What Steroid Meningitis Lawsuits Are There?
There have been hundreds of lawsuits over the link between fungal infections and steroid injections across the United States from Michigan to Tennessee. One case on October 16, 2012, occurred when Robert and Brenda Bensale filed a steroid meningitis lawsuit against the NECC. In their steroid meningitis lawsuit, the plaintiffs claim personal injuries, emotional distress, medical expenses, and other punitive damages as a result of Brenda Bensale’s exposure to the contaminated steroid injections. The Bensales hoped for coordination of all steroid meningitis lawsuits against the NECC (New England Compounding Center), into a class action lawsuit. The couple believed that consolidation into multidistrict litigation (MDL) would promote orderly, timely proceedings and allow for consistent rulings.
Similarly, In March 2013, Traci Maccoux of Brooklyn filed a lawsuit against a pain clinic called Medical Advanced Pain Specialists. Maccoux claims that the clinic was negligent in administering contaminated steroids. She was hospitalized for 10 days after developing steroid meningitis. Since developing the condition, she was unable to work or drive and was forced to drop out of school. Her medical bills total more than $110,000.
In 2023, the World Health Organization reports that there are still hundreds, if not thousands of infections being traced back to steroid injections.
Why Did People File Steroid Meningitis Lawsuits?
Many patients who received a dose of the contaminated steroid injections became susceptible to fungal meningitis. Fungal meningitis is dangerous, but not contagious. Patients also experienced localized infections including:
- Spinal infections
- Paraspinal infections
- Knee infections
- Shoulder infections
- Ankle infections
What Is the New England Compounding Center (NECC)?
The New England Compounding Center, or NECC, is an American pharmaceutical company that is responsible for manufacturing and administering the tainted steroid injections that have led to severe fungal infections across the country. As of 2022, however, the NECC Director of Operations was sentenced in federal court for conspiring against the FDA.
What Steroid Meningitis Lawsuit Settlements Are There?
In 2015, there was a 200 million dollar settlement reported for steroid meningitis patients who became infected after prescribed injections. The lawsuit was approved in court by the U.S. bankruptcy judge Henry Boruff for the New England Compounding Center’s drug misconduct. Several legal authorities have said this settlement is one of the largest contaminated medicine lawsuit cases they’ve ever seen in the United States.
What Is Steroid Meningitis?
Many people are referring to the fungal meningitis outbreak as “steroid meningitis.” This is because the fungal meningitis originated in the steroid injections from the NECC. However, fungal meningitis is the medical name for these cases of steroid meningitis. Fungal meningitis is not contagious, but the fungus that caused the steroid meningitis outbreak can survive on its own for long periods of time.
It is extremely rare for a person with a normal immune system to succumb to fungal meningitis. The outbreak of steroid meningitis in the United States in 2012 was the result of contamination with a brown-black mold known as Exserohilum rostratum. Cases resulting from the Cryptococcus neoformans fungus are the most common type of fungal meningitis. In Africa, cryptococcal meningitis causes roughly 20 to 25 percent of deaths among AIDS/HIV patients.
What Was the Steroid Meningitis Outbreak?
There are now more than 730 cases of illness from the contaminated steroid injections. As of March 2013, there were 51 reported deaths from the steroid contamination. The CDC worked with state health departments to estimate that roughly 14,000 patients were likely injected with the contaminated steroid and may be at risk of developing steroid meningitis. However, it is important to realize fungal meningitis can be slow to develop.
What Are the Symptoms of Steroid Meningitis?
The term meningitis refers to inflammation and swelling of the meninges, which are the membranes covering the brain and spinal cord. In most cases, meningitis is a reaction to a bacterial or viral infection. However, certain types of cancer or prescription drugs can cause meningitis as well. Meningitis may appear as a serious side effect of certain prescription drugs, or it may appear as a result of a contaminated medication.
What Is Fungal Meningitis?
Fungal meningitis differs from viral or bacterial meningitis. The symptoms of fungal meningitis are very slow to develop. It can take weeks to months for fungal meningitis side effects to fully appear. In contrast, bacterial meningitis can take a patient’s life in a matter of days. Viral meningitis can develop within a few hours, but it can remain dormant for years. Although some patients have spontaneously recovered, viral meningitis doesn’t react well to medication. It is typically dealt with on a management basis due to the lack of effective medication.
What Species of Fungi Lead to Fungal Meningitis?
There are several species of fungi that can lead to dangerous infections. Some of these fungi species that have been reported include:
- Histoplasma capsulatum
- Coccidioides immitis
- Cryptococcus neoformans
- Blastomyces dermatitidis
- Certain types of candida species
What Are the Warning Signs of Fungal Meningitis?
The most common warning signs of fungal meningitis are:
- Dizziness
- Disorientation, confusion, or any significantly altered mental status
- Decreased level of consciousness
- Hallucinations
- Slurred speech
- Rapid heartbeat
- Headache
- Nausea
- Fever
- Chills
- Stiff neck
- Photophobia, or an increased sensitivity to light
- The feeling of being generally sick, or “feeling very badly”
What Are the Serious Side Effects of Fungal Meningitis?
Some more serious side effects can occur after a tainted steroid injection. Patients experiencing any of these symptoms of fungal meningitis should contact a medical professional.
