Tag Archives: Generic Drugs

Levaquin Production Stopped by J&J/Janssen Pharmaceuticals

Janssen Pharmaceuticals, part of Johnson & Johnson, has stopped production of (brand-name) Levaquin, according to the article, “Drug maker stopped making popular antibiotic Levaquin amid concerns about mental health side effects” published on the Indianapolis ABC affiliate RTV6 The Indy Channel. Janssen/J&J stopped producing both oral and IV Levaquin in December, 2017. The discontinuation of Levaquin production was confirmed by a Janssen/J&J spokesperson who stated, “The decision to discontinue LEVAQUIN was made due to the wide availability of alternative treatment options, and our focus on developing innovative medicines designed to address unmet medical patient needs.” Though that statement is BS propaganda, it is a direct confirmation from a Janssen Pharmaceuticals spokesperson that JANSSEN/JOHNSON & JOHNSON HAS DISCONTINUED PRODUCTION OF LEVAQUIN.

THIS IS REALLY BIG NEWS! IT’S HUGE! WHOA!

LEVAQUIN HAS BEEN REMOVED FROM THE MARKET!

Unfortunately, there is still plenty of levofloxacin (generic Levaquin, made by hundreds or thousands of generic pharmaceutical producers) on the market, and it is maiming (and killing) thousands of people each year. The fight against these drugs is far from over.

Still, the removal of brand-name LEVAQUIN from the market is a really big deal, and it’s something that we, as a community, should celebrate.

We did this. All the people who filed complaints with the FDA, who testified before the FDA, EMA, and other regulatory agencies, who reached out to the press and told their stories, who shared their story of pain and suffering brought on by fluoroquinolones, all the people who shared articles about fluoroquinolone toxicity, all the scientists who did research showing the harm done by fluoroquinolones, all the advocates, all the people in the floxie community, and all the people who listened–we did this! We screamed loudly enough that people listened. Our efforts made a difference, and Janssen Pharmaceuticals has stopped making Levaquin.

“Never doubt that a small group of committed people can change the world. Indeed it is the only thing that ever has.”—Margaret Mead

I never thought that one of the pharmaceutical giants that has made billions from fluroquinolones would stop making them. Janssen Pharmaceuticals and J&J are huge–they are behemoths–and I never thought that we could move or effect them. But we did.

The efforts of everyone in the “floxie” community contributed to this outcome. We–you–should be proud.

That is my optimistic take on things. We all have an optimistic side. We all have a pessimistic side too, and here’s the bad news.

Janssen decided to stop making Levaquin because, a) their market share was small because generic levofloxacin is cheaper and widely available (“’Levaquin was only about 1 percent of the market share, and 99 percent was the generic,’ said Bennett.”), and b) they were facing significant lawsuits, and to avoid liability for the drugs they created, they pulled them from the market.

Victims of pharmaceuticals can’t sue drug-makers for harming them, they can only sue for “failure to warn” of the dangers of the drugs. This is ridiculous – I can sue you for hitting me in the face with a sledgehammer even if you warn me that you’re going to do it and that it’s going to hurt – but pharmaceutical companies aren’t held to the same standards as you or me. It’s assumed that their deadly products are mainly good and that warning of the potential for bad effects is sufficient to wash their hands of liability and responsibility. On top of that, they don’t even have to directly warn YOU, they only have to say that they warned your doctor, the “learned intermediary” of the dangers of the drugs (or, at least they have to in theory – it’s assumed that doctors actually know what’s on the warning labels for pharmaceuticals… but most don’t). Both the “failure to warn” notion and the “learned intermediary” notions are crap, and I hate them, but they’re how the system is set up.

