Tort Litigation is Part of the Regulatory System

Documentary about the Dangers of Fluoroquinolone Antibiotics details Institutional Capture and the Danger of Barring Litigation.

Certain Adverse Events

This documentary from 15 years ago illustrates how dangerous drugs can reach and stay on the market.

Fluoroquinolones Antibiotics can cause catastrophic, life altering damage at therapeutic doses, or after even a few as one pill. The FDA warns of the potential of “FQAD” - “Fluoroquinolone Associated Disability” (below).

Chapter one details FDA capture. This is an excellent primer on the problem. I highly encourage watching at least Chapter One.

“There was a time when the FDA and the US regulatory system was really the gold standard, and the rest of the world looked up to the United States in terms of being the leader in protecting the consumer. The FDA's job as mandated by law is to decide whether a drug is safe and effective enough to be approved for a given indication. What we've seen over the last couple of decades is an erosion of the regulatory power of the FDA and an unwillingness to use their authority. Two-thirds of the money that the FDA spends on reviewing drugs comes in direct cash payments from the industry. It has distorted enormously and dangerously the mission of the FDA.”

"Let's remember the FDA is underfunded. It relies on information entirely given to it by the regulated entity, by the drug company. People have a misapprehension; they think the FDA is out there doing clinical tests and approving a drug because it's really in its own laboratories determining that the product is safe and effective. No, no, that's not how it works. The way it works is that the industry itself, the company itself, gives it all the information that it's going to rely on in deciding whether to approve that drug."

“Preemption is essentially a doctrine in the law which says when the federal government has regulated in a particular area, then other kinds of regulation by the states or tort suits in the state courts may be preempted—in other words, barred—because the federal government has sole authority to regulate in that area.

“One of the areas in which we're really fighting hard against preemption is pharmaceuticals—drugs that are approved by the FDA. The argument, at its most basic level, is that you can sue to recover damages for your injuries from a mislabeled or defective drug, a drug that really shouldn't have been on the market or shouldn't have been labeled the way it was, even though the FDA approved it.”

Pre-emption is an effort to extend no liability to conventional pharmaceuticals.

Sounds familiar, doesn’t it?

“Our position has always been that we should simultaneously have the regulation of the FDA to try to ensure health and safety, but we should also have the regulation provided by the market through the personal injury tort system. This system, through the threat of litigation and having to compensate victims for their injuries, changes drug company behavior. They become concerned about safety not just to satisfy the FDA but also to avoid the risk of litigation.”

Link to YouTube Video- well spent 10 minutes.

There are 4 more very worthwhile chapters.

https://www.youtube.com/@CertainAdverseEvents

This PBS features FQ’s as an example of the inadequacy of adverse event report systems.

“Adverse drug reactions are the 4th leading cause of death in US.”

https://www.pbs.org/newshour/show/certain-antibiotics-spur-widening-reports-of-severe-side-effects

PBS 10-minute video segment from Newshour.

https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-advises-restricting-fluoroquinolone-antibiotic-use-certain

FDA “FQAD” Fluoroquinolone Associated Disability”

https://www.kaisergornick.com/documents/FQAD.pdf

I recommend that anytime you are given a prescription, prior to taking it search out to see if there are any patient support groups.

Paper: “Fluoroquinolones-Associated Disability: It Is Not All in Your Head”

“Since the late 1980s, twelve FQs have been discontinued due to adverse side effects. Some of the more notable side effects discussed in this review include photosensitivity, QT prolongation, hepatotoxicity, tendinopathies and central and peripheral nervous systems effect [17,18], which will be described more in detail in the next paragraph.”

Be Careful