The key to any pharmaceutical or medical device case is to retain experienced and knowledgeable experts. Whether your case involves substantiating a marketing claim or understanding a multifaceted safety signal, it is essential to recruit experts who can provide valuable insight into the complex scientific concepts that are central to your case. The first step is to determine which scientific discipline you should target.
The key to any pharmaceutical or medical device case is to retain experienced and knowledgeable experts. Whether your case involves substantiating a marketing claim or understanding a multifaceted safety signal, it is essential to recruit experts who can provide valuable insight into the complex scientific concepts that are central to your case. The first step is to determine which scientific discipline you should target. Below we describe 10 types of experts you should consider for your pharmaceutical or medical device case.
A pharmacologist, who studies the effects of drugs on the body, can be essential to a case alleging a drug or device caused bodily harm. You may need a clinical pharmacologist or a preclinical pharmacologist. Both types of pharmacologists focus on the mechanism of action (MOA) of the drug at issue and provide testimony about whether or not the drug is capable of causing the specified injury. Clinical pharmacologists tend to focus on the Phase 1 and Phase 2 data in human populations exposed to the drug in controlled environments. Preclinical pharmacologists have expertise in dealing with some of the more technical aspects of pharmacokinetics and pharmacodynamics, often conducted in animal models.
Toxicologists specialize in evaluating adverse health risks posed by drugs or devices. A clinical or medical toxicologist is a physician with a board certification in toxicology. A reproductive toxicologist is an individual (Ph.D. or MD) who specializes in evaluating adverse health effects of chemical exposures on the fetus or offspring. Risk assessment toxicologists focus on quantifying and assessing risks from chemical exposures. Some toxicologists have expertise in evaluating human exposures, while others specialize in assessing animal exposures. For device cases, you might want to consider an expert in the sub-discipline of biocompatibility testing. Individuals with expertise in biocompatibility can explain the biological responses to materials used in implantable medical devices. Meanwhile, a biomaterials expert can explain the physical properties of the device and its reliability. For device cases involving allegations of shedding or disintegration of the device, a toxicologist can assess whether or not the chemical or particles pose a hazard to human health.
Epidemiologists specialize in studying exposure-disease relationships. Epidemiologists relevant to drug and device cases are generally referred to as pharmacoepidemiologists. Because drug and device cases often involve rare safety events that might not have been identified in the clinical trial program, it is essential to address epidemiological studies conducted by the manufacturer or an independent research team. A skilled epidemiologist can analyze this data and respond to the plaintiff’s claims that the data support their case. Clinical trialists also belong in the epidemiology category. An experienced clinical trialist can defend the design, rigor and appropriateness of the clinical trials performed on the drug or device in your case.
A statistician can interpret the scientific data in your case using generally accepted statistical techniques. Whether you are confronting animal experiments, epidemiological studies, or in vitro mechanistic data, the statistician can respond to your adversary’s interpretation of the data. Depending on the complexity of the dataset and the plaintiff’s specific claims, you may want to consider engaging a biostatistician. In addition, depending on the specific endpoints related to the drug or device, you may require a statistician with experience in analyzing psychological, cardiovascular, cancer or neurological data. You may also need an expert who specializes in data analytics or informatics.
A regulatory expert can provide testimony affirming that your client complied with the relevant FDA regulations, and understands the nuances of the drug approval process and the post-marketing surveillance process. A former FDA employee is ideal, but an individual with regulatory process experience may be sufficient. In some cases, you may need a regulatory expert who can address advertising and labeling, including negotiations with FDA. Other cases focus on chemistry and manufacturing controls (CMC), and the physical properties of the drug. Some cases will require an assessment of the safety signaling programs in place before, during and after the public health issue emerged.
After evaluating the manufacturing process, a GMP expert will testify that the process worked properly, the manufacturer complied with the appropriate regulations, and company procedures were documented. Depending on your case, you may need an expert in one of the following sub-disciplines: materials handling, recall management, regulatory liaison issues, supply distribution.
Plaintiffs will often raise questions about the defendant’s research and development program. Sometimes the case involves allegations of corporate misconduct based on the defendant’s communication of the research results. Other times the plaintiff claims the defendant failed to invest in monitoring drug safety, but allocated excessive funding to marketing. The right R&D expert can develop a powerful affirmative message about your client’s commitment to addressing morbidity and mortality with regard to the drug or device in question. The best expert to address these issues may have a background in several disciplines (e.g., a medical doctor with experience in business ethics or a scientist responsible for drug pipeline development).
Because all drug and device personal injury cases involve alleged human health injuries to the plaintiff(s) in the case, you will need credentialed or practicing physicians in the medical specialties related to the allegations in the case. These experts will provide testimony on the plaintiff’s specific medical condition, verify accuracy of the diagnosis, and determine whether the medical community generally accepts a link between the drug or device and the disease state at issue. As a general rule, physicians in the medical sub-specialties will be more focused on specific causation than general causation. Medical sub-specialties relevant to drug and device cases include dermatology, neurology, psychiatry, pulmonology, and cardiology, among others.
Pharmaceutical or medical device cases often involve issues requiring a scientist in a specific discipline, including genetics/molecular biology, pathology, physiology, psychology, and neuroscience, among others. These experts, who can provide general information to the judge or jury, are integral components of the technical defense. Their testimony typically relates to general causation.
A general causation expert can adeptly evaluate the breadth of the science and medicine presented throughout the case and communicate the complete story about the drug’s alleged link to the disease in question. This expert can be a medically trained epidemiologist or toxicologist, or have a background that combines several of the disciplines listed above. This expert should have special knowledge and training that will allow them to synthesize all of the science in the case and come to an educated conclusion about causation or the lack thereof.
For information on experts who can strengthen your toxic tort case, read our recent post 10 Experts Who Can Bolster Your Toxic Tort Case Case.
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