Levaquin Trial Over Tendon Damage Underway in Federal Court
The first Levaquin trial, involving allegations that the popular antibiotic increases the risk of tendon ruptures, is underway in federal court in Minnesota.
The case was brought by John Schedin, 82, and is considered a bellwether trial for hundreds of other Levaquin lawsuits pending in federal and state courts throughout the country. The plaintiff alleges that Johnson & Johnson, and its subsidiary Ortho-McNeil-Janseen Pharmaceutical, failed to adequately warn patients and doctors about the risk of tendon damage from side effects of Levaquin.
Levaquin (levofloxacin) is a popular antibiotic that was first approved by the FDA in December 1996. It is prescribed to prevent infection by stopping the reproduction of bacteria, but it has also been found to be toxic to tendons, with users facing an increased risk of tendon damage and possible tendon ruptures from Levaquin.
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Learn MoreSchedin claims that he suffered Achilles tendon ruptures in both feet after being prescribed Levaquin. The trial is taking place before a jury in the U.S. District Court for the District of Minnesota, where all federal Levaquin suits have been consolidated for pretrial litigation as part of an MDL, or multidistrict litigation.
There are more than 2,600 similar lawsuits pending against Johnson & Johnson over tendon damage caused by Levaquin, according to a report by Bloomberg. Shedin’s case is one of six federal lawsuits selected for an early trial, known as a bellwether trial, to help attorneys gauge how juries will respond to evidence and testimony that is likely to be repeated throughout other suits. The outcome of this case and the other bellwether trials may help the parties reach a Levaquin settlement agreement or other resolution for the litigation.
On Monday, Schedin’s lawyer argued that Johnson & Johnson was aware of the risk of Levaquin tendon ruptures through adverse event reports from its distribution in Europe. However, the company allegedly suppressed data that showed Levaquin caused more ruptures than other antibiotics in its class and then helped engineer a study that concluded Levaquin caused no more tendon ruptures than other similar antibiotics. Schedin alleges that the study was rigged to provide the results Johnson & Johnson wanted and was not scientifically sound.
According to his complaint, Schedin was given Levaquin in 2005 at the age of 76 while suffering a respiratory infection. At that time, there was only one line in the medication guide mentioning a risk of tendon rupture. Later, the FDA determined that warning was inadequate.
In July 2008, the FDA required that a “black box” warning be added about the side effects of Levaquin and other similar antibiotics, which is the strongest warning that can be placed on a prescription medication. However, consumer advocates called for Levaquin tendon rupture warnings to be added at least two years earlier, with Public Citizen filing a petition with the FDA in 2006, insisting that consumers and the medical community be provided with clearer warnings about the risk of tendon damage.
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8 Comments
MARCIAApril 10, 2011 at 3:50 am
Was prescribed Levaquin (I.V.) in the hospital for the first time on February 26, 2010. Six days later, on March 3rd, I tried to walk to the restroom from my bed and was stunned by severe pain and stiffness in both Achilles Tendons and both hands. My tendons felt as though they had absolutely no elasticity whatsoever and the pain was at least an "eight." It is now thirteen months later and I sh[Show More]Was prescribed Levaquin (I.V.) in the hospital for the first time on February 26, 2010. Six days later, on March 3rd, I tried to walk to the restroom from my bed and was stunned by severe pain and stiffness in both Achilles Tendons and both hands. My tendons felt as though they had absolutely no elasticity whatsoever and the pain was at least an "eight." It is now thirteen months later and I show no signs of improvement. My primary care Doc brought up the connection with Levaquin and tendon problems to me in November of 2010; after being given Levaquin three more times since the initial dose. I have had Fibromyalgia since May of 2005 which may have made me more prone to problems. Has anyone out there been successful in suing Johnson & Johnson et al.? THANKS!
