An asset management firm that specializes in socially responsible investing has submitted a shareholder proposal to Johnson & Johnson in an attempt to force the health care giant to change its approach toward patients who were allegedly injured by its Levaquin antibiotic. So far, though, J&J has resisted the effort, according toThe Star-Ledger of New Jersey.
The move comes as some 2,600 lawsuits have started to move through federal and state courts over allegations that the antibiotic causes severe and lasting tendon damage, among other side effects. Three months ago, a New Jersey state court jury ruled that J&J was not responsible for damage suffered by two men who took the antibiotic. The decision was the second consecutive verdict that the drugmaker won, although J&J lost the first trial (back story).
The extent of the litigation and the ensuing publicity - including a PBS segment - are what prompted Jack Ucciferri, director of research and advocacy for Harrington Investments, to submit the shareholder proposal. “When something generates this much litigation and this much negative attention, maybe it’s time to take a look at whether the product is worth the hassle, and the expense,’’ he tells the paper. “We were appalled at the number of lawsuits.’’ His firm manages a total of about 16,000 for various clients.
[UPDATE: We spoke with Ucciferri and he told us this: "People are in tears and they feel they have no recourse. They're getting shut out by the courts. By the amount of litigation there seemed to be something worthy of consideration. And this is an issue area that I'm going to be looking at more closely. I believe the more communication between management and boards and shareholders the better.
"Management does all it can to silence an issue rather than bring out in the open. The notion that filing a proposal that we would cost a company unnecessary resources just to discuss the potential dangers of a product is a scurrilous argument... When that happens, the shareholders pay the price. It's unfortunate we have to battle with management to such an extent."]
However, a J&J spokesman tells the paper that the health care giant has asked the US Securities and Exchange Commission to disqualify the proposal because safety issues concerning Levaquin have been addressed in product warnings. “We’re very sensitive to the issues,’’ he tells the paper. [UPDATE: Here is the shareholder proposal submitted by Harrington].
This is far from the first time that socially responsible investing has emerged as an issue for drugmakers. Generally, the topic is raised in connection with prescription-drug prices. Last year, for instance, several religious groups - including an order of Catholic nuns and a chain of Catholic hospitals - unsuccessfully attempted to pressure a few drugmakers to exercise price restraint and placed proposals for votes at annual shareholder meetings (see here).
Whether Harrington will prevail is unclear. Paul Hodgson, a senior research associate at GMI, a corpoate governance researcher at GMI, notes that shareholder proposals are often disqualified based on the SEC’s ordinary business rule, which applies when a company and regulators believe shareholders are trying to make decisions for management. However, he tells the paper, that "if a drug is the subject of large litigation, it can affect the company’s bottom line and that is of concern to shareholders.’’
Initially, the Levaquin labeling warned about possible risks of tendon ruptures, but an upgraded Black Box warning was added nearly four years ago, following a lawsuit filed against the FDA by Public Citizen, which sought warnings on the entire class of antibiotics called fluroquinolones, which includes Levaquin (see here and here).
Even if Harrington succeeds in seeing its proposal make it to the J&J proxy for a shareholder vote, there is no guarantee the issue will resonate. As Sid Wolfe of Public Citizen notes, Levaquin has been a consistently big seller - generating nearly $1.5 billion in sales last year, for instance. “The company had every ability to do something earlier," he tells the paper. "But the truth is, the more warning there is on a drug, it will arguably reduce the use of it.’’ Meanwhile, patent protection expired last year.
27 Comments
I bought shares of Johnson and Johnson stock and attended their annual shareholder meeting in New Brunswick, NJ. This was a difficult trip with my Levaquin injuries. I was able to speak on the microphone during the question and answer period directly to CEO Mr. William Weldon, the JNJ board directors, and the shareholders. I kept my speech very civil and respectful. I didn't ask for anything for myself. I simply asked for further safety warnings on Levaquin and for medical research to help those of us that are suffering. I received a very loud round of applause from the shareholders. The vast majority of shareholders gave my speech a standing ovation. The JNJ shareholders were very conscientious. Many that are suffering from Levaquin are in wheelchairs, using walkers, or are bedridden for months, years, or permanently. I have been suffering for over six years. Mr. Weldon was so moved by my speech that he actually sat down with me after the meeting. He said he was sorry about what happened to me from Levaquin. I gave him medical documentation on Levaquin, which he accepted. He assured me that he would look into it and help me. I have yet to hear back from him. I honestly thought he was being sincere. I realize now that he sat down with me simply to do damage control based on my speech. He wanted to give the appearance to the shareholders, institutional investors, and the press that he truely cared. My family has taped copies of my shareholder speech.
