Think corporate Utopia. Think David vs. Goliath where Goliath enjoys a major handicap.

According to the U.S. Constitution, any decision to pre-empt state law must be authorized by Congress. However, several federal agencies have navigated around that obstacle (probably whining that it takes an act of Congress to trump state law) by inconspicuously writing language into the preamble of federal regulations and then using those preambles to change the law.

The issue, however, is not as clear cut as it would seem. Some trial courts have ruled the regulatory preambles to be permissible. The American Association for Justice on the other hand belies them to be unconstitutional. In any case, pre-emption effectively strips state government and courts – and the U.S. Congress – of its authority.

Not exactly the antithesis of “big government,” yet some politicians would whisk away any concerns as tort reform. To get a clearer picture of the dangers posed by corporate immunity, look at the individual cases – the examples of real people who are grappling with greatly diminished protection.

Look at Joe Randone and his family, who are suing Bayer. Randone was a 52-year-old heart patient when he was given Trasylol in an IV drip. Immediately after the surgery, Randone suffered from two heart attacks and kidney failure. His gall bladder had to be removed and he was so swollen he couldn’t close his eyes, which were eventually sewn shut to protect his corneas. Gangrene set in to his lower extremities and both of his legs had to be amputated. Randone held on like this for 8 months but ultimately passed away in his hospital bed. All of this happened while Bayer, the manufacturer of Trasylol, was aware of the drug’s dangers and took no measures to prove its safety one way or another, even after smaller tests indicated the drug was extremely dangerous.

Bayer is claiming immunity in this case because Trasylol was approved by the Food and Drug Administration. However, language in the preamble to the FDA’s prescription drug labeling rule may provide the easiest escape route for Bayer.

Who are the government and the FDA protecting? If pharmaceutical companies and medical device manufacturers receive complete immunity from the law, then they can knowingly market and sell dangerous drugs that leave scores of people injured or dead.

It is through the courts, and litigation, that the voice of the consumer is heard, and his rights protected. A recent editorial by the editors of the New England Journal of Medicine supports this idea.

SOURCE: Trasylol Recall › Zero accountability for drug companies?

Both complaints were filed in the St. Clair County Circuit Court.

Gary Harms received a Trasylol injection in 2005 while he was undergoing heart surgery at Des Peres Hospital in St. Louis, Missouri. He has since suffered from acute renal failure and requires regular dialysis to perform the functions of his failed kidneys.

Researchers first discovered a link between Trasylol and kidney failure in the early 1980s when lab animals that received the drug developed severe kidney failure. Subsequent tests confirmed Trasylol’s danger to humans, yet Bayer consistently denied the existence of a link between their drug and acute renal failure and death. The company also failed to fund and perform adequate clinical tests that would have conclusively demonstrated the drug’s risks.

Harms’ suit claims that he has suffered from emotional distress and anxiety, physical personal injury, medical expense, loss of consortium, services, love and affection, permanent loss of an important bodily function, permanent impairment of the ability to enjoy life and financial expenses. He seeks $550,000 in addition to attorney’s fees and other costs.

Richard Kopsie also received Trasylol during his coronary artery bypass graft surgery at Christian Hospital in St. Louis, Missouri in 1996. He experienced kidney failure shortly after surgery and required dialysis for years. Kopsie passed away in March 2003 at the age of 53, but his final years were marked by pain and suffering from Trasylol-induced injuries, medical costs, disability, and a diminished ability to enjoy life, according to the complaint filed by his wife Linda.

Linda Kopsie seeks a $1.1 million on 22 counts plus attorney’s feels and other costs against Bayer.

Both suits claim that Bayer acted negligently for continuing to market Trasylol when the drug’s dangers were known, for failing to alert the FDA to dangers of the drug, and failing to attach appropriate warnings and safety information to the drug. For years, Bayer also avoided performing large scale tests that would have effectively underscored the drug’s dangers.

SOURCE: Trasylol Recall › Two suits filed against Bayer in Illinois

Months later, Randone was still in the hospital fighting a losing battle for his life. The problem began during surgery, when Randone was hooked to an IV drip containing Trasylol for four hours.

Trasylol is administered to control blood loss during heart surgery. It is one of the most widely used drugs worldwide for that purpose.

After the surgery, the doctor told Randone’s wife Josephine and daughter Marissa that something was wrong, that Joe was experiencing complications.

“They didn’t go into specifics,” Marissa told the television program 60 Minutes. “Just that there were a lot of complications, and that making it through the night was basically our first concern.”

Just after surgery, Joe Randone experienced two heart attacks. Then his kidneys failed. Randone’s surgeon rightfully suspected that Trasylol was at fault. He recorded Randone’s complications as “aprotinin-induced graft thrombosis.” In other words, blood clotting caused by Trasylol.

Randone battled for his life in the months following his Trasylol IV. He was placed on dialysis so that machines could perform the work of his kidneys.

“It was a domino effect. Once the kidneys stopped working, then it affected other organs. He was so swollen that he couldn’t even close his eyes,” Josephine told CBS.

Circulation was so poor in Randone’s lower body that gangrene settled into both of his legs. Both legs were subsequently amputated.

Josephine described the experience as “a living hell” for both Joe and his family.

Randone died eight months after his heart surgery. His family filed a suit against Bayer in Suffolk County for $80 million.

Randone’s surgeon, Dr. Todd Rosengart, has filed a report with the FDA and has stopped using Trasylol.

SOURCE: Trasylol Recall › Death by Trasylol: one man’s story