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Texas Loses Patience, Sues FDA For Barring Import Of Lethal Injection Drug

FILE - This Oct. 14, 2015, file photo shows the Food and Drug Administration campus in Silver Spring, Md. The FDA announced Monday, Dec. 12, 2016, that it denied the request by Swedish Match to remove several health warnings from its smokeless tobacco pouches, though regulators left open the possibility for other labeling changes it seeks. It's the first decision of its kind handed down by the agency since it gained authority to review the relative risks of tobacco products in 2009. (AP Photo/Andrew Harnik, File)

On January 3, 2017, the Texas Department of Criminal Justice declared its impatience with the U.S. Food and Drug Administration by beginning a lawsuit over an impounded shipment of drugs. More than a year and half earlier, the FDA had detained 1,000 vials of sodium thiopental, which were intended to be used as lethal injections in the executions of condemned inmates in the state. The suit argued that law requires such an action to be resolved “within a reasonable time” and that the FDA’s delay is unlawful, thereby forcing a decision now.

Texas is one of 31 U.S. states that use lethal injections as the primary means of execution in death penalty cases; 19 states plus the District of Columbia, do not use this death penalty. Michigan was the first state to stop this execution method in 1846 and the last was Delaware in 2016.

In recent years, the states that use lethal injections have found these various drugs increasingly difficult to obtain, which began the hunt for alternatives and an increased demand for shipments from foreign countries. However, European general objection to the death penalty has made the hunt for drug alternatives ever more difficult. In 2010, some drug manufacturers in Europe began to ban shipment of the drugs used in lethal injections. England has banned the shipment of sodium thiopental, and in 2012, the European Union began regulations against shipment of drugs used for capital punishment.

Lethal injection in the United States is a three-step drug approach to death. An anesthetic or sedative such as pentobarbital is first administered to induce unconsciousness. Step two is a paralyzing agent such pancuronium, followed by step three, potassium chloride, which stops the heart.

The lethal injection process begins when the prisoner either walks to the execution chamber or is taken there on a gurney under restraints. An intravenous (IV) tube is inserted into each arm of the prisoner and threaded through an opening into another room where the executioner is located. At this point, curtains may be drawn to allow witnesses to view the execution and/or the inmate to make a final statement. The lethal injection process is said usually to cause death in about 7 minutes. However, some executions have taken far longer.

The lethal injection method of execution in the United States has decreased over the years, falling to the lowest quarter-century total in 2016. Besides the difficulty of obtaining drugs, there has been an increase in objections to the use of this method throughout the country. In 2016, for instance, Texas, which uses lethal injections more than any other state, had to delay several executions mainly because of legal fights.

In the 2017 lawsuit, Texas charges that the FDA’s year and a half delay in making a decision has demonstrated “gross incompetence or willful obstruction.” The FDA made no immediate comment on the lawsuit. Comments have come from other sources, however. The U.K. medical journal Lancet declared that in some states the medical professionals involved in these executions are not properly trained to carry out such actions. Some U.S. medical experts have voiced fears that this scramble for other lethal injection drugs will only lead to more inhumane executions.

Mark Sadaka from Pharma Watch Dog, the leading Drug Injury Lawyer, has a national practice and works with clients from New York to Alaska.