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Missouri Fought For Years To Hide Where It Got Its Execution Drugs. Now We Know What They Were Hiding.

The state of Missouri did everything it could to keep secret where it got the drugs it used to put 17 inmates to death. Now, BuzzFeed News has discovered the supplier is a pharmacy repeatedly found to engage in hazardous practices that could put patients — and convicts — at risk.

Posted on February 20, 2018, at 5:55 a.m. ET

The state of Missouri has engaged in a wide-ranging scheme — involving code names and envelopes stuffed with cash — to hide the fact that it paid a troubled pharmacy for the drugs it used to execute inmates.

Procuring execution drugs has become almost impossible, as major pharmaceutical companies stopped making them or refused to provide them for capital punishment. Missouri itself faced a crisis in early 2014, when the previous pharmacy it had been using was exposed in the press and stopped providing the state with drugs. Scrambling, Missouri found a new pharmacy and stockpiled the lethal injection drug pentobarbital, enabling it to set a record pace for executions, scheduling one a month for more than a year.

To hide the identity of the new pharmacy, the state has taken extraordinary steps. It uses a code name for the pharmacy in its official documents. Only a handful of state employees know the real name. The state fought at least six lawsuits to stop death row inmates and the press from knowing the pharmacy’s identity. Even the way Missouri buys and collects the drugs is cloak-and-dagger: The state sends a high-ranking corrections officer to a clandestine meeting with a company representative, exchanging an envelope full of cash for vials of pentobarbital. Since 2014, Missouri has spent more than $135,000 in such drug deals.

Death row inmates fear that drugs prepared by such pharmacies could result in a painful and protracted death.

But now, BuzzFeed News can reveal the supplier: Foundation Care, a 14-year-old pharmacy based in the suburbs of St. Louis that has been repeatedly found to engage in hazardous pharmaceutical procedures and whose cofounder has been been accused of regularly ordering prescription medications for himself without a doctor’s prescription. Late last year, Foundation Care was sold to a subsidiary of health care giant Centene Corporation. Before publication of this story, Centene declined to comment; after publication, it said that under its ownership, “Foundation Care has never supplied, and will never supply any pharmaceutical product to any state for the purpose of effectuating executions.”

According to two sources with knowledge of the matter, Missouri used Foundation Care’s drugs for 17 executions. The sources spoke on the condition of anonymity because of strict state laws that prohibit disclosing or publishing the identity of the supplier.

Foundation Care is what is known as a compounding pharmacy, one that mixes specialty drugs that are not readily available on the market. These pharmacies are more loosely regulated than traditional manufacturers, and slipshod practices at some of them have led to tainted drugs and deadly disease outbreaks.

Death row inmates fear that drugs prepared by such pharmacies could result in a painful and protracted death.

According to more than 900 pages of court records and regulatory findings, as well as interviews with more than half a dozen people familiar with the company, Foundation Care has been accused of multiple problems.

  • In 2007, the Food and Drug Administration inspected the pharmacy after a patient who took a drug supplied by Foundation Care developed pneumonia. The FDA found that the pharmacy was not testing all of its drugs for sterility and bacterial contamination, and it uncovered a lab report that indicated a vial of the pharmacy’s drugs had, in fact, been contaminated with bacteria. After initially denying that the vial was tainted with bacteria, the executives later insisted that they had purposefully infected it as part of a test, a story the FDA did not accept.
  • In 2013, the FDA designated Foundation Care a “high-risk” pharmacy, and when FDA agents showed up to inspect it, the company’s CEO tried to block them from entering and threatened legal action. Inspectors, who ultimately gained access, found “multiple examples” of lax procedures that the agency warned “could lead to contamination of drugs, potentially putting patients at risk.”
  • Two former senior employees — including the head of pharmacy operations — have alleged in a lawsuit that Foundation Care violated state or federal regulations by reselling drugs returned by patients, purposefully omitting the names of ingredients in drugs it prepared, and failing to notify other states about a $300,000 settlement with Kansas over allegations of Medicaid fraud. The suit also accuses one of the pharmacy’s founders of “regularly and frequently” ordering prescription medications for himself without a prescription, a crime that carries up to a year behind bars. One of the employees alleged that during a dispute with the founders, she was held against her will and feared she would be physically struck. Foundation Care and its founders have denied the allegations, and the suit is ongoing.
  • A suit by another former employee, a pharmacy tech, alleges that she complained to her supervisors and the Missouri Board of Pharmacy about “serious operational violations.” The employee alleged she was fired shortly after filing her complaint. The company denied the allegations and settled with the employee out of court.

