There is an effort currently underway to remove the rights of consumers to seek justice through the court system when they are injured by a product or drug. The issue is preemption, and it would essentially provide companies with immunity from lawsuits despite negligent action on their part.

How could this be? And why don’t more people know about it?

A recent report published by the American Association for Justice (AAJ), explains that federal preemption would circumvent state law by enacting federal policies that override state laws.

According to the U.S. Constitution, any decision to preempt state law must be authorized by Congress. However, several federal agencies have navigated around that obstacle by inconspicuously writing language into the preamble of federal regulations and then using those preambles to change the law.

In most cases, federal regulations are not as strict as state laws. Government regulations only set minimum safety standards, and can’t guarantee safety. However, the agencies are arguing that federal standards override state standards, thereby making any state tort claims void.

Currently, there is a case currently before the United States Supreme Court involving the Food & Drug Administration (FDA) that would protect manufacturers of toxic prescriptions drugs and faulty medical devices. If the Supreme Court rules that federal standards – in this case prior approval of a drug or product by the FDA – supersede state law, consumers will have no legal recourse if they are injured by a defective product or drug.

In August, support for a consumer’s right to justice in court was defended by the editors of the New England Journal of Medicine. Led by editor Dr. Jeffrey M. Drazen, the physicians said litigation is a “key defense mechanism” to insure drug safety. Furthermore, they pointed out that the FDA is ill equipped to be the sole guardian of drug safety, as it is often overwhelmed by problems ranging from serious side effects to unsafe manufacturing facilities.

This assertion is borne out by the host of negative incidents related to prescription drugs and medical equipment in just the last year, including contaminated heparin, which manufacturer Bayer said it believes was intentionally tainted during production in China; and psychological side effects associated with Chantix, which was banned from pilot and air controller use by the Federal Aviation Administration.

According to the Institute for Safe Medicine Practices, 2008 saw record levels of drug-related adverse events and deaths, with Chantix and heparin leading the pack.

In addition to the FDA, federal agencies involved in writing preemption into regulations include the National Highway Traffic Safety Administration (NHTSA), Consumer Product Safety Commission (CPSC), Department of Homeland Security, Pipeline and Hazardous Materials Safety Administration, Transportation Safety Administration and the Federal Railroad Administration.

The AAJ says, “When viewed through the context of unsafe products, preemption of state law means complete immunity from lawsuits for corporations and a full escape from accountability when they have knowingly injured and endangered Americans.”


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