Tag Archives: fda

Johnson & Johnson Fighting Attempts to Consolidate Levaquin Litigation

19 Nov

Johnson & Johnson (the manufacturer of Levaquin) is trying to prevent the first Levaquin lawsuits from being consolidated into a single trial. Plaintiffs’ attorneys want to have the first three “Bellweather” cases tried together. They claim that these cases are very similar; since the plaintiffs have similar injuries, claims, and situations, it is more efficient for the court to handle them as a single trial.

Attorneys for J&J disagree, arguing that the potential differences in the plaintiffs’ medical histories and their unique injuries suffered may confuse the jury.

There are now hundreds of cases pending against Levaquin in state and federal courts. The first cases to go to trial in products liability cases such as this are often the most important ones for both plaintiffs and defendants – if plaintiffs lose, future plaintiffs will find an emboldened defendent and face an uphill battle. However, if the first plaintiffs prevail, oftentimes the defendants may rethink their strategy and might find settlement to be a viable option. (Thus these first cases are referred to as Bellwether cases.)

The majority of the lawsuits allege that the antibiotic medication caused the plaintiffs tendon ruptures, tendonitis, and other tendon injuries.

In July of 2008, the U.S. Food and Drug Administration mandated the manufacturers of the fluoroquinolone class of antibiotics (including Levaquin, Cipro, Avelox & others) to include a “black box” warning label, which states clearly that there is significant risk of tendon injuries for users of these drugs. Prior to that date, any warnings of such injuries were not clearly displayed (allegedly buried in a long list of potential side effects. Currently, the language is clear:
WARNING
Fluoroquinolones, including LEVAQUIN®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [See WARNINGS AND PRECAUTIONS].

Source: http://www.injuryboard.com/printfriendly.aspx?id=274696 (Author: Scott Kappes)

Levaquin and the FDA: A Love Story (Part 6)

8 Nov

Here is the conclusion to the excellent documentary Certain Adverse Events. Does it sound familiar when Greg here finds out, 1 year after his adverse effects start, that there’s a link between Levaquin and his pain? For the full documentary, click here. If you would like to purchase this video, you can do so here.

FDA Funding – Where does the money come from?

4 Nov

Here’s a post from Ivanhoe Broadcast News. Some scary statistics: Americans are 10x more likely to be hospitalized from an adverse drug reaction than a car crash. These reactions are the 4th leading cause of death in the US. Doctors and patients need to read and understand the potential risks with these drugs, but the information given them needs to be accurate and fair. When the drug companies themselves are “paying for more than 1/2 of all reviews” (more than $600 million of the FDA’s budget, which the FDA needs to survive), can this information truly be impartial? Especially when the drug companies’ main incentive is to get it to market as soon as possible? You tell me – is “trust us” a good method of review for the FDA to base its reviews on?

Levaquin and the FDA: A Love Story (Part 5)

3 Nov

Here is Part 5 of the excellent documentary Certain Adverse Events. Memorable quote: “Why not start prescribing fluoroquinolones the way they were designed to be prescribed – as a last line of defense?”

Levaquin and the FDA: A Love Story (Part 4)

29 Oct

Here is Part 4 of the documentary Certain Adverse Events.   John Fratti from Levaquin Adverse Effects Blog is featured in this segment. If you have experienced similar adverse effects, post your experiences in the comments section.