Recently, the Centers for Disease Control and Prevention announced a Meningitis outbreak associated with steroid injections. The injections were given into the back to relieve pain. The steroid injection may have contained a fungus causing Fungal Meningitis.
The symptoms include:
If you or a family member have received back injections to relieve pain, you may develop Fungal Meningitis.
The unprecedented spread of meningitis associated with steroid injections manufactured by an unregulated compound pharmacy had dire consequences in October 2012 with thousands exposed, more than a hundred contracting the disease, and people needlessly dying. The contaminated injections have been traced to the New England Compounding Center (NECC) in Framingham, Mass, which like other compounding pharmacies is not regulated by the FDA and can sell drugs without FDA approval.
Federal inspectors removed samples of the suspect drug from New England Compounding Center to test for fungal contamination and the compounding pharmacy recalled its product on September 25, 2012. Federal inspectors found a foreign substance in an unopened vial containing the steroid injection in question.
The New England Compounding Center, licensed in all 50 states, shipped out a prodigious amount of the potentially contaminated steroid doses to 75 pain clinics in 23 states. After recalling the steroid injection substance the NECC shut down its entire manufacturing facility.
At least four places in Michigan received shipments of the medication:
Anyone who has contracted Fungal Meningitis, or suspect they might be a victim, should contact Cochran, Kroll & Associates immediately at 866-868-3779 for a free consultation to make sure their legal rights are protected.
There will be many individual lawsuits filed as well as several class action lawsuits. Victims are far better off hiring their own attorney to seek a remedy that meets their individual life requirements than to be lumped in with the needs of thousands of litigants in a class action lawsuit. Let Cochran, Kroll & Associates make sure you are fully reimbursed for harm done and that your future needs are provided for.
Some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding Center, which mixes up batches of drugs on their own, often for much lower prices than major manufacturers charge and with little of the federal oversight of drug safety and quality that is routine for the big companies.
Each of the patients contracting Fungal Meningitis certified by the U.S. Centers for Disease Control and Prevention had been injected with a preservative-free steroid called methylprednisolone acetate manufactured by the NECC. Common use of the injection is relief from pain.
Over the past 20 years, pain control has become a growth industry, bolstered by the worn-out knees and aching backs of baby boomers. Pain clinics began popping up around the country. Starting in the 1990s, spinal injections (lumbar epidural steroid injections) for back pain have skyrocketed. In 2011 alone some 2.5 million Medicare recipients had the injections, as did an equal number of younger people according to the International Spine Intervention Society. Many patients seek steroid injections in hopes of avoiding surgery. The injections combine a steroid and a numbing drug in an effort to soothe inflamed and irritated nerves. Patients often are told they may get weeks, months or even a year of relief.
The injections created a demand for steroids, including methylprednisolone acetate, the drug that New England Compounding Center was making. To be sure, many compounding pharmacies perform well, producing formulations of drugs for specialized needs. But compound pharmacies also provide hospitals and doctors with cheaper alternatives to FDA-approved drugs because in part, FDA scrutiny is not present. Compounding pharmacies also sometimes fill gaps left by shortages of drugs made by pharmaceutical companies.
Shortages may have played a role in the large purchases of the steroid injections manufactured by NECC. The two manufacturers of the generic version of the drug had stopped making it. Teva halted production in 2010 when it temporarily closed its Irvine, Calif., factory after receiving a warning letter from the FDA about manufacturing quality problems. The other manufacturer, Sandoz, stopped selling the product in the United States in 2012. Sandoz had also been reprimanded by the FDA for manufacturing problems.
While the FDA says the drug is not in short supply, the brand name product still available may have been considered too expensive, which could be why some medical practices turned to compounding pharmacies.
In addition, Medicare and some private insurers reimburse a fixed amount of about $300 for the injections, giving doctors another financial incentive to order the less costly compounded versions.
Meningitis can be caused by viruses, bacteria or fungi with the fungal type being the hardest to treat and devastating to patients because it can lead to strokes when the infection enters small blood vessels, causing clotting or bleeding. Some of the patients in the current outbreak have suffered strokes.
The symptoms of Fungal Meningitis include headache, stiff neck, worsening of neck or back pain, chills and fever. Anyone who has received back injections to relieve pain may develop Fungal Meningitis and if they do should call the law offices of Cochran, Kroll & Associates, PC of Livonia at 866-868-3779 for a free consultation.
In 1995 Michigan amended its product liability law to provide a broad defense for drug manufacturers who are sued for product defect. That law made drug manufacturers immune from liability if the drug was approved by the FDA and if the drug complied with FDA labeling requirements.
But compounding pharmacies, such as the New England Compounding Center, are not regulated by the FDA. Therefore, the steroid doses in question are not approved for safety and efficacy by the FDA and do not comply with FDA approval at the time the drug leaves the manufacturer or seller. Therefore, Michigan’s drug immunity law does not apply to these drugs or their manufacturers.
Attorneys at Cochran, Kroll & Associates have researched Michigan law and casework and are ready to make sure that those responsible for the Fungal Meningitis outbreak are held accountable. Call 866-868-3779 for a free consultation to take advantage of the skills, knowledge and litigation experience of our lawyers.
The Law Offices of Cochran, Kroll & Associates, P.C. is dedicated to representing individuals and families who have suffered catastrophic losses as a result of injuries, disabilities and death. The firm does not represent insurance companies or corporations but instead bases its practice upon representing individuals and families.
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