Seven Years Later and Still Hurting

By Walter F. Roche Jr.

"I am not going to get any better really. I just hope things do not get too much worse."
That's how Randy Dollyhigh,a North Carolina victim of the 2012 fungal meningitis outbreak put it when asked about his condition seven years after the deadly outbreak became public.
It was early in October of 2012 when the public first learned that a deadly outbreak had surfaced in Nashville. Soon it became clear that it was not limited to Tennessee. Soon after that state and federal health officials were able to trace the problem back to a rogue Massachusetts drug compounding firm.
Thousands of vials of a steroid, methylprednisolone acetate, laden with deadly fungi, had been shipped from Framingham, Mass. to health providers in more than 20 states. The deadly doses were then injected into the spines and joints of unsuspecting patients seeking relief from chronic pain.
Over 100 of the more than 800 victims have died, but for many of those that have survived, life has been no picnic.
Like Dollyhigh many of the victims complain of chronic bouts of severe pain that come suddenly and without warning.
He described some of those as "like being hit in the head with a club or a bat. The worst ones are in the head."
Dollyhigh, who says he had "a fantastic memory" before the outbreak, now cannot remember "names or simple things."
"One of the biggest problems after meningitis is that I cannot understand people very well," said Joan Peay of Nashville, Tenn., who suffered not just one but two separate bouts of fungal meningitis.
"I can hear volume, but have great difficulty understanding people.I often feel left out of conversations," Peay added
Peay, like Dollyhigh and other victims,says she suffers from recurring sharp pains in the back and neck.
"I sometimes get a cramp so bad I could pass out," Peay said.
"The disease seems to have aged me ten years. I just do not have much energy since then," Peay added.
Peay also reports having "a constant sound in my ears—like a very distant field of crickets or very light TV static. It is very annoying."
Many victims say it was not only the after effects of fungal meningitis that still sickens them but also the debilitating anti-fungal medications needed to treat the disease.
In fact Jack Pavlekovich, an Indiana victim, said his doctor told him that his current health problems stem more from the anti-fungal medications than from the initial bout of fungal meningitis.
A former police officer Pavlekovich said he needs to use a walker even when he is in his house. Like several other victims he said he has lost short term memory and suffers from sharp severe pains.
"I'll be watching tv and when the pain hits I'll actually jump out of my chair." he said.
Ken Borton, a Michigan victim, is still suffering from sudden, intense headaches that he gets treatments for every three months.
His wife Donna says he also continues to have "memory loss and seems to have no sense of time. He has no idea if he has been doing something for an hour, or three hours or more. He just keeps going and does not realize that he needs to stop and rest."
Dawn Elliott, an Indiana victim, says after effects of the fungal meningitis and the anti-fungal medications have left her hesitant to leave her home.
"This pretty much keeps me at home, afraid to go anywhere," Elliott said citing back and joint pains, bowel problems and multiple infections.
"I’ve been hurting quite a bit," Elliott said. "I am sick of this."

$15 million in Grant Funds to be Returned

By Walter F. Roche Jr.

Some $15 million or nearly a quarter of a $40 million grant earmarked for victims of the 2012 fungal meningitis outbreak will be returned to the federal government in the next few days when the final deadline for claims passes.
Officials of the Massachusetts Attorney General's office, which has been administering the program say the unused money must be returned on Sept. 30, the end of the federal fiscal year. The grant came from a U.S. Justice Department program to benefit crime victims.
The Massachusetts program was established to assist patients who were sickened by contaminated drugs produced by the New England Compounding Center of Framingham, Mass. The 2012 outbreak sickened hundreds and over 100 have died.
According to data from Attorney General Maura Healey's office some $23 million has been distributed to some 640 victims while 103 claims have been denied. The number of denied claims is likely to rise during the last few days of the program.
Some twenty victims have had claims approved since July, apparently as a result of a final outreach effort to contact all possible victims.
Under the program eligible victims qualified for an initial grant of $25,000. An additional $25,000 was available to survivors of those who died in the outbreak and those who suffered a permanent disability.
A federal criminal probe of NECC resulted in the 2014 indictment of 14 people with ties to NECC. Three of the 14 are now serving federal prison sentences.
Michigan, Tennessee and Virginia were among the hardest hit in the 2012 outbreak.
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NECC RXs Plead for Acquittal

By Walter F. Roche Jr.