Dr. Jay Cohen, a medical researcher and professor at the University of California, states that it is unconscionable that the manufacturers of these antibiotics have not attempted to study how to help people that are suffering.
Sincerely, John
I sustained terrible leg damage from a 10 day course of Levaquin in 2008. I was so shocked that an antibiotic could cause such painful, debilitating bi-lateral leg injuries, that I made a documentary about the dangers of Levaquin, titled, "Certain Adverse Events." The film features Sid Wolfe, who is quoted in this article, and the legal experts at Public Citizen. They sued the FDA in 2008 to force stronger warnings on Levaquin and all fluoroquinolone antibiotics. Once, I was an avid walker, and had a film career that required mobility and for me to be on my feet 12- 18 hours/day. That all ended from 10 pills of Levaquin.
I had only one IV dose of Levaquin, which has significantly changed my life. The reaction was immediate, fast and furious. Almost 2 years later I still suffer from the affects. I have small and large fiber peripheral nerve damage with sensory, motor and autonomic damage. I once was a very active person in my community and exercised daily. Now some days it is even difficult to get out of bed. I require the use of hand controls to drive, but still I am limited to driving short distances due to muscle fatigue. I can no longer have long phone conversations because of voice fatigue. Everyday household activities are very difficult for me, and I require help with most of them. This makes it very difficult for me to be the wife and mom that I would like to be. All because of one dose of Levaquin.
I took 750 mgs of Levaquin for 21 days in 2007 for supposed routine infection. Prior to, I was athletic, healthy, and no significant health problems. Today, I suffer from ongoing tendon/muscle issues, neuropathy, severe un-abating gastrointestinal issues, severe fatigue, and various autonomic issues. Had I been informed as to the risk of taking this medication I would have chosen a much safer alternative. In addition suffering is compounded because the medical community is woefully ignorant to the suffering that they can cause.
Thank you for shedding light on this important topic Mr. Silverman. Johnson & Johnson need to be reminded of their company's credo, to "put the needs and well-being of the people we serve first." Crippling people with one of their products, under-educating the medical community concerning the frequency, longevity, and severity of the adverse reactions associated with their product, and abandoning those very people that they "serve" with no treatment or cure demonstrates their failure to meet said credo. Thousands upon thousands of people have had their lives ruined due to their negligence. The medical community needs to be adequately educated about these serious safety concerns so that physicians may more accurately way the benefit to risk ratio when prescribing their patients Levaquin. Patients should have the right to informed consent.
I wasn't warned, and Levaquin ruined my life. I went from being a healthy, active elementary school teacher in my twenties, to a housebound mother in chronic pain, crippled for years by Levaquin. I have lost my mobility, my quality of life, my career, my home...all because I took Levaquin as a precaution after sinus surgery. Within 3 days, I was rendered immobile and in excruciating pain. I've been house/medical bed/wheelchair bound ever since. My entire body has been affected, all of my joints, tendons, muscles, connective tissues, and central & peripheral nervous systems...there's more but I will leave it at that. This tragic toxicity has devastated my family and at this point with no treatment or cure available for fluoroquinolone antibiotic toxicity, our future looks bleak.