When first approached by a reporter in 2015, Foundation Care’s CEO and head pharmacist, Dan Blakeley, flatly denied that his company supplied Missouri with its execution drugs.

“I don’t know what you’re talking about,” Blakeley said. “All I can tell you is your sourcing is mistaken.”

When a reporter visited in person this month and informed Blakeley that BuzzFeed News would be publishing a story identifying the pharmacy as Missouri’s supplier, his assistant said he didn’t want to talk. The pharmacy also did not respond to a detailed list of questions sent by email.

“M7’s decision to provide lethal chemicals to the Department was based on M7’s political views on the death penalty, and not based on economic reasons."
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In court papers, Foundation Care said that it sold execution drugs for political reasons. “M7’s decision to provide lethal chemicals to the Department was based on M7’s political views on the death penalty, and not based on economic reasons,” a representative for the pharmacy wrote in a 2016 affidavit, using the state’s code name for Foundation Care.

“M7’s decision to supply lethal chemicals anonymously arises out of M7’s fear of harassment and retaliation, both physical and financial, if M7’s identity is released.”

One question that remains unanswered is how Foundation Care itself obtained the pentobarbital it sold to the state — did it mix the drug on its own or somehow procure a manufactured version? Akorn Pharmaceuticals, the only manufacturer permitted to make the drug in the United States, requires its distributors to sign agreements that they will not sell its products to executioners.

The state of Missouri declined repeated requests for comment, but Foundation Care was selected as the state’s execution drug supplier by Matt Briesacher, who was then the general counsel for the Missouri Department of Corrections. He also declined a request to comment for this story, but in a sworn deposition, just weeks after he had selected the pharmacy, Breisacher refused to say how he found it or what he knew of its past.

"Did you make inquiry as to whether any professional complaints had been filed against M7?” Briesacher was asked.

"Yes," he said.

"And were there any?"

Briesacher's attorneys objected, and he declined to answer.

The entrance to Foundation Care's headquarters in Earth City, Missouri.
Chris McDaniel / BuzzFeed News

The entrance to Foundation Care's headquarters in Earth City, Missouri.

In August 2007, two investigators from the FDA descended on Foundation Care’s headquarters in Earth City, Missouri.

They were responding to a physician’s complaint, which alleged that Foundation Care had mixed and sold a drug that caused a “life threatening” illness to a patient with cystic fibrosis. After the patient took the drug, called Colistin, she had trouble breathing and developed a bad cough that made her vomit, the doctor wrote. Soon, the woman was hospitalized, and an X-ray showed signs of pneumonia.

In a subsequent lawsuit, Foundation Care denied wrongdoing and reached a settlement for an unknown sum years after the patient had died.

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In the 2007 inspection, investigators found the pharmacy was not testing all of its drugs for sterility and bacteria before shipping them to patients. While going through the pharmacy’s documents, the investigators also noticed a lab result that showed an “embedded object” in a drug the pharmacy mixed. The embedded object turned out to be bacteria.

At first, Blakeley, the company’s CEO, denied that it was bacteria, saying it was merely dust.

Days later, Blakeley said that he and another Foundation Care executive had purposefully infected the vial as part of a test, opening the vial with a can opener to replicate what a customer had done. Foundation Care produced no records to back up this account, so the agency refused to accept it and cited the pharmacy for not properly documenting and investigating what happened.

In 2012, compounding pharmacies across the country came under new scrutiny when one in Massachusetts mixed drugs that infected at least 750 people with meningitis, killing 76. In response, the FDA identified 29 compounding pharmacies across the US — including Foundation Care — that the agency deemed “high-risk.”

