Federal court hearing touches on secrecy of U.S. execution drugs

U.S. District Judge Kristine Baker will have heard four days of exhaustive testimony on the controversial lethal injection drugs that expire at the end of April before she rules on whether Arkansas’ aggressive schedule to execute seven death-row inmates beginning Monday is unconstitutional.

As the federal hearing wraps up Thursday (April 13) at the U.S. District Court in Little Rock, attorneys from both sides have drilled down into thousands of pages of medical studies, legal findings and regulatory filings concerning the three-drug protocol that will be used in the upcoming executions.

In particular, some of the testimony has referred to federal Securities and Exchange Commission (SEC) filings where Mylan and Pfizer Inc. first sought to keep the lid on a shareholder proposal by the New York State Common Retirement Fund (NYSCRF) more than two years ago regarding the making and distribution of drugs that have been part of the lethal injection protocol for Arkansas and other states.

Those filings began about the same time lawmakers in Arkansas passed a law two years ago that allows state Department of Correction officials to keep secret the information about the manufacturer, supplier and other details of drugs to execute death-row inmates. With that law in hand, Gov. Asa Hutchinson set execution dates for eight death row inmates in September 2015, which was later halted until the state Supreme Court decided favorably on the legality of the state’s secrecy law.

Under the execution protocol Arkansas plans to use Monday, an inmate on the execution table is first injected with the sedative midazolam to render him unconscious. That is followed by second drug, vercuronium bromide, which causes paralysis, and then potassium chloride stops the heart.

According to the SEC’s ‘no action” requests, Mylan and Pfizer first began seeking secrecy on execution drugs in early 2015 when both companies asked federal securities regulators to halt a shareholder proposal by NYSCRF asking for detailed information about their respective inventories of lethal injection products. In January 2015, the New York pension fund first asked Mylan to issue a report at the company’s annual meeting on “products for purposes of aiding executions, and including an analysis of potential reputational risks associated with such policy position.”

But Mylan countered by asking the SEC officials to omit NYSCRF’s proposal from its proxy filings, saying it contained “false and misleading statements” concerning the role and use of rocuronium bromide in lethal injections, Mylan’s role with respect to “lethal injection drugs,” and the possible financial impacts on Mylan related to execution drugs. In its answer to Mylan, the SEC’s legal staff offers supporting evidence from NYSCRF that the use of rocuronium bromide by a Mylan subsidiary had already been highlighted in news reports concerning botched executions. In some states, rocuronium bromide is used in place of vercuronium bromide in the three-drug protocol.

“There has been a controversy in recent years over the use of lethal injections to execute prisoners, which was highlighted most recently by the prolonged execution of an Oklahoma inmate in 2014,” states the SEC filing. “Mylan’s subsidiary, Mylan Institutional, manufactures a drug known as ‘rocuronium bromide,’ which at least two states have adopted for use as a substitute in lethal injections for the nationally scarce pancuronium bromide.”

The SEC letter to Mylan also points out that at least three of Mylan’s industry peers had taken steps to prevent their products from being utilized for lethal injections, but the Canonsburg, Penn.-based drugmaker chose not to take similar measures.

“Following restrictions by the European Union on the export of anesthetics used in lethal injections, U.S. states have looked to domestic corporations, including Mylan, for alternative drugs,” the SEC responded. “By being identified in the death penalty controversy, Mylan is said to have been exposed to reputational risk, jeopardized its role and reputation as a provider of health oriented products, and may face ‘increased financial and legal risk … resulting from the actual use of its products in executions.”

Pfizer Inc.’s chief counsel sent the SEC a similar letter asked federal regulators to exclude another shareholder proposal by NYSCRF from its annual report. However, this time the New York pension funds asked the pharmaceutical giant to describe the states where the company has to identify and remedy the flaws in its distribution system for the “restricted products” to prevent their sale to prisons for executions. In that filing, the SEC points out that Arkansas had already purchased potassium chloride from Pfizer subsidiary, Hospira, for use in the upcoming executions. Federal regulators also said that after acquiring Hospira, Pfizer adopted and implemented a policy regarding the use of its products in lethal injections that largely mirrored the policy Hospira already had in place.

“It is disingenuous for Pfizer to argue that this issue is one of ordinary business, when it has recognized the importance of the issue in question by adopting and implementing a policy restricting the use of its products in lethal injections and publishing this policy on its website,” the SEC stated. “Whether (Pfizer) is in compliance with its own policies is a matter of utmost importance to shareholders and an issue on that cannot be characterized as ordinary business.”

In July 2016, the Associated Press first reported that the Arkansas Department of Corrections had obtained its supply of vecuronium bromide from Hospira. According to SEC filings at or around the time Pfizer purchased Hospira for $16 billion in September 2015, the company began a policy “to implement the restricted distribution system under which Hospira and its distributors had ceased the direct sale to U.S. prison hospitals of products, specifically pancuronium bromide, potassium chloride, propofol, midazolam, hydromorphone, rocuronium bromide and vecuronium bromide.”

In the Mylan and Pfizer cases, the SEC eventually rejected the companies’ request in January 2016 to halt NYSCRF’s proposals, saying the companies failed to prove that information on lethal injection drugs should be concealed from shareholders.

A year later, the Arkansas Department of Corrections announced that the state’s supply of potassium chloride, one of three drugs in a cocktail used in executions, had expired. Last month, state correction officials announced they had obtained a new supply of potassium chloride and would proceed with the seven scheduled executions on Monday, unless there is a stay by state or federal courts.

One of the two other drugs, midazolam expires April 30.