The complaint charges that Johnson & Johnson was aware that Omnicare pharmacists made recommendations to physicians about what drugs should be prescribed to home residents. The complaint repeatedly mentions internal Johnson & Johnson e-mails and statements detailing the relationship with Omnicare. The government claims that those documents show that Johnson & Johnson came to see Omnicare pharmacists as an extension of its sales force.
According to the complaint, while Johnson & Johnson was allegedly paying kickbacks, Omnicare's annual purchases of Johnson & Johnson drugs nearly tripled to more than $280 million. For example:
*From September 2001 the market share of the antibiotic Levaquin’s increased to 66.4 percent from 19.2 percent at the end of 1998. At the same time, a similar antibiotic made by a different firm, Cipro, plunged to around 28 percent, from 80 percent.
*Use of Johnson & Johnson's antipsychotic Risperdal nearly tripled during the five-year-period it received payments from the drugmaker. Prosecutors claim Risperdal was used to control anxiety among patients with dementia and Alzheimer's disease, an off-label use of the drug. Drug makers are prohibited by law from promoting off-label uses.
Prosecutors allege that Johnson & Johnson's conduct caused false or fraudulent claims to be filed with Medicaid, the public health program for the poor and disabled.
As we reported previously, in November, Omnicare agreed to pay $98 million to settle charges related to the alleged Johnson & Johnson kickback scheme. As part of the settlement, Omnicare entered into a corporate integrity agreement with the Department of Health and Human Services.
The claims against Johnson & Johnson were initiated by whistleblowers who could receive a share of any money the government collects.
In conducting this latest fluoroquinolone study, researchers at Casey Eye Institute at the Oregon Health and Science University in Portland analyzed all eye-related adverse event associated with the drugs that had been reported in international databases and the medical literature between 1986 and 2008. The found 171 case reports of double vision. Of those, 75 cases were linked to Cipro, 9 to Tequin, 20 to Levaquin, 16 to Avelox, 11 to Noroxin and 40 to Floxin. In the 53 reported cases in which a patient stopped taking the medication, vision returned to normal quickly. In five of those cases where the patient was then given the drug again, the problem returned.
The more frequently prescribed fluoroquinolones were more likely to be the subject of double vision reports. This suggests that the problem involves the class of drugs rather than just one or two types of fluoroquinolones, the study authors said.
The study did not reach a conclusion as to the cause of the double vision, but did speculate that the antibiotics may have had an effect on tendons involving the eyes, impacting their ability to focus.
Fluoroquinolones are very strong antibiotics that are used to treat bacterial infections of the lungs, urinary tract and skin. They have been associated with a number of serious side effects, including tendonitis. Last July, the Food & Drug Administration (FDA) asked the manufacturers of fluoroquinolones to add a Black Box warning to the drugs’ labels because of their association with tendon damage. At the time, the FDA said the risk of tendon damage was greatest for those over age 60, those on concomitant steroid therapy, and kidney, heart, and lung transplant recipients. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. At the time of the warning, he FDA has received nearly 2,250 reports of tendon disorders and 775 reports of tendon ruptures among patients taking fluoroquinolones.
Other side effects associated wit fluoroquinolones have included liver damage, gastrointestinal problems, skin phototoxicity and nervous system problems. Several fluoroquinolones, including Tequin, have been withdrawn from the market because of side effect issues.
The lawsuits, which we recently reported as having begun to circulate through the courts, allege that Levaquin has caused Achilles' tendon ruptures and other damage. Just over a year ago, federal regulators ordered that Levaquin and similar antibiotics bear Black Box warnings about their association with serious tendon injuries.
In May we wrote that most litigation specialists expected thousands of people to file lawsuits against the makers of Levaquin and similar drugs. Last June, federal Levaquin lawsuits were consolidated in Multi-District Litigation before U.S. District Judge John R. Tunheim in the District of Minnesota.
Recently, attorneys representing Levaquin victims in New Jersey state court requested that those lawsuits be centralized before one judge, as well. Now, according to Law.com, that mass-tort status is expected to encompass thousands of cases against the same defendants arguing similar “complex issues of law and fact,” with patients alleging similar damages and injuries, said Law.com.
When the FDA required that the labeling of Levaquin and other fluoroquinolone antibiotics be revised to include a Black Box warning about tendon injuries in 2008, the FDA database showed 262 reported cases of tendon ruptures, 259 cases of tendonitis, and 274 cases of other tendon disorders associated with these drugs. The majority of tendon ruptures—61 percent—were tied to Levaquin.
