Generic drug companies fighting possible changes that would improve safety for all

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by Michael Heygood

Imagine that a generic drug maker realizes that one of its drug labels should be changed because the manufacturer has become aware of new and important information about the drug’s risks. The drug company should quickly make that change, right? It’s just common sense. The kind of common sense that can save lives. As it stands today, the generic company would not and could not make the change by itself.

Last year, the FDA proposed changes that that would authorize the makers of generic drugs to update safety labels independently to warn of newly discovered risks without waiting for the brand name company to so and without waiting for FDA approval. Such a change is needed to give both patients and doctors more timely warning of known, emerging risks associated with drugs.

However, the rule change is being strongly opposed by generic drug makers. Why? Because a drug company that has the power to improve its label and the knowledge that it should improve its label can be held responsible when death or injury results from the company failing to use its power and knowledge. Generic drug makers prefer the status quo—they have no responsibility for their labels.

The U.S. Supreme Court’s 2011 decision in PLIVA, Inc. v. Mensing noted that generic drug companies are required to use the same warnings already used by the name brand drug they are copying. They cannot change those warnings unless the name brand manufacturer changes its warnings. For that reason, the court held, generic drug manufacturers cannot be sued under state law for failure to warn of risks in their product labeling because they do not control the labeling under federal law. As a result, although one patient could sue a brand-name manufacturer for a failure to warn, another patient is not able to sue for the same injury caused by a similar failure to warn if the patient happened to be taking the generic version of the drug.

Significantly, generic drugs now constitute the majority of all prescriptions filled. The FDA estimates that approximately 420 drugs are now sold only in generic form. The Generic Pharmaceutical Association puts the number even higher, stating that for 45 percent of generics, no branded product is currently available.

Despite this radical transformation of the market for generic drugs, FDA regulation of generic labeling has remained substantially unchanged for decades. Unlike brand-name manufacturers, generic manufacturers are not permitted to make safety updates unless the brand-name does so first. The result is an obvious safety gap.

The rules need to change to keep pace with changes that have already occurred in the marketplace. The rules need to change to keep up with common sense. Safety needs to come before profits, for a change.

Heygood, Orr & Pearson fighting for safer drugs

The lawyers at Heygood, Orr & Pearson have made it a career priority to hold drug manufacturers accountable and responsible for their actions. As a result, we have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. We have represented hundreds of people regarding dangerous fentanyl pain patches, defective hip and knee implant devices, Yaz, Actos, Avandia and Accutane—to name just some examples.

Heygood, Orr & Pearson is AV-rated, the highest legal and ethical rating available from the leading law firm rating service. Our partners Michael Heygood, Jim Orr, and Eric Pearson are all Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization. Mr. Heygood and Mr. Orr are additionally Board Certified in Civil Trial Advocacy Law by the National Board of Trial Advocacy. Our partners been voted by their peers as “Super Lawyers” in the state of Texas* for several years in a row.

At Heygood, Orr & Pearson, we believe that when a drug company sells a drug or medical device that is dangerous and unsafe, they should be held responsible for the damage. We have the resources and experience to protect a person’s rights and the rights of their loved ones against irresponsible pharmaceutical companies and medical device manufacturers.

If you have been injured or have lost someone you care about because of defective or dangerous prescription drugs or medical devices, you deserve to have the manufacturer held responsible and to receive proper compensation. Contact us for a free consultation by calling toll-free at 1-877-446-9001 or by filling out the free consultation form on this page to find out more about your legal options.

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Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2014.