I survived my 7 days of Levaquin and I do mean survived. I took one pill and immediately checked out mentally. I have very few recollections of the 7 days of 500 mg once a day. My symptoms on the medication ranged from extreme nightmares, depersonalization, inability to sleep,anxiety attacks, missing time, delerium, fever for 2 hours after I took the pill, then dropped to 96.2 degrees and I was unable to get my body temp up, frozen to the core, inability to empty my bladder, itching, tinnitus, hair falling out, burning skin, broken teeth both times, irregular heartbeats, shaking so bad that I could barely feed myself, semi-hysteria, depression, suicidal thoughts, my skin literally hung from my bones due to collagen degeneration, , lost 15 pounds, my vision was gone almost overnight. I now have to wear glasses because my vision was so damaged I struggled to see my own hand in front of me. My bones hurt. My tendons snapped. My body ached. My joints swelled. A week after I stopped the meds, I suffered a severe tendon pull from opening a bottle of water. I have bilateral shoulder tendionnitis I could not extend my arm for 3 months. I could not raise my arms above my waist for 17 months. It burned like fire from the pull and my elbow filled with blood. My thyroid seemed to stop working as all of my hypothyroid symptoms returned on top of the Levaquin induced symptoms. My blood pressure was so high it terrified my doctor. I was a stroke just waiting to happen. It took me four months to regain my memory. I still remember very little of the floxing week. I do remember freaking out over the periods of missing time. I did tell everyone around me that I was having dark thoughts and voices telling me to kill myself. The Black Box warning should cover more than tendon ruptures, a tendon rupture is a joke compared to the real damage these drugs do.
Fifteen months ago I took one 750 mg pill of Levaquin for a UTI. Within an hour, I was on the bathroom floor at work, shaking uncontrollably, had a racing heart, couldn't breathe, etc. This was only the very beginning of what I was in store for. I couldn't eat and lost 20 lbs the first month. I was found to have hypothyroidism. I shake, my skin and muscles feel on fire, I have floaters and blurred vision, my muscles are weak and achy, my tendons feel like they'll snap when I walk, constant nausea, headaches, bladder, kidney and liver issues and the list goes on and on. Johnson & Johnson's warnings are not sufficient, because my doctor and pharmacist never warned me. Now this company is trying to silence everyone concerned about how devastating these antibiotics can be. Our numbers just keep increasing though. Eventually there will be so many of us affected that they'll have no choice but to acknowledge us!
I am a victim of Fluoroquinolone antibiotics. I took Cipro in december of 2010 and have only recently began to feel normal again over a year later. It has been the hardest thing I have endured in my life. I went from perfectly healthy to near death in two weeks after cipro. Dont let it happen to you!
I took two doses of 500 mg Cipro in May of 2011. Within 12 hours I couldn't bear weight on my left leg. Within a few weeks I was wheelchair bound for several months. It's been 8 months now, and I am still unable to walk normally and rely on a cane and/or walker if I need to walk further than the 100 feet to my mailbox. The additional symptoms of cns/pns, brain fog, insomnia, detachment, anxiety...those are horrid, but nothing is worse for me than the unrelenting pain in my 5 affected joints. Personally, I believe these antibiotics have their place, but never, EVER as a first line of treatment for a simple infection as they're being used now. Be your own health advocate. Do your research and learn the facts. Don't let this happen to you or those you love.
I took Cipro 5 pills in September 2011 for a bladder infection. The pain started in my legs and spread to my arms and shoulders. I could barely walk. I never felt anything like this in my life. I had photosensitivity, tinnitus, brain fog, severe fatigue. It has been 4 months, and I am still in pain everyday. My legs are better, but my shoulders and neck hurt pretty bad. Tomorrow I will see a doctor again for this. I pray that there is something he can do to help me. Most doctors will not admit that these drugs are at fault. I hope that something will be done to stop the use of these antibiotics (fluoroquinolones) in treating infections that could have been treated with another drug. They were not supposed to be used in this way.
In the fall of 2007 I was given Levaquin, one of several antibiotics in a class called fluoroquinolones which also includes Cipro, Avelox and some others. No one discussed the many possible side effects with me despite the fact that this drug has what is called a black box warning, the most serious warning about problems there is before a drug is removed from the marketplace entirely. In fact, more than half of all the related drugs have already been banned.
I immediately began to feel sick but I was already dealing with a variety of other post surgical issues and was whacked on pain pills so no one took me seriously. In the course of the next few months I endured a horrible series of medical problems and yet no one caring for me was able to figure out what was going on despite the fact that nearly all these things are listed in the literature about Levaquin.
