Stephen J. McConnell

PHILADELPHIA – Plaintiffs lawyers who file lawsuits over the warning labels on prescription drugs should be forced to show exactly what an appropriate warning would have read, a Philadelphia defense lawyer says.

Stephen McConnell of Reed Smith submitted his thoughts on a recent decision from U.S. District Court for the Western District of Pennsylvania in Bock v. Novartis Pharmaceuticals, a case about a deceased multiple myeloma patient named William M. Bock who was prescribed Zometa, a medication manufactured by Novartis and used for the purpose of managing metastatic bone cancer. 

According to his estate, the case’s plaintiffs, Bock’s use of Zometa later led him to contract osteonecrosis of the jaw (ONJ), a severe and permanently-disfiguring bone disease, symptomatic of oral lesions which expose the jaw bone area.

Bock’s estate contended this led to his death in July 2011, and that Novartis was liable for failing to properly warn Bock and his health care providers of the risks associated with the use of drugs like Zometa, such as ONJ.

However, in a decision on the case authored by U.S. District Court Judge Mark R. Hornak on Oct. 7, Novartis was granted summary judgment. Hornak wrote Bock’s estate had “failed to present any evidence that might create a triable issue of fact as to whether his injuries could have been avoided with a different warning.”

In a recent blog post, McConnell wrote the plaintiffs in that case confused warning adequacy with warning causation. 

“It is the latter that ends the case, because the treating doctors’ testimony was so clear that a different warning would have changed nothing,” McConnell wrote in the blog.

In cases like Bock v. Novartis Pharmaceuticals, McConnell wrote “courts should insist that plaintiffs state exactly what the warning should have been and show that such a warning would have prompted the doctor to make a different prescribing decision.”

In a recent interview with the Pennsylvania Record, McConnell echoed those sentiments.

“In too many cases, when the issue is why and how the current warning is inadequate, it becomes a moving target,” McConnell said. “Which is sort of frustrating, and it’s very frustrating in terms of setting up a warning causation defense.”

McConnell indicated plaintiffs attorneys providing specifics regarding the content of a proposed new warning is lacking in many drug and medical device cases.

“I don’t actually blame the plaintiff lawyers. They’re doing what we all would do; we want to keep our options open. My issue is that I think the courts, earlier on, ought to insist on some clarity or specificity as to what the warning should have said,” McConnell stated.

McConnell added a certain level of generality is “probably inevitable” and to be expected at the outset of a case, but there had to be a point where specificity entered the picture.

“As the case evolves, there has to be some degree of specificity so that the court can really test whether or not this is a case that should go to the jury,” McConnell said.

McConnell also commented on the issue of warning adequacy in drug and medical device cases, which often boil down to a matter of semantics.

“If you look at these warnings for drugs or devices, they are usually quite detailed and they lay out a lot of warnings,” McConnell said. “The problem is it’s too easy to take whatever it says and find one thing it doesn’t say, even a missing adjective, and say that’s what it should have said.” 

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at

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