By Jeanne Roberts

I normally write about corporate polluters, but a recent Supreme Court ruling – that consumers can’t sue the makers of defective medical devices – makes me so mad I could spit!

The ruling was handed down by Justice Antonin Scalia, the same man who - in a recent BBC interview - defended torture as a means of uncovering information. I would suggest Scalia ought to be ashamed of himself, but he clearly isn’t capable of feeling shame, which requires some degree of humility.

The ruling arises out of a lawsuit by Charles Riegel, whose Medtronic Evergreen catheter ruptured during implantation, eventually causing death. Medtronic no longer makes the Evergreen because patent infringement made production unprofitable. It is also likely that Riegel’s physician used the catheter inappropriately. Nonetheless, Medtronic’s history is one of profit-driven shoddiness. In 2007, a former Medtronic engineer charged the company with failing to properly test the Concerto device before launching it. That same year, Medtronic settled 2,682 lawsuits on its Sprint defibrillator, whose leads tended to break, delivering massive jolts of electricity. Five people died because the Sprint failed. In 2005, 11,000 Medtronic Marquis defibrillators were surgically removed and replaced with other devices in what the FDA called a “Class 2” recall – I hate to imagine what a Class 1 recall might involve! In 2004, two other Medtronic devices were recalled after four people died.

The only dissenting Supreme Court member in the Riegel case was Justice Ruth Ginsburg, who argued that the 1976 Medical Device Amendment (MDA) ruling – on which the seven other justices based their Medtronic decision – was never intended to prevent lawsuits but was, in fact, designed to protect consumers from defective design or manufacturing.

The ruling is a landmark decision, and is expected to affect not only medical devices but pharmaceuticals. One such case, Wyeth versus Levine, won a $6 million settlement for Diane Levine in a Vermont court. Wyeth, a drug manufacturer, subsequently appealed the decision. The Supreme Court hasn’t ruled yet, but many legal experts predict Wyeth will win, especially in light of the Medtronic decision. As this article goes to print, in fact, the Supreme Court is actually considering such a ruling.

The Food and Drug Administration, or FDA, is charged with protecting consumers via review of all new medications and devices. In fact, the FDA does very little research of its own and relies primarily on manufacturer’s recommendations. Of the thousands of medical devices patented every year, less than 100 are FDA-inspected. Devices tend to come to market under a grandfathering procedure (i.e., the device is approved based on a similar device already available). Drug manufacturers face slightly more severe criteria, but again the FDA relies primarily on the manufacturer’s studies and clinical trials. Unfortunately, manufacturers – who are in business to make money, not tell the truth – typically release only that information which presents their product in the best possible light.

This proved true in a recent study by Hull University. Two anti-depressants – Prozac from Eli Lilly, and Seroxat from GlaxoSmithKline – were shown only marginally effective, and then primarily for their placebo effect. Hull’s findings, published in the medical journal PLoS Medicine, are based on 47 clinical trials, including unpublished data the FDA clearly failed to consider. As a result, the UK’s National Institute for Health and Clinical Excellence (NICE) is reviewing its guidance on the use of antidepressants in general.

No one in the U.S. has similarly stepped forward to protect American consumers from the unreliable, exaggerated or falsified claims of drug or device manufacturers. The FDA is clearly unable to provide adequate oversight, and the Supreme Court – the last, legal resort for American consumers – appears to be sleeping with the enemy.

As early as last year, product liability attorneys warned that a Medtronic victory would deprive consumers of key legal weapons. David Prince, a law professor at the William Mitchell College of Law, disagrees, saying the Medtronic ruling won’t prevent suits, though it will make the process a lot harder. Time will tell, of course, but I’m willing to bet that 2008 will see the effective end of litigation by American consumers beset by corrupt manufacturers, an ineffective FDA and a crippled legal system.

Why am I such a pessimist? Between 2005-2006, FDA officials had 112 meetings with drug and device industry representatives but only five meetings with consumer and patient groups. Elsewhere in the healthcare industry, corruption runs equally rampant. In 2007 alone, insurance companies bilked Medicare of $75 billion, or one-fifth of the Medicare budget. They were able to do this because Medicare fraud oversight is virtually nonexistent and the Bush administration knows it. The disabled occupy another layer of the Bush hell. Social Security is virtually bankrupt, so states routinely reject first-time disability applications because they know that 75 percent of these applicants won’t appeal – either because they can’t afford a lawyer or because they don’t know they can. In fact, if not for the Bush administration’s accounting practices, which “cook the books” to keep the Social Security account funded, many seniors would not be able to collect either. Those under 40 will never collect.

The poor get poorer, while “Washington insiders” get the gravy. For example, federal law prohibits senior administration members from lobbying in private industry for about a year after leaving office, but this policy has been largely ignored under Bush. Michael Petrucelli, Victor Cerda, Carol DiBattiste, Tom Ridge, James Loy, and Asa Hutchinson have all transitioned from government to private industry with spectacularly lucrative results.

This transitioning also runs in the other direction, from industry to government (and back again). Take the case of Daniel E. Troy, one of the more than 100 top officials under Bush who moved into “regulating” the industries they once worked for. Troy, a former lawyer for major drug companies, was appointed chief counsel at the FDA. Troy resigned in 2004 and went to work for Sidley, Austin Brown & Wood, a legal firm representing drug companies like Eli Lilly. Charles Lambert, a former meat-industry lobbyist, remains in office as Deputy Undersecretary of the USDA, which helps decide how meat is labeled. The largest meat recall in history occurred on Lambert’s watch. Jeffrey Holmstead, a lawyer who represented an energy industry trade group, was appointed EPA Air and Radiation Chief. He resigned in 2005 and went to work for Bracewell and Giuliani, whose clients include utilities, coal-fired power plants and oil refineries. J. Steven Griles, a former lobbyist for oil and gas firms, was appointed Deputy Secretary of the U.S. Dept. of the Interior (which determines how much land can be exploited for gas and oil leases). Griles, appointed in 2001, continued to get almost $300,000 a year for the next four years from his former employer for his lobbying efforts – money which the Bush regime apparently didn’t view as a conflict of interest. Griles resigned in 2004 to start his own lobbying firm, Lundquist, Nethercutt and Griles. In 2007, Griles was convicted in the Jack Abramoff scandal and is serving time until July 2008.

In fact, under Bush, the only conflict of interest appears to be how much money to take before the industry’s deep pockets are emptied. Leaving the rest of us, who are not Washington insiders, to pay the price of this debauchery in higher costs, higher taxes, and federally-funded programs that no longer serve the people they were designed to help.