On Friday March 27, 2015 I testified before the U.S. Food and Drug Administration (FDA) asking them to change a rule that currently prohibits manufacturers of generic drugs from updating the warning labels for the drugs that they make.
Why, you may wonder, should anyone care whether or not generic drug manufacturers are able to update their warning labels?
EVERYONE should care about this issue because as long as generic drug manufacturers are unable to update drug warning labels, NO ONE who is hurt by a generic drug has any recourse against generic drug manufacturers, no matter how badly one is hurt by a generic drug. In 2013 the U.S. Supreme Court decided that, because generic drug manufacturers are required to copy the brand-name drug warning label, they cannot be held responsible for any harm done by the generic drug. People hurt by generic drugs didn’t take a name-brand drug, so they cannot sue the name-brand drug manufacturers. This leaves people hurt by generic drugs unable to hold anyone responsible for the damage done by generic drugs, and people are left without any legal recourse.
IF YOU ARE HURT BY A GENERIC DRUG, YOU CANNOT SUE. YOU HAVE NO RECOURSE WHATSOEVER.
This is appalling. More than 80% of the prescription drugs dispensed in America are generic. Everyone who takes a generic drug is unable to gain any sort of legal compensation, any sort of justice, when injuries are caused by those drugs. Think about that next time you take a generic drug.
Or, better yet, think about the following people, who also testified to the FDA about the harm caused by generic drugs, who are unable to gain any sort of justice or compensation for their losses. Their stories could be your story, or your child’s story, or your parent’s story.
Fluoxetine (Prozac) and Cardiac Malformations
Emily, a 29 year old who was taking fluoxetine, generic Prozac, throughout her pregnancy, gave birth to a baby boy who had a serious heart defect. Her son died when he was 2 weeks old. In 2011, Eli Lilly, the manufacturer of Prozac, admitted that, “there is some evidence of a possible small increase in the risk of cardiac malformations (eg ventricular and septal defects) associated with use of fluoxetine” (source). If Emily had taken Prozac, she would have been able to sue Eli Lilly, and possibly gain some sort of compensation for her losses. However, Emily took generic fluoxetine, so she has no recourse, no possibility of compensation, and no justice.
Metoclopramide (Reglan) and Tardive Dyskinesia
Anthony testified about his partner of 40 years who is suffering from severe tardive dyskinesia after taking metoclopramide, generic Reglan, for 11 years. Anthony’s partner can no longer speak or function independently. He is 100% dependent on Anthony for his care. “Tardive dyskinesia typically affects someone’s face, often causing uncontrolled grimaces and movement in the eyes, lips, tongue and jaw. Arms, fingers, toes, legs, hips and torso are also affected and may twitch and move rapidly and uncontrollably. These random body movements can be uncomfortable and painful as well as embarrassing and difficult to control, making it a social handicap. Severe cases of this disorder can be debilitating and make it difficult to perform simple tasks like talking, walking and eating.” (source) Because generic metoclopramide is what caused harm, neither Anthony nor his partner have any possibility of legal recourse.
Birth Control and Blood Clots
Taylor suffered from life-threatening blood clots at the age of 14 after taking generic birth-control pills. She is now 17 and suffers from permanent health complications because of the blood clots.
Levofloxacin (Levaquin), Tendon Ruptures, Neuropathy and More
Rachel spoke about how levofloxacin, generic Levaquin, caused her to have multiple tendon ruptures, and contributed to her developing a neurodegenerative condition called neurosarcoidosis. In addition to losing her health, Rachel “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.” She has no legal recourse because she took generic levofloxacin.
I testified about how Heather was hurt by ciprofloxacin, generic Cipro, and moxifloxacin, generic Avelox. After taking ciprofloxacin and moxifloxacin, Heather suffered from severe nerve pain, central nervous system issues such as panic attacks and brain fog. She had blood sugar regulation problems, irregular heartbeats and more. She lost her career as a massage therapist and had to declare bankruptcy. Her life was devastated because of her severe adverse reaction to these drugs. She is unable to sue the manufacturers of the drugs that hurt her though, because she took the generic versions of the drugs.
I also testified about how Sarah reported this about the effects of ciprofloxacin on her life, “Still suffering and disabled; can’t work, lost profession, lost financial security, lost marriage, lost hope for any reasonable quality of life. Denied by medical profession due to no known diagnostic biomarkers; denied legal recourse due to generic; denied SSDI due to the first two and denial by the FDA and everyone involved, and ultimately, will be denied as the most probable cause of my death.”