I was dizzy, nauseous, tired and confused. I lost control of my bladder and had horrific gas and diarrhea. My whole body hurt. I had blood clots. I had ruptured tendons and unexplained cartilage damage. My blood pressure went through the ceiling. My prostate bloated up. I had insomnia. I had pulmonary edema. My stomach hurt and I had terrible heartburn. I had a hematoma and huge varicose veins erupted on my leg. I had rashes all over, and mysterious bruises, and my wounds wouldn't heal. My skin felt like bugs were crawling around underneath it. I had tingling sensations in my back that went all over my body. I had unprompted sharp pains all over that appeared and disappeared. My joints hurt and they began popping loudly. I had ringing in my ears. I had wild crazy panic attacks. I couldn't understand what I was reading, or make sense of signs, or follow a TV show, or even tell time. My vision deteriorated rapidly. My blood oxygen levels were low. And for some reason I was really depressed.
As of January 2012, it's been almost four and a half years since I was floxed (that's the informal term for victims of fluoroquinolone toxicity) and I am still a mess. Fortunately, things aren't nearly as bad as they were. At this point I am able to work part time but that will probably not last a whole lot longer; my discs are crumbling and my knees are going. Unfortunately, the damage from fluoroquinolones is permanent and ongoing; as some things heal others continue to deteriorate.
Fluoroquinolones were designed to be a last resort antibiotic and yet they are being prescribed for sinus and urinary infections. The manufacturer admits that all these side effects happen but they claim that only 0.7% of the population will experience them, and yet if you Google these drugs page after page after page will come up with support groups and facebook pages and stories of misery just like mine. The problem is that the onset of these symptoms is often delayed, sometimes by months or even years so a huge percentage of the victims have no idea what caused the problems. They are then misdiagnosed. The other problem is that most people who get symptoms get most or all of them. The problems are systemic; fluoroquinolones alter the DNA. The problems are also permanent.
There is very little research being done in regards to this problem because the various producers of these drugs are making huge profits selling them. They are in complete denial that these problems even exist and the FDA is ridiculously underfunded and overworked.
Not only do these drugs need to be severely restricted in their use, but the various companies producing them need to compensate all the victims of their corporate greed and the executives need to be locked away in prison for the rest of their lives!
DO NOT TAKE LEVAQUIN, CIPRO, OR AVELOX!
Thank You,
Mark Girard
I am the victim of FQ poisoning that has destroyed my life for the last 5 years. I was never given a package insert to read and was never told about the dangers of these drugs. What a terrible injustice!
While my injuries are not from Levaquin, I sustained severe injuries from two other fluoroquinolone antibiotics, Cipro and Avelox. I was a previously healthy, very active, young woman with my whole life ahead of me before I was disabled by this dangerous class of antibiotics. I sustained severe gastrointestinal damage and disabling neurological injuries. I am no longer able to work and due to the severity of my injuries, I may never even be able to have children. I would like to thank John F. for his tireless efforts for the victims of fluoroquinolone toxicity. Thank you for making that speech! Even if Mr. Weldon was just doing damage control, you were still able to reach all the shareholders and that is a step in the right direction for all of us. So again, thank you!
I have been given so much Levaquin I might break the record !! For every ailment Levaquin or Cipro were prescribed. In 2009 and 2010 really finished me off. I had been battling muscle weakness,pain,stiffness and fatigue in the past along with a lot of pain. In 2009 I was given rounds and rounds of it. Face blew up nerve pain shooting everywhere. Gastrointestinal problems Stomach pain so bad along with the most extreme facial pain. I could not move, I was suicidal and was taken out of my home by the police. When I arrived at the hospital by ambulance I left I had no idea what I was doing. The neurolgical damage, The locked joints of hip and arms. Months of not being able to use my arms. Could barley dress myself or walk, memory loss multiple chemical sensitivities. Eating is a challlenge my body is so broken down it see food as a invader. I have to eat a special diet. I am not able to walk really long distances. Not be able to cope along with not getting any help from the medical world ! I even questioned my doctor about it. He assured me it was a good drug and not to play tennis when using it.I lost a big portion of my life because of Levaquin. My marriage failed because I was always sick, tired, and hurting. NEVER WAS I TOLD THIS DRUG WAS IN A BLACK BOX WARNING.
