Delays Threaten Drug Compounding Safety

By Walter F. Roche Jr.

Delays by federal regulators in fully implementing a 2013 law designed to regulate drug compounders is reckless and a threat to public health, according to the head of an advocacy group.
Michael Carome of Public Citizen said that officials of the U.S. Food and Drug Administration have taken more than six years and have yet to come up with a list of bulk drugs that drug compounders can use to safely produce their products.
Creation of the list was mandated in a 2013 federal law, the Drug Quality and Security Act (DQSA) passed in the wake of the deadly 2012 fungal meningitis outbreak. A proposed list has been created which is composed of drugs nominated for inclusion by interested parties, including so-called outsourcers who, under the law, are authorized to mass produce compound drugs without patient-specific prescriptions.
Carome said while he does believes the law has improved the overall regulation of pharmacy compounding, the failure to produce a definitive list of bulk drugs that meet the law's requirements has created a huge loophole.
"The FDA has implemented a blanket interim policy under which it has decided not to enforce a key provision (of 503B)," Carome wrote.
Public Citizen has expressed its concerns about FDA's "foot dragging" in letters to the FDA and members of Congress.
In a letter sent late last year to key congressional members Carome wrote that the failure of the FDA to draw up a definitive list was "indefensible, reckless, and a threat to public health."
He had said the same thing in a letter to the FDA a month earlier.
Carome also charged that the drugs were nominated for inclusion on the list "not to ensure that unmet clinical needs are satisfied but rather to meet commercial goals."
The FDA says that drawing up the mandated list is an agency priority.
"Hundreds of drugs were nominated for each list and we have been working to address those substances," FDA spokesman Jeremy Kahn wrote in response to questions. Kahn noted that the agency has issued a list of nine bulk drugs it has proposed to exclude from the list.
"FDA oversight of compounding continues to remain essential, because compounded drugs, while important to patients who need them, pose ongoing and serious risks if they are not manufactured properly," Kahn added.
He noted that the FDA continues to find cases in which patients suffer serious harm due to improperly compounded drugs.
"While some compounders work hard to meet quality standards including avoiding insanitary conditions, we recognize that there are still compounders that are not in compliance," he added.
In Congress bills to cut back some provisions of the 2013 law have been filed, but have not even come to a floor vote.
Backers of those bills have argued that the FDA's actions threaten to cut off the supply of needed compounded drugs. Those include special formulations of drugs to accommodate the needs of patients with allergies to components of mass manufactured drug products.
Liz Richardson of the Pew Charitable Trusts, which has taken an active role in the drug compounding issue, noted that a study by Pew found that state regulation of small compounders licensed by state pharmacy boards showed wide variation in the level of inspection and enforcement. She said an updated version of the study will be issued shortly. She noted that some states have acknowledged a lack of resources for compounding inspection and enforcement. And some state boards have yet to align their policies to the new federal law.
Richardson also expressed concern about the continuing discovery of illnesses caused by drug compounders who have failed to adhere to sterility and other minimum production standards.
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Prosecutors Appeal Conigliaro Acquittal

By Walter F. Roche Jr.

Contending that it was simply wrong, federal prosecutors are asking an appeals court to overturn the decision that cleared the part owner and an employee of a rogue drug compounding company of criminal conspiracy charges.
In a more than 100-page filing including multiple appendices, the U.S. Attorney wrote that the two defendants were motivated by greed and their actions had "disastrous public health consequences."
The appeal to the First Circuit Court of Appeals in Boston, Mass. comes in a criminal case stemming from the deadly 2012 fungal meningitis outbreak, which eventually took the lives of more than 100 patients among nearly 800 who were sickened.
In the filing prosecutors said U.S. District Court Judge Richard G. Stearns erred when he overturned the unanimous jury verdicts which had found Gregory Conigliaro and Sharon Carter guilty of conspiring to defraud the U.S. Food and Drug Administration.
Stearns June 7, 2019 ruling, the appeal states, is not only unprecedented, "it is also wrong."
Conigliaro, according to the appeal, was the number two person at the New England Compounding Center. He held the title of vice president and was part owner of the Framingham, Mass. company. Carter was NECC's director of operations and was involved in processing orders prior to shipment.
The two were among 14 people connected to NECC who were indicted in late 2014 following a two year probe of the deadly outbreak caused by NECC drugs contaminated with fungus.
Cited in the appeal were letters sent by Conigliaro to state and federal regulators in which he stated that NECC was a small family owned pharmacy that prepared compounded drugs based on individual patient specific prescriptions.
"The deception worked," the filing states, "but the consequences were devastating."
Citing the history of the statutes governing the FDA's legal authority to regulate drug manufacturers, the appeal states that despite conflicting court opinions the agency always had the authority to regulate companies manufacturing drugs.
"The district court erred in concluding that the defendants' convictions were legally impossible," the filing states.
Stating that NECC knew it had to have patient specific prescriptions to avoid being subject to stricter regulation by the FDA, the brief notes that Conigliaro personally directed an employee to create fake prescriptions for drugs shipped to a Boston hospital.
The appeal also disputes Stearns' conclusion that Conigliaro and Carter, due to confusion over the FDA's regulatory authority, did not have fair notice that what the company was doing was illegal.
"The defendants and others at NECC knowingly provided false information to the FDA," the appeal states, adding that "there was no ambiguity or lack of notice."
"If the FDA had known the truth about NECC's operations, the FDA would have taken action," the appeal states.