Clinoril (Sulindac) and Stevens-Johnson Syndrome
There are many more cases of death and injury caused by generic drugs. Clinoril, generic Sulindac, can cause horrific injuries, such as those suffered by Karen Bartlett, “who lost nearly two-thirds of her skin, was placed in a medically induced coma and is legally blind after suffering a reaction to the medication she took for a sore shoulder” (source). Over-the-counter pain relief pills and antibiotics can cause Stevens-Johnson Syndrome, a severe and life-threatening skin condition in which cell death causes the epidermis to separate from the dermis.
Acetaminphen, Ergotamine, Montelukast and More
Acetaminophen can cause liver injuries that can lead to death. Ergotamine, a drug used to treat migraine headaches, when administered improperly, can cause gangrene and loss of limbs. Montelukast, generic Singulair, can cause Churg–Strauss syndrome, rare form of eosinophilic vasculitis associated with asthma. There are hundreds of other examples of damage that can be caused by drugs.
Adverse Reactions and Generic Drugs – The FDA’s Role
Generic drugs are just as dangerous as name-brand drugs. Those who are hurt by drugs deserve recourse and compensation for their losses. To arbitrarily take away a person’s opportunity for justice, simply because he or she took a generic drug, is ridiculous and wrong. Currently, there is no justice for people who suffer from adverse effects of generic drugs. DO NOT take a generic drug until this situation changes.
The FDA can nullify the Supreme Court’s ruling, and enable those who are hurt by generic drugs to gain justice, simply by changing their rules so that generic drug manufacturers can update their warning labels just like name-brand drug manufacturers can. I hope they do so. I encouraged them to do so in my testimony.
The generic drug manufacturers are arguing that it would be onerous and costly for them to update the warning labels. Seeing as even generic drug manufacturers have billions in profits, that argument seems a bit shallow and disingenuous. The pharmaceutical industry as a whole has proposed to stop the discrepancy in justice between generic and name-brand drug manufacturers by making name-brand drug manufacturers equally inculpable for damage done by their drugs as generic drug manufacturers currently are. If the FDA “fixes” this situation by making all drug manufacturers unable to update their warning labels and therefore exempt from lawsuits, no victim of a pharmaceutical will have any legal recourse against the companies that hurt them, and a vital check on the power of the pharmaceutical industry will be lost.
I hope that the FDA does the right thing, and closes this loophole that is keeping millions of victims of pharmaceuticals from getting justice.
The FDA testimony can be viewed through these links:
- https://collaboration.fda.gov/p4vtitcjbcb/
- https://collaboration.fda.gov/p62plg4hlc4/
- https://collaboration.fda.gov/p1butpdfuap/
- https://collaboration.fda.gov/p16w66yyjfa/
Information about Fluoroquinolone Toxicity
Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.
Participate in Research
Hormones MatterTM is conducting research on the side effects and adverse events associated with the fluoroquinolone antibiotics, Cipro, Levaquin, Avelox and others: The Fluoroquinolone Antibiotics Side Effects Study. The study is anonymous, takes 20-30 minutes to complete and is open to anyone who has used a fluoroquinolone antibiotic. Please complete the study and help us understand the scope of fluoroquinolone reactions.
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My name is August Iaboni give me Levaquin in 2003 I was given the generic ran into thousand six window trying to settle and they claim that the first time I was given Levaquin and the next three times I was given the generic brand and because she is a reasonable doubt of not knowing when I got sick they do not want to pay either it was a generic brand that caused my problem or Or since I only took the original print the first time I believe Amanda when I took it I was hurt and now I’m in a wheelchair unable to find my way back to the way I was this is ridiculous and ashamed of the way we are being treated and get back to me had a or since I only took the original print the first time I believe Amanda when I took it I was hurt and now I’m in a wheelchair unable to find my way back to the way I was this is ridiculous and ashamed of the way we are being treated get back to me
fda sucks
Just today I received a phone call from the law firm handling my low Testosterone medication law suit. I began taking Low T shots in April 29, 2010 and on July 29, 2010 I experienced a pulmonary embolism. My case was filed on time with a law firm that was involved in the Low T lawsuit. Today I was told that because my Low T medication (shots) was a generic brand that I will have no recourse against the manufacturer. Manufacturers of these products are getting of scott free and that in itself is a crime and laws need changed.
