In recent years, contaminated medicines that were mass-produced by compounding pharmacies have been linked to a growing number of disease outbreaks. Numerous lawsuits have been filed by people who were injured by fungal meningitis, bacterial blood infections, joint infections, eye infections, abscesses, skin diseases, and more.
Need a Texas Compounding Pharmacy Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by contaminated medicine made by a compounding pharmacy, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
UPDATE: Downing Labs Recalls Compounded Drugs for Contamination Risk
October 21, 2015 — After years of concern about sterility, Downing Labs LLC has issued a recall for compounded drugs that may not be sterile. Click here to read more.
September 12, 2014 — Martin Avenue Pharmacy, Inc. has recalled all sterile medications after the FDA found problems with quality control procedures that could compromise the safety of sterile medications. Click here to read more.
September 11, 2014 — For the third time in the last 15 months, the FDA is demanding a recall of all “sterile” products from NuVision Pharmacy because the safety and sterility of the medications cannot be assured. Click here to read more.
July 31, 2014 — The Louisiana Record reports that a lawsuit has been filed by a woman who was injured by contaminated medicine from Main Street Family Pharmacy, a compounding pharmacy that recalled all of its medicines last year. Click here to read more.
July 21, 2014 — Unique Pharmaceuticals has recalled medications because they may not be sterile, according to a Safety Alert from the FDA after inspections of the facility in Texas found “insanitary” conditions. Click here to read more.
July 21, 2014 — The FDA has issued another warning advising healthcare professionals not to administer medications marketed as sterile by Downing Labs, LLC, also known as NuVision Pharmacy, because they may be contaminated. Click here to read more.
July 1, 2014 — As part of enhanced regulation of the compounding pharmacy industry, the U.S. Food and Drug Administration (FDA) has issued documents describing manufacturing expectations, enforcement policies for safety violations, and proposed revisions to a list of drugs that may not be compounded. Click here to read more.
Februrary 10, 2014 — Rx Formulations, a compounding pharmacy located in Mesa, Arizona, has announced a voluntary recall for calcium gluconate 10% injections after FDA inspectors found microbial contamination. Click here to read more.
November 19, 2013 — New law regulating compounding pharmacies will require high-volume companies who mass-produce drugs to register with the FDA as “outsourcing facilities,” and they will be subject to stricter quality control and inspection requirements. Click here to read more.
September 30, 2013 — In May 2013, all medicines from The Compounding Shop were recalled due to concerns about sterility. On September 3, FDA inspectors issued a “483” warning letter after finding serious problems, including bottles of budesonide solution that were cloudy and contained floating, white fungus. Click here to read more.
September 10, 2013 — Park Compounding Pharmacy recalls testosterone injections. Click here to read more.
September 9, 2013 — Avella Specialty Pharmacy recalls compounded drugs. Click here to read more.
September 5, 2013 — Medaus Pharmacy of Birmingham, Alabama has recalled certain lots of injection medicines because they cannot assure the sterility of the products. Click here to read more.
August 11, 2013 — Specialty Compounding, LLC, of Cedar Park, Texas, has recalled all lots of all sterile medicines made since May 9, 2013 due to possible contamination with the Rhodococcus equi bacteria. At least 15 people have developed bacterial blood infections after receiving intravenous (IV) infusions of calcium gluconate, which is used to treat calcium deficiencies and other conditions. Click here to read more.
June 6, 2013 — An FDA investigation of Main Street Family Pharmacy of Newbern, TN identified bacterial and fungal growth in samples of methylprednisolone actetate. The FDA has received 7 reports of skin and soft tissue abscesses, but no cases of fungal meningitis. Click here to read the FDA Warning.
March 21, 2013 — Clinical Specialties Compounding Pharmacy has recalled all products after receiving 5 reports of eye infections inside the eyeball of patients who received re-packaged Avastin, which is used to treat macular degeneration. Click here to read the FDA Warning.
October 4, 2012 — An outbreak of fungal meningitis has been linked to contaminated epidural steroid injections manufactured by New England Compounding Center (NECC). As of August 2013, at least 63 people have died and 749 people were injured by fungal meningitis, spinal infection, joint infection, or stroke. Click here to read more.
What is a Compounding Pharmacy?
Compounding pharmacies are the modern-day equivalent of an apothecary — pharmacists who take raw pharmaceutical ingredients and mix them into custom-made drugs for individual patients based on a doctor’s prescription. For example, a doctor might order a liquid medicine for a patient who can’t swallow, or a preservative-free and allergen-free mixture for sensitive patients.
What is the problem with Compounding Pharmacies?
By law, compounding pharmacies are not allowed to manufacture pharmaceutical drugs for the mass-market without a prescription — that would require the same licenses and FDA oversight as major pharmaceutical drug companies.
Unfortunately, a growing number of disease outbreaks have been linked to drugs that were mass-produced by compounding pharmacies and distributed without prescriptions throughout the United States. For example, in 2012, a fungal meningitis outbreak was linked to mass-produced medicines manufactured by New England Compounding Center (NECC). Although compounding pharmacies are supposed to make custom drugs for individual patients, NECC distributed 17,000 vials of the injections to 23 states.
What is the FDA Doing?
After the fungal meningitis outbreak of 2012, the U.S. Food and Drug Administration (FDA) has substantially increased efforts to inspect compounding pharmacies. In 2013, dozens of compounding pharmacies were inspected and cited with a “483” Warning Letter, which is used to document problems discovered during inspections.
Compounding Pharmacies and Fungal Meningitis
Meningitis is an infection of the spine that can also reach the brain. It can be caused by a bacteria, virus, or fungus that enters the spinal fluid. The infection causes inflammation of the meninges, which is the lining around the spinal cord and the brain. In severe cases, meningitis can cause permanent brain damage, seizures, and death.
Symptoms of fungal meningitis:
- Fever
- Headache
- Stiff neck
- Nausea and vomiting
- Light sensitivity (photophobia)
- Altered mental status
Compounding Pharmacies and Bacterial Blood Infections
Bacterial blood infections occur when a bacteria invades the bloodstream, travels throughout the body, and infects blood vessels and vital organs. In severe cases, the infection can lead to a life-threatening inflammatory response called septic shock, which can cause blood clots, organ damage, heart failure, and death.
Symptoms of a bacterial blood infection:
- High fever
- Low body temperature (body chills)
- Increased heart rate (tachycardia)
- Low blood pressure
- Abnormal white blood cell count
- Respiratory distress, rapid breathing, or shortness of breath
- Nausea, vomiting
- Abdominal pain
- Malaise (feeling or looking ill and anxious)
- Confusion
- Sepsis and septic shock
- And more
Need a Compounding Pharmacy Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact our Texas compounding pharmacy lawyers for a free lawsuit review.
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