Saturday, March 28, 2015

FDA Hearing- March 27, 2015 (with webcast links)

On March 5, the American Association for Justice (AAJ) contacted me and they invited me to testify at an FDA Hearing on March 27. The hearing centered around closing the loophole caused by the Pliva v. Mensing Supreme Court decision, which states that generic drug makers cannot be held responsible for the damage their medications cause.

Generic medications make up 80% of all prescriptions filled in the United States. But generic drug manufacturers are not allowed to independently update their labels to warn of newly discovered side effects. And they can't be held accountable if their drugs injure or kill.

The FDA has proposed a plan to fix the problem, but the generic drug industry is lobbying against it. The plan has already been delayed once, and it could be delayed again. This is why we were asked to testify at the FDA Hearing, so we could speak for everyone who took generic medication and were damaged by it. We went there to publicly call on the FDA to move forward in ensuring all prescription medications, including generic drugs, carry current and accurate safety warnings, because safety is an issue that cannot wait. Both brand name and generic manufacturers should be held accountable for the safety of their products.

Originally, we were supposed to speak at a Congressional Hearing on March 26 but the AAJ needed to prep us for the FDA Hearing and there wasn't time to prep us for both hearings. Representatives from the AAJ attended the Congressional Hearing and we are told that it went very well.

On March 26, I arrived at the Sheraton in Silver Spring, Maryland. At 5PM, we attended the prep meeting with Rose Hernandez, Michelle Kimmel, Sarah Rooney, and Ben Somberg from the American Association for Justice.

I had the pleasure of meeting Lisa Bloomquist, who also traveled to Maryland to testify at the FDA. Lisa and I were there to testify to represent the fluoroquinolone community. QVF Ambassador Jonathan Furman joined us- at his own expense- to help Lisa and I. He was a big help and I appreciate that he sacrificed his time to help us.

At the prep meeting, we met many others who were affected by generic medications. The stories were heartbreaking.

There was Emily, who lost her infant son after she took a generic medication she was told was safe during pregnancy.

Diana, who needed part of her arm amputated.

Anthony, whose life partner of almost 40 years deteriorated so much after taking generic Reglan that he resides in a nursing home and needs round the clock care.

Taylor, who is now 16 years old and lives with life threatening blood clots since she was 13. She almost died and has had over a dozen surgeries. She still lives with blood clots in her lungs.

Keith, whose child has Spina Bifida. He and his wife can barely afford medical care and relies on welfare to get by.

We then practiced our testimony.

Here is Lisa practicing hers. She did a fantastic job.

Here is me practicing mine.

The FDA Hearing was held in Building 31, Room 1503 at the Food and Drug Administration on March 27.

We went through security (where the metal plates and screws I have in my body set off the metal detectors and I had to show my medical devices card), and then checked in to get our FDA Speaker badges.

Here is the meeting agenda:

Because the hearing was running early, I testified at approximately 3PM instead of the scheduled 3:52PM time slot.

This was my testimony. It was accompanied by a Power Point presentation. The clicker to control it was broken so an official with the FDA had to click through the slides for me.

*UPDATE: April 6, 2015 9:30AM: 
Webcast of the FDA Hearing can be found here:
Part 1 Lisa Bloomquist is the first speaker.
Part 2
Part 3
Part 4
I am the third speaker.

"My name is Rachel Brummert. I am Executive Director of Quinolone Vigilance Foundation, a non-profit research and advocacy organization. My travel expenses were paid by the American Association for Justice.

In my work, I hear many stories from people who have been injured and disabled after taking generic fluoroquinolone antibiotics, such as levofloxacin, ciprofloxacin, and moxifloxacin. As someone who suffered injury myself, I am here to talk about my personal experience with levofloxacin.

In 2006, I was prescribed Levaquin to treat a suspected sinus infection.

A few days after I took it, I felt a burning sensation in my hands and feet. By the following week, my left foot went numb, and to this day, it is still numb.

I have ruptured nine tendons. My Achilles tendon once in my right foot, twice in my left foot, and I ruptured tendons in my right wrist, right elbow, left thumb, left ring finger, and both knees.

