[Ip-health] FW: [Strategy Lab] Supreme Court To Consider Whether To Bar Liability Lawsuits Against Pharmaceutical Companies

[Kaytee Riek]

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------ Forwarded Message
From: Coco Jervis <coco@champnetwork.org>
Date: Mon, 8 Sep 2008 14:09:39 -0400
To: Strategy Lab <strategylab@lists.mayfirst.org>
Subject: [Strategy Lab] Supreme Court To Consider Whether To Bar Liability
Lawsuits Against Pharmaceutical Companies


This is yet another example of how the Bush Administration is trying to
circumvent consumer protection laws. By making big PhRMA immune from
liability it will gradually shield drug makers from real accountability for
corporate mistakes and malfeasance that result in harmful or potential
deadly drug adverse reactions which are ofcourse a frequent major concern
for people living with HIV. According to a 1999 report by the Institute of
Medicine, adverse drug reactions are the fourth leading cause of death in
the United States and more than two million serious reactions occur every
year.  Lastly, given that some of the Supreme Court justices own major stock
in this industry how is it possible that they will be impartial?! (see
http://www.pharmalot.com/2008/05/supreme-court-justices-stock-holdings-preem
ption/)

Drug makers seek shield from lawsuits


Email Picture
<http://www.latimes.com/news/nationworld/nation/lat-supremecour_gy0fstke2007
0925085417,0,7859509,email.photo>
By David G. Savage, Los Angeles Times Staff Writer
 September 7, 2008
WASHINGTON -- Bridget Robb was awakened last December
<http://judiciary.senate.gov/testimony.cfm?id=3404&wit_id=7231> by a
powerful electric shock to her chest. "It was a jolt of electricity. It felt
like being shot in the chest or being hit by lightning," said the
34-year-old mother from a Philadelphia suburb.

She knew the cause of her agony. A device implanted in her chest was
supposed to shock her, but only if her heart had quit. Instead, because of
frayed wires, it misfired 31 times in 13 minutes.


She underwent two operations to replace the defective device, requiring
months of recovery.

Robb appears to be blocked from suing the manufacturer for compensation.
Earlier this year, the Supreme Court reinterpreted a 32-year-old federal law
as barring suits against makers of government-approved medical devices.

Now, in a case to be heard this fall, the court will consider whether to
extend this shield against lawsuits to the makers of prescription medicines
and over-the-counter drugs.

If so, it could make for a far-reaching change in the law, one brought about
with little public debate. Having failed to persuade Congress or the states
to limit such suits, the Bush administration and the pharmaceutical industry
went to court, and now they stand on the verge of shutting down tens of
thousands of lawsuits that have cost the industry billions of dollars in
jury verdicts and settlements.

"This is a radical restructuring of the American civil justice system," said
Georgetown law professor David C. Vladeck, formerly of the consumer advocacy
group Public Citizen.

Until recently, the right to a civil jury trial has been a historic
protection for consumers. People hurt by a defective product could sue and
ask a jury to award them damages. But the high court has been increasingly
skeptical of lawsuits and civil juries. A series of recent rulings has
limited lawsuits against businesses, but the biggest test will come before
the court on the day before the presidential election.

The new case before the court concerns a 62-year-old musician from Vermont
whose right arm was amputated after an anti-nausea drug was improperly
injected into an artery and caused gangrene. She sued the drug maker and was
awarded $6.7 million by a Vermont jury. The high court agreed to hear the
drug maker's appeal that the woman's suit, and others like it, should be
thrown out.

Advocates for the pharmaceutical industry say it makes more sense to have
experts at the Food and Drug Administration -- rather than jurors -- decide
whether a drug is safe or dangerous. In 2005 alone, 17,000 suits were filed
against drug makers, they say.

"Do we really want a jury in Peoria or Santa Fe deciding whether the design
of a medical device needs to be changed?" asked Washington lawyer Ted Olson,
who represented Medtronic this year in the medical devices case. And the
same logic applies to prescription drugs, he said.

