Florida Firm Recalling Compounded Drug

FDA Announces Glades Drugs' Nationwide Voluntary Recall Of Compounded Multivitamins Containing High Amounts Of Vitamin D3 (Cholecalciferol)

FDA Press Release

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For Immediate Release

November 25, 2015

Contact

Consumers

Faith Washington, Pharmacist
 (866) 597-3296

Firm Press Release

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol), distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports of several adverse events potentially associated with these compounded capsules made by Glades Drugs.
Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated. Patients suffering adverse effects from high Vitamin D levels (Cholecalciferol) may not initially show symptoms. Therefore, patients who have received these compounded capsules should stop taking this medication and immediately seek medical attention.
Symptoms of short-term vitamin D toxicity are due to high calcium levels (also known as hypercalcemia) and include confusion, increased urination, increased thirst, loss of appetite, vomiting, and muscle weakness. Acute hypercalcemia may intensify tendencies for heart arrhythmias and seizures and may increase the effects of certain heart drugs. Long-term toxicity may cause kidney failure, increase in calcium deposits in the blood and soft tissue, bone demineralization and pain. Patients with conditions such as liver disease or chronic kidney failure may be at increased risk for developing vitamin D toxicity.
Health care providers should quarantine and return any products subject to this recall to the company at: Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476. Glades Drugs sent recall letters to patients, attempted to contact them by phone, and called prescribing physicians.
FDA encourages health care professionals and patients to report adverse reactions to the FDA’s MedWatch Adverse Event Reporting program:

Saint Thomas CEO Drew Top Salary

By Walter F. Roche Jr.

The former CEO at Nashville's Saint Thomas health care companies drew the largest salary for the second year in a row, according to tax returns for the organizations.
The tax return, known as a 990, showed Michael Schatzlein, drew salary, bonuses and other benefits totaling just under $2 million. He also drew a supplemental retirement payment valued at $179,379.
Schatzlein moved on to an executive post at Saint Thomas' parent company, Ascension Health, in July of last year.
Schatzlein's successor, Karen Springer, drew pay and benefits totaling $588,581 in the year before her promotion.
In the prior fiscal year Schatzlein earned salary, benefits and bonuses totaling just over $2 million.
The tax return covers the fiscal year ending June 30, 2014.
Other top earners at Saint Thomas include physicians James Baker 2nd, Joseph Boyd and Vafa Mansouri, all of whom collected salaries and benefits for more than $1 million.
Former executive vice president Wesley Littrell was paid $570,266, including a $480,256 severance payment. He also got $71,292 in supplemental retirement payments.
Former executive vice president Alan Strauss collected $745,241 in salary and benefits plus $8,236 in supplemental retirement.
Others topping $1 million in salary and benefits, according to the return, were physicians Mark Koenig and Stephen Fahrig.
The returns show revenue for the fiscal year dropped from $462.3 million to $434 million at Saint Thomas West and from $421.2 million to $407.8 million at Saint Thomas Midtown.
Revenues at Saint Thomas Rutherford were $249 million, down from $252  million the year before.

First New York Outbreak Victim Steps Forward

By Walter F. Roche Jr.

A New York woman has been given until Dec. 1 to file proof that she was one of the victims of the 2012 fungal meningitis outbreak.
U.S. Bankruptcy Judge Henry J. Boroff Monday approved the request by the attorney for Lilliana Balanta to allow her to file a claim even though the deadline has long since passed.
Balanta is apparently the first and only victim from New York. The official count by federal officials includes no New York cases.
According to the petition, Balanta was injected with a steroid from the New England Compounding Center on Aug. 16, 2012 at the New York Spine and Sport Rehabilitation facility in the Bronx.
The petition states that she immediately experienced "severe pain at the injection site, skin infection
at the injection site, headaches, nausea, dizziness and vomiting."
A subsequent test showed no evidence of fungal meningitis.
Balanta's doctor informed her by letter in late October that she may have been injected with a drug produced by NECC, according to the filing.
Balanta "became emotionally distressed because she had been suffering many of the symptoms listed," her petition states.
Her lawyer, Devon Wilt, said in the petition that he did not learn about the filing deadline until after he had filed a lawsuit against NECC and related parties in early July of this year.
Balanta's is one of a handful of claims to be allowed after the deadline.
Victims who can prove they were victims of the outbreak will share in some $200 million amassed by NECC's bankruptcy trustee.
Over all some 778 patients across the country were sickened in the outbreak and 76 of them died.
Two of NECC's top officials have been charged with more than two dozen counts of second degree murder and they are scheduled to go on trial in April of next year.
State and federal regulators have concluded that NECC shipped thousands of vials of fungus laden steroids to health facilities in more than 20 states.
Contact: wfrochejr999@gmail.com

Efforts Underway to Protect Awards to Outbreak Victims

By Walter F. Roche Jr.

