Levaquin Blog

Six cases have just been identified as “bellwether” trials for all Levaquin lawsuits in by U.S. District Judge John Tunheim.  The early trial dates are set to help determine how juries will respond to evidence and testimony that would likely be presented in other similar lawsuits that allege Johnson & Johnson’s Levaquin increases the risk of tendon damage.

[A “bellwether” case is one that is chosen as a sample of many similar cases.  The goal is to get an idea of how the many other (in the case of Levaquin, many thousands) similar lawsuits will be decided, so that the defendants and future plantiffs can begin to establish how much their case may eventually be worth if they went to trial, and then hopefully sustain meaningful negotiations where settlements (and less costly trials) can take place.]

According to aboutlawsuits.com (click here for full story):

All lawsuits over Levaquin filed in various federal district courts throughout the United States are centralized before for pretrial litigation in the U.S. District Court for the District of Minnesota. The cases involve similar allegations that the drug maker failed to adequately warn about the increased risk of tendon ruptures and other tendon injuries that can occur from side effects of Levaquin.

According to a pretrial order issued on February 12, the plaintiffs and defendants have agreed on the first six cases that will be prepared for trial. The lawsuits were picked from a pool of 15 cases that were previously identified as potential bellwether cases, and include Levaquin suits brought by Sharon Johnson, Calvin Christensen, Richard Kirkes, John Schedin, Edward Karkoska and Eugene Markina.

The order calls for depositions of experts in the cases to be completed by June 30, and the first case should be ready for trial by the end of October. However, Judge Tunheim did not say when the first trial will start, indicating that decisions will be made at a later date about the order in which the cases will be tried and whether they will be submitted to juries individually or as part of a consolidated trial.

In December, Judge Tunheim denied a motion by plaintiffs to consolidate three of the bellwether Levaquin trials. Plaintiffs argued that the consolidation of the cases into one trial would promote judicial efficiency while still testing the merits of the arguments of future cases. After defendants opposed the plan, Judge Tunheim determined that it was too early to determine whether the cases were alike enough to try them together. He left the door open for plaintiffs to submit a new motion later in the discovery process when more was known about the cases.

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Five Illinois residents have filed suit against Johnson and Johnson, Ortho-McNeil Pharmaceutical, Johnson and Johnson Pharmaceutical Research and Development and Walgreens after they say an antibiotic caused them severe tendon problems.

Plaintiffs Susan Price, Jerry Mahlandt, Johnna Woosley, David Force and Rachel Speiser say they took the antibiotic Levaquin, which is normally prescribed for upper respiratory infection, urinary tract infections, prostatitis and other bacterial infections.

What the plaintiffs claim they did not know at the time they took Levaquin is that it causes a higher incidence of tendon injuries, including tendon rupture, in people who are older than 60 or who are on corticosteroid therapy, according to the complaint filed Sept. 2 in St. Clair County Circuit Court.

“Levaquin-induced tendon injury involves the degradation of the tendon tissue, leading to severe and permanent injuries,” the suit states.

As a result of their taking the antibiotic, all the plaintiffs say they suffered severe and permanent tendon injuries.

Levaquin is part of a class of antibiotics known as fluoroquinolones and was originally introduced into the U.S. in 1997, the complaint says.

When Levaquin entered the market, warnings about tendon side effects were required on all fluoroquinolone labels, but were buried in a long list of potential adverse reactions, the plaintiffs claim. In addition, the warnings did not advise that tendon injury was tripled with fluoroquinolone use in people older than 60 and in those who are on corticosteroid therapy, according to the complaint.

In fact, Levaquin manufacturers marketed the drug toward the elderly, especially those with upper respiratory infections who were likely to be chronic corticosteroid users, the suit states.

“More disturbingly, Defendants’ promotional campaign was themed on Levaquin’s excellent safety profile and failed to disclose the risks of tendon injury,” the complaint says.

After world-wide studies revealed the tendon risks to Levaquin users, the defendants updated their label for the antibiotic, the plaintiffs claim. However, the new warning only included information about the risks to people who were on corticosteroid therapy and contained no warnings about risks to the elderly, according to the complaint.

