A federal court jury in Minneapolis has decided the health care giant failed to properly warn about the risk of tendon damage linked to its Levaquin antibiotic and awarded damages of $1.8 million in compensatory and punitive damages to 82-year-old John Schedin. However, the jury rejected his claim that J&J violated state consumer-fraud law by misrepresenting or concealing information.
The retired salesman ruptured both Achilles tendons after taking the antibiotic and subsequently charged J&J and its Ortho-McNeil-Janssen Pharmaceuticals with failing to warn about tendon damage. He filed suit in 2008. During the trial, he testified his quality of life has declined - he can't vacation with his family and when he goes to bed, he must "crawl" up the stairs on his hands and knees (here is his lawsuit).
Two years ago, you may recall, the FDA required J&J and others that make the class of antibiotics known as fluoroquinolones to add warnings about the risk of tendonitis and tendon ruptures (back story). The risks are greatest in those over 60 years old; kidney, heart, and lung transplant recipients, and when used in conjunction with steroids, according to the FDA.
Schedin's lawyers charged that Ortho-McNeil failed to send doctors letters about Levaquin’s risks before the 2008 label change and that his doctor would have otherwise prescribed a different antibiotic. Although as Bloomberg News notes, the jury assigned 75 percent of the liability to J&J, 10 percent to Schedin and 15 percent to his doctor, reducing the judgment against Ortho to $630,000. There are approximately 2,600 Levaquin lawsuits in federal and state courts.
16 Comments
Congrats Mr. Schedin, I also have crawled on my hands and knees thanks to Levaquin. I have had 13 additional tendon surgeries besides Achilles and I can't wait for the truth to be told. Good luck to you in your recovery, but no amount of money makes up for the pain and suffering of tendon ruptures.
Finally, the drug company has to pay--Keep the law suits coming! Levaquin took me out of the game on Aug. 7, 2010. Johnson and Johnson, you make a nasty, cruel drug. Remember--NO FLUOROQUINOLONES, they cripple your body and your spirit. A huge thank you to the men and women of the jury.
Justice is served! FQ antibiotics have ruined my life. Indeed, I'd turn down 100 million to just get back 50% of my health, but that's not an option... hopefully these fines will at least prevent others from going through what I am by discouraging irresponsible use!
The lawsuit has turned out in the right direction, but they depended on the fact that in 2008 there were little or no warnings about tendon problems with the drug. Since that time many other patients have had their lives ruined (including my own) because they were prescribed Levaquin and they trusted their doctors and pharmacists. I believe the doctors are still prescribing Levaquin at an alarming rate and now the drug companies have a protective excuse because they have a warning label. Because doctors don't seem to know or care about someone's problems with this dangerous drug, it is now all on the patient's shoulders to make all the decisions concerning drug safety. I find the whole concept of putting the responsibility for risks and safety on the patient to be ridiculous. All the drug company has to do is hide behind a warning label. Then the patient bears the brunt of the bad prescrition. In this new situation the doctors, pharmacisits and drug companies are off the hook. There is something wrong with this picture.
One very, very small step in the right direction. But the thing that needs done most is to spread the word. I've printed up business cards warning about the dangers of levaquin, avelox, cipro, and floxin, and pass them out to anyone I meet. I tell them my story, how a round each of avelox and levaquin made me act and feel fifty years older than I actually am. After four months of living hell, I'm one of the lucky ones -- I recovered fully. Most "floxies" don't. I warn people that unless they are in a dire life threatening situation, don't ever take these demon drugs. The risk is not worth any purported benefit.
Levaquin left me with autonomic, motor, and sensory damage,& Innapropriate sinus tachycardia. I would give the millions back too, if I could have my life back.....also wrecked my hearing, vision, sense of taste & smell...It has been 4 years this month...the 1st pill did me in...The real kicker is I was given this drug for a UTI that I did'nt even have..I was dehydrated & the Dr. misdiagnosed me....My life has been hell ever since as the symptoms of damage seem to get worse as more time goes by....Thank you Levaquin, You frigged up my life !
I was injured from Levaquin right around the same time as John Schedin.
I also was prescribed this drug for beginning bronchitis.
My medical situation at that time was fainting with low electrolytes from a three day long flu bug and crushing my face. After being revived by an EMT team I was rushed to our local ER.
On top of my flu, I had a concussion, crushed face and broken septum, electrolyte imbalance and beginning bronchitis.
After two hours on an IV I was sent HOME! Against my incredulous and desperate please to be kept in the hospital with the most traumatic injury state of my life.
But, sorry, take these two pills ( levaquin) and be on your way.
I fainted again 3 minutes away from the hospital. I was rushed back by my frantic wife and put in a recorvery room where the next morning I was given two more levaquin pills.
No pamphlets.
Again sent home. That night in bed I developed symptoms so horrific I was crying in fear of dying. So week I couldn't lift my arms and having a difficult time breathing.
My arms and hands would get burning hot then cold and numb! It felt like my arms were being ripped out of their sockets! GI tract went nuts. Electric zaps all over...so many others.
Raced back to this same ER in morning by ambulance. They did basic tests and diagnosed "anxiety!"
Later, specialist diagnosed tendinitis, torn rotator cuff tear, brady cardia, GI tract ulceration ( couldn't eat and lost 40 lbs in 2 and 1/2 months)and many other unprecedented symptoms.