Compounding pharmacies are supposed to mix medications for the specific needs of patients. For example, a patient who needs a certain drug that comes in pill form but who can only take it as a liquid could use a compounding pharmacy to make it. Compounding pharmacies are regulated mostly by states, and the drugs they produce have a significantly higher failure rate than those of manufactured drugs, which are regulated by the FDA. Inspections by the Missouri Board of Pharmacy over the past decade found that 1 in 5 drugs created by compounding pharmacies failed to meet standards.

A photograph taken by FDA investigators shows a Foundation Care employee entering the pharmacy's clean room.
FOIA

A photograph taken by FDA investigators shows a Foundation Care employee entering the pharmacy's clean room.

In March 2013, in the wake of the meningitis outbreak, FDA inspectors again showed up at Foundation Care’s front door, but Blakeley, the CEO and head pharmacist, didn’t want to let them in. “Mr. Blakeley didn’t believe we had the authority to inspect his facility unless we had a product complaint or drug recall,” the lead FDA investigator wrote in a report.

After arguing with the investigators over whether they could enter or take documents, Blakeley eventually relented.

The three investigators found “multiple examples” of sloppy work that could lead to contaminated drugs. The inspectors also found that the pharmacy was not doing enough to “assure that drug products conform to appropriate standards of identity, strength, quality and purity.” The inspectors found inadequate hand-washing and questionable gloving practices, and they determined that a test for sterility and a common toxin had not been conducted since at least the previous year.

Foundation Care’s conduct “could lead to contamination of drugs, potentially putting patients at risk.”
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When the inspectors told Blakeley what they found, he “stated if we post our findings he will seek legal counsel and come at us with a vengeance, anyone involved,” the investigator wrote.

Foundation Care would later tell the FDA that it would enact changes in response to some of the findings. But to many of the criticisms, the pharmacy’s response was that it didn’t need to change its practices because it adhered to state standards. (After the 2012 meningitis outbreak, the FDA sought greater oversight of companies such as Foundation Care — and, in fact, cited the pharmacy’s practices as a specific reason why the agency needed more control over drug compounders.)

Following its second inspection of Foundation Care, the FDA sent a letter to the Missouri Board of Pharmacy in February 2014 warning that the pharmacy’s conduct “could lead to contamination of drugs, potentially putting patients at risk.”

It is unclear whether the Missouri pharmacy board took steps to oversee Foundation Care, because the state refused to turn over inspection records to BuzzFeed News. But on the very day the FDA warned Missouri about the company, executioners injected Foundation Care’s drugs into a death row inmate.

Mark Davis / BuzzFeed News

Regulators are not the only ones who raised alarms about Foundation Care. Inside the company, employees said their bosses engaged in dangerous pharmaceutical practices, asked them to break the law, and, when they refused, meted out swift retaliation.

In 2017, two of the company’s top employees — Katie Mothershed, who had been the head of pharmacy operations, and Gina Jaksetic, the former senior director of client relations — filed suit in state court, accusing the pharmacy of serious violations. Among them: Foundation Care took medications returned by patients and, in violation of state law, resold them to other customers; Blakeley and Foundation Care CFO Mike Schultz asked employees to omit some ingredients from the label of a pain-killing cream; and Schultz ordered drugs for himself without a prescription.

According to the suit, the pharmacy’s founders breached another legal requirement when they refused to tell other states that Foundation Care had reached a settlement with Kansas over allegations of Medicaid fraud. (In 2015, without admitting wrongdoing, the pharmacy had agreed to reimburse the state of Kansas for $300,000.)

Blakeley and Schultz both carried guns in the office, the suit says, and Schultz frequently yelled at and demeaned the women. Mothershed described a meeting with the two executives that became so heated that Blakeley stood in the doorway and physically barred her and Jaksetic. Meanwhile, “Schultz repeatedly yelled at Mothershed to ‘shut up’ and ‘shut her mouth,’” according to the lawsuit. “Schultz also repeatedly yelled ‘who do you work for’ in an animated, intimidating manner.”

Schultz “sprang toward Mothershed with his hands in the air,” the suit says, and both Jaksetic and Mothershed believed he was going to hit her.