Hundreds of victims of the 2012 deadly fungal meningitis outbreak have been put on notice that insurance companies and the federal government will be seeking a share of any cash awards they win from a related $200 million bankruptcy settlement.
The lien notices, in fact, have sparked a wave of anger and outrage.
Behind the scenes, however, efforts are underway to at least ease the impact of those so-called subrogation claims.
Frederic Ellis, a Boston attorney who represents victims of the outbreak, said in an interview on Monday that negotiations have been initiated with the federal agency, the Centers for Medicare and Medicaid Services, to reduce the amount of claims.
"We're trying to negotiate a settlement," Ellis said, adding that agreements for a reduced payment are common in mass tort claim cases. "We do it all the time."
"This is common in these kinds of cases," Ellis said citing a settlement reached in a case involving faulty transvaginal mesh.
He said the hope is to reach a settlement based on the type of injury suffered by victims. A similar method, utilizing a point system, has been established to determine the awards in  the bankruptcy of the New England Compounding Center, the defunct Massachusetts drug firm blamed for the outbreak.
"We're trying to simplify things and avoid extra administrative costs," Ellis said. "We're trying to come up with a formula."
He said that since the majority of victims were elderly and on Medicare, the initial negotiations are with CMS. Once an agreement is reached there, Ellis said they will turn to major insurance carriers to attempt parallel agreements.
In a court session last week in Boston Ellis disclosed that the anticipated awards for the most severe cases, those resulting in death, were expected to be in the range of $175,000 to $200,000.
He stressed that those figures were just an estimate and could change depending upon some yet to be determined factors, such as tax refunds that the former NECC owners have agreed to give up.
Ellis said in the interview that letters informing victims of expected awards from the bankruptcy could go out before the end of the year, while actual checks would be issued by early Spring.
He said the first payments will be "interim awards," set at some where between 50 and 70 percent of the anticipated final award.
The 2012 outbreak sickened 778 patients across the country, killing 76 of them. State and federal regulators concluded thousands of fungus riddled vials of methylprednisolone acetate from NECC were the cause.
Contact:wfrochejr999@gmail.com

Court Gets First Estimate of Meningitis Awards to Victims

By Walter F. Roche Jr.

A Boston attorney told a federal judge that victims of the 2012 fungal meningitis outbreak should not be expecting large awards from the bankruptcy case of the firm blamed for the fatal outbreak.
Fredric Ellis, one of the attorneys representing victims, estimated that the highest awards would range from $175,000 to $200,000 and those amounts could be offset by liens filed by insurance companies and other parties that paid for victims' medical care. Lesser amounts would go to those suffering lesser injuries.
"They're not going to be large sums," Ellis told U.S. District Judge Rya Zobel in her Boston courtroom.
The disclosure is the first time an actual dollar amount has been publicly disclosed.
Ellis said that claims could be processed by the end of the year but actual payments could come in March of next year.
The estimate came in a monthly status conference before Zobel on over 100 civil cases filed in the wake of the outbreak which sickened 778 patients in over 20 states, killing 78 of them.
The suits pending before Zobel are separate from the bankruptcy case of the New England Compounding Center, the defunct firm that shipped fungus laden steroid to health facilities across the country.
Suits before Zobel are against other parties including the medical facilities where patients were injected in the spine and joints with preservative free methylprednisolone acetate.
Much of the more than hour long hearing was focused on whether the case of a Nashville man, Wayne Reed, should be among the first to go to trial.
George Nolan, Reed's attorney, recounted how his client, who suffered from Lou Gehrig's Disease, lost his wife and sole caretaker in the outbreak. She died after being injected in the neck at the Saint Thomas Outpatient Neurosurgical Center with NECC steroids, Nolan said.
He said that because of his illness, Reed is gradually losing the ability to speak and eventually he won't be able to testify.
Marcy Greer, representing Saint Thomas, said that under rules set up by the court, the defendants already had moved to strike the Reed case from the list of so-called bellwether or representative cases.
"It's an incredibly sympathetic case," Greer said, adding that it was not representative of most cases.
"It's going to derail the process," she said. "We've really got to get representative cases.
Gerard Stranch, a Nashville lawyer representing victims, said that the clinics had submitted a list of representative cases that could later be dismissed without ever getting to trial.
Greer denied that charge and said the effort was to pick cases that "move towards the middle. We did not put cases in that would be eliminated."
Stranch urged a new process for selecting bellwether cases which would put the final decision in the judge's hands.
Zobel took the matter under advisement.
Kristen Johnson informed the judge that a $10.5 million settlement had been reached in a class action suit against Michigan Pain Specialists, a Michigan clinic.
In a second case, another Michigan clinic, Neuromuscular and Rehabilitation Associates, was cleared of malpractice charges in connection with the outbreak.