Because victims of pharmaceuticals can only sue for “failure to warn” the door for them to sue is only open when the drug warning labels change. Fluoroquinolone warning labels have undergone significant changes in recent years. In reverse-chronological order, the following warning label changes have been added to fluoroquinolone labels:

  • In July, 2018, fluoroquinolone warning labels were changed to note that, “Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects” – Drug Safety Communication
  • In July, 2016, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together” – Drug Safety Communication
  • In May, 2016, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects” – Drug Safety Communication
  • In August, 2013, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection” – Drug Safety Communication
  • In July, 2008, fluoroquinolone warning labels were changed to note that, “FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients.” – Drug Safety Communication

With each of these warning label changes, the door opened for people to sue Janssen and Johnson & Johnson for the harm that Levaquin did to them. (It should be noted that each of these warning labels changed because of advocacy done by the “floxie” community. We screamed, and, slowly, the FDA listened.) Some people did successfully sue the drug companies that hurt them–they gained some compensation and justice.

Perhaps it’s cynical, but it certainly seems more logical than the BS explanation the Janssen spokesperson gave (noted above) that the reason that Janssen Pharmaceuticals took Levaquin off the market was because they didn’t want to be held liable for the blood sugar level changes and the mental health side-effects of Levaquin. They weren’t making much money off it anyhow (because of generics taking the bulk of the market share), this warning label update opened up a new load of liability, and they did a cost-benefit analysis that led them to take it off the market.

All’s well that ends well, and they took Levaquin off the market, and that’s a good thing, right? Well, it’s more complicated than that.

Because of a stupid and asinine rule put in place by the FDA and a lousy decision of the Supreme Court, victims of generic pharmaceuticals cannot sue generic pharmaceutical manufacturers. It all goes back to the “failure to warn” rules noted above. The FDA says that only brand-name drug manufacturers can change drug warning labels, and since generic drug manufacturers can’t change the warning labels, they cannot be held responsible for what’s on the warning labels. This results in victims of generic drugs being unable to hold anyone responsible for the harm done to them by the drugs. There have been a couple cases where brand-name drug companies were held responsible for the harm done by generic drugs, but the precedent wasn’t set very solidly, and most attorneys in most states still aren’t taking cases of people who have been hurt by generic pharmaceuticals. Still, I think that Janssen and J&J saw the writing on the wall–that they could potentially be held responsible for all the Levaquin and levofloxacin-induced mental health side effects, permanently disabling side effects, permanent peripheral neuropathy, tendon tears, and more. So, they hedged their bets. Their legal team, I’m betting, will now argue that they can’t be held responsible for the harm done by levofloxacin because they don’t even make Levaquin any more, and how can they be held responsible for a product that they don’t even produce? My reply is that they can, and should, be held responsible for the drug that THEY CREATED. Johnson & Johnson created and held the patent on Levaquin for a long time. They made billions of dollars off of it. They can, and should, be held responsible for the effects of their creation. The generic drug companies should also be held responsible for the harm that their drugs do, and the FDA should be held responsible for their warning labels (and failure to warn the public about these incredibly dangerous drugs).

We pushed the FDA to change their warning labels. They did, and we should be proud of that. The warning label changes scared Janssen and J&J enough that they stopped production of Levaquin, and we should be proud of that too.

We should also be diligent about the consequences of the removal of Levaquin from the market, and we should continue to work for change in the legal/justice system so that it leans more toward justice for victims, and less toward corporate protection. It is horridly difficult for victims of pharmaceuticals to gain justice or compensation through the legal system as it is currently set up. Janssen pharmaceuticals just made a move to make it even more difficult for victims of Levaquin and levofloxacin to gain justice.

Know what they’re doing. Stay on top of them. Celebrate our victories, then come back to the battlefield fighting. As long as millions of prescriptions of levofloxacin are distributed each year, and thousands of people are maimed by the drugs, our fight isn’t over.

Generic Drugs and (a lack of) Justice

IF YOU ARE HURT BY A GENERIC DRUG, YOU CANNOT SUE.  YOU HAVE NO RECOURSE WHATSOEVER.

What a sad state of affairs.

More information about this travesty can be found in the post, “HURT BY A GENERIC DRUG? VICTIMS HAVE NO RECOURSE UNLESS THE FDA CHANGES RULES” on Hormones Matter.

The FDA can change a rule and enable people who are hurt by generic drugs to gain the same level of recourse as those who are hurt by name-brand drugs.  I hope that the FDA does the right thing.