After 45 minutes, the suit says, Blakeley moved aside and let the women leave.

The two women declined to speak with BuzzFeed News. Their attorney declined to comment.

Foundation Care lawyers have denied the allegations in court filings.

Another employee sued Foundation Care for racial discrimination in July 2016.

Yolandra Smith, a pharmacy tech who is black, said she was threatened and fired because she complained to her superiors and the Missouri Board of Pharmacy about “serious operational violations.” The nature of those allegations is unclear, because the state refused to turn over records to BuzzFeed News.

After she was fired, Smith accused Foundation Care of filing false information in an effort to keep her from receiving unemployment benefits. She said that Foundation Care’s owners treated her differently because of her race.

The pharmacy denied the allegations and settled out of court. Smith also declined to speak with BuzzFeed News.

Mark Davis / BuzzFeed News
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Shortly before each execution, David Dormire would climb into his car carrying an envelope stuffed with more than $7,000 in cash, nearly all of it in $100 bills. Dormire, the second in command at the Missouri Department of Corrections, was buying lethal injection drugs for the state.

No other corrections employee would join him on his trips, out of concern that too many people would know who he was buying the drugs from. Only a handful of people within the Department of Corrections knew the pharmacy’s real name.

Dormire would hand over an envelope of $7,178.88 to “M7,” the state’s code name for Foundation Care. In exchange, Dormire got four vials of pentobarbital, or 10 grams. It was double what was required for one execution, providing the state a backup in case things went wrong.

Shortly before each execution, David Dormire would climb into his car carrying an envelope stuffed with more than $7,000 in cash, nearly all of it in $100 bills.

The purchase of execution drugs is the only state function known to operate in such secrecy, skirting anti-fraud rules by deploying envelopes of cash and brushing aside the requirement for a witness to the transactions.

Nationwide, the secrecy behind lethal injections has led to botched execution attempts and illegal drug deals. In 2015, a Georgia execution had to be called off after the executioners discovered the syringe had particles floating in it. Georgia promised a transparent investigation into what went wrong, but when the results did not fit with the state’s theory that the drug was compromised because of the cold temperatures it was stored in, the state attempted to withhold the results from the public, the media, and the courts.

Oklahoma executed a man with the wrong lethal injection drug after the pharmacist knowingly sent the wrong drug, and the state nearly made the same mistake again before it noticed the error. A grand jury, led by the state’s conservative attorney general, produced a report that placed much of the blame on the secrecy. Finding the way that Oklahoma procured the drugs “surreptitious” and “questionable at best,” the grand jury said the secrecy “contributed greatly to the Department's receipt of the wrong execution drugs.”

“[T]his investigation revealed that the paranoia of identifying participants clouded the Department's judgment and caused administrators to blatantly violate their own policies,” the grand jury found.

For years, Missouri death row inmates’ attorneys have tried in vain to pull back the curtain on who is supplying the drugs.

Starting in October 2013, Missouri began obtaining its drugs from an Oklahoma-based compounding pharmacy called the Apothecary Shoppe. Reporters quickly discovered that the pharmacy was selling execution drugs despite not being licensed to sell medicines in Missouri, a practice that would normally be a felony. Shortly after the pharmacy’s name was revealed, it agreed to no longer sell execution drugs.

The state quickly found a new seller but doubled down on secrecy, refusing to disclose any information at all about the new pharmacy, Foundation Care. But there were hints: An attorney representing the state’s carefully anonymized supplier had previously represented Foundation Care in an unrelated lawsuit in 2011. The attorney did not respond to a request for comment.

The state argued that identifying their supplier would expose it to boycotts and harassment, and make it impossible to carry out the death penalty.

Inmates’ lawyers argued the secrecy puts their clients at great risk of a painful death, but then–attorney general Chris Koster’s office dismissed their concerns as unfounded. There was “no reason to believe that the execution will not, like previous Missouri executions using pentobarbital, be rapid and painless,” argued an attorney for the state.