At the time, the FDA warned that pain, swelling, inflammation, and tears of tendons including the Achilles, shoulder, hand, or other areas can happen in patients taking Levaquin. The agency said such injuries were more likely to occur in people who are over 60 years of age, taking steroids (corticosteroids), or who have undergone a kidney, heart, or lung transplant. The most common tendon injury associated with Levaquin involves the Achilles tendon.
In some cases, Levaquin tendon ruptures have required surgical repair, and victims have needed to undergo extensive rehab. Tendon rupture can occur during or after completion of a course of Levaquin, although cases occurring up to several months after completion of therapy have been reported.
New York law firm, Parker, Waichman & Alonso is among the firms that have filed Levaquin lawsuits in New Jersey.
According to a prior Wall Street Journal report, one of the latest Levaquin lawsuits filed in a New Jersey state court on behalf of three plaintiffs from around the U.S. charged that Johnson & Johnson and Ortho-McNeil represented Levaquin as a safe antibiotic despite its known association with tendon damage. The attorney representing the three Levaquin plaintiffs also pointed out that the drug is far more expensive than generic alternatives that have better safety profiles, the Journal said.
Just a little over a year since federal regulators ordered that Levaquin The Reader release and similar antibiotics bear Black Box warnings about their association with serious tendon injuries, the first Levaquin lawsuits are beginning to circulate through the courts.
According to The Wall Street Journal, one of the latest Levaquin lawsuits was just filed in a New Jersey state court on behalf of three plaintiffs from around the U.S. The lawsuit charges that Johnson & Johnson and Ortho-McNeil represented Levaquin as a safe antibiotic despite its known association with tendon damage. The attorney representing the three Levaquin plaintiffs also pointed out that the drug is far more expensive than generic alternatives that have better safety profiles, the Journal said.
In 2008, the Food & Drug Administration
(FDA) required that the labeling of Levaquin and other fluoroquinolone antibiotics be revised to include a Black Box warning about tendon injuries. At the time, the FDA database showed 262 reported cases of tendon ruptures, 259 cases of tendinitis, and 274 cases of other tendon disorders associated with these drugs. The majority of tendon ruptures - 61 percent - were tied to Levaquin.
At the time, the FDA warned that pain, swelling, inflammation, and tears of tendons including the Achilles, shoulder, hand, or others can happen in patients taking Levaquin. The agency said such injuries were more likely to occur in people who are over 60 years of age, taking steroids (corticosteroids), or who have undergone a kidney, heart, or lung transplant. Becket dvd 9 pspJimi Hendrix: The Uncut Story dvdrip Dracula: Dead and Loving It full movie The most common tendon injury associated with Levaquin involves the Achilles tendon. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, and the thumb have also been reported. In some cases, Levaquin tendon ruptures have required surgical repair, and victims have needed to undergo extensive rehab. Tendon rupture can occur during or after completion of a course of Levaquin, although cases occurring up to several months after completion of therapy have been reported. The Vanguard psp
The Illustrated Man movies The first Levaquin tendon injury trial is expected to begin sometime in the late summer of 2010. Most litigation specialists expect thousands of people to file such lawsuits against the makers of Levaquin and similar drugs. Last June, federal Levaquin lawsuits were consolidated in a Multidistrict Litigation before U.S. District Judge John R. Tunheim in the District of Minnesota. Recently, attorneys representing Levaquin victims in New Jersey state court requested that those lawsuits be centralized before one judge, as well.
The first fluoroquinolone was introduced in 1986. Critics of these drugs allege that fluoroquinolone antibiotics were developed and put on the fast track for Food & Drug Administration (FDA) approval without the benefit of adequate premarket testing to accurately determine the probability of certain side effects within the general population. After gaining FDA approval, the new fluoroquinolone antibiotics were aggressively marketed by the manufacturers.
Cipro became widely known when it was used to treat and prevent anthrax infections in people exposed to the virus as a result of the 2001 mail attacks. While Cipro was apparently an effective weapon against anthrax, it left some victims with lingering health problems.
Last July, the FDA asked the manufacturers of Cipro and other fluoroquinolones to add a black box warning to the drugs’ labels about their association with tendon damage. The FDA said the risk of tendon damage was greatest for those over age 60, those on concomitant steroid therapy, and kidney, heart, and lung transplant recipients. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. At the time of the warning, he FDA has received nearly 2,250 reports of tendon disorders and 775 reports of tendon ruptures among patients taking fluoroquinolones, though the actual numbers are likely much greater since most side effects are never reported.
