Friday, April 22, 2011

Death-row lawyer: Nebraska bought lethal-injection drug from rogue broker

Kayem Pharma Mumbai office entrance
Source: Reprieve More here
The Nebraska Supreme Court late Thursday rejected a complex appeal by death-row inmate Carey Dean Moore and ordered him to be executed on June 14.

In doing so, the court rejected arguments by Moore's lawyers challenging the legality of Nebraska's purchase from an Indian company of 1 of 3 drugs used in the state's lethal-injection protocol and questioning whether the state even bought the right drug.

Jerry Soucie, a lawyer with the Nebraska Commission on Public Advocacy, had asked the court to order a lower court to hear the issue of the state's purchase.

"The subject matter of the proceeding pending herein is not one which the Nebraska Supreme Court may ‘remand' to a district court," Chief Justice Michael Heavican wrote.

Soucie declined immediate comment.

Meanwhile, court documents filed earlier Thursday said the state might have bought the lethal injection drug from a rogue pharmacy broker who just wanted to make quick money.

The state paid $2,056 to Kayem Pharmaceutical Pvt. Ltd. for 500 grams of sodium thiopental. The drug has been in short supply since last year and the only U.S. manufacturer, Hospira Inc., is ending production because of death-penalty opposition overseas.

But in an email this week to Soucie, the CEO of Kayem said the state bought the drug from a pharmacy broker who deceived the company -- even going as far as registering it to do business in Nevada without its knowledge.

CEO Navneet Verma said an Indian citizen named Chris Harris approached his company last year about being a pharmacy broker for Kayem.

Harris later allegedly told Verma he and another man, Tony Atwater of Steuben, Maine, already had registered the company as a corporation in Nevada under the name Kayem Pharmaceutical LLC.

"This sudden and abrupt formation of a company by this duo has given rise to suspicion about ... deceit by the hands of this duo," Verma said. "... The intention of this duo was clear to us as they wanted to make quick money ... getting themselves in the unethical practices ... detrimental to Kayem Pharmaceutical."

Verma said the sale of the drug was between Harris and Steve Urosevich, chief operating officer for the Nebraska Department of Correctional Services.

He said Kayem simply supplied the drug to Harris. Verma also said the company since has cut ties with Harris.

"The inescapable conclusion is that Chris Harris and Kayem are rogue foreign pharmaceutical brokers/distributors and that the importation of a controlled substance by DCS was in violation of the applicable federal statutes," Soucie wrote in court filings.

Soucie says the address listed by Harris with the Nevada Secretary of State's office is that of a mail forwarding service called "Mostly Mail," which advertises mail boxes for rent.

Harris did not immediately respond to an email request seeking comment.

Atwater said Verma approved of their registering Kayem in Nevada, but the 2 had a subsequent falling out over money and parted ways.

Kayem completed a federal "Certificate of Origin" dated Dec. 8, 2010, that said the drug shipped to the Nebraska Department of Correctional Services was "Thiopentone ... thiosol sodium" manufactured by Neon Laboratories Ltd. of Mumbai, India.

The state's lethal injection protocol calls for using "sodium thiopental." It appears, Soucie said, that the state might have bought a generic version.

"The state's own attachment to the motion for an execution date does NOT allow for the use of ‘thiopentone' or ‘thiosol sodium' as the first of the drugs in the lethal execution cocktail," Soucie said in a motion to the high court asking for a hearing.

He said federal law requires that before a new drug is used in the United States, the manufacturer must file an application with the Food and Drug Administration outlining the drug's safety, composition and manufacturing process, among other things.

To market a generic drug in the United States, a manufacturer must file an application showing the FDA has approved its active ingredients.

Verma said his company is not so licensed. Nor, he said, is Kayem or Neon Laboratories registered with the Drug Enforcement Administration and authorized to deliver controlled substances to the United States.

Soucie said the DEA registration held by the Corrections Department does not authorize it to directly import drugs from a foreign supplier.

The DEA recently seized Georgia's entire supply of sodium thiopental, which defense attorneys say came from a questionable British supplier. The DEA said there were questions about how it was imported.

FDA spokeswoman Shelly Burgess has said the agency could not comment on the Nebraska case. The DEA referred inquiries to the U.S. Department of Justice, which also has declined comment.

Nebraska corrections officials deferred comment to state Attorney General Jon Bruning's office. Said Bruning: "The court order speaks for itself."

In court papers, the attorney general's office said Soucie should not be allowed to ask for a hearing since the high court had been asked to set an execution date for Moore.

In his filing, Soucie wrote, "without evidence of compliance with these federal regulatory requirements, there is no basis upon which to presume the efficacy of these specific drugs obtained from Kayem and that they do not present a ‘substantial' or ‘objectively intolerable risk of harm' during a judicial execution."

According to documents reviewed by the Journal Star, the corrections department paid Phil Patterson Inc., an import company based in Omaha, to facilitate shipment of the drug from India.

Kayem issued the certificate of origin for the drug and the shipment was under the supervision of customs officials in India and the United States, said Megan Cooley, who oversaw the importation for Phil Patterson Inc.

Once the shipment arrived in the United States, it was tested by Medtox Laboratories in St. Paul, Minn., to verify that it was sodium thiopental, according to the documents.

Soucie also questions the legitimacy of Kayem to make a lethal injection drug.

He said Kayem's main facility in India is in a ground-floor apartment in Mumbai.

"There are 2 small rooms, one serving as an office and the other as a storage room," Soucie said. "There is no air conditioning or climate control at this building.

"Kayem Pharmaceuticals does not appear to be involved in the direct formulation of any medications with the exception of Indian herbal remedies to alleviate symptoms of arthritis, upper respiratory infections, constipation, hemorrhoids and inadequate male sexual performance," Soucie said. "Kayem's primary business activity appears to be the production of tablets, capsules, ointments and injectable products as a subcontractor for other generic drug companies located in India."

A federal lawsuit has been filed in Arizona challenging the use of the drugs from overseas suppliers, saying they may be substandard and could lead to problems during executions.

As for the drug Nebraska got, Atwater said it is the real thing.

"It's all legal," he said.

The Nebraska Legislature approved lethal injection as the state's method of execution in May 2009.

Moore, 53, has been on death row since 1980. He was sentenced to die for killing Omaha cab drivers Maynard D. Helgeland and Reuel Eugene Van Ness during botched robberies in 1979.

The state has not executed an inmate since Robert Williams died in the electric chair in 1997.


Source: Lincoln Journal Star, April 22, 2011
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