*UPDATED MARCH 5, 2015 10:42 PM EST: The AAJ has received recommendations for testimony and is no longer accepting recommendations. A final decision will be made soon. Please continue submitting your Public Comments on the FDA website linked below. Although the recommendation period has ended for testimony, it is extremely important to share your stories on the website. Your comments will be read and considered in the decision making process as to whether this rule is passed. Thank you to everyone who have submitted comments and stories.
Update blog can be found here.
*UPDATED MARCH 4, 2015 6:18PM EST
As you all know, fluoroquinolone lawsuits have been filed against Johnson & Johnson and Bayer on behalf of victims who took the brand name fluoroquinolones Levaquin, Cipro, and Avelox.
More information can be found here.
But were you denied justice because you took a generic fluoroquinolone?
As part of an ongoing project, victims are asked to share their story with the FDA. This is for everyone who took a generic; this is not limited to those who took a generic fluoroquinolone.
Quinolone Vigilance Foundation has been compiling contact information for those who took a generic fluoroquinolone in hopes of overturning the Supreme Court decision in which victims cannot sue for damage caused by generic medications.
The FDA is putting out a rule to overcome the limitations of the Pliva v. Mensing Supreme Court decision, which states that generic drug makers cannot be sued.
To ensure that this rule can overcome that decision, the FDA is compiling Public Comments on their website.
In addition to sharing your story with the FDA and submitting your Public Comments, please continue sending your name, contact information, the name of the generic fluoroquinolone that you took, when you took it and how it affected you to Executive Director Rachel Brummert at Rachel@saferpills.org.
Please submit your Public Comments before April 1, 2015.
The FDA will compile the Public Comments and present them at an FDA Hearing. In addition to the Public Comments, the FDA has set aside one day to hear public testimony. Only a half dozen people will be selected to testify in person. Those people will be chosen from among those who submit Public Comments on the FDA website, and from referrals from QVF to the American Association for Justice (AAJ). Ms. Brummert will be testifying at the FDA Hearing at the end of this month.
Quinolone Vigilance Foundation is honored to be part of this and it is our hope that the Public Comments that are submitted to the FDA will ensure the success of getting the Pliva v Mensing decision overturned. Everyone who were harmed by a generic medication deserve justice. The more Public Comments that are submitted, the better chance that generic drug victims can help hold generic drug makers as accountable for the damage as brand name drug makers.
We understand the frustrations of those who could not file a lawsuit with Baron & Budd Law Firm, Clarkson Law Firm, and Gallagher & Kennedy Law Firm because they were ineligible due to taking a generic. This is the opportunity to include everyone who was harmed.
The law firms handling the fluoroquinolone lawsuits, and are members of the American Association for Justice have also reached out to victims they were not previously able to help due to the generic issue and they have referred those people to the AAJ. Those who were referred to the AAJ may have also reached out to other victims so that the AAJ can choose a few other victims to testify.
Some guidelines to consider when submitting your Public Comments:
Your story can be as short or as long as you like. We also encourage you to make a statement at the end of your story that includes the following bullet points, but in your own words:
- As someone with first-hand generic drug experience
- The FDA should finalize the proposed rule as written
- The proposed rule warns of hazards of taking generic drugs
- The proposed rule promotes safety by holding generic drug manufacturers accountable
- Delay will only lead to more Americans being hurt
This is the place you can go to read the FDA’s proposed rule and share your story: Over on the right hand side, you’ll see a button that says “Comment Now” and you can either write it there, copy and paste it there, or attach a document you have already written.