While surgery fixed the tendons, anything that is operated on on will never be the same and for the last nine years and counting, I have been in pain every day.

Routine tasks are difficult for me. A few years later I have also been diagnosed with a neurodegenerative disease after taking levofloxacin while I was in the hospital. I have lost a large portion of my short term memory and I continue to lose more long term memory every day.

My cognitive and motor function will continue to decline until I am no longer able to take care of myself.

The damage caused by medications I took was more than just financial hardship.

I can no longer afford my home because of increasingly skyrocketing medical expenses and surgeries and I was forced to move. I lost my career that I loved with immeasurable passion and lost good income.

It also has taken an emotional toll on my family who are forced to take on the role of caretakers as I continue to decline.

In addition to being here to tell my own account of how I was injured by a generic medication, I am also here to tell the stories of others who were supposed to be here today, and can't.

Greg Spooner, a husband and father of two, was a healthy, athletic college professor in California.

He took ciprofloxacin in February 2010 for a suspected minor infection. He lost his job of more than 18 years after becoming disabled and he lost his home, forcing him to move.

He has had surgery to repair the damage and he needs more, which he cannot afford right now. He has joint pain, tendon pain, and nerve pain every day and it makes it difficult for him to do routine tasks and play with his young children.

Because he took a generic, no one is accountable for his injuries.

Jeff Stephens is 44 years old and lives in Georgia. He was going to be here today to tell his story, and he can't be because he is so sick and the trip here could kill him.

He took levofloxacin for a suspected sinus infection in January 2013.

He was a world traveler, and had a great job for over 20 years. He is now disabled after taking the generic levofloxacin.

He lost his job after he became disabled and he can no longer afford medical treatments. His parents are hemorrhaging their retirement money to help him pay for treatments and food. He cannot walk unassisted and frequently uses a wheelchair.

He was a healthy man until he took generic Levaquin. Because he took a generic medication, he has been denied justice after suffering severe brain damage, heart palpitations, shortness of breath, musculoskeletal problems, gastric problems, neuropathy, insomnia, and over 20 other adverse reactions.

I am urging the FDA to finalize the rule as it is written. 

This proposed rule will ensure that generic drug companies are responsible for warning the public of the risks involved in taking the medications they sell so that others do not suffer the same way that everyone who testified today has suffered.

Those of us who are here today, despite our suffering, are only a handful of the people who have been irreparably harmed. Those injured by generic drugs have suffered the same injuries and disabilities as those who took brand name medications and justice has been denied because of the current generic drug safety loophole.

The FDA has the power and responsibility to ensure patients are warned and to promote safety by making sure generic drug makers are accountable for their products just as brand name-drug makers are. If this rule is not finalized quickly, it is only adding injury to injury and leaving patients at risk.

Thank you for your time and consideration."

The generic drug industry also had the opportunity to testify. I was not present for that but I was told by people who were that the FDA panel aggressively grilled them and called them out on the misinformation they testified to.

When I was testifying, and I noticed when other victims testified that the FDA panel was paying very close attention to our testimonies.

It was an honor to have been asked to testify and working with the American Association for Justice was an amazing experience.

The AAJ is petitioning the FDA to close the generic drug loophole. To show your support and urge the FDA to finalize the proposed rule as it is written and to do it quickly before more people are hurt or killed, please sign this petition and share it with everyone you know.

Rachel Brummert
President/Executive Director
Quinolone Vigilance Foundation

Thursday, March 26, 2015

FDA testimony

Lisa Bloomquist and I are in Silver Spring, Maryland, just outside Washington, DC. Tomorrow we will be testifying at an FDA Hearing in White Oak, Maryland.

This evening, we attended an FDA prep meeting with the American Association for Justice (AAJ). We went over strategy and practiced our testimony in front of everyone who traveled here to testify and the AAJ.

The stories we heard are absolutely heartbreaking.

This is Lisa practicing her testimony at the dinner meeting. She did an awesome job and she will do a great job tomorrow.

