Patent Baristas

The U.S. House of Representatives approved $3.78 billion prepare for a possible avian flu epidemic, including stockpiling potential vaccines, training emergency officials and increasing international surveillance. At the last minute, an unrelated provision (called the Public Readiness and Emergency Preparedness Act) to protect vaccine, drug and medical device makers against lawsuits in a public health or bioterror emergency. The avian flu funding was attached to an unrelated FY 2006 Defense appropriations bill (H.R. 2863 – H. Rept. 109-359), and passed by the House by a vote of 308-106.

Under the provisions of the bill, drug companies are given complete immunity from civil liability for all aspects of the development and production of drugs, vaccines or devices specified by the government. There is no limitation in scope to pandemic flu or even to major public health hazards. Instead, the immunity can apply to just about any product directed at an “epidemic” and includes any product that mitigates the side effects of a drug used to counteract an epidemic. So, in theory, if a medicine produces high blood pressure or pain, then any blood pressure or pain medication could also be covered.

Consumer and health groups opposed the vaccine liability provisions, which were sought by pharmaceuticals, saying it would protect companies from “gross negligence.” Some said the measure could make medical personnel and other emergency workers reluctant to get vaccinated if there was a chance they could suffer negative reactions and not get compensated.

The current measure to shield drug manufacturers from lawsuits is an effort to encourage them to develop new vaccines. But, the bill would make it very difficult for people harmed by vaccines distributed during a national health emergency to pursue legal action against the manufacturer. An earlier bill by Sen. Richard Burr, would also establish a Biomedical Advanced Research and Development Agency (BARDA) that critics say would be exempted from public and congressional scrutiny.

Here, the liability shield proposed can be granted to any product used to prevent or treat an epidemic or a pandemic, and the Secretary of Health and Human Services decides what that means. It also provided a compensation program without any of funding. The legislation puts in place a compensation system modeled after what Congress approved for those who experience harmful side effects from the smallpox vaccine. Under the program, pandemic flu vaccine recipients or their families could apply for lost income, medical expenses and death benefits but the legislation appropriates no money for the compensation fund.

The possibility of an avian flu epidemic, as well as the use of biological weapons, has spurred interest in stepping up production of new vaccines. Proponents argue that big drugmakers would never take much interest in vaccines until they were given strong protections against lawsuits. Here, the bill requires plaintiffs to prove “willful misconduct” by drugmakers in order to seek redress for harm. That’s a higher standard than negligence, which is the failure to exercise reasonable care.

Just what constitutes “willful misconduct“? The definition of “willful misconduct” depends in some measure on which court is deciding the issue but some common factors that courts will consider are: (1) knowledge that an action will probably result in injury or damage, (2) reckless disregard of the consequences of an action, or (3) deliberately failing to discharge a duty related to safety. Courts may also consider other factors.

Willful misconduct is the intentional doing of an act which one has a duty to refrain from doing or the intentional failure to do an act which one has the duty to do when he or she has actual knowledge of the peril that will be created and intentionally fails to avert injury. On the other hand, wanton misconduct is the intentional doing of an act which one has a duty to refrain from doing or the intentional failure to do an act which one has a duty to do, in reckless disregard of the consequences and under such surrounding circumstances and conditions that a reasonable person would know, or should know, that such conduct would, in a high degree of probability, result in substantial harm to another.

[update] The Senate passed the bill 93-0 and it was sent to the President on December 28, 2005.