Joyce Richards lives with epilepsy. For the past 20 years the list of prescription drugs she's taken, to control seizures, to counter depression, to control shakes, to gain weight (and minimize side effects of weight-loss with epilepsy drugs) could fill a law book. But prescription drug benefits are hit-and-miss.
The 37-year-old may have six months of minimal attacks, and then her body reacts violently with the same prescription drugs she's taken for weeks. Inevitably she ends up in prolonged hostpital care between two and four times per year where Richards starts all over again with new drugs, while doctors experiment and tweak levels of medications to whip her back into -- where she was a year earlier. Her ongoing medical cycling of seizures and drug balancing confine her home.
She would love to work; however, no employer will take the
Whether or not her pharmaceutical drugs or medical device cause more harm or indeed help -- this will no longer be determined in court. The Bush administration has changed the way in which consumers may sue pharmaceutical manufacturers -- simply, you can not.
The White House says that consumers may not recover damages for injuries of products approved by the Food and Drug Administration (FDA), which the Justice Department says is a position that reflects a change in government policy and persuades judges to accept the new strategy.
Any consumer who sues manufacturers would undermine public health and interfere with federal regulation of drugs and devices, government prosecutors argue.
Lay judges may not second guess the FDA the government contended in their arguments against Barbara Horn, a Pennsylvania woman who sued over a faulty heart pump that killed her husband. The appeals court tossed Horn's case out after the Bush administration said federal law barred claims on products produced under federal specifications. When the FDA approved the heart pump, the law read that states could provide additional protection to consumers, but the Bush administration said the agency's approval criteria has changed. Individual consumers have no right to sue, which benefits everyone.
If lawsuits of this caliber are allowed, good products may be removed from the market, the government said. Horn's attorney, Allison Zieve, said the government turned about-face and these rulings against consumers amount to backdoor type of tort reform that shields manufactures from damage.
The Bush administration ruled that the FDA is uniquely qualified to determine when federal law should take precedence over state law and that the FDA authority is vindicated in regulating drug products.
President Bush pushed for "tort reform" in 2002, relieving the FDA of product liability, it is good health policy and good tort reform, Bush advisors said. Bush says trial lawyers impose undo burdens on the economy and drive-up health costs. Trail lawyers, incidentally, as a campaign contributor, have donated millions to John Kerry's presidential campaign. Vice president hopeful, Sen. John Edwards (D-NC) pushed for the Senate to pass a patient's rights bill which included the right to sue on faulty products. The measured failed to pass.
To protect Pfizer, the maker of Zoloft (a drug plantiffs claim cause some patients to commit suicide,) the government filed legal briefs to waive Pfizer's liability after several Zoloft patients took their lives and surviving family members sued. Plantiffs requested Pfizer add "warning labels" to Zoloft to alert patients of possible side effects. The Bush administration says the FDA approved Zoloft, and see no need for warning patients and that any unnecessary warning could deprive patients the benefits of taking Zoloft. Pfizer denies any link between patients who take Zoloft and those who experience suicidal tendencies. Pfizer donated $650,000 to the Bush re-election campaign up through 2003 -- 2004 data is not published.
Paxil, an anti-depressant drug known for debilitating side effects and weight gain saw a number of consumer lawsuits against parent company GlaxoSmithKline; however the Bush administration has stepped in saying any lawsuits would overly deter use of life-improving medication. The Bush administration challenged patient claims and said that Paxil is not habit forming. GlaxoSmithKline USA and UK have donated almost $1 million in campaign contributions to the Bush re-election campaign up through 2003 -- 2004 data is not published.
With new FDA and pharmaceutical manufacturing legal clout, whichever and whatever pharmaceutical prescriptions you may be taking or might be taking in the future, be forewarned that it is up to the consumer -- not the doctor -- to know side effects of these medications or devices. Upon your disability or death from faulty prescription drugs or devices, your family may not sue the maker on your behalf.