Lawyers Differ on Impact of Michigan Meningitis Verdict

By Walter F. Roche Jr.

Lawyers for Tennessee victims of the 2012 fungal meningitis outbreak say a verdict in a Michigan case clearing physicians there of malpractice claims, differs in several ways from the cases filed for their clients, but clinic attorneys say the jury got it right.
A Michigan jury Thursday cleared three physicians of malpractice charges brought in behalf of some 170 victims of the fatal 2012 outbreak blamed on fungus tainted steroids injected into the spines and joints of unsuspecting patients.
Mark Chalos, a Nashville lawyer representing Tennessee victims, said that the facts in the Michigan case do not parallel the claims in his and other Tennessee cases.
But Chris Tardio, one of those representing Tennessee clinics, said there are parallels.
"The plaintiffs' lawyer in Michigan tried the same allegations made against the health care providers in Tennessee," said Tardio. "The jury reached the correct decision that physicians and nurses are not responsible for misconduct by a company that promised its products were sterile."
Stressing that he had not yet had time to fully analyze the verdict, Chalos said, "It is clear the conduct of the Michigan clinics and the claims brought under Michigan law are substantively different from the circumstances in Tennessee."
In most of the Tennessee cases, the suits have been filed against the Saint Thomas Outpatient Neurosurgical Center, the Nashville facility where they were given injections of methylprednisolone acetate.
"Most importantly," Chalos continued, "St. Thomas's conduct, including participating  in the fraud by submitting fake names to obtain drugs and violating patient safety rules, was far riskier and more outrageous than what the Michigan clinic was alleged to have done."
Gerard Stranch, another attorney representing Tennessee victims, expressed a similar opinion.
"Given the significant differences in law and claims asserted, along with the more culpable conduct of the Tennessee defendants, this verdict has no precedential value to the Tennessee plaintiffs or defendants," Stranch said.
The Tennessee plaintiffs' lawyers have argued that because of Tennessee's unique product liability law, claims can be made against St. Thomas and two other Tennessee clinics. The law, they contend, allows plaintiffs to file claims against the seller of a defective product in cases where the original source of the product is bankrupt.

The steroids were produced by the New England Compounding Center, a Massachusetts firm which filed for bankruptcy in late 2012.
Lawyers for the Tennessee clinics, however have disputed the claim that their clients can be considered sellers.
The 2012 outbreak sickened 778 patients across the country killing 76 of them.
The Tennessee cases are among hundreds that have been consolidated before a federal judge in Boston. U.S. District Judge Rya Zobel has set a tentative trial date of next spring for the first of those Tennessee cases.

