[Ip-health] Supreme Court rules Drug Companies exempt from Lawsuits

Riaz K Tayob riaz.tayob at gmail.com
Tue Jul 23 12:05:46 PDT 2013

{more profits... the best democracy (and judiciary) money can buy? who 
needs ALEC?}

      Supreme Court rules Drug Companies exempt from Lawsuits

Saturday, July 20, 2013

In case readers missed it with all the coverage of the Trayvon Martin 
murder trial and the Supreme Court's rulings on gay marriage and the 
Voting Rights Act, the US Supreme Court also made a ruling on lawsuits 
against drug companies for fraud, mislabeling, side effects and 
accidental death. From now on, 80 percent of all drugs are exempt from 
legal liability.

Drug companies failed to warn patients that toxic epidermal necrolysis 
was a side effect. But the Supreme Court ruled they're still not liable 
for damages.In a 5-4 vote, the US Supreme Court struck down a lower 
court's ruling and award for the victim of a pharmaceutical drug's 
adverse reaction. According to the victim and the state courts, the drug 
caused a flesh-eating side effect that left the patient permanently 
disfigured over most of her body.

The adverse reaction was hidden by the drug maker and later forced to be 
included on all warning labels. But the highest court in the land ruled 
that the victim had no legal grounds to sue the corporation because its 
drugs are exempt from lawsuits.

      Karen Bartlett vs. Mutual Pharmaceutical Company

In 2004, Karen Bartlett was prescribed the generic anti-inflammatory 
drug Sulindac, manufactured by Mutual Pharmaceutical, for her sore 
shoulder. Three weeks after taking the drug, Bartlett began suffering 
from a disease called, 'toxic epidermal necrolysis'. The condition is 
extremely painful and causes the victim's skin to peel off, exposing raw 
flesh in the same manner as a third degree burn victim.

Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing 
that the drug company included no warning about the possible side 
effect. A court agreed and awarded her $21 million. The FDA went on to 
force both Mutual, as well as the original drug manufacturer Merck & 
Co., to include the side effect on the two drugs' warning labels going 

Now, nine years after the tragedy began, the US Supreme Court overturned 
the state court's verdict and award. Justices cited the fact that all 
generic drugs and their manufacturers, some 80% of all drugs consumed in 
the United States, are exempt from liability for side effects, 
mislabeling or virtually any other negative reactions caused by their 
drugs. In short, the Court ruled that the FDA has ultimate authority 
over pharmaceuticals in the US. And if the FDA says a drug is safe, that 
takes precedent over actual facts, real victims and any and all adverse 

      Court ruling

The Court's ruling a week ago on behalf of generic drug makers is 
actually a continuation of a ruling made by the same Court in 2011. At 
that time, the Justices ruled that the original inventors and 
manufacturers of pharmaceutical drugs, also known as 'name brand' drugs, 
are the only ones that can be sued for mislabeling, fraud or adverse 
drug reactions and side effects. If the generic versions of the drugs 
are made from the exact same formula and labeled with the exact same 
warnings as their brand name counterparts, the generics and their 
manufacturers were not liable.

The Court ruled, "Because it is impossible for Mutual and other 
similarly situated manufacturers to comply with both state and federal 
law, New Hampshire's warning-based design-defect cause of action is 
pre-empted with respect to FDA-approved drugs sold in interstate commerce."

And that ruling flies in the face of both common sense and justice. And 
as Karen Bartlett can now attest, it leaves 240 million Americans 
unprotected from the deadly and torturous side effects of pharmaceutical 
drugs. As a reminder, the number one cause of preventable or accidental 
death in the US is pharmaceutical drugs.

      Critics react

Immediately upon the Supreme Court's ruling, both drug manufacturers and 
Wall Street investors were celebrating. As one financial analyst pointed 
out, drug company profits should skyrocket going forward. Not only do 
the pharmaceutical companies no longer have to worry about safety or 
side effects, they are exempt from the multi-million dollar 
court-imposed settlements awarded to victims of their drugs.

One industry critic was quoted by Reuters 
after the verdict. "Today's court decision provides a disincentive for 
generic makers of drugs to monitor safety of their products and to make 
sure that they have a surveillance system in place to detect adverse 
events that pose a threat to patients," Michael Carome, director of 
Public Citizen's Health Research Group told the news outlet.

Senate Judiciary Committee Chairman Patrick Leahy (D-VT) was quick to 
react to the ruling by writing a stern letter to FDA Commissioner 
Margaret Hamburg, "A consumer should not have her rights foreclosed 
simply because she takes the generic version of a prescription drug."

But an attorney for the drug companies, Jay P. Lefkowitz, took the 
opposing position saying, "It makes much more sense to rely on the 
judgments of the scientific and medical experts at the FDA, who look at 
drug issues for the nation at large, than those of a single state court 
jury that only has in front of it the terribly unfortunate circumstances 
of an adverse drug reaction."

In other words, if the FDA says something is safe, it doesn't matter if 
that decision is wrong or the result of lies, fraud or deception on the 
part of the world's pharmaceutical companies. And there's no way to sue 
the FDA for being wrong and costing millions of unsuspecting Americans 
their lives. That result leaves 240 million Americans unprotected from 
an industry responsible for more preventable deaths in the US than any 
other cause.

July 7, 2013. Washington, Whiteout Press 

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