Written by Sadaka Associates
Friday, 21 March 2008 22:11
Stephanie Mencimer, Mother Jones
When it comes to notorious Bush political appointees, Daniel Troy’s name doesn’t usually make the top-10 list, overshadowed as he is by more high profile cronies such as FEMA’s Michael Brown. But for three years in the president’s first term, Troy served as the chief counsel to the Food and Drug Administration (FDA), where he quietly advanced a legal revolution that is playing out in earnest in the U.S. Supreme Court this year. This revolution has the potential to affect the health and safety of the nation’s citizens for years to come, all while making Troy a rich man. In fact, his career is an illustration of how the Bush administration’s revolving door has allowed industry lawyers to radically reshape regulatory agencies to benefit the big businesses they once represented and then profit from those changes when they return to the private sector.
Learn More: Mother Jones
New Supreme Court Bends to Big Business – Leaves Consumers Out in the Cold
Written by Sadaka Associates
Wednesday, 27 February 2008 20:31
Donna Riegel filed suit against Medtronic after a Medtronic catheter burst inside the artery of her husband Charles causing him to undergo emergency bypass surgery in 1996. Although Charles Riegel survived the surgery, he passed since, and Donna carried the fight all the way to the Supreme Court.
On Wednesday, February 20, 2008, in an 8-1 decision, the Supreme Court ruled against the estate of Riegel stating that devices subject to PMA are preempted insofar as they are not based on the violation of FDA laws. Federal law requires that a company must submit an application to the U.S. Food and Drug Administration (“FDA”) before a medical device can be sold. Medical devices are classified as Class I, II, or III. Generally speaking, Class III devices pose the most danger to the public. The FDA can approve a Class III medical device when a manufacturer shows that the device is either substantially equivalent to a device already on the market through the 510K process or that the device is safe through the pre-market approval process (PMA).
The catheter that caused Charles Riegel’s injuries was approved by the FDA through pre-market approval (PMA). PMA is the most stringent type of review required by the FDA. The main difference between 510K and PMA is that 510K focuses on substantial equivalency to a product already approved to go to market whereas PMA focuses on the safety of a previously unapproved product.
In simple terms: you can no longer sue a company for putting out a bad medical device if it goes through the PMA process.
What does this mean to you?
The Supreme Court dealt the American public a tremendous blow. No longer are you safe from desperate companies looking for patents to please shareholders. The Court wrongly relies on the supposed “scientific prowess” of an inept and dysfunctional federal Food and Drug Agency.
What can you do?
Only congress can fix this wrong.
WRITE YOUR CONGRESSPERSON [visit Public Citizen at www.citizen.org or People Over Profits at www.peopleoverprofits.org]
Written by Sadaka Associates
Thursday, 10 January 2008 15:06
Dave Stewart’s 72-year-old mother went to Stanford University Medical Center for double knee-replacement surgery in April. Four days later, she was dead.
To Stewart, an anesthesiologist, it seemed a classic case of medical malpractice. After the operation, his mother developed sharp abdominal pain that she described as “10 on a scale of 1 to 10,” according to her medical records.
The hospital failed to diagnose the cause of her pain and continued to treat her with narcotics. Her vital signs became unstable and she was moved to the intensive care unit, but she died of complications from an untreated bowel obstruction. State regulators cited the hospital in the case this fall.
Stewart and his two sisters decided to sue, and they approached two dozen lawyers. One after another declined to take the case, always for the same reason: It wasn’t worth the money.
In 1975, California enacted legislation capping malpractice payments after an outcry from doctors and insurers that oversized awards and skyrocketing insurance rates were driving physicians out of the state.
The law limited the amount of money for “pain and suffering” — usually the physical and emotional stress caused from an injury — to $250,000. There is no limit on what patients can collect for loss of future wages or other expenses.
Learn More: LA Times
This is a great article from the LA Times. The fact that tort reform creates a judicial system that discriminates against the poor and the elderly is revealed in this article.
As bit of background, when an attorney decides to take a case there are multiple considerations. A major consideration is the amount of damages that could be recovered. Simply put, damages can be thought of as economic (based primarily on how much the person was earning at the time of the accident) and non-economic damages. Non-economic damages include recovery for “pain and suffering”. Tort reform focuses on limiting the amount of recovery for pain and suffering through caps. For example, if a jury returned a verdict for $1,000,000.00 for pain and suffering in a state with $300,000.00 cap than the verdict will be reduced to $300,000.00.
The thing is caps on pain and suffering do not rise with the costs of litigation. Therefore, economic damages are critical to determining whether or not an attorney will take a case in a state with caps on non-economic damages.
As a result, individuals that were not earning much when they were injured in a state with caps will not find legal representation. For example, a cashier working for $12.00/hr gets paralyzed by a drunk driver in a state with caps on pain and suffering. As a result of the caps, the amount of money that she can recover is tied closely with the amount of money she could make over the rest of her “working life”. At $12.00/hr that could only amount to a few hundred thousand dollars. With the costs of trial and living rising substantially, attorneys will not take a case where the economic damages are not substantial thereby excluding our paralyzed cashier and the rest of the working poor and the elderly from the legal system. Is that fair? Is it fair that insurance companies who provide medical malpractice insurance to doctors show increased profits year after year and pay out less and less while raising premiums? Read this article and think about it.
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