Boston- Two pharmacists facing potentially lengthy jail terms told a federal judge that it wasn't their job to question the patently fake names on prescriptions they routinely processed for shipment.
Lawyers for Kathy Chin and Michelle Thomas said their clients, both licensed pharmacists, were only assigned to ensure that the right drugs were being shipped to the correct medical facility.
The two are appealing their May conviction on violations of the Food Drug and Cosmetic Act with intent to defraud or deceive.
While not disputing that prescriptions were processed for the likes of Charlie Cheeto and Filet O Fish, Chin's lawyer, Joan Griffin, said prosecutors had presented no evidence that the defendants had intended to defraud or deceive anyone.
"There's no way anyone could think they were legitimate," Assistant U.S. Attorney Amanda Strachan countered, recounting the testimony of an official of the Massachusetts Pharmacy Board, who said during the Spring trial that state law required pharmacists to verify that each prescription was being dispensed to a specific patient.
Chin and Thomas were employees of the New England Compounding Center, the long defunct Massachusetts company blamed for a deadly 2012 fungal meningitis outbreak caused by deadly fungi in drugs that were supposed to be sterile.
But Chin and Thomas were not charged with any role in producing the deadly steroids but rather for routinely clearing drugs for shipment prescription drugs being prescribed for obviously fake named patients.
Griffin and Michael C. Bourbeau, Thomas' lawyer, both insisted that their clients weren't verifying the names of patients but simply verifying the right drugs were being shipped to the right physicians or medical facilities.
U.S. District Judge Richard G. Stearns questioned Strachan about the trial testimony that NECC had a separate verification department that checked legitimacy of the orders before they were sent to Chin and Thomas.
Strachan responded noting that the trial evidence showed the verification unit did not include a licensed pharmacist and state law required that a pharmacist do the verification.
Chin and Thomas, Strachan said, were the ones putting their signatures on NECC's verification forms.
"The law could not be more clear. There had to be a patient specific prescription," she stated.
Stearns, however, questioned whether NECC was operating in a gray area, in which neither state or federal regulators had clear authority.
Strachan countered by noting the trial testimony of Janet Woodcock, a top FDA official, who said that had the FDA known NECC was mass producing drugs without valid prescriptions there was no doubt they should have been subject to FDA regulation.
Throughout the session prosecutors and defense attorneys cited prior rulings by Stearns as favoring their opposing positions. The case is the fourth heard by Stearns stemming from the 2014 grand jury indictment of 14 people connected to NECC. In the most recent ruling Stearns overturned jury guilty verdicts on Gregory Conigliaro and Sharon Carter. Conigliaro was a vice president and part owner of the company..
Three of the 14 are currently serving jail terms following conviction on racketeering and mail fraud charges. That includes Glenn Chin, the husband of Kathy Chin, who is serving an eight year sentence.

Chin, Thomas Appeal Hearing Set

By Walter F. Roche Jr.