“Accordingly, despite the 2002 label change, Levaquin prescriptions only increased and tendon injuries mounted,” the suit states.

Other European countries began discussing the requirement of heightened label change as early as 2001, and collaborated with Johnson and Johnson PRD to perform a study on the antibiotic’s effects, the complaint says.

The plaintiffs claim that Johnson and Johnson PRD, however, only analyzed achilles tendon ruptures in its study and did not assess the risk of Levaquin tendon toxicity. In addition, Johnson and Johnson PRD created an algorithm that excluded nearly 70 percent of health claims for the elderly who suffered Achilles tendon rupture, according to the complaint.

“The algorithm used CPT procedure codes that only related to surgical repair,” the suit states. “This algorithm thereby excluded all those Achilles tendon rupture cases where the patient was casted or booted, as is the case in the elderly population. By manipulating the data, Defendant Johnson and Johnson PRD was able to exclude the very group that was prone to tendon rupture.”

As a result, the Johnson and Johnson PRD study found no increased risk of achilles tendon rupture and found neither age nor corticosteroid use altered the findings, the complaint says.

As a result, the Levaquin label was not changed as had been recommended.

Because the defendants issued no warnings to doctors, physicians continued to prescribe the antibiotic, the plaintiffs claim.

However, Levaquin was responsible for 1,044 reports of tendon injuries and 282 reports of tendon ruptures from 1997 through 2005, according to the complaint.

Injuries continued to soar as Levaquin’s popularity increased, the suit states.

Even the Illinois attorney general took notice and in 2005 submitted a petition to the FDA requesting that a black box warning be placed on the antibiotic’s label, the complaint says.

Although the black box warning was not been placed on Levaquin’s packaging, a revised label was placed on the antibiotic in April 2007. However, the plaintiffs say the label continued to bury warning about tendon risks and did not contain a warning about Levaquin’s greater association with tendon toxicity as compared to other fluoroquinlones.

Finally, in July 2008, a revised Levaquin label contained a black box warning, but still fails to warn about its higher risk of tendon toxicity compared to other similar antibiotics, according to the complaint.

In the 10-count suit, the plaintiffs allege strict liability, negligence, breach of implied warranties, breach of express warranty, common law fraud, violation of the Illinois Consumer Fraud Act, unjust enrichment, breach of warranty and failure to warn.

Johnson and Johnson and its subsidiary, Ortho-McNeil, are named as defendants because they test and manufacture Levaquin. Walgreens sold the plaintiffs the drug, the suit states.

The plaintiffs are seeking actual and compensatory damages, plus costs, pre- and post-judgment interest and other relief the court deems just.

By: Kelly Holleran

Source: www.madisonrecord.vom

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Tendon injuries happen – just ask Andre Brown of the New York Giants or Misty May-Treanor of Dancing with the Stars.  That doesn’t mean that they are inevitable. 

Two-time Olympic beach volleyball gold medalist Misty May-Treanor had surgery to repair a torn Achilles' tendon a day after she dropped out of the "Dancing with the Stars" competition. Source: AP Photo

Although Achilles Tendons may just “snap” for no apparent reason, studies have shown that the risk of people taking Levaquin suffering this “sudden” injury is increased many times over than those not taking Levaquin.  Levaquin is an important drug, but it is VERY strong and the benefits do not always outweigh the risks. Speak to your doctor about alternative drugs before committing to the Levaquin course of action.

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Tendons are the tough fibers that connect muscle to bone. For example, the Achilles tendon connects the calf muscle to the heel bone. Tendon injuries typically occur near joints, such as the knee, ankle, shoulder and elbow. Tendon injuries could occur suddenly, but usually it is the result of many tiny tears to the tendon that have happened over time.

What causes a tendon injury?

Tendon injuries are usually the result of gradual wear and tear to the tendon from overuse or aging. Anyone can suffer a tendon injury, but people who make the same motions over and over in their daily activities are more at risk to damage a tendon.

A tendon injury can happen suddenly or gradually over time. A sudden injury is more likely to occur when the tendon has been weakened over time.