Pre-Trial Testimony Ends In Outbreak Case

From Donna Borton

Pre-trial testimony ended today in the second degree murder trial of two pharmacists with a key witness detailing the multiple violations routinely observed in a room where sterile and ultimately lethal drugs were being prepared.
Joseph Connelly, who worked as a pharmacy technician at the now defunct New England Compounding Center, said drugs were shipped without testing, cleaning logs were falsified and paint would bubble up on the floor of the room where sterile drugs were being produced.
His testimony came in the final day of testimony in the pre-trial hearing for Glenn Chin and Barry Cadden who are facing 11 counts of second degree murder for their roles in the 2012 fungal meningitis outbreak. Both have been present for the two weeks of testimony
Cadden was NECC's president and part owner, while Chin was the supervisor in the clean room which Connolly described for District Court Judge Shauna Murphy.
After opposing briefs are filed by all sides and final arguments presented on March 27, Murphy will decide on April 16 whether the two will be bound over for trial in circuit court.
Connolly who explained why it was critical for sanitary standards to be maintained in a clean room, then testified about the multiple ways things were not right at NECC, a drug compounding firm in Framingham, Mass.
His testimony came as 15 victims of the outbreak and their families and survivors looked on in the Howell, Mich. courtroom. Some have been present for all five sessions.
Describing the bubbling paint on the floor, rusted legs of tables, condensation on the outside of a refrigerator, black liquid oozing from one of the hoods and even regular visits from insects, Connolly said Chin was the supervisor, but not a very good one.
Connolly said he worked in the clean room from 2009 until NECC was shut down by state and federal regulators.
He said during his tenure drugs were sometimes shipped without testing on the same day they were produced, cleaning logs were filled out even though the cleaning never occurred and the atmosphere and behavior in the work area was often inappropriate.
Mistakes were being made, Connolly said, describing the frenzied atmosphere at NECC in 2012 when orders suddenly exploded. He said that efforts to enlist Chin's aid were unsuccessful.
Connolly said that in the Fall of 2012, production was suddenly halted and all hands were told to just start cleaning everything.
Stating that everything was chaotic, Connolly said suddenly drugs were being thrown out.
At a subsequent company-wide meeting Connolly said they were told NECC was temporarily shutting down. He said he later learned from a newscast that five Tennessee patients who had been injected with an NECC steroid had died.
Under cross examination by James Buttrey, Chin's lawyer, Connolly was asked whether any contamination could have come from some other source.
Gerald Gleeson, Cadden's lawyer, asked Connolly if Cadden was actually present in the clean room.
Connolly said he never saw Cadden in the clean room and Chin was his direct supervisor and Cadden was Chin's boss
He also said that when he raised an issue with Chin, Chin would talk to Cadden and then would let him know what Cadden wanted done.
Also testifying Friday was former NECC employee Nicholas Booth, who also worked in the clean room. He testified that he saw cracks and paint chipping on the floors. He said the black liquid dripping from one of the hoods would just be cleaned up at the end of the day. He also testified to the increase in orders, less time spent on cleaning, the priority put on getting the drugs out and the intense cleaning they were told to do one day when they had to stop production.
Booth said he witnessed conversations between Cadden and Chin at the lunch table where they discussed sending out product even though test results had not come back.

