U.S. justices block generic drug liability lawsuits (Supreme Court)

Reuters ^ | June 24, 2013 | Lawrence Hurley and Bill Berkrot

[opentalk]

WASHINGTON/NEW YORK, June 24 (Reuters) - The U.S. Supreme Court ruled on Monday that generic drugmakers cannot be sued under state law for adverse reactions to their products, a decision that consumer advocates called a blow to patient safety.

In a 5-4 vote, the court ruled for Mutual Pharmaceutical Co, owned by Sun Pharmaceutical Industries Ltd, overturning a multimillion-dollar jury award to a badly injured patient in New Hampshire who alleged a generic drug she had taken was unsafe based on its chemical design.

The majority opinion, written by Justice Samuel Alito, said the state's law could not run against federal laws on prescription medicines whose design has been approved by the U.S. Food and Drug Administration.

A Supreme Court ruling in 2011 found that pharmaceutical companies that make branded drugs are liable for inadequacies in safety warnings of a medicine's label, but not the makers of cheaper copies of those medicines.

Consumer watchdog group Public Citizen said the Supreme Court decision on Monday undermines patient safety at a time when about 80 percent of U.S. prescriptions are filled with generic medicines.

[Perdogg]

Here is the per curiam

http://www.supremecourt.gov/opinions/12pdf/12-142_8njq.pdf

[Buckeye McFrog]

Thus the Feds maintain their position as the One Stop Shop for influence peddling.

[Perdogg]

No, The supremacy clause was stated in the decision. The opinion was written by Alito and supported by the courts conservatives, plus Kennedy.

[Erik Latranyi]

Jeep should have stuck to its guns and not issued a recall on vehicles that exceeded all motor vehicle safety standards in place at the time.

[opentalk]

From article:

… Bartlett suffered a rare hypersensitivity reaction three weeks after she started taking it. Her skin began to peel off, leaving her severely disfigured with burn-like lesions over two-thirds of her body and nearly blind

At the time Bartlett filled her prescription, sulindac's label did not specifically refer to the serious skin reaction known as toxic epidermal necrolysis

[Buckeye McFrog]

Yep. The Supremacy Clause is WHY the Congress has become the One Stop Shop for Influence Peddling.

Much simpler than trying to deal with fifty Rick Perrys and ten thousand state legislators out there.

[opentalk]

[bert]

-—— a blow to patient safety.-——

A blow to former ambulance chasers who see the drug companies as free money

There should be a counter suit that destroys the lawyer bringing the suit

[Theoria]

Have lawsuits and get rid of regulations. Nothing wrong with redress.

[bert]

The lawyer/drug co’s is not redress. It is assault for fees, pure and simple.

[DannyTN]

Lawsuits are expensive and occur only after damage is already done.

Regs are expensive too, but not as expensive as lawsuits and are often helpful in preventing damage.

There is a place for both.

[VeniVidiVici]

They (the ambulance chasers) had successfully argued before the lower court that generic manufacturers facing design-defect claims could comply with both federal and state law by choosing not to make the drug at all.

Oh there you go. That would have been a much better outcome /s

BS lawsuit.

[catnipman]

I feel really sorry for this woman, but the SCOTUS decision makes sense to me. Generic drug companies are simply relying on the original FDA approval process, which is based on data submitted by the original drug maker and analyzed by the FDA. Assuming the generic drug is a faithful reproduction (an assumption I question more and more each day regarding many generics), then IF the original approval process faithfully met all of the federal requirements AND there was no skulduggery of any kind regarding faked or cherry-picked data, etc., then to me, this is a common sense ruling.

To me, it would seem the woman would have to prove the original drug company and/or the FDA committed some kind of fraudulent or illegal act regarding this particular horrific side-effect, e.g., they knew about this reaction and covered it up by NOT including it on the list of known reactions.

[a fool in paradise]

Insurance companies (soon to be the government) mandates using generics and the knock offs aren’t accountable for the outcomes of dodgey merchandise. Wonderful.

[opentalk]

Exactly, generic drugs are about 80 percent of U.S. prescriptions

[bravo whiskey]

another 5-4 decision.

[Amendment10]

The majority opinion, written by Justice Samuel Alito, said the state's law could not run against federal laws on prescription medicines whose design has been approved by the U.S. Food and Drug Administration.

Just as with constitutionally indefensible Obamacare, I think that official clarifications of the limits of Congress's Commerce clause powers by Thomas Jefferson and case precedent established by Supreme Court show that Justice Alito and other activist majority justices are wrong about this issue imo. More specifically, regardless what FDR's activist justices wanted everybody to believe about Congress's Commerce Clause powers, using terms like "does not extend" and "exclusively," Jefferson had noted that Congress has no business sticking its big nose into intrastate commerce.

“For the power given to Congress by the Constitution does not extend to the internal regulation of the commerce of a State, (that is to say of the commerce between citizen and citizen,) which remain exclusively (emphases added) with its own legislature; but to its external commerce only, that is to say, its commerce with another State, or with foreign nations, or with the Indian tribes.” –Thomas Jefferson, Jefferson’s Opinion on the Constitutionality of a National Bank : 1791.

"State inspection laws, health laws, and laws for regulating the internal commerce of a State, and those which respect turnpike roads, ferries, &c. are not within the power granted to Congress (emphases added)." --Gibbons v. Ogden, 1824.