Michigan Record Eagle Press Report

By MICHELLE MERLIN mmerlin@record-eagle.com | Posted 3 hours ago
TRAVERSE CITY — Jurors took less than three hours to decide Traverse City doctors who injected patients with a tainted steroid did not act negligently when they did so.
Jurors in 13th Circuit Court on Thursday ruled in a class-action lawsuit filed on behalf of about 170 local Michiganders who received the injections from Neuromuscular & Rehabilitation Associates of Northern Michigan. Three representative patients had to undergo anti-fungal treatment and were hospitalized multiple times after they were injected with the steroid.
The drug came from the New England Compounding Center, a Massachusetts-based compounding pharmacy that sent the steroid compounds across the country in 2012. Tainted batches of the company's compounds caused an outbreak of fungal meningitis and other infections in at least 20 states that killed more than 60 people.
Tim Dardas, an attorney who represented the doctors, said this was the first case against physicians to go to trial that was related to the NECC steroid recall.
"(The physicians) did what was reasonable, they did what was appropriate, and they did what was in the best interest of their patients," Dardas said.
Robert Sickels, an attorney speaking on behalf of the patients, said during closing arguments the physicians at the practice were to blame for ordering the steroids in bulk from a compounding pharmacy, instead of an FDA-regulated manufacturer. He also said they should have informed their patients they were injecting a preservative-free medicine from a compounding pharmacy into their bodies.
"Had they bought from a manufacturer, none of this would have happened, none of it," Sickels said.
Compounding pharmacies are supposed to produce drugs based on individual prescriptions, not in bulk, he told jurors Thursday.
Sickels asked jurors to award three class representatives between $200,000 and $440,000 for pain and suffering and several thousand more dollars to pay back insurance companies for the patients' medical expenses.
Randy Juip, the attorney for the defendants, said the doctors used the medication for eight years without incident and reasonably relied on regulatory agencies to let them know if something was amiss.
"It would be impossible, impossible to practice medicine if the standard of care required that you investigate the background, investigate the regulatory history, and doubt the reliability of your suppliers,"Juip said.
The jury did not find that the three doctors — Richard Ball, James MacKenzie and Stephen Andriese — acted with negligence that caused injury to their patients.
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NECC Owners Retain Pricey Real Estate

By Walter F. Roche Jr.

Even after paying out some $47.5 million to settle a bankruptcy case, land records show the owners of the defunct New England Compounding Center continue to hold onto millions of dollars worth of real estate.
They have done so in the wake of one of the worst outbreaks in U.S. history, an outbreak triggered by the shipment of fungus infested drugs from NECC that were injected into the bodies of hundreds of unsuspecting patients, killing 76 of the 778 who were sickened.
Douglas Conigliaro and his wife Carla, for instance, own homes in Dedham, Mass, Florida and Boston's Beacon Hill. Carla was the majority owner of NECC. Douglas headed a sister marketing firm. They paid $4.1 million for the condo in Boston. The Winter Park, Fla. home was purchased for $1.2 million.
Last year Gregory Conigliaro sold his interest in a Cape Cod property and a Southborough home to his wife, who still owns them. The properties are valued at $2.6 million.  Gregory Conigliaro was also an NECC owner.
Barry Cadden, an NECC owner and founder, still owns his $1.7 million home in Wrentham, Mass.
Douglas, Carla and Gregory Conigliaro and Barry Cadden are under indictment with charges ranging from second degree murder to racketeering and mail fraud.
Cadden, the chief pharmacist, has been charged with 26 counts of second degree murder. Carla and Douglas Conigliaro are charged with evading federal law by making a series of bank withdrawals just under a federal reporting limit.
The two are also charged with withdrawing money from bank accounts that were under a court ordered freeze.
Gregory Conigliaro has been charged with conspiracy to defraud the U.S. Food and Drug Administration.
Though some of the real estate holdings were under a freeze imposed in the NECC  bankruptcy, that was lifted late last year by U.S. Bankruptcy Judge Henry Boroff.
Federal prosecutors did seize assets from the Cadden and the Conigliaros valued at a little over $18 million in May. Those assets included several bank accounts, a boat and a car.
Cadden, court and land records show, used his Wrentham home as collateral for $500,000 bail after his arrest in December of last year.
As part of the settlement in the bankruptcy case, the Caddens and Conigliaros agreed to pay $47.5 million into a trust fund which will be used to pay victims of the 2012 outbreak.
Douglas and Carla Conigliaro were hit with a tax lien on their Boston condo last month, but the couple came up with the $13,743.03 tax payment by the end of the month. Boston assessment records put the current value of the condo at $4,549,400.
Contact: wfrochejr999@gmail.com