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FDA Not the Only Authority on Drug Safety

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Two lawsuits prove that the FDA is not the only authority on drug safety. Consumers who sued prescription drug manufacturers in two different states won cases against them. In each case, courts ruled that FDA approval of a drug does not mean manufacturers are safe from lawsuits connected with drug injuries.

Bush Administration Held Drug Makers Responsible Only to the FDA

In 2006, the Bush administration appointed political representatives at the FDA who reversed the previous federal stance on preemption[1]. This policy effectively shielded drug makers from lawsuits over injuries caused by FDA approved drugs. However, the administration’s policy failed to hold up in court.

The Suits

In Wyeth v. Levine, Case No. 06-1249[2], the injured (Diana Levine) sued the drug manufacturer (Wyeth) for failing to warn about the risk of gangrene from Phenergan when administered through push IV.  Levine contracted gangrene and lost her forearm from the disease. The Supreme Court ruled that the previous court was correct to allow Levine to sue Wyeth for her injuries.

In Gaeta v. Perrigo, Case No. 09-15001[3], the United States Court of Appeals for the Ninth District reversed a previous court’s decision that barred suit based on FDA policy protecting manufacturers from suit. In that case, the court looked to similar rulings that applied the same standard of care in warning about side effects to both brand name and generic drug manufacturers.

Failure-to-Warn About Side Effects

These lawsuits show that when a manufacturer fails to warn about a side effect, that manufacturer becomes responsible for resulting injuries, regardless of FDA approval. In both cases, people who sued believed that drug makers should have offered more information about the risks. The side effects suffered by these individuals were never part of the FDA regulation process, which means that the FDA passed the drugs without any knowledge of these particular risks.

Generic Drug Makers no Different

Manufacturers who make generic medicines operate under rules that are less strict than the rules applying to brand name drug makers. The idea is to make generic medicine less expensive than the brand name products by reducing approval costs. However, courts have interpreted the law to apply to generic medicine manufacturers as well when the medicine fails to meet certain safety rules, such as warning against side effects.

Cases Allowed for Drugs Passed by the FDA

The United States Supreme Court was the first to allow a customer to sue a drug manufacturer after the 2006 policy change. Even though the FDA did not require the drug maker to list certain possible side effects on the medicine, the court ruled that the customer had the right to sue the company for failing to list that side effect.

Contact Us

If you or someone you love suffered injury because of an unlisted side effect or defective drug, contact our offices for information about your legal rights. Our professional attorneys can give you advice about your problem and help you decide whether you should file a lawsuit to recoup your damages.


[1] http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a.Wv.XE5dvPc
[2] http://www.supremecourt.gov/opinions/08pdf/06-1249.pdf
[3] http://www.ca9.uscourts.gov/datastore/opinions/2011/01/24/09-15001.pdf

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