CDC Tracked Deadly Outbreak Mold

From Donna Borton


A government expert testified today about the desperate 2012 search to clearly identify the mold that was sickening more and more patients even killing some of them.
Mary Brandt, of the U.S. Centers for Disease Control and Prevention, told Michigan District Court Judge Shauna Murphy her aid was enlisted by another CDC scientist who had been assigned to investigate what appeared to be a growing and deadly outbreak of fungal meningitis.
Though the first samples came from Tennessee,soon there were others from Michigan and other states.
Brandt was testifying in a pre-trial hearing for Barry J. Cadden and Glenn Chin, both connected to the Massachusetts drug compounding that was eventually identified as the source of the mold and ultimately the outbreak itself. Cadden was president and part owner of the New England Compounding Center and Chin was a supervising pharmacist in the clean room where the deadly drugs were prepared.
They are both charged with second degree murder in the deaths of 11 Michigan patients injected with methylprednisolone acetate from NECC.
Cadden and Chin, dressed in orange prison jump suits, have been present for this week's hearings. They already are serving federal prison terms for their involvement in the outbreak.
Eventually over 800 patients were sickened and over 100 have died as a result of what federal officials have called the worst outbreak in U.S. history caused by a prescription drug.
Brandt, who currently holds the title of Director of Laboratory Safety, headed CDC's Division of Myotic Diseases at the time of the outbreak.
Under questioning by Assistant Attorney General Denise Hart, Brandt described how her unit began receiving samples from the patients who had been identified as outbreak victims. Though the first three samples came from Tennessee, other samples later arrived from North Carolina and Michigan, indicating much more serious involvement.
She said some of the Michigan sample were different because some of the patients had abscesses in joints injected with the steroids.
Those patients underwent surgery and fluid from the abscesses were sent to Brandt and her colleagues for analysis.
She said eventually the fungus extracted from victims, aspergillus fumigatus, matched up with the fungus found in drugs recovered from NECC in its Framingham, Mass. offices. She said that meningitis caused by fungus is very rare and she and others became increasingly alarmed as it became apparent the outbreak was not limited to Tennessee.
Prosecutors also entered into evidence emails recovered from Cadden's computer when the FDA raided NECC's offices in the Fall of 2012. In one email Cadden states that he had 100 percent control of the company. In another he instructed Chin to hire more monkeys to label drugs being shipped out.
The hearing to determine whether Chin and Cadden will be put on trial for the chargeswill resume for a last day tomorrow (Friday) at 8:30 a.m. Both sides will then submit briefs prior to a ruling by Murphy.

Testimony Links Trail of Contamination

From Donna Borton

Prosecution witnesses today linked the deadly steroids that killed 11 Michigan patients in 2012 back to their source, a Massachusetts drug compounding company where the two defendants now on trial for second degree murder worked.
The witnesses from the U.S. Food and Drug Administration testified about drugs from a Michigan clinic and traced them back to the New England Compounding Center where filthy and unsanitary conditions were found despite a last minute clean up effort.
The testimony before Livingston District Court Judge Shauna Murphy came in a pre-trial hearing in the cases of Barry J. Cadden and Glenn Chin, who are facing the second degree murder charges for their roles in the 2012 fungal meningitis outbreak which killed dozens of unsuspecting patients, who were injected with steroids laden with deadly fungi.
Eight victims or their survivors were on hand for the session.
The hearing is being held to determine if there is sufficient evidence to bring the case to trial. Cadden and Chin, both pharmacists, already are serving federal prison terms for their roles in the outbreak. Cadden was NECC's president and part owner, while Chin was an NECC supervising pharmacist.
FDA Special Agent Benedict Celso described how 229 vials of methylprednisolone acetetate were sent to the FDA from Michigan Pain Specialists and other sites where Michigan victims had been injected.
He described how the vials were logged in as evidence and then sent out for testing.
The attorney for Barry J. Cadden at one point asked for Celso's testimony to be stricken from the record because he said his cross examination was being limited. The motion was denied.
Celso's testimony was followed by Almaris Alonso Claudio,an FDA microbiologist who went to examine NECC's Framingham, Mass. facilities as the outbreak began to explode in the fall of 2012.
She described finding heavily dirtied sticky mats at the entrance to the clean room where the steroids had been prepared. She said grass, which can be a breeding ground for fungus, was observed on the mats.
She testified that on a tour of the NECC plant she observed leaking water and said records showed humidity spiked at night at NECC because the air conditioning was turned off.
She said that when she learned the identity of the fungus they were searching for - aspergillus fumigatus - she became concerned and ordered specially fitted masks for herself and her staff.
She also described how NECC had an open pass through which was used to transfer items to and from the clean room.
Another concern she cited was that the presence of condensation in an autoclave used to ensure sterility of drugs being produced. Under cross examination she said that once a cycle has been completed the inside of the autoclave should be dry.
The final witness was FDA microbiologist David Craft who testified about the tests conducted on 29 of the vials of methylprednisolone acetate gathered in Michigan. He said five of the 29 tested positive for fungi.
Testimony will continue Thursday at 8:30 a.m.

