Archives for June 2014

Closely-held Corporate Christians Win Crusade Against Contraceptive Coverage

The Supreme Court issued a 5-4 ruling in Burwell v Hobby Lobby, holding that closely held corporations cannot be required to provide contraception coverage. The court was asked to determine if the Religious Freedom Restoration Act (RFRA) (P.L. 103-141) allows a for-profit corporation to deny its employees the health coverage of contraceptives to which the employees are otherwise entitled by federal law, based on the religious objection of the corporation’s owners.  Justice Alito issued the majority opinion, joined by the Chief Justice and Justices Scalia, Thomas, and Kennedy. Justice Kennedy wrote a concurring opinion. Justice Ginsburg wrote a dissent in which she was joined by Justice Sotomayor; she was also joined in part by Justices Breyer and Kagan, who separately issued a dissent.

In 2012, Hobby Lobby, a national craft store chain, filed suit against then-HHS Secretary Kathleen Sebelius and various federal government entities, alleging that the preventive care services provision of the ACA, which requires Hobby Lobby to cover FDA-approved contraception in its employee health plans, violated its rights. Hobby Lobby objected because it considers some forms of contraception to be abortifacients, such as Ella®, Plan B One-Step®, and intrauterine devices, and subsequently argued that the preventive care services provision violated the RFRA, the Free Exercise Clause of the First Amendment, and the Administrative Procedure Act. At the direction of the Tenth Circuit, the district court granted Hobby Lobby a preliminary injunction barring the federal government from enforcing the preventive services provision of the ACA.

The Solicitor General petitioned the Supreme Court to hear the case, and the petition was granted. At that time the case was consolidated with a Conestoga Wood Specialties Corp v Sebelius (now Conestoga Wood Specialties Corp. v Burwell), which involved a secular for-profit corporation alleging that the mandate violated its shareholders’ Mennonite beliefs. The Third Circuit had upheld the denial of a preliminary injunction in the case.

For a full history of the cases, please click here.

In-depth analysis of this case will be posted later in the week.

 

Hobby Lobby & Conestoga Decision Anticipated; History of Litigation

On Monday, June 30, the U.S. Supreme Court is expected to deliver its decision in Sebelius v. Hobby Lobby (No. 13-354). The Affordable Care Act’s provision requiring group health plans (whether offered by an employer or through the health insurance Marketplace) and individual health plans to include specific preventive health services, including contraception coverage at no extra cost to the insured, has generated more litigation than any other part of the law.

Since November 2012, Wolters Kluwer Law & Business has published over a dozen articles on the two cases at the heart of the litigation involving Hobby Lobby and Conestoga Wood Specialties Corp. These articles have appeared in Health Law Daily and Health Reform WK-EDGE. The decisions themselves, as well as related decisions on the contraception coverage controversy involving for-profit and not-for-profit institutions, appear in Wolters Kluwer’s Health Reform KnowlEDGE™ Center.

In this Special Briefing, we have gathered together all of Wolters Kluwer’s reporting on these two cases. When the Supreme Court releases its decision, our analysis of the decision will be available within hours of the release for our Health Law Daily and Health Reform WK-EDGE subscribers. For our blog readers, please expect news of the decision on Monday, with more in-depth analysis later in the week.

See the Special Briefing here.

 

HIV Vaccine Results Faked by Iowa State Assistant Professor

The Associated Press (AP) and USA Today report that federal prosecutors in the Southern District of Iowa have filed charges against former Iowa State University assistant professor of biomedical sciences Dong-Pyou Han, after he confessed to spiking samples of rabbit blood with human antibodies to make an investigational HIV vaccine look promising. The AP reports that Han received millions in fraudulent National Institutes of Health (NIH) grants over several years based on his research. As USA Today reported in December 2013, the rabbit blood results were presented at numerous scientific meetings over the years, and other laboratories became suspicious when they could not duplicate Han’s results.

