Supreme Court sides with pharmaceutical industry in two decisions

June 24, 2011

By David G. Savage, Los Angeles Times

The Supreme Court gave the pharmaceutical industry a pair of victories, shielding the makers of generic drugs from most lawsuits by injured patients and declaring that drug makers have a free-speech right to buy private prescription records to boost their sales pitches to doctors.

In both decisions Thursday, the court’s conservative bloc formed the majority, and most of its liberals dissented.

About 75% of the prescriptions written in this country are for lower-cost generic versions of brand-name drugs. Federal law requires the makers of brand-name drugs to label their products with FDA-approved warning information and to update the warnings when reports of new problems arise.

But in a 5-4 decision, the high court said this same legal duty to warn patients of newly revealed dangers did not extend to the makers of copy-cat generic drugs.

Justice Clarence Thomas reasoned that the warning labels were the responsibility of the brand-name makers and the Food and Drug Administration. He said that because generics were just copies, their makers could not be sued for inadequate warnings if those warnings didn’t exist on the original.

Thomas said the federal regulatory law trumped the state liability law in this instance and therefore shielded the generic makers. “We acknowledge the unfortunate hand” that was dealt to the patients whose suits were dismissed Thursday, he wrote in his majority opinion.

The patients, Gladys Mensing and Julie Demahy, developed tardive dyskinesia, a severe neurological disorder, after taking metoclopramide, a generic form of the drug Reglan for digestive problems, including acid reflux. They sued, alleging that the drug maker failed to warn them of the danger of taking this drug for more than 12 weeks. Studies had suggested a potentially increased risk of the condition — and Reglan was eventually required to carry a “black box” warning about it. That wasn’t the case at the time.

In tossing out their claims in Pliva Inc. vs. Mensing, Thomas put the blame on “the special, and different, regulation of generic drugs.”

They are supposed to be copy-cat versions of the original, he said, so the makers cannot be sued for failing to give patients new and different warnings as they develop.

But the dissenters, led by Justice Sonia Sotomayor, said the generic drug maker should have alerted the FDA to the danger and then updated its warning label. “This outcome makes little sense,” she wrote. Justices Ruth Bader Ginsburg, Stephen G. Breyer and Elena Kagan agreed.

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2 Comments - what are your thoughts?

  • 2nd Supporter says:

    Mr. W,
    The salient point is RISK. Are you willing to take the risk of a dangerous life altering side effect not matter if it is generic or original, warned or unwarned? But the POINT IS, those warnings DIDN’T exist on the original brand name drug so the generic drug can’t be sued for something that DIDN’T EXIST! Re-read the article. Note this quote “Justice Clarence Thomas reasoned that the warning labels were the responsibility of the brand-name makers and the Food and Drug Administration. He said that because generics were just copies, their makers could not be sued for inadequate warnings IF THOSE WARNINGS DIDN’T EXIST ON THE ORIGINAL.” iT’S CYSTAL CLEAR… RESPONSIBILITY OF THE UNKNOWN SIDE EFFECTS IS THE RISK OF THE PATIENT NOT THE DRUG COMPANY, PROVIDED ALL DUE DILIGENCE IS DONE IN WARNING THE PATIENT WHICH IT WAS.

  • Joe Wilbur says:

    This particular ruling by the Supreme Court is not so supreme and doesn’t rule on behalf of the health and benefits of the citizens of the United States.
    Constantly, we hear that we have the best health care in the world. With the above ruling, I believe this statement to be false, we have the most expensive healthcare in the world.
    We have, sitting in the seats of the Suprene Court, obviously some so called human beings that don’t care about the health of the common man. If any one of these individuals would have contacted this same disease, obviously preventable with information from the pharmacuticals,they would be in court with a suit themselves. I just don’t understand how one citizen can alienate anothers life.
    The FDA says that we should not take drugs from another country because of the safety aspects-what safety are we guarenteed in this country that the maufactors of drugs that don’t have to tell what the side effects are and the Supreme Court agrees. So that leads me to believe that if I have to take a chance in my future healthcare why not get the least expensive way to perhaps get an unwanted side effect that the Supreme Court says is allowable because it is generic. Thank you Justices. Of course, a lot of the drugs that are in dispute from both the USA and foreign countries are manufactured in the good ole USA.

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