Ford & Associates Nationwide Legal Services, A.P.C., Responds to Recent FDA Health Warning Label Requirements For Testosterone Drugs in Relation to Defective Drug Laws
The San Diego injury law firm reacts to the FDA's new testosterone label requirements warning that testosterone replacement products may cause cardiovascular risks, such as heart attacks and strokes. Pending defective drug lawsuits have been filed in the federal multidistrict litigation in U.S. District Court, Northern District of Illinois, congruent with FDA "Low-T" label changes.
San Diego, CA., April 15, 2015 (Newswire.com) - Following a testosterone screening conducted by The Endocrine Society and documented by the National Center for Biotechnology Information in March 2015, the FDA has issued label requirements on testosterone replacement products to feature possible health risks associated with testosterone drug use. These label requirements follow a January 2014 FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products, which announced the FDA was reviewing the cardiovascular risks allegedly associated with testosterone therapy.*
According to court documents regarding lawsuits filed under Testosterone Replacement Therapy Product Liability Litigation - MDL No. 2545 in U.S. District Court, Northern District of Illinois, testosterone lawsuit plaintiffs are claiming that the manufacturers of prescription drugs used to treat male hypogonadism (low testosterone, or “Low-T”) failed to warn patients and doctors of potential cardiovascular problems associated with drug use. Plaintiffs further allege that the medications were marketed as treatments for low testosterone related to aging, when the drugs are only FDA approved to treat hypogonadism caused by testicle, pituitary gland, or brain disorders.**
"Whether a manufacturer has omitted pertinent information, or fails to include safety warnings, that manufacturer can be held liable for defective-drug distribution. The product liability and defective drug attorneys at Ford & Associates can discuss your claim with you, and the specifics of your situation."
Mateo Martinez, Ford & Associates Case Manager
“Ford & Associates has researched documented testosterone studies by the Endocrine Society, and while we feel the newest FDA label requirements may help future users of “Low-T” replacement medications, men who have already allegedly suffered adverse health conditions from using such drugs may benefit from seeking the advice of a qualified testosterone lawyer to discuss their legal options.
From a legal standpoint, it's a drug manufacturer’s responsibility to include any potential side effects and warnings on a product's label, so consumers are made fully aware of any potential health risks associated with product usage. Product liability laws hold low-testosterone manufacturers responsible for developing and dispensing defective drugs, regardless of a previous FDA approval. Many people believe that when a drug gains FDA approval, it's safe for use, even use that isn't specifically approved by the FDA. Whether a manufacturer has omitted pertinent information, or fails to include safety warnings, that manufacturer can be held liable for defective-drug distribution. The product liability and defective drug attorneys at Ford & Associates can discuss your claim with you, and the specifics of your situation.”
– Mateo Martinez, Ford & Associates Case Manager
Ford & Associates notes that The Endocrine Society screening found prescription low testosterone therapy is often allegedly prescribed for men who have no medical need for such treatment. The screening looked at 2001-2010 insurance data from over 61,000 adult male patients being treated with testosterone replacement drugs. Over 19% of patients received testosterone prescriptions despite having normal levels of the hormone, while only 73% had their hormone levels tested before being prescribed testosterone therapy.***
According to court documents regarding lawsuits filed under Testosterone Replacement Therapy Product Liability Litigation - MDL No. 2545, the following Low-T drugs are in question for causing adverse health conditions:
• Gel: AndroGel, Axiron, and Bio-T Gel
• Gel: Fortesta and Testim
• Patches: AndroDerm
• Injections: Delatestryl
• Injections: Depo-Testosterone
• Implants: Testopel
• Pills: Striant
*fda.gov/Drugs/DrugSafety/ucm436259, FDA, March 3, 2015
**fda.gov/Drugs/DrugSafety/ucm383904.htm, FDA, January 31, 2014
***ncbi.nlm.nih.gov/pubmed/25729103, Public Health Report, March-April 2015
About Ford & Associates Nationwide Legal Services, A.P.C.
Ford & Associates Nationwide Legal Services, A.P.C., is a San Diego based injury firm that handles each testosterone therapy lawsuit with unparalleled competence, compassion, and skill. The firm's attorneys are aggressive in their pursuit of justice for every client they serve, and will leave no stone unturned until a favorable outcome has been reached as allowed by law.
If you or a loved one has suffered injuries from using a low-testosterone replacement drug, you may be entitled to file a claim. For more information on testosterone lawsuits, and answers to low testosterone lawsuit questions, contact Ford & Associates today at 800-817-7777 for a free, no-obligation case review.
Ford & Associates Nationwide Legal Services, A.P.C.
3555 4th Ave
San Diego, CA 92103
800-817-7777
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