Government Regulators to Preempt State Regulators?

September 25, 2008

I don’t think so…

NEW YORK TIMES
April 13, 2008
LETTER

Drug Makers’ Advantage

To the Editor:

Re “Drug Makers Near Old Goal: A Legal Shield” (front page, April 6):

There
is a kind of Alice-in-Wonderland quality as the Supreme Court comes
closer to affirming Food and Drug Administration pre-emption.

Every few months, another study concludes that the F.D.A. cannot fulfill even its basic responsibilities. Until the Bush administration, the F.D.A.
itself viewed civil liability and its own regulation as complementary
systems of consumer protection. And yet we are about to throw one of
those systems away.

Like the doctrine of pre-emptive war that led to Iraq, F.D.A.
pre-emption is a policy concocted in oblivion, an ideology without
connection to the ways the agency and industry actually work. The
editors of The New England Journal of Medicine recently wrote that that
policy would have cataclysmic consequences for patients’ rights,
industry accountability and public health.

It is not often that
doctors defend trial lawyers. Having now heard what the most respected
voice in American medicine has to say, we should have no illusions
where we are headed.

Henry Greenspan, Ph.D.
Ann Arbor, Mich., April 7, 2008

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Surprise! Unapproved Product is Unsafe.

September 24, 2008

One thing I have a difficult time in apprehending is how is it that unapproved drugs and solutions can find their way into the market place so easily? Isn’t the purpose of the Food & Drug Administration to oversee and make sure that food and drugs sold in the market are safe before they are found to be unsafe? It does not take much to know a product is unsafe when people have been hurt… Unless people are used in the testing of a product placed into the market place all with the FDA’s blessing.

All this just does not make sense to me.

Unapproved Eye Solution, Papain Drugs Cited by U.S.

The U.S. told companies to stop selling certain unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects had been associated with both products.The Food and Drug Administration warned it may act against companies that continue to sell ophthalmic balanced salt solution for the eyes and topical drugs containing papain, drawn from papayas, without regulatory approval, the agency said today in a statement.

After years of devoting few resources to unapproved drugs, FDA officials in 2006 said they would begin to crack down on the medicines. The agency has estimated they account for about 2 percent of prescriptions.

Companies selling unapproved versions of the eye drug and lesion treatment “have bypassed the requirement of the law and put consumers at risk,” said Deborah M. Autor, director of the FDA’s drug compliance office, on a conference call with reporters.

Unapproved versions of the eye drugs have been sold by Deerfield, Illinois-based Baxter International Inc., Lake Forest, Illinois-based Hospira Inc. and B. Braun Medical Inc., part of B. Braun Melsungen AG, a closely held company based in Melsungen, Germany, according to the FDA.

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Cost v. Coverage

September 16, 2008

Robert Samuelson on the Health-Care Surprise

Whoever wins should put health care at the top of his agenda. But the central problem is not improving coverage. It’s controlling costs. In 1960, health care accounted for $1 of every $20 spent in the U.S. economy; now that’s $1 of every $6, and the Congressional Budget Office projects that it could be $1 of every $4 by 2025. Ponder that: a quarter of the U.S. economy devoted to health care. Would we be better off? Probably not. Countless studies have shown that many diagnostic tests, surgeries and medical devices are either ineffective or unneeded. “More expensive care,” notes CBO director Peter Orszag, “does not always mean better care.”

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About the McDonald's Case

September 11, 2008

I hear a lot about the McDonald’s case and how frivolous lawsuits are hurting consumers. Of course no one is in favor of frivolous lawsuits. But, generally, frivolous lawsuits get dismissed or never get filed. Where attorneys work on a percentage of recovery basis, no attorney would want to spend time and money on a case where he knows there will be no recovery at all or chances of recovery is slim to none. It simply would not make sense to throw money away… And attorneys are not in the business of throwing money away.

Here is the story behind the McDonald Case:

Stella Liebeck of Albuquerque, New Mexico, was in the passenger seat of her grandson’s car when she was severely burned by McDonalds’ coffee in February 1992. Liebeck, 79 at the time, ordered coffee that was served in a styrofoam cup at the drive through window of a local McDonalds.

After receiving the order, the grandson pulled his car forward and stopped momentarily so that Liebeck could add cream and sugar to her coffee. (Critics of civil justice, who have pounced on this case, often charge that Liebeck was driving the car or that the vehicle was in motion when she spilled the coffee; neither is true.) Liebeck placed the cup between her knees and attempted to remove the plastic lid from the cup. As she removed the lid, the entire contents of the cup spilled into her lap.

The sweatpants Liebeck was wearing absorbed the coffee and held it next to her skin. A vascular surgeon determined that Liebeck suffered full thickness burns (or third-degree burns) over 6 percent of her body, including her inner thighs, perineum, buttocks, and genital and groin areas. She was hospitalized for eight days, during which time she underwent skin grafting. Liebeck, who also underwent debridement reatments, sought to settle her claim for $20,000, but McDonalds refused.

During discovery, McDonalds produced documents showing more than 700 claims by people burned by its coffee between 1982 and 1992. Some claims involved third-degree burns substantially similar to Liebecks. This history documented McDonalds’ knowledge about the extent and nature of this hazard.

McDonalds also said during discovery that, based on a consultants advice, it held its coffee at between 180 and 190 degrees fahrenheit to maintain optimum taste. He admitted that he had not evaluated the safety ramifications at this temperature. Other establishments sell coffee at substantially lower temperatures, and coffee served at home is generally 135 to 140 degrees.

Further, McDonalds’ quality assurance manager testified that the company actively enforces a requirement that coffee be held in the pot at 185 degrees, plus or minus five degrees. He also testified that a burn
hazard exists with any food substance served at 140 degrees or above, and that McDonalds coffee, at the temperature at which it was poured into styrofoam cups, was not fit for consumption because it would burn the mouth and throat. The quality assurance manager admitted that burns would occur, but testified that McDonalds had no intention of reducing the “holding temperature” of its coffee.

Plaintiffs’ expert, a scholar in thermodynamics applied to human skin burns, testified that liquids, at 180 degrees, will cause a full thickness burn to human skin in two to seven seconds. Other testimony showed that as the temperature decreased toward 155 degrees, the extent of the burn relative to the temperature decreases exponentially. Thus, if Liebeck’s spill had involved coffee at 155 degrees, the liquid would have cooled and given her time to avoid a serious burn.

McDonalds asserted that customers buy coffee on their way to work or home, intending to consume it here. However, the company’s own research showed that customers intend to consume the coffee immediately while driving.

McDonalds also argued that consumers know coffee is hot and that its customers want it that way. The company admitted its customers were unaware that they could suffer third degree burns from the coffee and that a statement on the side of the cup was not a “warning” but a “reminder” since the location of the writing would not warn customers of the hazard.

The jury awarded Liebeck $200,000 in compensatory damages. This amount was reduced to $160,000 because the jury found Liebeck 20 percent at fault in the spill. The jury also awarded Liebeck $2.7 million in punitive damages, which equals about two days of McDonalds’ coffee sales.

Post-verdict investigation found that the temperature of coffee at the local Albuquerque McDonalds had dropped to 158 degrees Fahrenheit.

The trial court subsequently reduced the punitive award to $480,000 – or three times compensatory damages – even though the judge called McDonalds’ conduct reckless, callous and willful.

After an appeal, the parties reached a confidential settlement.

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