Consumers just lost another potential tool to hold certain drug makers liable for their injuries in a recent move by the Food and Drug Administration (FDA). The reversal at the end of 2018 by the FDA of a previous proposal to protect drug consumers means that they cannot sue generic drug manufacturers in court for product safety issues.
The FDA regulates food and drug products, including the U.S. pharmaceutical industry. The industry is comprised of brand name and generic manufacturers, and as most consumers are aware, generic drugs are generally a lower cost. By recent estimates over eighty percent of drugs used in the United States are generics.
Generic drugs can be substituted for the brand name drug in many cases by the pharmacy, and are designed to be equivalent and often less costly versions of the original brand developed by the brand manufacturer. Brand name drug manufacturers, when developing a new drug, must apply to the FDA for approval of a new product and submit label and clinical trial information as part of the process. They can later update the drug label – which contains all the required information – with any new updated product information.
Generic drug manufacturers also must file for approval of the drug with the FDA. They file with a version of the brand name information and must also demonstrate conforming to FDA standards that the drug is safe, is pharmaceutically equivalent to the brand name, that they can manufacture it correctly, and other requirements.
However, one significant difference that affects consumers in relation to the 2018 change is in the updating of drug labels. The FDA in 2013 had proposed allowing generic drug manufacturers to update labeling information when the brand name did. This also had the effect of allowing consumers to hold generic drug makers legally responsible for their product.
But in the new change, the FDA reversed that labeling plan, stating that it would have imposed new costs and regulatory burdens on the manufacturers. The result is that U.S. patients who use generic brand drugs will not see label updates, and thus have no legal methods to hold them accountable for harm from a defective or dangerous product.
Product Safety Concerns
Consumers rely on the food and medical products they use to be safe. Every year people are injured by negligence or defects in the products they use and trust. In the case of medications, the consequences of either can often be serious and deadly.
Generic drug manufacturers campaigned against this change, and with the cancellation of this rule, received a financial windfall by remaining immune from lawsuits. In the future Congress can develop new legislation addressing this issue; but currently consumers are left with limited options to receive the compensation they deserve for product injuries involving generic drugs.
Anyone affected by a defective, dangerous, or falsely marketed generic medical product should consult with a Philadelphia products liability lawyer to discuss all their options.
Philadelphia Products Liability Lawyers at McCann Dillon Jaffe & Lamb, LLC Assist Clients Hurt by Generic Drugs
The Philadelphia products liability lawyers at McCann Dillon Jaffe & Lamb, LLC have experience and a record of results dealing with cases involving defective drugs. We have fought against large corporations and held them accountable. Please contact us for a free initial consultation at 215-569-8488 or complete our online form. We represent clients in Philadelphia, Delaware County, Chester County, and across Pennsylvania, Delaware, and New Jersey.