This is me practicing my testimony.

QVF Richmond, Virginia Ambassador Jonathan Furman traveled here to support Lisa and I.

This is me, Jonathan, and Lisa after the dinner meeting.

The FDA Hearing tomorrow will be live streamed. Lisa is scheduled to testify at 8:30AM (Eastern Time). Mine is scheduled for 3:50PM.

To watch it live click here. Follow the link under Webcast.

The FDA Hearing is not specifically for fluoroquinolones. It is about generic drug makers not being held accountable for the damage their medications cause and protecting the public. This hearing is very important because it could overturn the Pliva v. Mensing Supreme Court decision.

Generic drug makers will also be testifying and both sides will be represented. The American Association for Justice told us this evening that victims will outnumber the generic drug makers at the hearing tomorrow.

Listening to the stories of others who have been injured, they are absolutely heartbreaking and will have a powerful impact.

Lisa and I are here not only to tell our stories, but also tell the stories of others. I wish we could tell everyone's story but unfortunately we can't. Lisa was affected herself, as was I. I took both brand name Levaquin in 2006 (there was an error in our press release that we are working on correcting) and was given levofloxacin years later while in the hospital without my knowledge or consent. I learned of it after reading my medical records.

 If the FDA rule passes as it is currently written, it's a victory for everyone who has been harmed by a generic medication.

Wish us luck!

-Rachel Brummert
President/Executive Director
Quinolone Vigilance Foundation

Tuesday, March 24, 2015

Press Release: Quinolone Vigilance Foundation Requests FDA to Close Generic Drug Loophole

*Original Press Release contained an error. Below is the corrected version*

Quinolone Vigilance Foundation Requests FDA to Close Generic Drug Loophole

Executive Director Rachel Brummert to Testify at FDA Hearing


HAMILTON, N.J., March 24, 2015 /PRNewswire-iReach/ -- When Rachel Brummert went to her doctor for a suspected sinus infection, he wrote a prescription for Levaquin, a powerful antibiotic, which she assumed was safe. She was later prescribed levofloxacin for a bone infection. At the pharmacy, she was given the generic version of the drug because her insurance would not pay for the brand name, Levaquin. It was too expensive. Rachel didn't mind. The generic was equivalent to the brand name drug, and it was cheaper.

Unfortunately, Rachel suffered a severe and disabling reaction to Levaquin and levofloxacin. That is when she discovered a hidden cost to generics. Patients who are harmed by a generic drug cannot sue the manufacturer of the drug. Even more shocking, manufacturers of generic drugs are not required to update the patient guides or warning labels. The drug she assumed was safe and inexpensive was, in fact, neither. Although Rachel has suffered through nine tendon ruptures, peripheral neuropathy, chronic gastric problems, and was diagnosed with a serious neurodegenerative disorder, all directly related to her use of these drugs, she has virtually no legal recourse.

All of that may change thanks to Rachel and others like her. On March 27, 2015, Quinolone Vigilance Foundation Executive Director Rachel Brummert will testify before the FDA at the Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products hearing in White Oak, Maryland. She hopes that by sharing her story, and the stories of other victims, the FDA will finally take action and close this generic drug safety legal loophole. "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", says Ms. Brummert.

The Quinolone Vigilance Foundation ( is a non-profit, charitable organization that fosters, initiates, and funds research on Fluoroquinolone Toxicity. We also advocate for injured and disabled patients who took a fluoroquinolone, and we educate patients and doctors so they can make an informed decision about their health.
Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839,




Monday, March 23, 2015

Press Release: QVF Partners With Mesh Warrior Foundation

Quinolone Vigilance Foundation announces partnership with The Mesh Warrior Foundation.

Press Release

Quinolone Vigilance Foundation, Mesh Warrior Foundation Join Forces to Raise Awareness of Dangers of Pharmaceutical Products

 Organizations Partner to Educate Patients and Doctors about Fluoroquinolones, Transvaginal Mesh

 HAMILTON, N.J., March 23, 2015 /PRNewswire-iReach/ -- The Quinolone Vigilance Foundation ( and The Mesh Warrior Foundation ( announced today that they have joined forces to raise awareness of the dangers of fluoroquinolones and the transvaginal mesh medical device. Many women who suffered complications after implantation of a transvaginal mesh were prescribed fluoroquinolones and put at further risk for health issues as a result.

