We were surprised by the article in the New York Times this weekend about how the Supreme Court revises some of its opinions years later. Those changes are picked up in some reporters, but not others. Some of those changes are relatively minor (e.g., Justice Scalia correcting his statement of what the EPA’s position was on a particular issue) but others are not. The article sent us into a reverie of wishful thinking about ‘correcting’ the Wyeth v. Levine opinion to take into account the non-automatic nature of Changes Being Effected, or to excise Riegel’s frolic and detour on parallel claim exceptions, or to foreclose the Solicitor General’s new, crabbed interpretation of FDA preemption applying only to device-specific actions. But why stop at Supreme Court opinions? Looking back over the years, we can think of many things we said and wrote that we’d now like to edit. That wedding toast where the ex-girlfriend, rather than the bride, was saluted would be fixed. And now in our dotage we finally realized the correct answer to the question of whether “this makes me look fat.” It reminds us of the classic definition of a gaffe: telling the truth at the wrong place and time.
Many of the cases we post about here could use a bit of editing. When the blogging team goes over the cases on offer for any given week, the phrase “mixed bag” comes up more often than any other. That shouldn’t be surprising. For every wonderful one-two punch Mensing/anti-Contecase, or every Bausch/Perez train wreck, we get ten cases that are more like what we see regularly in real-life – cases that have a little good and a little bad. We cannot exactly edit those cases, but we can accentuate the positive in our humble reviews. That’s what we will do with Kruszka v. Novartis Pharms. Corp., 2014 U.S. Dist. LEXIS 68439 (D. Minn. May 19, 2014). Kruszka is yet another Aredia-Zometa case where a cancer survivor alleges that the drugs that helped her survive cancer caused osteonecrosis of the jaw (ONJ). Some of the rulings we like better than others. While we cannot edit the opinion, we can certainly highlight the good stuff while mumbling sotto voce about the bad. With the glow of the long holiday weekend not yet worn off, we are reluctant to be the deliverer of evil.
The plaintiff in Kruszka was diagnosed with blood cancer in the form of multiple myeloma in 2000. That cancer resulted in hypercalcemia, a compression fracture in her spine, and lytic lesions in her skull, spine, and bones. Multiple myeloma patients’ survival rate is approximately six months where no treatment is received. Doctors told the plaintiff she could expect to live six weeks without treatment. But she did receive treatment. Her doctor prescribed Aredia to protect against bone damage and treated the plaintiff with chemotherapy. She received both branded and generic bisphosphonates. The good news is that she lived. The bad news is that a couple of years later she was diagnosed with chronic osteomyelitis (infection in the bone). The plaintiff was prescribed a prolonged course of four different antibiotics after her prior treatments were determined to be ”suboptimal.” Dead bone was removed from the jaw area in 2003. A year later, the plaintiff complained of numbness in her jaw, chin, and lip resulting in difficulty swallowing and chewing, a “deformed face” and other issues. The plaintiff alleged that the damage to her face and jaw changed her life dramatically, including her speech, eating, social interactions. She had to give up her church choir. There is no doubt that the plaintiff earned sympathy. She was also, as of November 2013, still alive.
In 2004, Dr. Gertz, an oncologist who treated the plaintiff, gave her information regarding an association between bisphosphonate use and the development of ONJ. The defendant had started providing warnings related to an association between bisphosphonate use and ONJ in its FDA-approved labeling of Aredia and Zometa in September 2003. The label was revised in 2004 to include precautions relating to dental procedures. A Dear Doctor letter went out.
The plaintiff proffered several expert opinions, both from retained experts and from her treating doctors. Dr. Marx, an oral surgeon, was one of the retained experts. He submitted a host of general causation opinions, including on the effect of dose and duration. As a general matter, it is usually tougher to exclude general causation opinions than specific causation opinion, but the defendant here did pretty well. The court concluded that Dr. Marx could not reliably testify as to the results or efficacy of differing dose and duration. He also could not “opine regarding whether dosage changes impact the efficacy of the drugs at issue.” Kruszka, 2014 U.S. Dist. LEXIS 68439 at *20. The defendant also cut back on Dr. Marx’s specific causation opinions, persuading the court that Dr. Marx was “not qualified to give the opinion that a different dose would have prevented or lessened the risk of the plaintiff’s jaw disease, or that an oncologist could or should have prescribed her a different dose or duration.” Id. at *21. But we will avert our gaze and hurry past the court’s conclusion that Dr. Marx could opine on the biological mechanisms through which biophosphonates could cause ONJ. If you are a glutton for punishment, read at *22-23.
