The Supreme Court will hear a case next term that could decide whether drug companies may escape liability for harm caused by their products and hide behind FDA approval. The issue in the case involves Johnson & Johnson’s prescription birth control patch, Ortho Evra, which delivered much more estrogen than the company originally disclosed. The Ortho Evra patch was a popular form of birth control as an alternative to the birth control pill. For women, medication dosing errors of estrogen may cause an increased risk of blood clots and strokes and has been linked to one death.
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When seeking FDA approval for the drug, Johnson & Johnson manipulated their internal studies about Ortho Evra and deliberately hid information from the FDA that their product delivered such a high dose of estrogen. The drug manufacturer’s dishonesty is a major problem: the FDA relies on internal manufacturer tests and reports when deciding to approve a new drug. These falsified documents raise serious questions about the safety of FDA approval for new drugs.
Johnson & Johnson claims that it should not be responsible for any damages caused by estrogen overdoses because the FDA approved their product and the product label. The company believes it should be shielded from pharmaceutical lawsuits even though the FDA was not fully aware of the risks from the medication to patients.
Pharmaceutical industry commentators believe that patient lawsuits may help to protect pharmaceutical consumers by providing extra oversight. Other lawsuits have involved pain medications like Vioxx, the diabetes treatment Rezulin, anti-depressants, and heartburn treatments.