What are some symptoms of tendonitis?

Tendonitis usually causes pain, stiffness and loss of strength in the injured area.

• The pain may get worse when you use the tendon.
• There may be more pain and stiffness during the night or when you get up in the morning.
• If there is inflammation, the area may be tender, red, warm, or swollen.
• There may be a “crunchy” sound or feeling when the tendon is used.

How is a tendon injury diagnosed?

How is tendonitis treated?

There are many home remedies available for minor pains.  These include:

• Resting the affected area, and avoiding activities that worsen the pain.
• Applying ice for 10 to 15 minutes at a time, up to two times an hour, for the first three days.
• Continuing using ice as long as it provides relief.
• Taking over-the-counter pain relievers such as ibuprofen if needed.
• Stretching and exercising to prevent stiffness.

Doctors might also suggest physical therapy. With severe and long lasting injuries, doctors may see fit the use of a splint, brace, or cast to hold the tendon still.

It could take weeks or months for a tendon injury to heal. If the injured tendon is used prematurely, more damage could occur.

Source: Yahoo Health

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Tendon and ligament injuries and tendonitis are often symptoms of conditions or diseases such as, or caused by lifestyle or workplace activities, but could also be side effects associated with certain medications, such as Levaquin. Below is a list of diseases and conditions associated with symptoms like Tendon and Ligament Injuries and Tendonitis, as well as a list of medications related to similar side effects. We are not medical professionals, and these may not be comprehensive lists. Please contact your doctor if you are experiencing any of the following symptoms or side effects, or similar health issues.
Tendon and Ligament Injuries and Tendonitis are Symptoms of:

Rotator Cuff Injury: The rotator cuff us the group of muscles and tendons that attach you upper arm bone to your shoulder blade. Rotator cuff injury is irritation of or damage to these muscles and tendons, including tendonitis and tendon injuries in the rotator cuff. Common causes include falling, poor posture, age, and improper lifting.

Group O Blood Type: People with type O blood can only receive transfusions of type O blood, but they can safely donate to people with the other blood types. There is a higher incidence of tendon rupture in people with group O blood than other blood types.

Decreased Blood Supply: Decrease blood supply to the tendons and ligaments means inadequate oxygen and nutrient delivery to the area. This makes injuries more likely to occur and is believed to be a contributing factor to higher rates of these types of injuries in older people. It also makes the injuries slower to heal.

Sports Injury: The high forces involved in sports can cause overuse injuries to the tendons and ligaments as well as acute injuries from accidents while playing. Ligaments and tendons can become stretched, resulting in a sprain or strain. Tendonitis, or irritation of the tendon, is also common in athletes.

Rheumatoid Arthritis: Rheumatoid arthritis is an autoimmune condition that causes inflammation in the joints and sometimes the surrounding tissue including tendons, ligaments, and muscles. These surrounding tissues are weakened leading to tendon and ligament injuries.
Tendon and Ligament Injuries and Tendonitis are Side

Effects Associated with:

Levaquin: Levaquin is a fluoroquinolone antibiotic used to treat pneumonia, chronic bronchitis, sinus infections, acute kidney infections, chronic prostrate infections, and skin infections. Side effects of fluoroquinolones include an increased risk of tendonitis, tendon injury, and ligament injury, as well as life threatening side effects including renal failure, toxic epidermal necrolysis, and more.

Cipro: Cipro is another fluoroquinolone antibiotic. It is used to treat infections caused by E. coli, typhoid fever, anthrax, urinary tract infections and other bacterial infections. Cipro side effects can include tendon and ligament injuries, tendonitis, hallucinations, confusion, paranoia, and severe allergic reactions.

Statin Drugs: Statin drugs, such as Lescol, Pravachol, Crestor, and Zocor, are used to lower cholesterol by inhibiting an enzyme in the liver that is necessary for cholesterol production. Statins have been associated with an increased incidence of tendon and ligament injuries and tendonitis, as well as many other side effects including numbness and tingling in the arms and hands, muscle weakness, pain in the fingers and toes, and loss of balance. (Source: www.usrecallnews.com)

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