Campbell Estate Fees Delayed Indefinitely

By Walter F. Roche

Fees of up to $1,050 an hour for a key lawyer involved in the estate of the late Glen Campbell have been put on an indefinite hold after several hearing dates on the matter had been postponed.
The fee request had first been submitted last year in Davidson Probate Court by Campbell's widow, Kimberly, but several hearing dates were scheduled and then re-scheduled.
The latest filing calls for an indefinite postponement.
"If the matter is reset for hearing, Mrs. Campbell will file and serve notice of hearing," the filing states.
The most recent hearing had been scheduled for Jan. 30. The filing gives no indication of the reasons for the postponements and attorneys for the estate did not respond to questions
The fee request in question was for estate work done by the law firm of Greenberg Traurig LLC or GT Law and its Los Angeles partner Jay L. Cooper.
In an affidavit accompanying the fee request, Cooper disclosed he was charging $1,050 an hour for his services provided in 2018 and 2019. His 2017 fee was $980 an hour.
The petition cites seven reasons justifying Cooper's fee including "complicated legal issues" involving Campbell's royalty fees and "interests of third parties" in some of those fees. The petition also notes Cooper's nearly 30 year relationship with the singer.
"Royalty interests and intellectual property assets (are) by far the estate's most valuable assets," the Nov. 13 petition states.
Included in the 158-page fee request was a highly redacted accounting of the services provided by Cooper and several of his colleagues, including his son The petition states that an unredacted version can be provided to the judge, but it would not be made public.
The fee request for GT Law totals $211,538 plus expenses of $10,255. The filing discloses however that $91,393 already has been paid, leaving a balance due of $130,400.
Also delayed indefinitely under the recent motion was an accounting fee request for $20,107 from the firm of Gursey Schneider.
Campbell died Aug. 8, 2017 following a long battle with Alzheimer's disease.
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NECC Workers Detail Decline

From Donna Borton

Two former employees of the company that shipped thousands of vials of deadly contaminated steroids across the country today described the deteriorating conditions at their workplace that led to a deadly outbreak of fungal meningitis.
Testifying in Livingston District Court in Howell, Mich. Owen Finnegan and Steven Haynes told Judge Shauna Murphy how production was rushed, tests were skipped and sterility standards abandoned in 2012 when the New England Compounding Center was flooded with orders.
Finnegan, who worked as a pharmacy technician in the clean room where methylprednisolone acetate was produced, said the emphasis was getting the drugs out the door. Cleaning logs were not being initialed and he and his colleagues were asked to fill out the cleaning logs whether or not the required cleaning had actually been done.
The drug was being shipped to doctors and clinics for injection into the spines and joints of unsuspecting patients.
The testimony came in the criminal trial of two key figures at NECC, Barry Cadden and Glenn Chin. Both have been charged with 11 counts of second degree murder for their roles in producing tainted drugs that took the lives of 11 Michigan resident.
Cadden was president and part owner of NECC. Chin was Finnegan's boss and supervised the clean room where the fungus laden drugs were produced.
Finnegan said it was Chin who told him to ship out drugs on which sterility and other tests had not yet been performed.
He also described an NECC process called "botching" the lots in which new and untested drugs were given old lot numbers to make it appear they had been tested. In the rush to fill orders just before the outbreak Finnegan said drugs were being shipped out on the same day they were produced.
Haynes, who worked at NECC from 2010 until it was shuttered in the fall of 2012, gave testimony backing up Finnegn's.
He said that when he questioned Chin about drugs being shipped out before tests were performed, Chin told him, 'That's why we have lawyers.'"
Haynes also described how production suddenly stopped in the fall of 2012 shortly before inspectors from the U.S. Food and Drug Administration raided NECC's Framingham, Mass. facilities. He said suddenly stock was being thrown out and everyone was assigned to cleaning.
Haynes said he and other workers were frustrated because no one would tell them what was going on. He said their superiors told them the problem was not with the NECC drugs but with the doctors who were injecting them into patients.
Testimony is scheduled to resume Wednesday at 8:30 a.m.
Chin and Cadden already are serving federal prison terms following their convictions on racketeering, conspiracy and mail fraud charge. Chin's release on the federal charges is due on Jan. 1, 2025 while Cadden's release date is April 4, 2025.
If convicted on the Michigan charges both could face life sentences. The current pre-trial hearings are being held to determine if there is sufficient evidence to bring Cadden and Chin to trial.