i was given Levaquin intravenously in the hospital for a colon infection. i felt terrible while I was taking the drug, but was told it was from the infection, not eating, etc. I was sent home with an additional 10 days of Levaquin and still felt horrible, but didn't realize an antibiotic could wreak such havoc. I was never warned about the drug or asked if this is what I wanted to take. About a month after taking the Levaquin, I became extremely ill and no one could figure out why. I couldn't get out of bed, I had diarrhea, nausea, brain fog, very low blood pressure and felt like I was dying. To make matters worse, I was prescribed Cipro because my tests showed that I had some sort of unspecifiied infection. After the round of Cipro, I became extremely ill. I had diarrhea for over a week, I couldn't eat - I lost 20 pounds in less than two months - developed extreme insomnia, colitis, sensitivity to all drugs and supplements. I was taken off of work for 3.5 months and to add insult to injury, the short term disability insurer for my employter (Aetna) refused to pay benefits because they said I wasn't ill enough and had no specific diagnosis. I couldn't take care of my children and my husband had to take over doing everything for me and our children. All I could do was get out of bed and try to eat meals - it was horrible. I was dumbfounded that all the doctors couldn't "figure out" what was wrong with me, when I knew exactly what was wrong with me - these drugs destroyed my health!! I had to completely change my life - I started eating a gluten free diet, only organic food, very little sugar, no alcohol, etc. Over a year later, I am doing better, but still suffer from the effects of this drug. I was healthy and a runner prior to taking these drugs - I can no longer run. My body literally cannot handle it. My eyesight has gotten significantly worse. I have to be very careful about what I eat so that the horrible diarrhea doesn't kick in. I just recently started sleeping better, on my own, without taking a million supplements to help me sleep (and occasionally still need to take something to help me sleep). I have very little stamina, which makes work very difficult. I recently developed a throat infection after having the flu and was dumbfounded that the first thing the doctor at urgent care wanted to give me was Levaquin. This drug is clearly dangerous and there are other antibiotics that can be used for simple sinus/throat/UTIs - I don't understand why the medical community finds it necessary to routinely prescribe an antibiotic that carries a black label warning. It is the height of irresponsibility. I no longer have any faith or trust in the traditional medical community or the FDA - they don't protect consumers - both are beholden to big pharma and their money.
J&J spokesman tells the paper “We’re very sensitive to the issues,’’ he tells the paper. What a joke. Sensitive about MONEY not PEOPLE Shame on them. Sensitive try having your life taken away.
Visit our facebook page The Fluoroquinolone Wall of Pain
Click on photos then on the faces to read the stories below.
Then we will talk about sensitive.
Here are some links for more information.
https://www.facebook.com/pages/The-Fluoroquinolone-Wall-of-Pain/209182505773463
https://www.facebook.com/FluoroquinoloneToxicity
https://www.facebook.com/pages/Quinolone-Vigilance-Foundation/207825862569629
https://www.facebook.com/pages/My-Quin-Story/147096572013607?sk=wall
https://www.facebook.com/lifeintherabbithole?ref=pb
https://www.facebook.com/pages/Certain-Adverse-Events/119358281061?ref=pb
https://www.facebook.com/pages/Bitter-Pills-Inside-the-Hazardous-World-of-Legal-Drugs/140914509264541
https://www.facebook.com/pages/Certain-Adverse-Events/119358281061?ref=pb
I took 10 days of a fluoroquinolone in 2009. I used to be an athlete: Gym 2-3x/week, commute to work by bicycle, hiking, biking and kayaking on the weekend. I climbed Half Dome the summer before taking the medicine, and was planning on hiking Mt. Whitney (highest mountain in the contiguous US) just 3 months after the fateful day I took these pills. I immediately developed severe tendonitis that spread throughout my body within a week. I also developed neuropathy, vision floaters and tinnitus (ear ringing). None of these symptoms have even slightly improved over the 2 years that have passed since then. The black box warning is completely inadequate. The drug companies are spending literally hundreds of thousands of dollars, not to find treatment for us, but to fight us in court and suppress this information (by fighting this shareholder proposal). Google the side effects on these medicines and you will quickly learn that thousands have been crippled by these dangerous drugs.
