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Medicines that Make Matters Worse

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There are many medications on the market designed to improve symptoms of disease. Both over-the-counter and prescription medications are expected to undergo a rigorous FDA approval process before being marketed to the public.

But unbeknownst to both consumers and the medical community, many of these drugs have not been approved by the FDA. Some medicines, particularly older ones, may have ingredients that lack FDA approval and therefore pose a risk to the public. Other drugs may have received approval, yet are connected with serious harm to consumers. If you find yourself facing serious consequences after exposure to medicines, you may want to engage an experienced attorney to help you through your recovery. Consider cases from the past several years:

  • In 2010, Forest Pharmaceuticals, Inc. agreed to pay over $300 million in criminal and civil penalties related to the distribution of the hypothyroidism drug Levothroid and the marketing of an anti-depressant drug named Celexa.
  • According to a 2011 filing, Healthpoint Ltd. allegedly ignored FDA notices regarding the ineffectiveness of a key ingredient in Xenaderm, a topical cream used to treat bedsores. When Healthpoint disregarded these FDA warnings, it placed consumers at risk and made large profits at the expense of Medicare and Medicaid.
  • A $22 million settlement resulted when Schwarz Pharma Inc. neglected to advise the Centers for Medicare and Medicaid Services (CMS) that unapproved medicines were ineligible for Medicaid or Medicare coverage. Deponit, a skin patch used to treat angina, and Hyoscyamine Sulfate ER, an anti-cramping drug used to treat urinary tract and intestinal disorders, were both determined to be on the market illegally.
  • Boehringer Ingelheim will pay $650 million to roughly 4,000 claimants who suffered severe side effects following the use of Pradaxa, a blood thinner that had no antidote to reverse the effects of the drug. Patients experienced serious bleeding issues and sometimes even death.
  • Pfizer paid $273 million in claims related to the smoking cessation drug Chantix in 2012. The drug is associated with extreme depression, suicidal thoughts, and other behavioral issues.
  • Merck is currently defending itself against claims that Fosamax litigants have experienced bone injuries, including femur fractures.

Concerns About Drugs Marketed Without FDA Approval

The FDA is tasked with ensuring the effectiveness and safety of drugs. During the process of drug approval, companies must establish that their products maintain  a consistent purity, quality and strength. They must also provide appropriate labeling outlining safe use and potential risks that may be associated with the medicine.

The obvious concern when companies bypass the FDA approval process is that drugs may not meet current quality and labeling standards, resulting in patient harm.

When your health is seriously impacted after taking dangerous medications, whose side effects far outweigh their benefits, you want assured, aggressive legal representation. Our personal injury teams in Daytona and Ormond Beach have the experience and the ethics to pursue justice on your behalf. Contact the Law Office of Robert W. Elton today for a confidential, no-cost consultation

Resources:

justice.gov/opa/pr/schwarz-pharma-pays-22-million-settle-false-claims-allegations-concerning-reimbursement

justice.gov/opa/pr/us-files-complaint-against-texas-based-healthpoint-ltd-under-false-claims-act

fda.gov/ICECI/CriminalInvestigations/ucm226396.htm