LindaApril 9, 2011 at 8:37 pm
I took Savella for only one week and at 10 p.m. , after not feeling good all day, my son took me to the emergency room. They put IV's in my arm heart monitors on my chest. I had a rapid heartbeat of 175 and it took two cardioversions to finally shock my heart into a normal rythem. I know it was the Savella because I never had this problem before and certainly not since. I suffer from neuropath[Show More]I took Savella for only one week and at 10 p.m. , after not feeling good all day, my son took me to the emergency room. They put IV's in my arm heart monitors on my chest. I had a rapid heartbeat of 175 and it took two cardioversions to finally shock my heart into a normal rythem. I know it was the Savella because I never had this problem before and certainly not since. I suffer from neuropathy in both feet and my doctor gave me a sample and told me to try it and see if I had some relief. My heart went into atrial flutter with rapid ventricular response. Please if an attorney wants to contact me regarding this I have all the paperwork from the hospital that night. Savella should be taken off the market NOW and everyone who suffered from the drug should be compesated......thank you
L LincolnApril 9, 2011 at 6:18 am
Yes, you ALL need a lawyer! I have one! They have been very professional. And NO...not a coincidence on your shoulder. Levaquin caused tear in my rotator cuff and the labrynth muscle in the shoulder!! Both require surgery. painful!! I have had the very same symptoms most of you had. I started taking it and just woke up with extreme joint pain and could barely walk! Ridiculous that the FDA knew t[Show More]Yes, you ALL need a lawyer! I have one! They have been very professional. And NO...not a coincidence on your shoulder. Levaquin caused tear in my rotator cuff and the labrynth muscle in the shoulder!! Both require surgery. painful!! I have had the very same symptoms most of you had. I started taking it and just woke up with extreme joint pain and could barely walk! Ridiculous that the FDA knew this but STILL no warning was placed on presc bottles. PLEASE CALL AND GET ATTY ASAP!
N ReadingerApril 1, 2011 at 12:48 am
On December 31,2010, I began taking Levaquin for 10 days. One month later, I was shaking a 3 liter cannister of liquid weighing about 5 pounds when I felt a sudden sharp pain in my left shoulder. An MRI revealed a tear of my rotator cuff and complete tear of my biceps tendon. ( As a result of a fall on my right shoulder 4 1/2 years ago, I had a partial tear of the biceps. SInce this initial in[Show More]On December 31,2010, I began taking Levaquin for 10 days. One month later, I was shaking a 3 liter cannister of liquid weighing about 5 pounds when I felt a sudden sharp pain in my left shoulder. An MRI revealed a tear of my rotator cuff and complete tear of my biceps tendon. ( As a result of a fall on my right shoulder 4 1/2 years ago, I had a partial tear of the biceps. SInce this initial injury, I have done many physical activities with my upper extremtities. I question if this injury is a coincidence or a side effect of Levaquin.
J. MinorMarch 28, 2011 at 1:51 pm
Within 2 days of being prescribed Levaquin, I couldn't move either arm beyond the height of my waist. Even though I looked it up and quit taking it right away, It has become so severe that some days, I can't pull the covers off myself to get out of bed. Since I experience several disabilities, my physicians aren't listening. The pain is becoming worse,and considering the Levaquin was prescribed la[Show More]Within 2 days of being prescribed Levaquin, I couldn't move either arm beyond the height of my waist. Even though I looked it up and quit taking it right away, It has become so severe that some days, I can't pull the covers off myself to get out of bed. Since I experience several disabilities, my physicians aren't listening. The pain is becoming worse,and considering the Levaquin was prescribed last SUMMER, and no one will even do anything beyond an x-ray which looks "mostly" nornal, I have nowhere to go. My Rhuematologist said that since these symptoms have lasted this long, it is unlikely to be caused by the drug. HE NEEDS TO READ THE PDR!!! I realize my situation pales in comparison to what those before me have said; my thoughts and prayers are with you. WE need a lawyer to take on a pro bono case against this drug company. Maybe they will listen to the incredible damages it has caused and take it OFF the markert, at the very least....
