The analytical gap, in Dr. Marx’s opinion is demonstrated by setting out his premises and conclusions:Premise: Studies show that a certain regimen of Zometa helps treat cancer-related bone conditions, but may cause ONJ.Premise: Other studies show that less Zometa will result in less ONJ.Conclusion: A regimen using less Zometa will help treat cancer-related bone conditions.This is a classic logical fallacy—an irrelevant conclusion.It is not helpful to the finder of fact for Dr. Marx to state that a drug used to fight cancer related diseases has a particular negative side effect, and that reducing the dosage and/or frequency of that drug will reduce the occurrence of the negative side effect. Rather, Dr. Marx must also provide some factual support that reducing the dosage and/or frequency of that drug will not only reduce the occurrence of the negative side effect, but will also be effective at fighting cancer-related diseases. Unfortunately, Dr. Marx offers no evidence as to the efficacy of a reduced Zometa regimen . . .
Friday, September 21, 2012
Returning to a Favorite Spot
One member of our blogging team (we’ll let you guess who) recently returned from her (well, that narrows it down a bit) first real camping trip. The kind with a tent, sleeping bags, no electricity. You get the idea. This wasn’t just a step, but rather a huge leap outside this blogger’s comfort zone – which runs more toward poolside bar service somewhere where the view is only obstructed by palm trees. Before the trip images of big red welts from mosquito bites, spiders and ticks taking up residence in our hair, and critters of any size wandering around at night left us more than a little disconcerted. An ample supply of wine was stowed with the gear. A Google maps search had located nearby hotels. And the iPhone car charger was packed. We were ready for anything.
Most importantly, as it turns out, we were ready for some fun. The weather near the Appalachian Trail in Pennsylvania was almost perfect. Sunny and warm during the day. Just chilly enough at night to make you want to huddle around the camp fire. Perfect weather for hiking, fishing, roasting marshmallows and hot dogs, and telling ghost stories. The perfect environment for separating the kids from their DVD players, iPads and assorted other portable electronic devices – something we quickly realized was necessary when, as we drove into the mountains we heard from the back seat: Wow, it’s like a real life 3D movie. Yikes! (But don’t tell them about the car charger).
Perhaps best of all was the stillness of the early mornings. No alarms going off. No sounds of traffic congestion. No being bombarded by streaming bad news from all over the world. Just big, deep breaths of fresh air. It made us think of …well, of camping again. Much like the sandy beaches and umbrella drinks (which remain our top destination for relaxing) – when you discover a place you like, you find yourself wanting to return. Even on the ride home, you start thinking about the next time. Fun places are fun places. So, we revisit them with fond memories of the last trip and anticipation that more fun is right around the corner.
That’s sort of how we feel about the Aredia/Zometa litigation. We’ve been there before, we generally like it, and so we go back again.
This week, the A/Z litigation added to its lengthy string of successes (see prior posts on A/Z cases here) with a Daubert (slip op.) and a summary judgment (slip op.) win all rolled into one in the case of Conklin v. Novartis Pharmaceuticals Corporation, No. 9:11-cv-00178-RC, (E.D. Tex. Sept. 19, 2012).
While the case was pending in the Aredia/Zometa MDL, the court granted defendant’s motion for summary judgment on plaintiff’s (and 7 other TX residents’) failure to warn claims. Daubert slip op. at 5. Shortly after remand, in an attempt to avoid the implications of the MDL court’s ruling, plaintiff notified the remand court that the case would proceed on “design defect under Texas law.” Id. at 8. Plaintiff claimed that Dr. Robert Marx, an oral surgeon and one of plaintiffs’ leading MDL experts, had an alternative design theory that saved her remaining claims. Id. As Dr. Marx’s declaration was plaintiff’s sole support for those remaining design defect claims, the court first ruled on defendant’s motion to strike under Daubert.
Dr. Marx’s opinion was that a decreased dosage and/or frequency of Zometa administration would both reduce the risk of the side effect suffered by plaintiff (ONJ) and still efficaciously treat cancer-related bone damage. Id. at 16. Unfortunately for plaintiff, the court found both that Dr. Marx was unqualified to render such an opinion and that the opinion itself was unsupported. First, the court noted that Dr. Marx is neither an oncologist nor pharmacologist and therefore not qualified to offer an opinion on what dosage of Zometa would effectively treat cancer-related bone damage. Further, in disqualifying Dr. Marx, the court noted that he “had to rely on studies or opinions of other experts to opine of the efficacy or utility of his ‘safe alternative design.’” Id.
But the court didn’t stop there. Delving deeper into the shaky foundation of Dr. Marx’s opinion, the court stated:
Id. at 18. Based upon Dr. Marx’s inability to show that a reduced dose or duration of Zometa treatment would be as efficacious as the FDA-approved dose or duration, Dr. Marx’s “alternative design” opinion was stricken.
The court then turned to defendant’s motion for summary judgment. The MDL court having done away with plaintiff’s failure to warn, and by extension her breach of express warranty claims, Summary judgment slip op. at 8, the remand court was left to consider strict liability design defect, negligence per se and breach of implied warranty. First, the court quickly recognized that plaintiff’s negligence per se and breach of implied warranty claims were “re-packaged design defect or failure to warn claims.” Id. Since the MDL court had ruled that plaintiff’s failure-to-warn claims were foreclosed, and since plaintiff had offered no admissible evidence of a safer alternative design -- the court granted summary judgment for defendant. Id. at 9-11. Two wins, no waiting.
As you know from our prior posts, the Conklin decision is just the latest in a string of defense wins in the Aredia/Zometa litigation. But just like a good vacation – we don’t mind revisiting if the trip brings a smile to our face.
As always congratulations and thanks to our friend Joe Hollingsworth for keeping us up to speed on this litigation.