What Is Epilepsy?
Epilepsy is a condition of the brain that can lead to seizures. The disorder is a common nervous system disorder that affects a large portion of the U.S. population. However, some infections such as fungal meningitis have been shown to lead to symptoms of epilepsy.
What Are the Symptoms of Epilepsy?
The key symptom associated with epilepsy is a seizure, however, more specific symptoms include:
- loss of consciousness
- jerking movements of the body
- Stiffness
- Confusion
- Staring
- Increased psychological agitation such as:
- Anxiety
- Aggression
What Is Deafness?
Hearing loss, or deafness, results from an impairment in the ear drums. While hearing loss is characterized as a reduced ability to hear, deafness is when a person cannot understand any sound even when it is amplified. In cases of severe meningitis infections, some people have reported hearing loss or have become permanently deaf.
What Are the Symptoms of Deafness?
The key signs associated with deafness are hearing muffled sounds, being unable to understand conversations, and having trouble understanding different pitches of sound. If someone becomes deaf they will likely need a hearing aid or will need to communicate with writing or sign language.
What Is Neurological Damage?
Neurological damage can sometimes occur after exposure to tainted steroid injections. Brain damage or neurological disorders should never be taken lightly as they can severely impact someone’s quality of life.
What Are the Symptoms of Neurological Damage?
The most frequent symptoms detected with neurological damage or disorders are confusion, balance problems, lack of coordination, whole-body weakness, loss of awareness or consciousness, paralysis, or a loss of sensation due to damage to the nervous system.
In severe cases, death may also occur due to steroid meningitis. If you or a loved one experiences any of the severe warning signs and symptoms of an infection seek medical attention immediately.
What NECC FDA Health Violations Are There?
Compounding pharmacies are not subject to the same Food and Drug Administration (FDA) scrutiny as standard drug manufacturing companies. Compounding pharmacies, such as the NECC, are classified as specialty pharmacies. These companies alter, combine, and mix various ingredients to create prescription drugs for individual use. Patients with specific allergies or other personal needs are able to get customized prescriptions. Due to the individual and customized nature of the drugs, compounding pharmacies typically make smaller lots of drugs at a time.
There is an outcry from the public for better regulation of compounding pharmacies, such as the NECC. When FDA investigators visited the NECC facilities, they discovered unidentified “greenish-black” materials in several vials of the injectable MPA steroid. This confirmed suspicions that the MPA steroids from NECC were contaminated. Furthermore, the contaminated vials were merely a portion of numerous health violations identified during the inspection.
Was There Consolidation of NECC Fungal Meningitis Cases?
While the NECC supported the potential consolidation of the steroid meningitis lawsuits, the compounding pharmacy did motion to put fungal meningitis lawsuits on stay until the next year. In November 2012, Judge F. Dennis Saylor IV denied the NECC’s motion for a stay until 2013. Judge Saylor then proceeded to order the consolidation of Massachusetts steroid meningitis lawsuits. Plaintiffs of federally filed steroid meningitis lawsuits motioned to expedite consolidation due to fears of the NECC filing for bankruptcy. In late November 2012, the Judicial Panel on Multidistrict Litigation (JPML) refused to expedite the steroid meningitis lawsuits’ consolidation. By February 2013, the JPML transferred all federal steroid meningitis lawsuits to MDL in the U.S. District Court for the District of Massachusetts.
Cases of steroid meningitis, or fungal meningitis, have varying rates of recovery. Certain factors, such as age, sex, and immune system sensitivity, can affect whether or not a patient fully recovers from fungal meningitis. Approximately 14 percent of fungal meningitis survivors experience hearing loss. Roughly 10 percent of surviving fungal meningitis patients endure permanent cognitive impairment. According to the CDC as of 2023, lawsuits associated with fungal meningitis from steroid infections continue to climb.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
Sources
- CDC works 24/7. (2023, November 22). Centers for Disease Control and Prevention. https://www.cdc.gov/
- Epilepsy – Symptoms and causes – Mayo Clinic. (2023, October 14). Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/epilepsy/symptoms-causes/syc-20350093
- Felman, A. (2023, April 11). What’s to know about deafness and hearing loss? https://www.medicalnewstoday.com/articles/249285#hearing-loss-vs-deafness
- Former director of operations for New England Compounding Center sentenced. (2022, December 14). https://www.justice.gov/usao-ma/pr/former-director-operations-new-england-compounding-center-sentenced
- Fungal meningitis | CDC. (n.d.). https://www.cdc.gov/meningitis/fungal.html
- Health Alert Network (HAN) – 00492 | Important Updates on Outbreak of Fungal Meningitis in U.S. Patients Who Underwent Surgical Procedures under Epidural Anesthesia in Matamoros, Mexico. (n.d.). https://emergency.cdc.gov/han/2023/han00492.asp
- Item. (2023, June 1). https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON470
- Neurological disorders. (n.d.). https://dphhs.mt.gov/schoolhealth/chronichealth/neurologicaldisorders
- New England Compounding Center: Judge approves $200 million settlement in meningitis outbreak. (2015, May 20). CBS News. https://www.cbsnews.com/news/judge-approves-200-million-settlement-over-meningitis-outbreak/