The fluoroquinolones, antibiotics, is a long story of what can go wrong with what is perceived as a safe product. Common fluoroquinolones are: Avelox®, Cipro®, and Levaquin®. Fluoroquinolones (FLQ) are among the most prescribed antibiotics so adverse events can have significant public health implications for many.
The early controversy over FLQ involved tendonitis and Achilles tendon rupture. In the early 90’s medical research focused on tendon rupture. Researchers speculated that FLQ’s affected collagen in some way because tendons are composed collagen fibers. Collagen is a unique structure that is stronger than steel. It is found throughout the body in cartilage, blood vessels, the cornea, muscles and the gastrointestinal tract.
There are several types of collagen. Type I and type III collagen comprise the majority of collagen in the Achilles tendon. Approximately 90% of collagen in normal tendons is Type I and 10% is Type III. Over the years medical studies have coalesce around the proposition that FLQ interfered with collagen fibrils found in Type I collagen. Medical studies indicate discuss FLQ’s such as Cipro exert a negative effect on tendon structure or its healing process through the mechanism by up-regulating gelantinase (MMP-2) expression. According to the Tsai study, type I collagen is degraded after treatment with ciprofloxacin. Over the years fluoroquinolone tendon ruptures are a recognized complication of this class of drugs.
In a study titled: “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” the authors found that fluoroquinolones may contribute to aortic aneurysms. The study involved 1,744,360 patients who received at least one fluoroquinolone prescription compared to 1,086,410 patients who received no fluoroquinolone prescription. In the study current fluoroquinolone use lead to increased hazard of aortic aneurysms of 2.72. The study authors also tested subgroups and the results were similar. Pathology sections of aortic aneurysms and aortic dissections demonstrate abnormalities of collagen content, concentrations and ratios.
In 2008, the FDA required the manufacturers of fluoroquinolones to put a Black Box warning on their label alerting users and prescribing physicians of the substantial risk of tendon ruptures. However, the label remained silent about a more deadly adverse reaction – aortic aneurysm.
Often times when analysis begins on a potential case for litigation a simple question is posed should they have known? In FLQ aortic aneurysm cases the answer,is based on the many years of science surrounding tendon ruptures, they should have known and they should have studied. The similarities between tendon composition and the aorta are too great to dismiss. This litigation is a classic failure to study and warn case.
In FLQ litigation preemption of generic drugs will have a substantial impact on many cases. Briefly, in Pliva v. Mensing, the United States Supreme Court ruled that lawsuits against generic drug manufacturers are preempted by federal drug regulations which require a generic drug label to match the brand warning label word for word regardless of mounting evidence that a generic drug carries a risk far greater than what is disclosed in the label. The case has essentially eliminated all claims form users of generic drugs from bring claims against generic manufacturers. There are a few exceptions or nuances to this rule but not many.
So, how do you know if you have a case?
We will start by analyzing your prescription medicine history paying particular attention to the national drug code to determine who manufactured the FLQ you used. Once we have identified the manufacturer we will let you know your options. Hopefully, a brand product was used. If so then additional medical records will be reviewed.
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Salt Lake City, UT 84111