Drug litigation is a particularly complex area of the law – and one where opponents are typically large companies with ample financial and legal resources. Often they’re aligned with some of the most powerful defense firms in the country. Lawyers who tackle these cases not only need to have a mastery of the law and courtroom strategies, but significant resources themselves.
Pharmacology itself is complicated because it has the potential to affect individuals very differently both from an efficacy and a safety standpoint. The Unites States is a melting pot of individuals with many different ethnic origins. These genetic differences can have a significant impact on the way different individuals metabolize drugs. Some people may be able to take a drug and have it work perfectly therapeutically, while others can have significant side effects including anaphylactic reactions and/or permanent disability.
Studies by Harvard researchers estimating negligence-caused deaths at up to 98,000 each year – more than twice the number of people who die in automobile accidents.
If it’s caused by a defective product, then the case ventures into the arena of product liability. In this instance, an investigation into the product’s development is launched where assistance from a drug development expert and FDA medical officer is key.
If a relatively large number of people begin having severe adverse events from drugs in the FDA’s Medwatch or AERS database, drug companies are obligated to report those adverse events in the form of communications to prescribers, pharmacies as well as potentially report those changes in a drug’s official FDA labeling. If the drug company fails to communicate severe or serious adverse events to prescribers and consumers, it can be cause for FDA lawyers to pursue litigation for damages to the patients, if they occur.
Consulting with experts with experience in the FDA is the best way to determine if the drug either a) should never have been put on the market, b) should have come with a stronger warning, or c) should have been recalled sooner, and a pharmaceutical expert witness, especially one with experience in the FDA, is a surefire way to make the strongest case for your client.
FDA Law and Regulations
FDA law has specific requirements when it comes to requirements for reporting adverse events from drugs in clinical trials. Prior to Food and Drug Administration Amendments Act (FDAAA) of Section 801 requirements, drug companies used to be able to selectively hide the results findings of certain clinical trials. In other words, if a pharmaceutical company’s drug trials used to come up with a negative result, drug companies had no obligation to publish those results because the clinical trial findings and data was their property. There was no FDA law requiring drug companies to inform the public that their drug didn’t work for a certain labeled or off-labeled indication, for instance. FDA lawyers and members of congress helped write and then lobbied for this act to pass in 2007.
Experts with Former FDA all have varying experience working with FDA law and FDA lawyers as part of their former jobs with the FDA. As reporting and testifying FDA experts, they can greatly aid both defense and prosecution cases with regards to pharmaceutical law and litigation cases with drug companies. The same is true for cases with medical malpractice cases involving prescription pharmaceuticals and/or complex pharmacology and serious adverse events.
Medical ethics run hand-in-hand with FDA law and FDA lawyers. Specific laws do not exist for every single nuance of human experimentation and the clinical testing of drugs. Clinical trial professionals including nurses, pharmacists and physicians are responsible for relying on their morals and rules of conduct when it comes to medical ethics. This includes one of the most common rules of medical ethics: making sure clinical trial subjects have a complete understanding of what will occur during clinical testing the form of informed consent. FDA Regulations and Clinical Trial Experts are thoroughly knowledgeable in that area of medical ethics either from their academic training and from their medical ethics training at the FDA.
About the Food & Drug Administration
The American public has the safest, most expensive and most advanced drug regulation system in the world. In fact, compared to the pharmaceutical industry, no other industry is as regulated as the US Food and Drug Administration’s pharmaceutical development and testing process.
The main overseeing agency is the FDA’s Center for Drug Evaluation and Research (CDER). The center’s primary duty is to assess newly developed drugs before they may be prescribed.
CDER’s evaluation not only prevents false claims but also provides practitioners and patients full disclosure on how their prescription and over the counter medications work. FDA’s CDER ensures that all drugs, including brand-name and generic, work correctly and that their health benefits outweigh their known risks.
The mission of the Food and Drug Administration is to ensure that drugs marketed in this country are safe and efficient. CDER does not test drugs, but it does conduct limited testing in the areas of quality control, safety, and effectiveness.
FDA medical officers are the drug reviewers for the FDA, and they personally approve both new drug applications and amended application indications on existing approved FDA products as part of their duties as medical officers. Medical officers have responsibilities and experience in the area of drug development, new and amended drug applications, labeling, drug safety auditing, clinical reviews of investigational new drug, medical devices, and biologic licensing applications. Needless to say, they are greatly familiar with the FDA review process.
New Drug Clinical Trials and Review Process
Drug approval has anywhere from just a few to many, many legal implications, with regards to the current standards of medical or drug therapy. Medical officers work closely with an FDA lawyer to ensure that the CFR is being followed explicitly (an FDA lawyer duty) and that patients are protected and are taking a drug which is both safe and efficacious (and FDA medical officer duty).
All novel phase I and II clinical trial designs are discussed during official meetings between the pharmaceutical company and the FDA to ensure that they are following the current state-of-the-art standards and that they are ethical and safe.
The New Drug Application and Review Process is already poised to become even more complicated as the pace of medical innovation increases with time.
Current bills in the U.S. House of Representatives (including the “21st Century Cures Initiative” bill) are proposing dramatic increases in spending for The National Institutes of Health and the FDA, in order to decrease review times and the update current standards to to keep up with the latest innovative state-of-the-art technology currently being introduced in all phases of the drug review process. Funding is also poised to bolster long-term drug safety post-marketing monitoring process.
With these changing and increasingly speedy methodologies, mistakes are all too common, and having the aid of an FDA expert will make all the difference in both pharmaceutical and malpractice lawsuits.
Glossary of Terms:
FDA Law — The FDA makes its clinical and regulatory decisions based on US Code of Federal Regulations. There are substantial FDA regulatory requirements which must be met in order to approve a pharmaceutical for use in The United States. FDA Law specifies approval requirements regarding a drug’s efficacy and laws requiring drug safety. FDA law experts may be useful in determining the application of the law in specific cases for drug approval drug labeling changes and drug labeling approvals.
FDA Lawyer — Attorneys are experts in the law, but the application of the law at the FDA is specialized. The FDA follows the CFR, but also takes into account prior clinical and regulatory decisions made at the FDA. An FDA lawyer should depend on the expert testimony of an FDA Medical officer for expert testimony on exactly the way drugs are approved at the FDA, and if/when regulatory action is taken on an emerging drug safety signal.
FDA litigation (or lawsuit) — Drug company prosecution or drug company defense may be for a wide variety of reasons. They include off-label marketing, kickback, off-label promotion, failure to warn, mislabeling, poor manufacturing processes, medicare fraud, false claims, drug safety violations, and other violations of the FDCA. Because the FDA lawsuits involve very complicated and case-specific interpretations of the FDCA, expert testimony from a drug development expert who is familiar with the code of federal regulations and has FDA experience and fully understands and can interpret the FDA’s method of thinking.