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FDA Expert Trial Litigation [Who is Considered an Expert in a Court of Law?]

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Case Study

Who is considered an expert in a court of law?

Complex trials often come down to expert witnesses, the scientist, for example, who can testify that the contamination in the water caused the plaintiffs’ cancer. This is especially true in the realm of pharmaceuticals, which is one of the most regulated industries in the country by the FDA.

For 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.

So who, then, qualifies as an expert on how physicians use drug labels? The case Reece v. Astrazeneca Pharmaceuticals, LP teaches a valuable lesson: FDA officers. (500 F. Supp. 2d 736, S.D. 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. 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.

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.

You can out find more on the topic here.

Why are they better positioned?

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. 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.

So what happens when you don’t have the right kind of expert?

Well, here’s another example of a case centered around drug labeling.

Novartis had the task of defending several fairly large and complex product liability cases involving two of its cancer-related drugs, Aredia and Zometa. The core of the allegations centered on those drugs’ putative connections with osteonecrosis of the jaw (ONJ)–a condition as painful as it sounds. One theory of liability hinged on whether the drugs’ labels properly warned patients of the risk of ONJ. 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.

As part of its core mission to ensure the safety and efficacy of drugs in the U.S. the FDA regulates, with military precision, the specific wording that goes into drug labels. 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.

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.

In practice, however, courts don’t agree that physicians are the best experts for these issues. Again this is because physicians will have varying interpretations of the labels which doesn’t benefit the decision makers in court.

In the Aredia/Zometa litigation, Novartis sought to exclude the testimony of Dr. James M. Vogel, a physician and associate professor at Mount Sinai Hospital. The plaintiffs sought to use Dr. Vogel’s testimony to explain the adequacy of Novartis’s labeling. But while the Multidistrict Litigation Panel–the body responsible for streamlining the Aredia/Zometa litigation–ruled that Dr. Vogel could indeed testify on the “medical accuracy” of Aredia’s and Zometa’s labels, one of the underlying trial courts in the District of Arizona doubted that Dr. Vogel was competent to testify as to the precise wording and effect of Aredia’s and Zometa’s labels.

This was complicated by Dr. Vogel’s own deposition testimony where he admitted that he was not a “drug labeling expert” having no knowledge or information as to the FDA regulations regarding the process of drug labeling. Just because physicians read drug labels, doesn’t mean they understand the extensive process that goes into writing them.

The upshot of these rulings is that, in the Aredia/Zometa litigation, Dr. Vogel can testify as to whether the information within the labels is medically accurate, but may not be able to testify as to the reasonableness of the language used in those labels.

In this particular case it would have been more beneficial to have a physician with experience within the FDA itself to provide a full testimony that would be accepted by the court.

Several other cases have distinguished expert physician testimony offered to prove the accuracy of the label as opposed to the effect of its wording. In In re Seroquel Products Liability Litigation, for example, the trial court excluded the plaintiffs’ expert physician testimony “regarding whether physicians generally read and comprehend drug labels, or whether doctors generally understand the contents of the Seroquel label,” but allowed them to “express opinions regarding the accuracy and adequacy of the Seroquel label.” (No. 6:06-md-1769, 2009 WL 3806436, at *8 (M.D. Fla. July 29, 2009).) And in another case, the court excluded similar testimony regarding how physicians perceived the accused drug’s labeling as “speculative.” (In re Rezulin Products Liability Litigation, 309 F. Supp. 2d 531, 555-57 (S.D.N.Y. 2004).)

Physicians read drug labels carefully, and make critical patient care decisions based on those labels, but it’s the FDA that tightly controls how those labels are worded.

Therefore the experts on those labels are not the physicians. Rather, they’re the FDA regulators and Medical Safety Officers who wordsmith the labels to ensure that they are appropriate and informative.

This logic doesn’t just apply to drug labeling however. For other cases pharmacologists are often called upon to testify only to realize that while they know the drug in question, its side effects and benefits, they do not have information on hand as to the clinical trial process of that drug, access to the FAERS database (the list of all adverse effects recorded for a drug or medical device), nor do they know the regulatory process that drug went through within the FDA itself.

For medical lawyers, having the right expert witness from the start of the case is imperative. It only makes sense to seek the expertise of those who have worked with the FDA.

To speak with former FDA experts, contact us here.

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