Generic drugs often listed in defective products claims

On Behalf of | Oct 25, 2016 | Product Liability |

Thousands of people in Hawaii and throughout the nation are injured every year in situations where another party was negligent in some way. Where defective products are concerned, all those within the line of manufacturing, sales and distribution can be held liable for damages when evidence presented convinces the court that such liability exists. Various commercial drugs and medications are often listed in product liability claims. Recently, changes proposed by the FDA have raised concerns among generic drug manufacturers.

Current laws state that generic drug warning labels must exactly match their brand name counterparts. In the past, this has served as somewhat of a protection against liability claims since generic drug manufacturers cannot add to or delete any information currently listed on the brand name label of the same drug. Newly proposed labeling legislation would allow generic drug manufacturers to make changes on their own labels.

Some say this would be anything but beneficial and could possibly lead to more product liability claims in the future. If a consumer were to purchase a generic drug that the manufacturer was able to label independently of the brand name product, the consumer might sue the manufacturer if an injury or illness occurs related to inadequate labeling. This appears to be one of the reasons many generic drug manufacturer trade groups are strongly opposed to the suggested changes. 

Generic drug makers would no longer be immune to product warning label liability lawsuits. Whether the proposed legislation will pass into law remains to be seen. One thing is certain, however; any person in Hawaii or another state who believes defective products (whether generic drugs or not) have caused injury or illness may pursue the matter in court by retaining the assistance of a personal injury attorney experienced in handling product liability claims.

Source:, “Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims”, Bradley C. Graveline, Manish K. Mehta, Oct. 14, 2016