Cadden, Chin Outbreak Hearings Resume

Court report from Donna Borton

An expert from the U.S. Centers for Disease Control and Prevention testified today about the frantic efforts to find the cause of an apparent outbreak of fungal meningitis that suddenly blossomed in Tennessee in the fall of 2012.
Testifying in a pre-trial hearing for two former pharmacists charged with multiple counts of second degree murder, Benjamin Park MD said that while at first the outbreak appeared to be confined to Tennessee, a fourth case in North Carolina signaled that the dimensions of the disaster were not localized but much more widespread.
In some two hours of testimony in Livingston County District Court in Howell, Mich., Park described how his agency needed to find out the source of the outbreak, identify potential victims and determine the best course of treatment as quickly as possible.
Assistant Attorney General Denise Hart asked Park if he thought the outbreak was preventable, but Barry J.Cadden's lawyer objected arguing that Park was not qualified to make that assessment. The objection was overruled.
"These outbreaks can and should be prevented," Park then responded.
Park had already testified in a prior federal trial that the outbreak was "entirely preventable."
The defendants, Cadden and Glen Chin, worked at a now defunct drug compounding firm in Massachusetts which produced thousands of vials of steroids contaminated with deadly fungi. Over 800 patients were sickened in the outbreak and over 100 have died.
Cadden and Chin already are serving federal prison sentences following their conviction on racketeering, conspiracy and mail fraud charges. Two federal juries, however, cleared them of second degree murder charges. They are now facing 11 counts of second degree murder brought by the Michigan Attorney General.
Cadden was president and part-owner of the New England Compounding Center and Chin was a supervising pharmacist in the clean room where the deadly steroids were produced.
In earlier testimony Thursday a Michigan pathologist detailed the autopsy findings from five victims of the outbreak.
Jeffrey Jentzen MD acknowledged the five died of complications due to steroid injections and the manner of death was listed on death certificates as accidental, but he noted that the medical definition of the manner of death was not necessarily the legal definition.
James Buttrey, the attorney for defendant Glenn Chin, questioned whether the manner of death finding could be changed after a death certificate has been issued. Jentzen said it could be changed only if there was a medical determination to change it.
Gerald Gleeson, the attorney for Barry J. Cadden questioned Jentzen about a Powerpoint that was put together by the witness and an Indiana colleague, in which the colleague stated that the mold, which caused the deadly outbreak, was an accident.
Jentzen reiterated that there was a difference between the legal and medical definition of accidental.
Earlier in the day Stephanie Stokes from ARL Bio Pharma resumed her testimony from the prior hearing in which she discussed the testing her company did for the New England Compounding Center, the company headed by Cadden and which produced the deadly drugs.
Under questioning by Gleeson, Stokes said that when NECC began sending in many more drug samples to be tested just before the outbreak became public, ARL increased its staff and equipment to meet the demand.
Stokes had testified in another pre-trial session in November. The current hearings will continue Friday and three days next week.
Cadden and Chin already are serving federal prison sentences following their conviction on racketeering, conspiracy and mail fraud charges. Two federal juries, however, cleared them of second degree murder charges.
Cadden is serving a nine year federal sentence while Chin was sentenced to eight years.

Ronzio Sentencing Set for July

By Walter F. Roche Jr.

