Our experience in drug litigation includes countless cases involving a wide array of drugs and food supplements, and an equally broad range of legal issues. Our experience in drug litigation dates back to the 1980’s, and includes class actions and federal multi-district litigation (MDL) as well as mass-tort claims. Our knowledge of pharmacology, chemistry and medicine have empowered us to achieve brilliant results on behalf of our clients.
We have lectured nationally on litigation issues related to human clinical trials and drug liability. Our experience in drug litigation includes major civil actions in state and federal court, including cases before the United States 10th Circuit Court of Appeals.
In addition to the above, our experience in drug litigation includes:
- Hatch-Waxman Act issues
- Phospho-soda laxative kidney damage claims
- Albuterol cases
- Psycho-pharmaceutical cases
- Prescription mis-fill cases
- Contaminated drug claims
- Pharmaceutical plant security
- Labeling and warnings cases
- Food supplement cases
- Vitamin cases
- Ibuprofen claims
- FDA preemption issues
- Food flavoring cases
- Human clinical trial issues
- Drug approval issues
- Punitive damage issues
- Consumer protection claims
- Institutional Review Board conflicts
Federal Preemption and FDA Involvement
The role of the Food and Drug Administration in drug and medical device cases is significant. We track FDA developments and we understand the nuances of the drug approval process. Because the law regarding federal preemption is rapidly changing, and has in fact been impacted by a number of recent decisions of the U.S. Supreme Court, it is essential to utilize counsel in such cases who are familiar with this rapidly developing area of law, as well as the biological and technological aspects of these cases. We have also analyzed and litigated drug patents, as well as claims arising from off-label prescriptions and new clinical uses under the Hatch-Waxman amendments to the Food, Drug & Cosmetics Act.
We work harder than other lawyers to understand the biochemical mechanisms of action related to drugs and to understand the interrelations between drugs as well as how side effects of drugs are caused and what they include. We evaluate clinical trial information, post-sale incident reports, Adverse Medical Event (AME) reports, advertizing, published literature and the claims of competitors, as well as the information available to the consumer on various websites.
The key to success in litigation is to be realistic and careful in terms of how a "win" is defined under the circumstances of any given dispute. No two cases are exactly alike. Remember that no attorney or firm can guarantee success according to any arbitrary standard or in terms of a favorable result at trial. Whether or not to try a case or settle a case is a decision a client makes with the advise of an attorney, and no attorney can guarantee anything about the outcome of a civil case. Any case, tried to a jury or a court, might be resolved unfavorably. Trials are inherently unpredictable. Statements contained on this website regarding the ability of the professionals at Godfrey | Johnson, P.C., are based upon good faith perceptions of our abilities demonstrated over years of practice, and are not intended to imply that the attorneys have never lost a case or that we can assure that any particular case will be won at trial or on motions. The best way to evaluate any case is to communicate about it in depth with qualified legal counsel, providing all relevant information to the attorney. It is dangerous to withhold facts from an attorney, and can lead to the delivery of legal advise that is fundamentally flawed. No attorney can prevent this from happening, as attorneys all must rely to some extent upon the information that is provided to them by their clients. The best way to evaluate an attorney is by that attorney's track record, and ours is open for discussion in any specific field. Our abilities as described on this website are based upon experience in actual cases, which have been successful more often than not. ©2015 Godfrey | Johnson, P.C. All rights reserved.