 

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FDA Testimony

Generic Fluoroquinolone Testimony FDA

Me practicing my speech. I won’t wear my fleece hoodie for the real thing. :p

I’m in Washington D.C. and will be testifying to the FDA at approximately 8:30 am EST on Friday March 27, 2015.  Rachel Brummert, President of the QVF will be testifying at approximately 3:50 pm EST the same day.

You can view our testimony through the webcast link noted in this FDA meeting announcement – http://www.fda.gov/Drugs/NewsEvents/ucm431265.htm

Rachel and I will do our best to tell stories of pain and suffering caused by fluoroquinolones, and to encourage the FDA to change the rules that are keeping people who are hurt by generic drugs from gaining recourse through the justice system.

A couple of notes – I wasn’t able to fit in all of the stories that were sent to me.  I had to cut many poignant stories because of time–I’m allowed to speak for 5 minutes.  Everyone who sent me your story – THANK YOU!  I wish that I could tell them all!

Also, this hearing is not about fluoroquinolones specifically.  It is about the fact that generic drug manufacturers cannot be held legally responsible for the damage done by their products.  Many people who have been hurt by various generic drugs will be testifying.  Generic drug manufacturers will also be testifying.  I can’t imagine what they’ll say though.  Are they actually going to argue that they shouldn’t be held responsible for the safety of their products?  Probably.  But if they can’t be held responsible for the damage done by their products, who will be held responsible?  The FDA?  Last I checked, suing government agencies wasn’t possible.  Generic drug manufacturers need to be held responsible for the damage caused by their drugs.  I hope that the FDA does what is in their power to make generic pharmaceutical companies liable for the drugs they make.

 

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Testifying for Justice for Victims of Generic Drugs

Thousands of victims of generic ciprofloxacin, levofloxacin, moxifloxacin and ofloxacin have been unable to pursue legal recourse because of a couple of Supreme Court decisions that ruled that generic drug manufacturers cannot be held liable for harm caused by their products.

You can read more about these horrible Supreme Court decisions in this June, 2013 New York Times article, “In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs.

People are just as legitimately hurt by generic drugs as they are by name-brand drugs.  Arbitrarily taking justice away from a person because they were hurt by a generic drug is infuriating and wrong.

I have been given the opportunity to do something about this horribly unjust situation.

I have been invited by the American Association for Justice to speak at a Congressional Hearing on Capitol Hill on March 26th and to testify at a FDA hearing on March 27th regarding the lack of legal recourse for those hurt by generic pharmaceuticals.

This is a VERY exciting opportunity and I am honored to be able to tell Congress and the FDA about the harm that generic fluoroquinolones have done, and to encourage them to enact legislative changes that enable those who have been harmed by generic drugs to seek recourse and gain justice.

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Rachel Brummert, President of the Quinolone Vigilance Foundation, will also be presenting/testifying and you can learn more about what this opportunity will involve for both of us by reading the March 6th post on www.saferpills.org, “Executive Director Rachel Brummert speaking at Congressional Hearing and FDA Hearing.

It would be great if as many stories as possible about the pain caused by generic fluoroquinolones could be heard.  There are a couple of ways that you can share your story of pain caused by a generic fluoroquinolone, and the lack of justice available to you.

First, you can submit a comment to the FDA.  Instructions on how to do so can be found in the March 4th post on www.saferpills.org, “Generic Drug Victims: Share your story.”  I encourage EVERYONE to submit their story as a public comment.  Public comments really do make a difference!

Second, both Rachel and I would love to share some of your stories in our testimonies.  If you can please email either of us your stories, and what you would like us to say on your behalf to Congress and the FDA, we will appreciate it!  My email address is floxiehope@gmail.com and Rachel’s is Rachel@saferpills.org.  Rachel and I will coordinate so that we can tell as many stories as possible within the time allotted to us.  We can’t promise that we’ll be able to get to everyone’s story, and we will need to edit the stories for time and relevance, but we would love to share as many impactful stories as possible.  Please send either me or Rachel your stories / what you want us to say on your behalf, asap.  We need to get a drafts of what we are going to say to the American Association for Justice by the end of this week.  Sorry for the time crunch and thank you very much!

Thank you,

Lisa

 

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