The sentencing for Robert Ronzio, a key government witness in the criminal case stemming from a deadly fungal meningitis, has been set for 10 a.m. July 27.
Ronzio, the one time sales chief for the New England Compounding Center, entered a guilty plea in December 2016 to a single charge, conspiracy to defraud the U.S.Food and Drug Administration. His sentencing had been set for April 22, but was later postponed indefinitely.
Ronzio testified extensively as a prosecution witness in the cases of several co-defendants including NECC's president and part owner Barry J. Cadden.
In a related action Monday federal prosecutors issued an order to seize $1,224,456, one half the proceeds from the recent sale of Cadden's Wrentham home. Under a negotiated forfeiture order, the U.S. Attorney agreed to take only half of the sale proceeds. The other half goes to Cadden's wife, who was never charged in the case.
Ronzio will be appearing before U.S. District Judge Richard G. Stearns, who has presided over all the NECC criminal cases.
In addition to the Cadden trial, Ronzio testified in the case against Glenn Chin, a supervising NECC pharmacist. Cadden and Chin were convicted on charges of racketeering, conspiracy and violations of the Food Drug and Cosmetic Act. Two separate federal juries declined to convict the two on second degree murder charges.
But the two are now facing second degree murder charges in Michigan and preliminary hearings in that case will `resume on Thursday in Livingston County District Court in Howell, Mich.
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Outbreak: Michigan Murder Trial to Resume

By Walter F. Roche Jr.

Nearly a dozen witnesses are set to testify about the grim details of a deadly 2012 fungal meningitis outbreak in the second degree murder trial of two former drug company pharmacists.
Preliminary hearings in the trial of Barry J. Cadden and Glenn Chin are set to resume on Feb. 13 in a Michigan courtroom. The two have been charged with 11 counts of second degree murder for their roles in the outbreak which has led to the death of some 100 victims nationwide.
Cadden and Chin already are serving sentences in federal prison following their convictions on racketeering and mail fraud charges, but two federal juries declined to convict them on second degree murder charges.
Cadden was president and part owner of the New England Compounding Center, the company that produced fungus riddled steroids that caused the outbreak. Chin was a supervisor in the NECC clean room where the deadly doses were prepared.
Virtually all of the witnesses expected to appear in Michigan already have testified in U.S. District Court in Boston, Mass. Their prior testimony gives hints of what can be expected in the two weeks of upcoming hearings.
They include Dr. Benjamin Park and Mary Brandt of the U.S. Centers for Disease Control and Prevention. Both testified about the desperate race to find the cause of the growing number of deaths.
Park told jurors he felt like he was looking over a cliff and could not see the bottom as he tried to determine the ultimate scope of the outbreak.
Brandt said there was little known about the mysterious cause of the deaths.
"We had to know what fungus we had..There was very little expertise," she testified.
She told jurors a major step forward came when they began using a new real-time test to quickly identify what type of fungus they were dealing with.
Dr. Jeffrey Jentzen, a Michigan medical examiner, detailed for jurors the way the fungus, once injected into the spines of victims, worked its way up the spinal column to literally destroy brain tissue.
Federal prosecutors attempted to have Jentzen show jurors photos of the destroyed brain tissue, but U.S. District Judge Richard G. Stearns ruled that would be too prejudicial and inflammatory.
Also on the witness list is U.S. Food and Drug Administration Special Agent Benedict Celso who testified about Chin's 2012 arrest as he was about to board a plane for China.
Other witneses testified about the shocking conditions they discovered when they raided NECC's Framingham, Mass. headquarters.
"I couldn't believe what I was hearing," said Almaris Alonzo Claudio of the U.S. Food and Drug Administration, of her reaction when told the air conditioning was turned off at night in NECC's drug production area. She said temperatures and humidity soared as a result.
Former NECC employees like Nichols Booth and Owen Finnegan testified about drugs being sent out without sterility or other testing and the routine use of expired ingredients.
Former employee Joseph Connelly described how he saw Chin and Cadden conferring just before untested drugs were shipped out.
Tiffany Hyde, a microbiologist for an Oklahoma testing company described her reaction when fungus bloomed in a petri dish when she was testing an NECC drug sample. She was so surprised she said she stopped to take a picture.
Cadden and Chin have been charged in the deaths of 11 Michigan patients: Jennie Barth, Patricia Malafouris, Ruth Madouse, Donna Kruzich, Paula Brent, Lyn Laperriere, Sally Roe, Mary Plettl, Gayle Gibson, Emma Todd and Karine Baxter. Nine of those victims' deaths were included in the federal case, but the deaths of Barth, Malafourios and Madouse were not. That raises the possibility that a double jeopardy claim could be filed on the nine repeat cases. Cadden and Chin's attorneys did not respond to questions about that possibility.
The hearings scheduled for Feb. 13, 14, 19, 20, and 21 are being held to determine whether there is sufficient evidence to take the two defendants to trial.
The Michigan charges were filed by former Michigan Attorney General Bill Schuette just before he left office. Current Attorney General Dana Nessel has taken over the prosecution.
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