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Drug makers worry warning label change could cost billions

On Behalf of | Jul 8, 2014 | Business Litigation

A business that provides products or services to consumers should do everything possible to ensure protection against lawsuits. Many company owners in Houston may find that a misstep can quickly lead to business litigation. Providing adequate warning to consumers regarding the risks of an item or activity could prevent such legal action.

The Food and Drug Administration is stirring up controversy with the way certain warnings are delivered. Generic drugs, which comprise more than 80 percent of prescription medications ordered in the United States, do not have legal requirements to updated labels following news of its brand name counterpart causing harm until the brand name drug updates its label. Once the generic drug has an FDA-approved label, consumers are not allowed to sue a company based on failure-to-warn allegations.

The FDA would like to see generic drug makers update their information as soon as certain risks are made known. The agency says that this change will help consumers through giving them the same legal rights if they are harmed by either a generic or brand name drug. However, opponents claim that it could leave generic manufacturers exposed to an increase in torts that could cost billions of dollars. That, in turn, could mean higher prices on generic drugs as the cost is passed on to the consumer.

Any business that must provide a warning to consumers should consult with an attorney to avoid potential issues. When a product liability suit is filed, it is imperative to seek legal help in order to protect the company’s interests and assets.

Source: Modern Healthcare, “FDA’s generic-drug label rule draws controversy,” Joe Carlson, June 28, 2014 


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