******************
The Southern District of Illinois delivered a giant lumpof coal when it denied the defendant’s motion for summary judgment in a Zometacase last week. In Rutz v. Novartis Pharmaceuticals Corp., 2012 U.S.Dist. LEXIS 177779 (S.D. Ill. Dec. 17, 2012), plaintiff claimed that hisdecedent developed bisphosphonate-related osteonecrosis of the jaw (“BRONJ”)after taking Zometa for 3 years while undergoing treatment for breastcancer. In considering defendant’ssummary judgment motion, the court looked first at the evidence on specificcausation, then considered the evidence on warnings. Because the warnings discussion is the mosttroubling - and basically obviates the need for a specific causation discussion– we’ll look at the court’s warnings analysis first.
The record indicated that plaintiff’s decedent tookZometa from June 2002 through August 2005. Id. at *6. According to the opinion, the defendant learned of the drug’s association with BRONJ in 2002, and subsequently amendedits labeling in September 2003, February 2004 and September 2004; it also sentDear Doctor letters in September 2004. Id. at *12. Ms. Rutz’s doctor got this letter, but continuedto prescribe the drug for her until August 2005. Id. at*5. That’s right: he continued toprescribe for two years after the first label change. Perhaps not surprisingly, the defendantargued that there was no evidence that it should have acted more quickly toimplement a different warning. Id. at*12. The court merely found that thedefendant’s actions created an issue of fact as to whether it should havewarned sooner or differently. Id. at *14-15. Completely absent is any discussion of the prescriber’s testimony on the warnings, or why he decidedto continue prescribing the drug through three label changes and a Dear Doctorletter – for nearly a year after the latter, in fact. While we don’t know the doctor’s thinking, asBexis noted in a prior post, where the alternative to therapyis likely to be death from cancer, it’s tough to prove that a doctor wouldchoose not to prescribe a drug based on the possibility of a lesser injury.
Plaintiff argued that the prescriber was not a learnedintermediary, and also, that he would have heeded a warning if it had beenadequate. Id. at * 17. Loose language in some Illinois cases permits plaintiffs to argue that the learned intermediary doctrine should be set aside (what they really mean is that the warning can be found inadequate) if the jury determinesthat the prescriber was not sufficiently warned, but the court didn’t take thison. Instead, it punted on deciding as amatter of law whether this prescriber was a learned intermediary. Id.at 18. This muddied the waters for thediscussion on heeding presumption, as the court admitted that if thedoctor was a learned intermediary, it was not clear whether a heedingpresumption would apply. Undaunted bythis fact, the court handled this obstacle by deciding that even if thisprescriber was considered a learned intermediary, a heeding presumption wouldapply (again, that’s after admitting that there was no controlling Illinoisauthority on this point). Id. To support this conclusion, the court relied on a decision from theIllinois Appeals Court, which applied Texas law and found a heedingpresumption applies to learned intermediaries. Bexis undoubtedly had an aneurism when he read that, given Erie, predicting expansions of state law, and all that. See, the problem with the Rutz court’s reliance on the Illinois appellateopinion was that the appellate court not only didn't apply Illinois law, but got Texas law wrong. Readers of the blog will remember that in Ackermann v. Wyeth, the Fifth Circuitfound that the heeding presumption does not apply to learned intermediaries,and that even if it did, it would mean only that the doctor “would haveincorporated the additional risk into his [or her] decisional calculus.” However, relying on the incorrectstatement of Texas law and one decision from a sister court (the NorthernDistrict of Illinois), the Rutz courtproclaimed that “the heeding presumption is a natural result of or corollary tothe learned intermediary doctrine.” Id. at *20. Thus, if Mrs. Rutz’s prescriber was a learnedintermediary, there was a presumption that he would have heeded an adequatewarning. While this seems dangerously close to circularlogic to us (and not at all natural), it’s also contrary to the law in a numberof jurisdictions. As the blog hasdiscussed in the past, Thomas v. HoffmanLaRoche , 949 F.2d 806 (5th Cir. 1992), contains a goodsubstantive discussion of why the heeding presumption should not apply inlearned intermediary cases.
Continuing with the theme of things that don’t existin Illinois law . . . . Illinois does not have a statutory presumption ofadequacy for FDA-approved drugs, so as you might have guessed, there was nochance the defendant was getting judgment as a matter of law on thatbasis. But the court was unwilling toconsider the adequacy of the warning as a matter of law in general, based onwhat it called the law-of-the-case doctrine. For this argument, however, the court relied not on rulings from the Rutz case, but on another Zometa case inwhich the MDL court - applying Florida law, no less - found that the adequacyof the warning was a question for the jury.
Based on the warnings analysis, a discussion of thecourt’s treatment of the specific causation argument may be unnecessary, buthumor us. In his deposition, theplaintiff’s expert had admitted that Rutz’s condition did not meet the accepteddefinition of BRONJ developed by the medical community. Id.at *7. The court found several ways toget around this troubling admission. First, it noted that the definition had not been developed until afterthe decedent was diagnosed. Then, thecourt rejected the definition itself. According to the criteria in the definition, in order to support adiagnosis of BRONJ, the patient must have at least eight weeks of exposed bone. However, the Rutz court accepted plaintiff’s expert’s opinion that BRONJ couldbe present with only 4-5 weeks of exposed bone. The problem with this opinion (besides the fact that it goes against thethinking of the rest of the medical community)? This decedent didn’t have a singleincident of exposed bone documented in her medical records. Remarkably, the court handled thisinconvenient fact by holding:
Given that Rutz may have had exposed bone which wasnot recorded, it would be unfair to permit [defendant] to use the absence of arecord to conclude that BRONJ was not present . . . . [a] jury could determinethat other indicia of BRONJ – such as non-healing wounds – made it likely thatexposed bone was present.”
Id. at *10-11. The court also glossed over the defendant’s argument that this decedenthad other disease processes that could cause ONJ. Id. at*7. Where did the burden of proof go? The record has nothing to support causation. Absence of evidence is just that ... absence of evidence.
Let’s hope this opinion, with its many missteps,doesn’t haunt defendants in drug cases like some sort of ghost of Christmasespast.
Hiç yorum yok:
Yorum Gönder