compounding standards placing cancer patients in immediate jeopardy.
The findings by the Pennsylvania Health Department forced the Pottstown Hospital to immediately shutdown its cancer center pharmacy where supposedly sterile drugs were being compounded for administration to cancer patients.
The report concluded that hospital management and staffers "failed to ensure established procedures for hand hygiene and donning protective gear were followed for the compounding of hazardous drugs."
State surveyors observed staffers working under hoods without required protective gear. Numerous violations of the industry standard code known as Chapter 797 were observed.
Officials of Tower Health, the holding company for the hospital did not respond to requests for comment. The hospital did file a corrective action plan with the state in response to some but not all of the deficiencies.
State surveyors also cited the 232 bed Pottstown facility for an array of violations of the federally mandated Life Safety Code. The report states that the main hospital building "exceeds the maximum story height allowed"and several areas lacked the required fire ratings.
Other violations also were noted in several areas other than the cancer center pharmacy.
Staffers failed to follow proper procedures for blood transfusions and mold was observed in an ice machine.
Still other deficiencies included failure to ensure the privacy of patient records and improper cleaning of endoscopy equipment.
IV bags were observed without expiration dates and expired gloves and drugs were also observed in the endoscopy area.
In the clean room where critical procedures were performed gaps were observed on counter tops, floors were damaged and even when microbial sample showed contamination, no action was taken. According to the report there were over 30 incidents of microbial growth without documented follow up.
The facility "failed to ensure environmental microbial samples were evaluated," the lengthy report states.
The descriptions in the report were similar to the court testimony in the recent trials of former officials of the New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak.
In those trials federal investigators described similar deviations from the 797 standards including the failure to take corrective action when environmental tests showed evidence of contamination in the clean rooms. The two NECC official were found guilty of racketeering, mail fraud and related charges and are now serving prison sentences.
Still other citations included failure to have adequate post anesthesia services for pediatric
surgical patients and failure to maintain proper temperatures in an operating room.
Pottstown was one of five hospitals purchased by Tower Health from Community Health Associates last year for $418 million.
Another hospital purchased from CHA was the Brandywine Hospital in Coatsville, which was also the subject of a recent critical health department report.
That facility was cited for failure to comply with the state Child Protective Services Act. According to the surveyors, hospital staffers watching a monitor observed a visitor touching a child in an appropriate manner but subsequently failed to properly report the incident immediately. Instead, a report was filed three days late, the report states. The incident occurred on Aug. 27, 2017, two months before the purchase.
Brandywine also was cited for failure to properly follow up on patients who had discharged themselves against medical advice.
The surveyors found that Brandywine failed to contact the patients' outpatient therapists.
Contact: wfrochejr999@gmail.com

180 More Checks Go to Outbreak Victims

By Walter F. Roche Jr.

Another 180 checks have been mailed out by the Massachusetts Attorney General's office to victims of the 2012 fungal meningitis outbreak, according to officials of that agency.
Aides to Attorney General Maura Healey said Wednesday the checks totaling $5.325 million were issued Friday to the 180 victims or their survivors.
The fund was established by a $40 million grant from the U.S. Justice Department in response to repeated requests from U.S. Rep. Mike Bishop, a Michigan Republican whose district was especially hard hit by the outbreak.
The outbreak sickened at least 778 patients killing 76 of them. It was caused by steroids heavily contaminated with fungus that were shipped from a now defunct drug compounder, the New England Compounding Center in Framingham, Mass.
The deadline for applying for payments from the fund expired June 30, but it has now been extended yet again to Sept. 30. More than $18 million of the $40 million available was claimed by the Friday deadline.
According to the state agency those receiving the checks were notified in advance and were provided tracking numbers.
Some of the checks were mailed to attorneys representing victims, rather than the victims themselves.
Contact: wfrochejr999@gmail.com

Compounding Outsourcer Recalling Drugs

From the FDA


Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling



Fagron Sterile Services of Wichita KS is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

Risk Statement: In the event that 5mL rather than the intended 3mL is administered to a patient, adverse events from Neostigmine Methylsulfate overdosage can range from nausea, vomiting, diarrhea, excessive salivation and sweating, increased bronchial secretions, miosis, bradycardia or tachycardia, cardiospasm, bronchospasm, incoordination, muscle cramps, fasciculation, paralysis, to Cholinergic Crisis resulting in death.




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