Levaquin Blog

LevaquinBlog would like to draw attention to some excellent analysis by the blog www.myquinstory.info .  We encourage you to read the entire post, but here’s some of the most compelling data:

According to Medwatch, the adverse drug reporting arm of the FDA, the following statistics are available on fluoroquinolone antibiotics, from a period from 1997 to 2007: Levaquin 39,128 adverse drug reactions (ADR’S) and 808 deaths, Floxin 13,495 ADR’s and 311 deaths, Cipro 40,395 ADR’s and 837 deaths, Avelox 30,160 ADR’s and 337 deaths, and Proquin 40,151 ADR’s and 831 deaths.  For this list of FQs, and it is not a total inclusive list, the total adverse drugs reactions are 163,329 with deaths totaling 3,124. According to the FDA, reports to Medwatch only represent between 1% and 10% of the actual numbers of occurrence.  Why?

The FDA states that most people have never heard of the Medwatch program and a lot of doctors are not inclined to waste their valuable time in reporting adverse drug reactions or telling patients about it.  Looking at the facts from the FDA’s own admission, deaths from FQ’s could easily total over 30,000, based on if only 10% of the actual occurrences have been reported.

Now humor me for a minute as my logical mind kicks in.  Toyota recalls millions of cars and has to appear before congressional hearings because of the possibility that a defect cause 275 crashes and 18 deaths over 11 years, and the fluoroquinolones antibiotics have caused, at the very least, 163,329 ADR’s and 3,124 deaths, and no hearings, no outcry, no acknowledgement from the medical community? Why?

What do you think?  Should Congress, the media and the public spend more time analysing and worrying about Toyota’s car defects or the ongoing danger that is flouroquinolone toxicity (together with the FDA’s malaise when it comes to protecting the public)?  Which is really more a danger to the public?

See full post here: http://www.myquinstory.info/?p=202

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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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Here’s a nice summary of the risks of Levaquin and why it is still on the market;

Dear Dr. Donohue: Just how dangerous is the drug Levaquin? I read that it should not be given to a person over 60…
- A.S.
Dr. Dohohue: Levaquin (levofloxacin) is a newer antibiotic that has rescued many from dangerous infections and has been lifesaving for quite a few. Common side effects include nausea, diarrhea, dizziness, insomnia, headache and constipation. Those are potential side effects of almost all drugs.

More-serious side effects are tendon inflammation and even tendon rupture. The Achilles tendon, the heel cord, is the one most often affected. The medicine makes some people quite sensitive to sunlight and sunburn. It has caused liver and kidney damage. It might affect the way the heart beats and could cause dangerous heart rhythms. These things are more likely to happen to people over 60. With all this, how could such a medicine be allowed on the market? These outcomes are exceedingly rare, and the drug’s benefits greatly tip the scales in its favor.

Source: http://www.herald-review.com/lifestyles/health-med-fit/article_2906a269-7b4b-543d-ace6-7ab9abc4909b.html

As Dr. Paul Donohoe, a nationally-syndicated columnist whose health article is carried in over 175 newspapers, states (although if you’re reading this you’ll know we strongly believe that these results are anything but “exceedingly rare”, as most people would not have even thought, let alone reported, that a tendon injury could possibly be caused by a pill that they’ve only taken a few times days, weeks or months earlier), there are significant benefits unique to Levaquin.  This doesn’t change the fact that there are dangerous risks associated with the drug, and the “unique benefits” in many cases do not benefit the consumer, whose ailments oftentimes may be fixed with a less drastic measure.

As for the complaints consumers (and we at LevaquinBlog) have, it is not enough that the “benefits outweigh the risks” for the drug to be on the market.  What is necessary, both morally as well as legally, is that these risks are known by the same people who learn about their benefits.   That is, if we are going to hear how great it is (Levaquin is so wonderful! You only need to take 5 pills instead of 21!), then the risks should be equally available and accessible.  And this didn’t happen.  While the studies were available to Orth-McNeil, they did not properly warn the public (including consumers and doctors) until the FDA forced its hand.

That is the cause of all the lawsuits out there – not that Levaquin causes these terrible symptoms, but that Orth0-McNeil knew about these risks and didn’t warn us until it was too late.

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As a follow-up to last week’s breaking news about the Johnson & Johnson / Omnicare kickback scandal, some details are emerging (see below).  It seems that J&J was making illegal payments to pharmacies to promote their drugs, which were being reimbursed by Medicare and the good ol’ taxpayer.  So not only did you suffer that achilles tendon rupture, but you and your taxes paid for the marketing efforts behind it, too.

Some of the emails released include the following gems:

• In 2002, J&J’sLevaquin antibiotic saw a 19 percent share gain in five months. The reaction of one executive, informed of the news in an email was that it was “scary” that the company had such power.
• When Omnicare demanded money from J&J, the J&J exec wrote in an email to a colleague: “I wasn’t going to go to jail for Dan, Omnicare, or for that matter J&J”.

Here’s the statement J&J gave after the complaint was filed:  “We are reviewing the complaint filed today and will address the government’s lawsuit in court.  We believe airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate.  We look forward to the opportunity to present our evidence in court.”

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That is whether you need it or not. Today the US Government filed a lawsuit against Levaquin’s maker, J&J, for paying kickbacks to one of the country’s largest pharmacy chains, Omnicare. It says Omnicare was given illegal payments in the 10s of millions to promote its drugs over competitors.

The government cited a company statement from September 2001 describing Levaquin’s market share at Omnicare’s pharmacies increasing to 66.4 percent from 19.2 percent at the end of 1998. Meanwhile, the market share of a competing antibiotic, Cipro, plunged to around 28 percent, from 80 percent. Apparently, this wasn’t by accident. 

I’m sure there’s more than a few limping and suffering Americans who’d like to show their gratitude to the folks at Omnicare and J&J for their business acumen.

Read more about the booming successes of J&J and Levaquin here or here.

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