A transvaginal mesh (TVM) is a medical device designed to treat women's health problems such as pelvic organ prolapse and stress urinary incontinence. Implanted through the vagina, TVM is comparable to a man-made net, acting as a means of support for pelvic muscles that are not functioning properly.

However, several problems have been associated with TVM implantation. They include device erosion through the vagina wall, extreme pain, bleeding, infection, bowel and bladder perforation, incontinence and others.

Infections are particularly commonplace after TVM devices are implanted. In order to combat this issue, patients often receive a type of antibiotic drug known as a fluoroquinolone. Drugs in this classification include the medications Levaquin, Cipro and Avelox.

Fluoroquinolones have been linked to mitochondrial toxicity, a condition that can lead to several serious health issues, including brain disorders, muscle weakness, and others. According to the U.S. Food and Drug Administration, fluoroquinolones can also lead to nerve damage if taken orally or intravenously. Despite the evidence linking these drugs to severe problems, they continue to be prescribed not only to patients suffering from TVM-related complications, but also for relatively routine infections such as urinary tract infections and sinus infections. (

“Many patients implanted with transvaginal mesh were not made aware of the device’s severe adverse events and permanent side effects including nerve damage, painful sex, chronic pain, painful scar tissue formation and debilitating injury to voluntary and involuntary muscles. Furthermore, as the mesh erodes through tissues like the urethra, recurrent infection including frequent UTI is common. In my opinion, when a patient is prescribed fluoroquinolones as a first-line defense to combat infection associated with transvaginal mesh, it’s literally adding injury to injury,” said Aaron Leigh Horton, founder and executive director of The Mesh Warrior Foundation. “The goal of our partnership with the Quinolone Vigilance Foundation is to educate doctors and patients alike about the dangers of prescribing fluroquinolones as a first-line defense in treating recurrent UTIs or other common infections in mesh-injured patients. These patients have already suffered a devastating loss of quality of life, and I feel that prescribing another treatment which carries significant risks of further permanent injury, is simply taking too high a risk.”

"We are proud to partner with The Mesh Warrior Foundation in an effort to stop the incredible suffering TVM patients have experienced after being prescribed fluoroquinolones," said Rachel Brummert, President and Executive Director of the Quinolone Vigilance Foundation. "Patients are being unnecessarily harmed, not only by defective medical devices but also by off-label use of powerful medications."

The Quinolone Vigilance Foundation is a non-profit, charitable organization that fosters, initiates, and funds research on Fluoroquinolone Toxicity. We also advocate for injured and disabled patients who took a fluoroquinolone, and we educate patients and doctors so they can make an informed decision about their health.

The Mesh Warrior Foundation is a collection of volunteers, injured patients and injured family members. We support all those who, male or female, have been harmed by the dangerous medical device called medical polypropylene mesh.

Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839,

Sunday, March 22, 2015

Neurodegenerative Disease and Memory Loss

Have you ever walked into a room and forgot why?

Or went to the store and forget the one thing you went in there for?

Or forgot someone's name?

It happens to all of us.

It's frustrating for anyone, and it's usually dismissed as getting older, or as my friends like to joke, C.R.S, better known as Can't Remember Squat. Okay, okay, it's not “squat” but let's keep this rated PG.

It's annoying when these things happen, but when you have a neurodegenerative disease, what most people think of as a minor annoyance is an every day battle and it is evidence that the progression of your disease has advanced.

After taking Levaquin in 2006, I was diagnosed with the progressive form of Neurosarcoidosis, a neurodegenerative disease. I didn't find out until years later that a class of antibiotics called fluoroquinolones are linked to neurodegenerative disorders. Suddenly it made sense why my cognitive and motor function is in decline. Had I been warned of this risk, I never would have taken it. Sadly, the FDA has chosen to not warn doctors or patients of this risk. It was through a Freedom of Information request that the FDA report ever saw the light of day, and I'm glad it did so others can be warned.