Two former pharmacists will go before a federal judge this week and ask him to do the same thing he did with two of their co-defendants, overturn unanimous guilty jury verdicts and acquit them of all charges.
Kathy Chin, 47, and Michelle Thomas, 35, were convicted in May of violations of the Food Drug and Cosmetic Act following a four day trial. They were among 14 indicted in 2014 following a two year probe of the deadly 2012 fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns, who will hear the acquittal arguments Friday, already has granted acquittal motions to Gregory Conigliaro and Sharon Carter.
As an alternative to acquittal Chin and Thomas also asked for a new trial, contending that much of the evidence presented at the trial involved wrongdoing by other parties.
Carter, Conigliaro, Chin and Thomas were all employed by the New England Compounding Center, the defunct company blamed for the outbreak.
Chin's lawyer, Joan Griffin, has argued that her client was convicted of not doing something that wasn't even part of her job. In her acquittal motion, Griffin said Chin simply checked to see that the drugs already compounded by other NECC employees matched up with the orders placed with the company and were being sent to the correct address
"The fact that she happens to be a pharmacist does not make Ms. Chin responsible for the actions or in-actions of the corporation," Griffin wrote.
Federal prosecutors, however, point to prescriptions processed by Chin and Thomas with obviously fictitious names like Filet O Fish, Rug Doctor and Chester Cheeto. The acquittal motions are flawed and without merit and simply repeat arguments already rejected by the judge and the jury, the prosecutors contend.
The filings by Assistant U.S. Attorneys George Varghese and Amanda Strachan charge that Thomas and Chin played indispensable roles in NECC's fraudulent schemes. They also noted jurors found that the two acted with intent to defraud and deceit.
Stearns earlier acquitted both Thomas and Chin of some of the charges, but his ruling was reversed and the charges reinstated by an appeals court.
Last week Stearns re-set sentencing hearings for the two defendants. Chin's session is set for Oct. 17 and Thomas for the next day. Previously he canceled the original August sentencing dates.
Chin was convicted of four counts of violating the Food Drug and Cosmetic Act while Thomas was convicted of two counts.
Chin is the wife of Glenn Chin, who was a supervising pharmacist at NECC.
Glenn Chin was convicted of racketeering, conspiracy and mail fraud in 2017 and is serving an eight year sentence at a federal prison in Pennsylvania.
Two other NECC defendants are also in federal custody following their conviction on charges stemming from the 20114 indictment.
NECC president and part owner Barry J. Cadden is serving a nine year sentence on racketeering and mail fraud charges while Gene Svirskiy is serving a 2.5 year sentence on racketeering and mail fraud charges.
Contact: wfrochejr999@gmail.com

Additional Hearing Dates Set

By Walter F. Roche Jr.

Two additional preliminary hearing dates have been set in the second degree murder cases against two former Massachusetts pharmacists.
In a scheduling conference yesterday in Livingston District Court in Howell Michigan, prosecutors and defense attorneys agreed to a total of four days for a preliminary examination in the case against Barry J. Cadden and Glenn Chin.
The hearing dates are Nov. 14 and 15 and Dec. 10 and 11. The November dates had been set previously.
The two defendants were not present and may also waive their right to attend the four preliminary examination sessions.
The two were charged with 11 counts of second degree murder for their roles in the 2012 fungal meningitis outbreak. The 11 victims died in the outbreak after being injected with fungus infested drugs manufactured by the New England Compounding Center.
Cadden was president and part owner of NECC and Chin was a supervising pharmacist.
Chin and Cadden already are serving federal prison sentences following their conviction on racketeering, conspiracy and mail fraud charges.
Contact: wfrochejr999@gmail.com

Cadden, Chin Hearing in Michigan

By Walter F. Roche Jr.

Eleven second degree murder charges lodged against two former Massachusetts pharmacists will be the subject of a hearing next week before a Michigan judge who must determine whether there is probable cause to believe they committed the crimes.
The two defendants, Barry J. Cadden and Glenn Chin, will not be in attendance however, according to a spokeswoman for Michigan Attorney General Dana Nessel. The hearing will be held in Livingston District Court in Howell. The session begins at 8 a.m on Tuesday.
Cadden and Chin already are serving federal prison sentences for their roles at the New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak. They were both convicted of racketeering, conspiracy and mail fraud charges as a result of a two year probe of the outbreak.
Kelly Rossman-McKinney, the spokeswoman for Nessel, said the two defendants waived their rights to attend the upcoming probable cause session, but they are expected to attend two days of hearings on the murder charges beginning on Nov. 14.
Cadden was president and part owner of the New England Compounding Center, while Chin was a supervising pharmacist at the Framingham, Mass. company.
Under Michigan law the judge must decide if facts asserted by the attorney general are sufficient to cause a fair minded person of average intelligence to believe the defendants committed the crimes alleged.
Cadden and Chin were also charged with second degree murder in the federal case but two separate juries cleared them of those charges. Both are serving sentences at federal prisons in Pennsylvania. Cadden is serving a nine year sentence while Chin's sentence is eight years.
Chin and Cadden were brought to Michigan for a hearing in June.
Contact: wfrochejr999@gmail.com