CindyFebruary 8, 2011 at 6:47 pm
I was prescribed Levaquin for resistant strep in late October, 2010. After taking this medication for 2 days, my right thumb was so swollen and red it wasn't functioning. At that point I read the "warnings" and saw the black box warning on tendons. I have SLE and have already had repeated problems with joint pain and a long history of tendonitis. I called the ENT that prescribed it, reporting that[Show More]I was prescribed Levaquin for resistant strep in late October, 2010. After taking this medication for 2 days, my right thumb was so swollen and red it wasn't functioning. At that point I read the "warnings" and saw the black box warning on tendons. I have SLE and have already had repeated problems with joint pain and a long history of tendonitis. I called the ENT that prescribed it, reporting that I was in extreme pain and that my right elbow was now also affected to the point I could no longer pour coffee. I asked him specifically about the tendon problems associated with the drug to which he responded I needn't worry - it was a 1 in a million chance and I replied I had been that "one in a million many times". At this point, he told me I watched too many movies. After the second day of taking the drug I stopped due to the increasing tendon problems I was experiencing and at that point I sought out my GP for her advice. I was sitting right there when she looked up "joint pain" and informed me that there was no indication for "joint pain" and that I was probably experiencing a "lupus flare". She advised me to take the remaining Levoquin prescription. My thumb returned to normal after a few weeks, however my right elbow has been permanently effected. After about a month, I went back to the ENT, still fighting strep in my tonsils. At this point he wrote me a prescription for Avelox and told me the elbow would "clear up in time". I went home and promptly looked up Avelox and was very angry to find he had prescribed a sister drug to the one I had just complained about. Luckily, I had a standing appointment with my Rhuematologist, who I consulted with about the possibility of my elbow tendonitis being related to Levaquin. It was her opinion the tendonitis was undoubtedly related, as I showed no other markers of a SLE flare such as the usual accompanying rash and blood test elevations and advised me against taking another course of what amounted to the same medication. I told my ENT of the pain involved in my right elbow which was undoubtedly tendonitis CAUSED by Levaquin according to my Rhuematogist and wanted him to report the drug as having produced this effect to the FDA for them to track. Instead, he gave me a lecture on the difficulties of bringing a drug to market and informed me the only step remaining if I refused the medication was tonsillectomy. After discussing the situation with my husband, I called his office and made another appointment to discuss the tonsillectomy and brought my husband with me. During this appointment I informed him of my decision not to take the Avelox because I was afraid it would worsen an already bad situation. He was very put out that another doctor had overridden his choice of prescriptions and told me that I had "too many cooks in the kitchen" and I needed to decide who to trust. This should of been a major "black box" warning to me to run from his office and find another doctor, yet he was highly recommended. He performed a tonsillectomy on December 16, 2010. I am completely healed from the operation which did yield both Strep C and Strep F living in crypts for who knows how long as I've been suffering from "tonsillitis" for years with out ever fully getting rid of the strep. Now I feel that both the ENT and my GP are at fault. Both knew that I had tendon issues, I complained to both regarding my elbow pain and my fear of taking the medication that specifically warned against it's use. I requested both report my reaction to the appropriate FDA agency that tracks "bad reactions" and determines a drug's safety and to list Levaquin as an allergy on my chart. To my knowledge neither doctor has complied with my request as they both had a hand in failing to realize the potential threat to my health, despite clear indications from me regarding the cause and effect of Levaquin.
michaelDecember 7, 2010 at 6:06 pm
That evil drug killed my soul mate. Even after the first course, she had bad tendon problems, and what do the doctors do prescribe it twice more and send her home with water pills for her swollen extemeties. Criminal conduct on somebodies part!!!!!!!
ThereseNovember 17, 2010 at 12:36 pm
Too little information, too late to help all the injured. What a travasty to the general population, just for profit.