It has also been reported that in September 2013 Han wrote a two-page letter, littered with grammar errors, announcing his resignation from Iowa State. In that letter, Han stated “I am very ashamed myself about my misconduct. My misconduct is not done in order to hurt someone. All cause by my foolishness and are my faulty and responsibility.” A spokesperson for Iowa State University has confirmed that Han resigned in October 2013.

The AP spoke to Ivan Oransky, a co-founder of Retraction Watch, which tracks research misconduct, who says there have been only a handful of similar prosecutions in the last 30 years because the U.S. Office of Research Integrity, which investigates misconduct, doesn’t have the authority to prosecute, and most cases involve smaller amounts of money.

James Bradac, who helps oversee AIDS vaccine grants for NIH told USA Today in December 2013 that Hans apparently added human blood components to the rabbit blood to skew results. Bradac said this was the worst case of research fraud he had seen in his 24 years at NIH. According to Bradac, the human blood came from people whose bodies had produced antibodies to HIV. The presence of these antibodies in the rabbits’ blood made it appear that the vaccine was spurring the animals to build defenses against HIV, Bradac said.

Highlight on Nebraska: State Hopes Early Testing Will Curb West Nile Infections

Nebraska health departments began testing for West Nile virus in June 2014, although most human cases of West Nile are reported in August and September. On June 1, the Scotts Bluff County Health Department started collecting mosquitoes and  accepting dead birds for testing. The city of Gering, located in Scotts Bluff County, began spraying for mosquitoes on June 10. Although it may seem early for testing, the Two Rivers Public Health Department announced that mosquitoes testing positive for West Nile have been found in Cherry County, Nebraska.

West Nile Virus

According to the Centers for Disease Control (CDC), West Nile is most commonly transmitted to humans by mosquitoes. Humans cannot become infected with West Nile by handling infected birds, whether alive or dead. Health departments often test dead birds for West Nile, however, as a way to gauge rates of mosquito infection in an area.

The vast majority—70 to 80 percent—of infected humans do not develop any symptoms, but those who do develop symptoms may experience fever, headache, joint pains, vomiting, diarrhea, or rash. Less than 1 percent of infected humans will develop a serious neurological illness, such as encephalitis or meningitis; of those who develop neurologic infections, about 10 percent will die. There is no vaccine or antiviral treatment for West Nile virus infection, though over-the-counter medicines can relieve some symptoms.

Prevention

Preventing mosquito bites is the most effective way to prevent West Nile infection. The CDC recommends the following:

  • Using insect repellents containing DEET, picaridin, IR3535, oil of lemon eucalyptus, or para-menthane-diol when outside.
  • Wearing long sleeves, long pants, and socks when outdoors; clothing can be sprayed with repellent containing permethrin or another EPA-registered repellent for extra protection.
  • Taking extra care during peak mosquito biting hours—from dusk to dawn.
  • Installing or repairing screens on windows and doors to keep mosquitoes outside.
  • Emptying standing water from flowerpots, gutters, buckets, pool covers, pet water dishes, discarded tires, and birdbaths on a regular basis to help reduce the number of mosquitoes around your home.
  • Supporting local community mosquito control programs.
  • Reporting dead birds to local authorities.

Nebraska Programs

The Nebraska Department of Health and Human Services, Division of Public Safety, has developed a West Nile Virus Surveillance Program to track and prevent the spread of infection. There have been no reported human cases of West Nile infection yet in 2014; however, in 2013 there were 226 cases reported, five of which resulted in death. Nebraskans seeking additional information about West Nile should call (402) 471-2937; those who found a dead bird can find the correct number for their county’s surveillance program here. The state also has special information for farmers regarding mosquito-breeding on their land.

Horses

Horses can become infected with West Nile virus by mosquito bites, but cannot transmit the virus to humans. There is an approved vaccine for horses that requires two doses, three to six weeks apart. The University of Nebraska-Lincoln provides diagnostic testing for West Nile virus at its Veterinary Diagnostic Center.