Neurodegenerative disease describes the progressive loss of structure or function of neurons including death of neurons. Neurons don't typically reproduce or replace themselves so when they become damaged, or they die, they can't be replaced. The progressive form of Neurosarcoidosis is incurable and debilitating. There will come a time when I am no longer able to take care of myself.

That is a scary thought.

A lumbar puncture found elevated protein levels and elevated lymphocytes. A brain MRI found space-taking lesions. A biopsy of brain tissue showed granulomas- the tell-tale indication of Neurosarcoidosis.

Granulomas affect the way an organ functions. In the brain, they cause seizures, chronic meningitis, memory and motor impairment, and many other debilitating symptoms. It is extremely hard to treat.

It is amazing to me how things have changed. I used to have a near-photographic memory. I used to be able to look at something, or read something, and remember it.

Now that this disease is progressing and the memory loss is increasing, it has made things hard.

I've had to make allowances in my life to accommodate my new normal. My short term memory is very poor. I am losing a lot of my long term memory as well. I have no recollection of anything prior to around 13 years old. Age 13 to 28 are spotty. I see pictures and I can't place where the photo was taken. Most of the time I can't put a name to the person in the photo with me. This is especially distressing when it is a relative that I have known my whole life. When I look at photos, it feels like I am watching someone else's life.

  • To help remember names, I use mnemonic devices. For example, we had an electrician come to replace the fuse box. His name is Richard. He was wearing a hoodie and it was made from a heavy material that looked like it had a wool blend. I am allergic to wool. Wool makes me itchy. So I remembered his name as RICHard because his hoodie looked ITCHy.

  • In my phone, I assign photos to caller ID and I also put how I know the person next to their name, even family.

  • My house is littered with Post-It notes. My memory has gotten so poor that I have had to leave a Post-It in the bathroom to remind me to brush my teeth, brush my hair, etc. As this progresses more I will have to leave Post-Its reminding me how to do those tasks. Using a white board and my Boogie Board have also been helpful.

  • My medication is divided into colored containers. A Post-It reminds me which medications I need to take at certain intervals.

  • I keep my purse near the front door. My keys are attached to the purse. You can't leave without your keys so anything I need to take with me, I put near my purse and keys. I also have a Post-It note next to the door as a secondary reminder.

  • I find that keeping lots of short lists is less overwhelming than having fewer long lists. 

  • Repetition doesn't always help me remember something, but it does allow me to be less frustrated by the situation.

  • Setting alarms on phone.

  • My neurologist says that laughing activates different parts of the brain. I don't know how much this is true, but who doesn't like to laugh? I am lucky to be surrounded by people who make me laugh every day and I love watching funny videos on YouTube.

  • I keep journals documenting every day the most mundane things, like what the weather is like, what I have for dinner, that I saw a bird in the bird house in the backyard, that I saw my elderly neighbor take his daily walk.
  • I use the microwave as much as possible. If I use the stove, I make sure someone is home with me so I don't forget to turn it off.

I am 44 years old and relatively young. My mind and body will will continue betray me until it steals my breath.

Since the FDA themselves won't warn doctors and patients of the risk for neurodegenerative disease, it's up to all of us.

It is too late for me, but it isn't for you.

Rachel Brummert
President/Executive Director
Quinolone Vigilance Foundation

Saturday, March 14, 2015

QVF Fundraiser- 3/13/15

Last night, at the Grog and Tankard in Stafford, Virginia, something really amazing came together.

Months in the making, our fundraiser came to fruition.

Christian Justus, the bass player for Echoes of Solitude, is a friend of mine. I've been keeping up with photos from shows they've played and on a whim, I reached out to him and asked if they did fundraisers. QVF has done online auctions and we receive private donations, but we have never held a live event and we thought we'd see if we could throw something together.
QVF Ambassador Jonathan Furman, Bass player for Echoes of Solitude 
Christian Justus, and Executive Director Rachel Brummert.

