The Quinolone Vigilance Foundation Asked the FDA to Close the Generic Drug Loophole and We’re Standing Behind Them — Here’s Why

Rachel Brummert of the Quinolone Vigilance Foundation recently testified before the FDA at the “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” hearing in White Oak, Maryland. Up for discussion was the generic drug loophole, a loophole that we try to warn people about as much as possible.

When people hear about the loophole — a loophole that means generic drug users may not have the same legal rights as brand drug users — they are shocked; they think it can’t be true, no way, no how, they start asking why, start asking what if?, start bargaining as if there was a different way.

We wish we could tell you it wasn’t true. But it’s just a fact. Taking a generic drug rather than a name brand — even if you did not have another choice because that’s what your doctor prescribed or because your health insurance did not cover the brand — often means you will not be able to file a lawsuit against the drug manufacturer should you find yourself suffering from serious side effects due to the generic drug.

It is beyond unfortunate, because people who took the brand name drug and suffered the exact same ill health effects are usually able to able to file a lawsuit — helping to get the compensation they need to cover expensive medical bills while also sending a clear message to the drug manufacturers.

But it’s the sad truth today — generics just don’t come with the rights that all patients deserve.

But that doesn’t mean that’s how it has to be tomorrow, and we can thank individuals like Rachel Brummert of the Quinolone Vigilance Foundation for that.

Like many patients who have been injured by pharmaceutical drugs and turned to advocacy, Rachel Brummert knows the dangers of pharmaceutical negligence firsthand. And, most unfortunately of all, she also knows about the major disadvantages that come with generics.

Rachel and QVF work with patients who took a fluoroquinolone antibiotic, just like the many people we represent, only to suffer devastating health effects, and mountains upon mountains of medical bills, doctor visits and chronic pain. Unfortunately, many of these patients took a generic — and did not know they were giving up their right to file a lawsuit when they filled and took their prescription. Almost certainly that’s not something the doctor explained or something the pharmacist told them.

As Rachel tells it, "Lives could be saved and injuries prevented if all prescription medications carried up-to-date and adequate warning labels. Finalizing the proposed rule by the FDA will promote safety by holding generic drug manufacturers accountable for the damage their products cause. A delay in finalizing the proposed rule will only lead to more patients being hurt.”

We are so proud of Rachel Brummert and all of her work with the Quinolone Vigilance Foundation. It’s because of individuals like Rachel that we see hope for the future in terms of generic drug legal rights.

If you or someone you know took a fluoroquinolone antibiotic such as Avelox, Cipro or Levaquin and developed nerve damage, you may be able to file a lawsuit. We encourage you to contact a fluoroquinolone lawyer at Baron and Budd at 866-520-2755 or contact us online to learn more.

And before you give up — call us even if you think you took generic as the different names and types of fluoroquinolone antibiotics are confusing and our lawyers may be able to help you learn once and for all whether you took brand or generic, and whether you can file a lawsuit.

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