The plaintiff sought to have her treating doctor opine that Aredia contributed to her ONJ. Jurors seem to believe treaters more than hired guns, so this is potentially good stuff for the plaintiff. But the court held that Dr. Gertz’s specific causation opinion lacked an adequate scientific methodology. The plaintiff presented “no evidence that Dr. Gertz performed a differential diagnosis regarding the cause” of the plaintiff’s jaw condition, and “there is also no testimony that he reviewed or ruled out any other causes.” Id. at *27. When he was asked specifically for the basis of his opinion that there was a causal link between bisphosphonates and the plaintiff’s ONJ, Dr. Gertz stated that the basis of his opinion that Aredia was “contributory” was “personal experience and my understanding of the literature surrounding bisphosphonate use and osteonecrosis of the jaw.” Id. at *28. The court was unimpressed by that fairly standard litany of bona fides, and even less impressed by the fact that “Dr. Gertz could not even opine on whether the plaintiff’s jaw problems were ONJ, making an opinion on causation for the plaintiff’s conditions unreliable.” Id.
The plaintiff proffered another specific causation opinion from another treater, Dr. Juhlin. The battleground for expert opinions by treaters is usually whether the opinions were developed during the course and scope of the doctor’s treatment of that particular patient. That hurdle seems to have tripped up the plaintiff here, as the plaintiff sought “to base Dr. Juhlin’s specific causation testimony on views he developed long after” he treated the plaintiff. Id. at *29. This sort of post hoc opinion “does not form the basis of an expert opinion based on ‘the exacting standards of reliability’ required by Rule 702.” Id.
But the plaintiff did manage to get a retained expert’s opinion past Daubert. It’s the usual dreary stuff on goes-to-weight-not-admissibility and the super-dreary stuff on resolving-doubts-in-favor-of-admissibility. Id. at *32-33. It makes us sad – as sad as we are that Mad Men is over until 2015, or that Bert Cooper died. And here, we do not even get a consoling musical number.
Just as with the Daubert rulings, the summary judgment rulings in Kruszka are a mixed bag. The court granted summary judgment in part as to liability for injuries post-January 2002 to the extent the injury is tied to generic drugs, but denied summary judgment to the extent that the plaintiff’s claims related to injuries caused by Aredia that remained in the plaintiff’s system as a result of Aredia’s half-life. Id. at *38. We’ll admit that this permutation of post-Mensing analysis is one we have not seen before.
The failure to warn claim survives. Why? Here’s a quote from the case that is one of our least favorites (if we could edit Kruszka, this line gets serious red ink treatment): “If at least one treating physician, not necessarily the original prescriber of the drug, would have behaved differently, this is sufficient to survive summary judgment.” Id. at *44.
Let’s end on a positive note or two, shall we? The breach of warranty claim was subsumed by the Minnesota strict liability claims and thus was dismissed. The plaintiff argued that the issue should be reserved for the jury charge conference. We do not see why and neither did the court. Id. at *46-47. Finally (at least “finally” for us, because we will pretend the last section of the opinion, which allowed the plaintiffs to proceed to trial with their punitive damages claim, does not exist), the court dismissed the negligent design defect claim. The plaintiff argued that the defendant failed to test for ONJ in its trial subjects and that a lower dose and duration might have been safer. The court held that the “fact that issues of duration and dose are contested is not enough to create a genuine issue of material fact on a design defect claim.” Id. at *49. The plaintiff proffered a 2003 company e-mail concerning the possibility of different dosages for Zometa. But “the fact that a different dose may be possible does not address whether a different dose of Aredia reduces the risk of ONJ without impairing Aredia’s usefulness.” Id. at *50.
We wouldn’t edit that reasoning even a little bit.