It was beyond our wildest dreams.

Christian put me in touch with Chris Rosenbaum of Dark Anubis Promotions. We went from one band to five.

QVF Ambassador Jonathan Furman and his girlfriend Paula Morgan came out to help me. As we walked up the ramp, we were greeted by Chris Welborn, a member of the band Service of Shadows, and the awesome guy who planned our event. He did an amazing job.

Chris introduced us to everyone and they were so welcoming and helpful. We really enjoyed getting to know everyone.

What struck me before the show, and certainly during the show, was that there was a true sense of friendship and fellowship. The bands didn't keep to themselves until their set. They were dancing and cheering for each other and truly enjoyed each others music and company.

QVF Executive Director Rachel Brummert with
lead singers from goddess Crow, Echoes of Solitude, and Helafyde.

I confess, Metal was never my thing. But I had an amazing time last night. All 5 bands were at the top of their game, And. Were. Awesome. The energy is infectious.

While the bands were setting up, they came over to us and were looking at all our awareness materials and they were horrified by what they saw and heard about fluoroquinolone antibiotics. They helped us pass out brochures and flyers. They wore our wrist bands. They told us stories of people they know who take these medications.

QVF Ambassador Jonathan Furman was called up to the stage to talk about our work. Jon is a guy who commands an audience and does it with humor. I spent 12 hours with him and Paula Morgan. They were so helpful and so fun to be around.

 There was a guy who is also from New Jersey who was there and we bonded over that. 

There was a woman there whose mother took a fluoroquinolone antibiotic. We left some brochures with her. I wish I spent more time with her but it was so chaotic when I got there, so if she is reading this, please feel free to follow up with me. I was very touched that she came out to support us.

One story I will never forget was when a young woman named Rebecca came up to us. She is a caretaker for a 14 year old girl who has a chromosomal disorder. This teenage girl had several back surgeries and her last surgery was botched. She was put on Levaquin to prevent infection. She is paralyzed and suffered severe psychosis after taking it. Doctors couldn't figure out why that was happening to her. Rebecca told us she was reading our brochure and had an “ah-ha” moment. Jonathan and I spent a long time talking to her and we are dedicated to doing what we can to help her. She left us this note. We are only showing the bottom portion to protect her privacy. We were really touched that she wrote this for us.

Some of the bands asked us to leave brochures with them so they can continue helping us spread the word at other shows. They all genuinely care about the work we do.

The promoter and the bands have already asked us to do other events. We are honored and can't wait to do more.

To say that the event was a huge success is an understatement. We could not be more pleased with how it went.

As a thank you, we gave plaques to Dark Anubis Promotions, and to all of the bands. They were so surprised and grateful and they all gave me a big hug afterward.

To quote Rick, the lead singer from Helafyde: “We're huggers”.

I loved that.

The bands posted a photo of them with a thank you to us.

Every member of each band have a joyous love for music and have big hearts. There are not enough words in my vocabulary to express how I felt being in the midst of these talented and genuine people.

We thank the following for everything they've done for us:

The Grog & Tankard for hosting us.

Chris Rosenbaum, Chris Welborn, and Christian Justus for working so hard to put together this amazing show.

Helafyde, especially the lead singer who is the coolest dude ever and spent a lot of time talking to us about our work.

Echoes of Solitude.

Service of Shadows

goddness Crow (whose lead singer's name is also Rachel)


We had a blast and appreciate everyone who came together to make this special for us.

All of the photos we took from the event can be found here.  

If you were unable to attend, but would like to still help us continue our mission to fund research into Fluoroquinolone Toxicity, advocate for victims and their families, raise awareness about these very dangerous medications, and to educate the medical community, as well as help medical centers re-write their policies about Levaquin, Cipro, Avelox, and others: via PayPal


Quinolone Vigilance Foundation
PO Box 4023
Hamilton, NJ 08610

We are a 501(c)(3) charitable foundation and all donations are tax deductible.

Rachel Brummert
President/Executive Director
Quinolone Vigilance Foundation