Manufacturers have long chafed at this right to sue and the resulting big
jury verdicts. During the 1980s and 1990s, business lawyers and lobbyists
tried, with limited success, to persuade state legislatures and judges to
disallow some lawsuits and to limit damage awards.

The Bush administration tried a different approach. Bypassing Congress, it
had federal agencies reinterpret the laws on the books to conclude that jury
verdicts would conflict with federal policy.

Nowhere is this approach having more effect than in the area of drugs and
medical devices.

Before this decade, the FDA had maintained that regulatory laws passed by
Congress did not bar such lawsuits. Under the Bush administration, the FDA
changed course and said that its federal oversight of drugs and medical
devices barred most lawsuits concerning those products.

In February, the Supreme Court endorsed the administration's view in the
case of Riegel vs. Medtronic
<http://www.supremecourtus.gov/opinions/07pdf/06-179.pdf> . The justices in
an 8-1 decision rejected a suit filed by a New York man whose balloon
catheter burst in his chest.

The ruling was based on the Medical Device Amendments of 1976
<http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=
Cite> :+21USC360k, a law passed in the wake of the Dalkon Shield disaster.
This birth control device, introduced in 1970, was blamed for 12 deaths and
thousands of severe infections in young women.

To protect the public from unsafe devices, Congress told the FDA to approve
new medical devices before they went on the market. Nothing was said about
limiting lawsuits. At the time, California had its own law regulating the
sale of medical devices, and the new federal law said states could not
enforce "any requirement" that differed from the FDA rules.

This phrase was crucial to the high court's decision in February. The
justices said that a lawsuit filed under a state's consumer protection law
could impose an extra "requirement" on device makers and that, therefore,
the federal law "preempted" these suits.

 On Capitol Hill, Democrats reacted angrily. Sen. Edward M. Kennedy
(D-Mass.) and Rep. Henry A. Waxman (D-Beverly Hills) had been sponsors of
the 1976 law, and they said lawsuits provided extra protection for injured
persons. During the summer, they introduced a bill to reverse the court's
ruling. But Democrats say they will not take up the measure until next year.

On Nov. 3, the day before the presidential election, the court will hear the
case of Wyeth vs. Levine to decide whether to block suits against drug
makers.

"I never thought I would sue anybody," said Diana Levine, a Vermont musician
who has migraine headaches.

Her case involves a rare but previously reported complication of Phenergan,
a drug made by Wyeth. She had gone to a local clinic suffering from a severe
headache. She was given Demerol to relieve the pain and the second drug to
prevent vomiting and nausea. The warning label for Phenergan urges extreme
caution when administering the drug via injection so as to avoid striking an
artery.

The use of an intravenous drip would have posed no danger, medical experts
say, but instead the physician's assistant injected the drug into Levine's
arm and, apparently, struck an artery.

Within days, Levine was in a hospital with gangrene. Surgeons removed her
hand and then the lower part of her right arm. Levine, a widow, thought she
had lost her livelihood along with her arm, and she faced huge medical
bills.

She settled a case with the clinic and the physician's assistant and then
sued Wyeth, asserting that the drug maker should have warned against
injecting Phenergan under any circumstances. "Their drug is wonderful. The
problem is the method of administering it, and they knew it was dangerous,"
she said.

A jury in Montpelier, Vt., heard the evidence during a weeklong trial and
awarded Levine $6.7 million in damages. "It was so reassuring to think, 'My
God, our system of justice really works,' " Levine said.

But earlier this year, about the same time it shielded Medtronic and other
makers of medical devices, the Supreme Court agreed to hear Wyeth's appeal.

A broad collection of business groups, including the U.S. Chamber of
Commerce and the pharmaceutical industry, joined with the U.S. solicitor
general, representing the FDA, on Wyeth's side. They argue that the FDA had
approved the warning label for Phenergan and that a Vermont jury did not
have the authority or expertise to decide whether a stronger warning was
needed.