According to the Atlanta Constitution-Journal, the tendon risks associated with fluoroquinolones have been known for close to 20 years. The FDA warning only came after the agency was sued by a consumer group for ignoring the drugs' safety risks.
When the FDA finally had the makers of these drugs add warnings to their labels, it stopped short of requiring that drug companies send letters to doctors alerting them of the change. Only a few, such as Bayer HealthCare Pharmaceuticals the maker of Cipro and Avelox, and Oscient Pharmaceuticals, which sells Factive, have voluntarily done so.
As a result, fluoroquinolones are still being prescribed at a high rate, despite the fact that there are safer alternatives. According to the Atlanta Constitution-Journal, in 2007, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics. What's worse, studies have shown that these drugs are often used to treat diseases that don't even respond to antibiotics.
The fact that few doctors and patients are aware of the risks of fluoroquinolones is a serious concerns. The tendon damage often caused by these antibiotics can be mitigated if patients are treated - and switched to another antibiotic - as soon as they start feeling pain. But without the right knowledge, most won't even know the medicine they are taking could be causing their discomfort. If they continue taking the drug, the result could be a tendon rupture, which will require even more intervention - including surgery.
Cipro and Levaquin belong to the antibiotic group known as fluoroquinolones, which are sold by several drug makers under a variety of brand and generic names. Although the drug labels warn of the risk of tendon ruptures, none include black-box warnings. A black-box warning is in bold type, surrounded by a black box to make it stand out. Such warnings usually appear at the top of drug labels. Any advertising of products that carry black box labels must also include the black box warning information as part of the advertisement. The FDA also announced it will ask the drug companies to create a Medication Guide to be provided to patients to alert them about possible side effects.
Serious reports of tendonitis and tendon rupture are on the rise with the use of these drugs, which finally prompted the FDA to ask drug companies to add the stronger labeling. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. Tendons are the areas that connect your muscles to your joints. The Achilles tendon is at the back of the ankle. The risk of tendonitis and tendon rupture linked to drugs such as Cipro and Levaquin is "especially increased" in patients older than 60, as well as those who have received kidney, heart, or lung transplants and people on “concomitant” steroid therapy.
Fluoroquinolone Antimicrobial Drugs include: Cciprofloxacin, marketed as Cipro and generic ciprofloxacin; ciprofloxacin extended release, marketed as Cipro XR and Proquin XR; gemifloxacin, marketed as Factive; levofloxacin, marketed as Levaquin; moxifloxacin, marketed as Avelox; norfloxacin, marketed as Noroxin; and ofloxacin, marketed as Floxin and generic ofloxacin.
The FDA believes that the addition of a black box warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs.
The FDA warns that physicians “should advise patients, at the first sign of tendon pain, swelling, or inflammation—symptoms that typically precede tendon rupture and tendonitis—to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.” Fluoroquinolone is only suggested for the treatment or prevention of an infection proven to be caused by, or strongly suspected to be caused by, bacteria.
According to the FDA release, other side effects experienced in those taking Fluoroquinolones include “seizures, hallucinations, depression, heart rhythm changes (QTc prolongation and torsade de points), and intestine infection with diarrhea. Rarely, damage to the liver, kidneys or bone marrow, and changes to blood sugar may occur.”
Fluoroquinolones are used to treat bacterial infections in many different parts of the body. They work by killing bacteria or preventing their growth. From November 1997 through December 2005, the FDA received 262 reports of tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics. An additional 74 tendon ruptures have subsequently been reported to the FDA for a total of 336. But Public Citizen contends that only a small fraction of cases are typically reported to the FDA, so the actual number of ruptures and other tendon injuries attributable to the antibiotic is probably much higher.
Public Citizen announced yesterday that it had sued the FDA in the U.S. District Court for the District of Columbia over the issue of floroquinolone antibiotics and tendon damage. Public Citizen wants the court to force the FDA to act upon a petition the consumer group filed with the agency 16 months ago. So far, the FDA has failed to respond to the petition, which asked the agency to put a “black box” warning on fluoroquinolone antibiotics to make doctors and patients are more aware of the risk of serious tendon injury before tendons actually rupture.
The Public Citizen petition also urged the FDA to send a warning letter to physicians, as well as require an FDA-approved medication guide to be dispensed when prescriptions are filled. In a press release announcing the antibiotic lawsuit, Public Citizen asserted that stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics. “While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The current warning is buried in a long list of possible adverse reactions and is far too easy to miss.”
Public Citizen said in its complaint that by failing to act upon its fluoroquinolone petition, the FDA is violating the Administrative Procedure Act.