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:
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.
Hormones MatterTM conducts other crowdsourced surveys on medication reactions. To take one of our other surveys, click here.
To sign up for our newsletter and receive weekly updates on the latest research news, click here.
What Else Can I Do To Help?
Hormones MatterTM is completely unfunded at this juncture and we rely entirely on crowdsourcing and volunteers to conduct the research and produce quality health education materials for the public. If you’d like help us improve healthcare with better data, get involved. Become an advocate, spread the word about our site, our research and our mission. Suggest a study. Share a study. Join our team. Write for us. Partner with us. Help us grow.
To support Hormones Matter and our research projects – Crowdfund Us.