In response, consumer rights advocates say lawsuits can compensate patients
for injuries as well as alert the public to dangers the FDA might have
overlooked. "If I drive my car and the brakes fail and I hit someone, I'm
liable for the damage I caused," said law professor Vladeck. "Why should
companies have an immunity from liability that ordinary citizens don't have?
And that's what they are asking for."

----------

Toxic Drugs, Toxic System: Sociologist Predicts Drug Disasters, Says
Prescription Drug Harm Growing, Drug Testing, Approval And Marketing Flaws
http://www.medicalnewstoday.com/articles/117052.php
04 Aug 2008
Toxic drugs, toxic system: Sociologist predicts drug disasters, says
prescription drug harm growing, drug testing, approval and marketing flaws
 Americans are likely to be exposed to unacceptable side effects of
FDA-approved drugs such as Vioxx in the future because of fatal flaws in the
way new drugs are tested and marketed, according to research to be presented
today at the annual meeting of the American Sociological Association (ASA).

"Drug disasters are literally built into the current system of drug testing
and approvals in the United States," said Donald Light, the sociologist who
authored the study and a professor of comparative health policy at the
University of Medicine and Dentistry of New Jersey. "Recent changes in the
system have only increased the proportion of new drugs with serious risks."

According to a 1999 report for the Institute of Medicine, adverse drug
reactions (ADRs) are the fourth leading cause of death in the United States
and more than two million serious reactions occur every year. ADRs can occur
for a number of reasons, including improper prescribed dosage, drug abuse
and drug interactions.

Light's analysis identifies the organizational foundations of patient risk
from prescription drugs and suggests institutional reforms to help avoid or
reduce future drug disasters.

According to Light, rather than using current approved drugs as benchmarks
of efficacy, the existing testing system evaluates the effectiveness of new
drugs based on their effects compared to placebos. Systematic reviews
indicate that one in seven new drugs is superior to existing drugs, but two
in every seven new drugs result in side effects serious enough for action by
the U.S. Food and Drug Administration (FDA), including black box warnings,
adverse reaction warnings, or even withdrawal of the drug.

Based on this system, Light asserts that new drugs are twice as likely to
harm patients as to provide them with benefits superior to existing drugs.

Light's analysis suggests another flaw lies within the design of clinical
trials. He contends that pharmaceutical companies frequently design their
trails to minimize evidence of toxic side effects. To do so, they sample
from a healthier population atypical of patients who will actually take the
drug, excluding people who are older, poorer or who have multiple health
problems. Trials are run long enough to pick up main effects but not to
detect some long term side effects. Approvals are based on these data; so
drugs with harmful effects sometimes get through.

"Based on our current system, the designation of 'safe and effective' on
today's new drugs could be replaced with, 'apparently safe based on
incomplete information, and more effective than a placebo,'" Light said.

With regard to government oversight, Light cites serious under-funding of
the FDA, which creates a dependency on the pharmaceutical industry - the
industry FDA regulates - to pay its staff. In return for drug company
funding, Light says, the industry expects faster reviews, but faster reviews
potentially fail to identify serious long-term side effects.

"Speed-up reviews for safety have more than tripled the number of 'black box
warnings' of side effects or withdrawals after drugs are on the market,"
Light said. "Despite recent reforms to strengthen the FDA's role in
protecting the public from harmful drugs, the harm-benefit ratio is
worsening due to these reviews and relaxed rules that allow companies to
promote drugs for unapproved uses."

--
Coco Jervis, JD
Director of Policy
CHAMP - Community HIV/AIDS Mobilization Project
32 Broadway, Suite 1801
New York, NY 10004
t. 212.937.7955 x50
c. 646.342.4191
F. 401.633.7793
Coco@champnetwork.org
www.champnetwork.org <http://www.champnetwork.org>
AIDS2008.com


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