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Generic drug manufacturers worried about product liability

The FDA has suggested changes regarding the laws that govern product warning labels on generic drugs. Currently, such labels must exactly match those of their brand name counterparts. In the past, this has created a buffer for generic drug manufacturers against product liability lawsuits. The newly suggested changes have many generic drug manufacturers in Texas and elsewhere concerned.

Various generic drug trade groups have come out in strong opposition against the proposed changes. They say if these manufacturers are permitted to unilaterally update their own labels (whether or not brand name labels are changed) it would make them vulnerable to future product liability lawsuits, since they could then be held responsible for inadequate warning labels. As the law now stands, a consumer whose injuries were caused due to improper warning labels, would not normally be able to hold a generic drug manufacturer accountable since it is required that the generic label exactly match the brand name label.

Many people have suffered severe injuries and illness after taking generic drugs according to instructions on package labels. It is only right that injured victims be allowed to file product liability claims to seek monetary recovery for their losses in such situations. Whether newly proposed legislation passes into law may bear significant impact on consumers' future eligibility for filing claims.

Personal injury attorneys will no doubt be paying close attention to the legislative process with regard to the FDA's recent proposals. Anyone in Texas currently facing problems due to inadequate labeling that has led to injury may discuss product liability options with an experienced attorney in the area. Effective representation is often crucial toward successful outcomes in court.

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

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