The Drug Labeling Experts–They’re Not Who You Think

Currently, Novartis is defending several fairly large and complex products liability cases involving two of its cancer-related drugs, Aredia and Zometa. The core of the allegations centers on those drugs’ putative connections with osteonecrosis of the jaw (ONJ)–a condition as painful as it sounds. One theory of liability hinges 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.

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. And Novartis’s case will likely be no different. Both sides will almost certainly provide testimony about whether the drugs actually caused, or heightened the risk for, ONJ, what ONJ is, and what physicians would have done had they known about the drugs’ alleged risks. But a relatively dry, pretrial order in one of these cases raises the interesting question: Who’s a drug-labeling expert? And it seems it’s not who you’d think.

Drugs labels are those little paper inserts that come in pharmaceutical packaging, often folded in an accordion-like fashion. They’re typically filled with lots of important information about the drug’s dosage and side-effects. Here’s one example: Aredia’s most recent label. You may have never looked at your drugs’ labels–maybe you thought they were as important as the cotton ball in pill bottles–but your physician should have. Indeed, the purpose of drug labels is to give physicians the information they need to properly prescribe drugs.

As part of its core mission to ensure the safety and efficacy of drugs in the U.S. (and, to a lesser extent, as an effort in standardization) 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. You can see, for example, this back-and-forth between the FDA and Novartis over Aredia.

In theory, then, the best experts on how physicians interpret drug labels would be physicians themselves. They’re the ones for whom the labels are written, they’re the ones who would read (or are supposed to read) their contents, and they’re the ones who make decisions based on what the labels say. In theory, the best experts on the effects of Aredia’s and Zometa’s labels are the physicians who prescribe Aredia and Zometa.

In practice, however, courts don’t always agree that physicians are the best experts for these issues. 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, among many things, 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 likely complicated by Dr. Vogel’s own deposition testimony where he apparently admitted that he was not a “drug labeling expert.” 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.

Interestingly, this distinction doesn’t appear to be unique. 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).)

So who, then, qualifies as an expert on how physicians use drug labels? Reece v. Astrazeneca Pharmaceuticals, LP provides a suggestion: FDA officers. (500 F. Supp. 2d 736, S.D. Ohio 2007.) In that case, the court permitted the plaintiff to offer its expert’s testimony on all aspects of the 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 physician-bureaucrats, rather than plain practicing physicians, would appear to be better positioned to offer expert testimony as to the effect of FDA mandated drug labels.

At first blush, this reasoning strikes me as incredibly circular: Physicians carefully read drug labels to assess the propriety of prescribing pharmaceuticals to their patients. Because physicians read these labels carefully, and make critical patient care decisions based on those labels, the FDA tightly controls how those labels are worded. But the experts on those labels are not the physicians. Rather, they’re the FDA staffers who wordsmith the labels to ensure that they are appropriate and informative to their target audience: physicians.

Fortunately, this underlying circularity is not always the rule. Many courts follow the Fifth’s Circuit’s reasoning in Stahl v. Novartis Pharmaceuticals Corp. that prohibiting practicing physicians from testifying how their colleagues view a particular label “belies the essential purpose of the warning. Package inserts … are not written for medical experts schooled and skilled in the writing of warnings [but] written to inform fully and adequately the medical practitioner who is called upon … to prescribe the medication. The understanding and perception of [the prescribing physicians] is entirely relevant, for the sufficiency of the warning is dependent upon their reasonably anticipated comprehension.” (285 F.3d 254, 265 n.5 (2002) (quoting Mauldin v. Upjohn Co., 697 F.2d 644, 648 (5th Cir. 1983)).)

The Arizona district court has yet to issue a final order regarding the plaintiffs’ labeling experts. And it may very well allow the remainder of Dr. Vogel’s testimony. But one can hope that the court can break, or at least explain, the circular logic employed by other courts in determining who is, and isn’t, a labeling expert.

Jake Sherkow, CLB Fellow