![]() ![]() Many lawyers assume that the best experts on how physicians interpret drug labels would be physicians themselves as they’re the ones for whom the labels are written, the ones who would read (or are supposed to read) their contents, and the ones who make decisions based on what the labels say. Both before and after a drug goes on the market, the FDA works with pharmaceutical manufacturers to revise, again and again, the language used in drug labels. the FDA regulates, with military precision, the specific wording that goes into drug labels. ![]() In theory, had the labels properly described the risk of ONJ, physicians prescribing those drugs would have warned their patients of that risk, and Novartis wouldn’t be liable.Īs part of its core mission to ensure the safety and efficacy of drugs in the U.S. One theory of liability hinged on whether the drugs’ labels properly warned patients of the risk of ONJ. The core of the allegations centered on those drugs’ putative connections with osteonecrosis of the jaw (ONJ)–a condition as painful as it sounds. Novartis had the task of defending several fairly large and complex product liability cases involving two of its cancer-related drugs, Aredia and Zometa. Well, here’s another example of a case centered around drug labeling. So what happens when you don’t have the right kind of expert? #Medical device fda label expert witness cv how to#In drug labeling, while it’s true the labels on drugs are interpreted by physicians, it’s unfortunately too open to interpretation and different physicians will have varying views on it, whereas the former FDA drug labeling expert will know exactly what is written in the label and how to interpret that for a court of law. That’s because, in this case, not only did the expert witness have medical expertise, she understood the precise language used in drug labeling by the FDA. Thus, those with real regulations experience and expertise within the FDA, rather than plain practicing physicians, are better positioned to offer expert testimony as to the effect of FDA mandated drug labels. The court permitted the plaintiff to offer its expert’s testimony on all aspects of the drug labeling process because, in addition to being a doctor, she “worked as a medical officer with the FDA’s Center for Devices and Radiological Health” for four years. Ohio 2007.) The case was about drug labeling, the purpose of those labels is to give physicians the information they need to properly prescribe drugs. Astrazeneca Pharmaceuticals, LP teaches a valuable lesson: FDA officers. (500 F. ![]() So who, then, qualifies as an expert on how physicians use drug labels? The case Reece v. This is especially true in the realm of pharmaceuticals, which is one of the most regulated industries in the country by the FDA.įor these trials, the big question that often comes up is who counts as an expert witness? Is it the physician/psychiatrist? Pharmacists? If the expert used for testimony isn’t what the court considers to be an expert than they might disregard the testimony altogether which only hurts cases so it’s important to know who will help your case. Who is considered an expert in a court of law?Ĭomplex trials often come down to expert witnesses, the scientist, for example, who can testify that the contamination in the water caused the plaintiffs’ cancer. ![]()
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