Fluoroquinolone Antibiotic Toxicity (Cipro, Levaquin, Avelox, Floxin) causes Fibromyalgia & Chronic Pain
NOT RARE! Johnson & Johnson & Bayer are criminals.
Central Nervous System: - toxic psychosis - panic/anxiety - insomnia - seizures - tremors - dizziness - confusion - depression
Peripheral Nervous System: - numbness - pain - burning - tingling - stinging - weakness
Musculoskeletal System: - joint pain - tendon pain - tendon rupture - muscle pain (rhabdomyolysis – a potentially fatal, rapid muscle wasting ADR which may include dark or pink urine)
Cardiovascular System: - torsedes de pointes (a fatal arrhythmia) - heart attack - palpitations (irregular heartbeat) - bradycardia (slow heartbeat) - tachycardia (rapid heartbeat)
Immune System: - anaphylactic reaction (potentially fatal allergic reaction) - Stevens-Johnson syndrome (potentially fatal autoimmune reaction where the immune system attacks the skin)
Additional ADR’s: - renal (kidney) failure - liver failure (potentially fatal)
Drug Interactions – Fluoroquinolones should not be taken together with: - Corticosteroids (ie: prednisone) - NSAID’s, non-steroidal anti-inflammatory drugs ie: Advil, Nuprin, Motrin, Naprosyn, Aleve) - caffeine - theophylline (asthma medication)
This is only a partial list of known adverse events. There are numerous other potentially fatal adverse reactions associated with fluoroquinolone antibiotics. See the manufacturer’s package insert for more complete list of adverse reactions
Paul's story: I was given 10 days of Floxin in 1998. 13 years have gone by WHY
http://www.facebook.com/#!/photo.php?fbid=327336717291374&set=a.209189629106084.55463.209182505773463&type=3&theater
First, all fluoroquinolone antibiotics (e.g., Levaquin, Cipro, Avelox, etc.) can cause tendon damage and rupture. This has been known for years and years and years. It is not by any means new or hidden information. Tendon damage as reported as an adverse effect is very, very low. Over the years I've spoken to doctors, pharmacists, and yes company sales reps and they all poo-pood this as an adverse reaction to the drug(s). None of them believed it. And now low and behold we have the law suits. Fine. But all these patients/platiffs should ask their doctor why the drug was prescribed. Here's the the most common answer: they save lives. These drugs have saved many, many lives as resistance has developed to other alternative antibiotics. Thus, you may have been dead. Please note that if aspirin where invented today it would not receive FDA approval.
It was Paul Cahan, and NOT whoever this John F is who had commented here, who had bought one share of Johnson & Johnson's (J&J) stock so that he could attend the shareholder meeting and ask shareholders to:
1. Have J&J sales representatives discontinue the incentive program for selling Levaquin and Floxin so they can tell the truth about its toxicity to doctors.
2. Add to the Levaquin label that permanent delayed reactions can lead to chronic pain and the medication must be stopped at the slightest sign of reaction.
At the end of his speech, Cahan (who was in a wheelchair) asked William Weldon, J&J CEO, to "stick with your company credo—to help people," and he was given a standing ovation.
"At the reception, the chairman of their pharmaceutical group came up to me and said she wanted to help me," says Cahan. "She asked me to sign up as a research candidate and said, 'My people will get back to you; these drugs should never be used for common infections.' I wrote to the board of directors and phoned several times, but I heard nothing back from her or anyone else at J&J."
See: http://www.lawyersandsettlements.com/articles/levaquin/interview-levaquin-side-effects-5-15696.html
How about if we have the entire Board publicly each take a Levaquin pill at the next board meeting?
Sorry, meant next Shareholders meeting....