Errors by compounding pharmacies can lead to painful executions, Dr. Larry Sasich, a pharmaceutical expert, wrote in a 2014 report for a lawsuit filed by death row inmates. If the drug is contaminated, there could be a “substantial risk of pain and suffering.” If the pH levels are off, the inmate could feel like they are being burned alive. If the drug isn’t potent enough, the inmate could experience nausea and vomiting, or have difficulty breathing and eventually suffer brain damage — but still be alive. If the drug is too potent, on the other hand, the inmate could be suffocating or gasping for breath before they become unconscious.

Concerns about sterilization, pH levels, and drug potency were all specifically cited by the FDA investigators when they inspected Foundation Care.

It is not known if Foundation Care’s drugs caused prisoners to die in agony — in part because Missouri made it difficult if not impossible for witnesses to know if an inmate might be experiencing pain during an execution.

During the time it used Foundation Care’s drug to execute 17 people, Missouri had a practice of heavily sedating inmates before witnesses were escorted in. The execution chamber was soundproof; witnesses would not be able to hear gasping, such as witnesses have reported in other states. During the execution, inmates are strapped down tightly to a gurney then covered up with a sheet, making any movements difficult to detect.

During the many lawsuits seeking to expose Foundation Care, officials refused to answer basic questions about the pharmacy’s qualifications. The attorney who represented the state on execution matters told a federal judge that even he didn’t know the identity of “M7.”

Several federal judges expressed unease over the secrecy.

Inmate Michael Taylor was sentenced to death for killing and raping a 15-year-old girl in 1989 after abducting her from her school bus stop. A week before his execution in 2014, the state turned to a new supplier, M7, and refused to turn over any information about its qualifications.

“In fact, from the absolute dearth of information Missouri has disclosed to this court, the ‘pharmacy’ on which Missouri relies could be nothing more than a high school chemistry class.”
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Taylor and other death row inmates sued, arguing that Missouri’s secrecy made it impossible to know if they would be killed humanely. Taylor lost and appealed to the 8th Circuit Court of Appeals, which also decided against him, over the objections of three judges on the court.

“One must wonder at the skills of the compounding pharmacist,” Judge Kermit Bye wrote for the dissenting judges. “In fact, from the absolute dearth of information Missouri has disclosed to this court, the ‘pharmacy’ on which Missouri relies could be nothing more than a high school chemistry class.”

The case went to the US Supreme Court, which, despite the dissent of three justices, allowed the state to execute Taylor without knowing any information about Foundation Care.

After that, Missouri largely cleared out its death row — executing 17 prisoners with Foundation Care’s drugs.

The aggressive pace Missouri set — scheduling one execution per month — made the state an outlier in the death penalty. While other states slowed down their execution schedules, Missouri sped up, executing inmates at a faster clip than it had ever done before.

Missouri hasn’t carried out an execution in more than a year now, because it executed all of the eligible prisoners.

But now, a new inmate faces death. In March, the state intends to execute Russell Bucklew, who was convicted of killing his ex-girlfriend’s lover in front of his kids in 1996. Bucklew then kidnapped and raped his ex-girlfriend, and shot a police officer in a subsequent chase.

His attorneys have argued that he, in particular, faces a heightened risk of a botched execution. Bucklew has a rare disease that causes tumors in his nose and throat — experts for his defense say that lethally injecting him puts him at risk of choking to death.


For 13 years, Foundation Care was owned by its two founders, Blakeley and Schultz. But in October 2017, the two sold the pharmacy to a subsidiary of Centene Corporation, a publicly traded, St. Louis–based health care giant that brought in $40.6 billion in revenue last year. Both the pharmacy and Centene declined to say how much the company paid to acquire Foundation Care, and Centene did not respond to repeated requests for comment on whether it was aware that the pharmacy had sold execution drugs.

Former attorney general Chris Koster, who was in office when the state selected Foundation Care and who oversaw the legal battles that kept the pharmacy’s identity hidden for years, was term-limited out of the office in January 2017. When he left public service, Koster found a new job: senior vice president of corporate services at Centene.

The company declined to make him available for an interview or answer questions about whether he played any role in the purchase of Foundation Care. ●

UPDATE

This post has been updated to include a comment from Centene Corporation, which had not responded to repeated requests for comment before publication.

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