You know, I love it when I hear the words "In a 5-4 decision.." It just tells me that I better pucker up my asshole, grab my piece of wood and know that as an American, I'm going to be taking it.
Sure enough, now I wont even be able to get generic pain medication to help with that soreness without the risk of dying..
Washington (CNN) -- Two women who say they suffered severe medical complications from a generic drug lost their Supreme Court appeal Thursday, essentially ending their separate lawsuits against pharmaceutical manufacturers.
The justices in a 5-4 ruling said generic drug companies do not share the same level of responsibility as makers of brand-name equivalents, to update their warning labels when significant new risks emerge.
The financial and safety implications from the court's ruling, could prove enormous. Generic drugs currently account for more than 70% of prescriptions filled in the United States. That number is expected to rise in the coming years, with patent protection due to expire on several popular and lucrative consumer drugs, including Lipitor and Viagra.
The blockbuster health care reform bill championed by President Nobel Peace Prize winner Barack H. Obama would also encourage greater use of generics. About a third of generic drugs have no brand name competitors.
The court split along conservative-liberal lines.
"It is beyond dispute that the federal statutes and regulations that apply to brand-name drug manufacturers are meaningfully different than those that apply to generic drug manufacturers," said Justice Clarence Thomas. "Indeed it is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing drugs more quickly and cheaply to the public."
In dissent, Justice Sonia Sotomayor countered, "These divergent liability rules threaten to reduce consumer demand for generics... Nothing in the court's opinion convinces me that, in enacting the requirement that generic labels match their corresponding brand-name labels, Congress intended these results."
Justices Ruth Bader Ginsburg, Stephen Breyer, and Elena Kagan supported Sotomayor.
Gladys Mensing of Minnesota and Julie Demahy of Louisiana both were prescribed metoclopramide -- marketed as Reglan by Wyeth Pharmaceuticals -- to treat their heartburn and acid reflux. Their pharmacists separately filled the prescription with a generic equivalent made by PLIVA, Inc. and Actavis, Inc.
After four years of taking the drugs, the women each developed tardive dyskinesia, a severe longterm neurological disorder that causes involuntary muscle movements.
They sued the generic manufacturers of the metoclopramide, claiming that inadequate warnings were provided about the long-term risks of taking the medicine. It was also alleged there was growing evidence of the dangers posed by the drug, but that the companies took no steps to change the warning labels.
In 2009, the FDA acted on its own and issued an order to the makers of both brand-name and generic versions of metoclopramide to add a specific warning about the increased risks of developing tardive dyskinesia.
The generic drug makers are trying to dismiss the lawsuits. They cite a 1984 congressional law pre-empting state "failure-to-warn" claims.
Drug companies have long asserted various doctrines of pre-emption, saying they are protected from most product-liability claims if they have met federal safety approval standards. They argue that federal regulatory judgments trump state consumer safety laws, which are often tougher than Washington's standards.
But the high court had given a big victory to patients and consumer rights groups in 2009 when it ruled in favor of plaintiff Diana Winn Levine, when she sued Wyeth -- now owned by Pfizer -- after losing an arm to gangrene from a common, brand-name anti-nausea prescription medication. She had won a $7 million judgment from a Vermont jury for her claims.
The Obama administration is backing the plaintiffs, concerned that if state lawsuits are pre-empted by federal law, that will reduce the incentive for generic drug makers to provide the most current safety information to the FDA.
Though perhaps the point is not to loosen the market, it's actually to choke out the public trust for generics and enrich big Pharma. Because that's what this is - The Worse of Both Worlds - Big Pharma gets to scare people back to buying their overpriced medication and shitty fly-by-night companies get to poison people with poorly made knockoffs.
Though that's just half the point. The other half is to simply kill off poor people who buy generics of necessity. Who am I kidding? Nobody who makes drugs gives a shit about drug safety anyway. Let's just be reasonable about all this.
In this story it's not that generics weren't poorly made. They didn't have the same warning that the name brand carried. The issue could have been easily resolved by having warnings harmonized across different drugs by tying them to the name of the active ingredient, not to the drug's brand name.
What really is the big problem with generics is the amount of Bioayailabity of the active ingredient. The rules have just been relaxed to the point where you can be getting between 80 to 120% of the equivalent dose of the name brand medication.
Just look at this part of the story again:
But the high court had given a big victory to patients and consumer rights groups in 2009 when it ruled in favor of plaintiff Diana Winn Levine, when she sued Wyeth -- now owned by Pfizer -- after losing an arm to gangrene from a common, brand-name anti-nausea prescription medication. She had won a $7 million judgment from a Vermont jury for her claims.In a morbid way, this is actually the best part of all this. This is mainly an issue where Congress is not seeing the need to regulate drugs effectively at all. And really, how surprising is that?
I'll just finish it off that at one point in time, a time before this news article and when these rules go into effect, I would have shamed you for not already buying generic drugs and you required your "Tylenol" and "Advil" to be on the label of your pill box to make your bougie headahce go away.
Now after this.. well, I guess unless you want some brain clot, you'd probably be better off paying extra for those brand names.
We should just fast forward to 10 years from now in a world where the Justices in a 5-4 ruling say that brand-name drug companies do not share the same level of responsibility as makers of generic equivalents, and they are to update their warning labels when significant new risks emerge.
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