You have recourse. You can sue the doctor who prescribed the medication if it was prescribed incorrectly. That’s what I am going to do if my neuropathy and pain doesn’t resolve. Generic Cipro was ordered “just in case”for a UTI which is against what the FDA recommends while I was taking Aleve for pain, and I wasn’t informed of the possible permanent side effects. It’s a small step but if everyone starts suing their doctors, the doctors will think twice about precribing quinolones. I’m also fighting for the addition of written informed consent when prescribing these meds
I took 3 rounds of genetic LEVIQUIN generic
How do we change this law
This drug ruined my life
I’m ready to fight
That’s kind of funny I too was injured buy generic Levaquin levofloxacin now I have severe peripheral neuropathy and they put me on disability and I have no legal recourse because it was generic the law needs to be changed these drugs are harming people’s lives and no one seems to care
I was diagnosed with adult onset asthma in March 2007. I was given an albuterol inhaler and sent home. The albuterol made me feel jittery so I tried to find something that would be safe, perhaps something a child would be safe taking. So I asked my Doctor about Singulair. My husband went to his office and picked up some from him. I started feeling tingling in my feet. It got worse, so about a week later, I quit the Singulair. It was downhill after that. I had horrible nerve pain and it was like torture. In a few days iit got worse and my lower legs became paralyzed and my right hand. I had to use the rescue inhaler as my breathing was terrible.
In May 2007 I was admitted to emergency room for paralysis of my lower legs, my right arm and severe respiratory failure. The doctor diagnosed me two weeks later with Churg Strauss syndrome. When admitted, I told the emergency doctor that I believe this was a side effect of the Singulair. He said no, it wasn’t. I was in the hospital for 2 months unable to walk anymore and with foot drop in both feet. I still believe the singular caused it as I read that this was one of the reasons people get Churg Strauss. I even went to an attorney and he told me that unless there were others who came down with my illness after taking singular, that it would be hard to prove. And I didn’t know anyone then with Churg Strauss because it is such a rare disease. Is ther anything I can do? I do know others who have taken Singulair who also came down with Churg strauss. This drug is very very dangerous.
Would you be interested in sharing your story in a post on this blog? That way we can see if more folks suffered similarly. Others will be able to find you and each other more easily from a searchable blog post. If you’re interested, send us note via this link. https://www.hormonesmatter.com/write-for-hormones-matter/
Hi Janet,
I have heard from others who have had Churg Strauss brought on by Singulair. You are not alone. I will do my best to connect you with other sufferers. I am so, so, so sorry that this happened to you!
Regards,
Lisa
Hi Janet,
A friend gave me these resources for you:
These stories to let you know that you are not alone – http://www.cssassociation.org/patient-stories-77.html.
Also, these facebook groups have fellow CSS sufferers, and maybe they’ll have some good suggestions and resources for you:
https://www.facebook.com/groups/59554846652/?ref=br_rs
https://www.facebook.com/groups/228631963824688/?ref=br_rs
Regards,
Lisa
I took a generic levaquin, a week or so later I had an aortic dissection. It was descending so it was not fixed by surgery. I now have an aortic aneurysm. The tear is pasted together with blood clots. A CT scan every 6 mos to check the size of the aneurysm. Keep my bp below 120.
I am in the same boat with you. Took generic Leviquin 7 weeks later aortic dissection. Tore 2 layers of muscle from over my aortic valve down thru and ended in my thighs. Doctor said I would not survive operation. Tear was so big over the valve had to put in synthetic patch. The FDA is ridiculous, the Supreme Court is even more ridiculous. We do not have equal rights if we are poor. What else is new. This is also unconstitutional. WE the POOR in this country ARE NOT CREATED EQUAL. We have no legal rights! Only the rich do? Supreme Court never gave direction as to what to do. ONLY we cannot sue the generic company. Then where and who do the poor go to for compensation. Drop dead and then forget about it!!!
The FDA, the Supreme Court, Big Pharma, the insurance companies all have equal rights. They can afford brand name drugs. the constitution only applies to them? Everyone in the US should refuse generic drugs, maybe stop paying all the bills for the rich. Our taxes pay all the bills, they all get the huge tax brakes. Brand name drug manufacturers are responsible, it is their formula. They are killing us. Generic manufacturers are making the same formula. These drugs would never have reached the marketplace if the brand name manufacturers had not formulated them. WHY can’t we sue them? Already gave you the answer above.
I wonder how many people would take generic drugs if they were told the truth about their legal rights!!
This angers me to no end! What are people supposed to do??? It seems the medical est. and FDA are abandoning us ! I am vivid!