This ER never told me anything about this drug. Never said to stop it when I raced back in 36 hours in pain in tendons. They even said to keep taking it! Wouldn't allow me to ask if these horrific symptoms were possibly from Levaquin.
What a monster drug.
I filed a lawsuit claim in this same Minnesota Federal Court as John Schedin. I was also injured at the same time.
Hopefully, my case will be dealt with sooner than later.
These tendon damage lawsuits are just the beginning. I've seen my young,vibrant, beautiful daughter go from an active "I-can-do-anything"43 year old to an OLD woman, just because Levaquin was introduced into her IV when she was suffering from dehydration. Her WBC was elevated (because she was dehydrated) and so it was administered as a precaution. She has suffered Central Nervous System damage, is in constant pain, walks with a cane, has suffered muscle atrophy, small fiber neuropathy, large fiber neuropathy,memory loss, emotional instability, constant weakness. She must "bump" up the stairs to her bed at night.(All this happened beginning July 17, 2010.) Is this quality of life? I think not. Should Johnson & Johnson be held accountable? What about the clinic that administered the Levaquin? Could they not read the warnings about such damage prior to introducing this med into her IV? It's plainly included in the package insert. And if it is in the package insert why did the manufacturer see the need to continue to make this drug available?
I was given Levaquin through IV in an emergency clinic. I had ONE dose. I had an immediate reaction. To hopefully help I was given prednisone and NSAIDs, they made me worse. Too bad the doctors don't read the warnings that come with this med either. It specifically says not to give these meds with an adverse reaction because it will make it worse. It certainly did with me. For 8 days straight I felt I was being burned by acid from the inside out. It was the most excruciating pain I have even felt in my life. I am now left with severe damage to my peripheral nervous system with sensory, motor and autonomic involvement. My life as been forever changed. This is a small step in the right direction. Now we need to get awareness of the nervous system damage this drug can cause.
My wife was prescibed Levaquin. After 5 days she woke up form sleeping and her right anteior tendon ruptued completely. After a difficult sugery and 3 months in a non weight bearing cast she still cannot lift her foot. So now shefalls constanly and hasa greatly diminished quality of life.
These tendon damage lawsuits are just showing small glimpses into the horrendous ravages to the body that Levaquin causes. I've seen my young,vibrant, beautiful daughter go from an active "I-can-do-anything"43 year old, to being so debilitated that she has the physical limitations of an OLD woman. Through no fault of her own, Levaquin was introduced into an IV when she was suffering from dehydration. Her WBC was elevated (because she was dehydrated) and so this drug was administered "as a precaution". My precious daughter has suffered Central Nervous System damage, is in constant pain, walks with a cane, has suffered muscle atrophy, small fiber neuropathy, large fiber neuropathy,memory loss, emotional instability, constant weakness. She must "bump" up the stairs to her bed at night, if indeed, she has been able to even be up and about that day.She is unable to drive-a task all mothers in today's world find necessary;she is unable to prepare meals; she cannot shop for the family's groceries;she struggle to be present for her children and her husband; she frequently must spend days in bed unable to function at all(All this happened beginning July 17, 2010.) Does she have a desirable quality of life? I think not.Has her family suffered the loss and companionship of their mother and spouse? What will her future medical costs be? Will the family be bankrupt because of Levaquin? Should Johnson & Johnson be held accountable? What about the clinic that administered the Levaquin? Could the employees not read the warnings about such damage prior to introducing this med into her IV? Warnings are plainly included in the package insert. And if these dire warnings are necessary,then why did the manufacturer see the need to continue to make this drug available? How many sons, daughters, fathers, mothers, brothers, sisters, must have their lives destroyed because of irresponsible behavior by those very ones who claim to have developed agents that can cure us from illness.
Forest Labs has well-established franchises in the therapeutic areas of the central nervous and cardiovascular systems.
I was also "poison" by Levaquin. No problems for the 10 days I took it. But slowly over time the one tendon pain that started not long after taking Levaquin has turned into full body tendon issues. As an now ex athlete the past several years have been depressing and at times I certainly wished I wasn't here. These drugs (fqs) should be banned. In fact my mom who said for me to go to the Dr on that life ending day of the 1st tablet is a nurse and has been taking pain pills for so long due to tendon pain. She never even understood that the Cipro she had taken over the yrs started to get her. She is now unable to live her life like she would like.
Wow!!! I was prescribed Levaquin any number of times for severe bronchitis and pneumonia. At the same time, I was prescribed steroids, which, of course, made it all worse. Both IV and oral Levaquin have left me with five (5) shoulder surgeries, eight (8) finger surgeries and more to come. Rediculous and I can no longer use my right arm at all, as I have NO rotator cuff, nor any tendon to attatch it to. I, too, would give ANY amount of money to get my life back, but we all know I can't. It stinks, and all at a time when my life should be playing with my grandchildren and being able to enjoy traveling. Instead, I can hardly move and it is excrusiating to move. I really hope ALL of us who deserve a settlement get it, but I'm gussing that the corporate "Biggies" will get off for the most part. I hope not and I intend to continue telling my story aas others will be warned. I WANT MY LIFE BACK!!!!!
Thanks for ruining my life Levaquin. 5 years of pain from chronic tendon injuries and neuropathy due to this piece of crap drug.