TIM LEONARD, District Judge.
This is a pharmaceutical products liability lawsuit involving the Novartis Pharmaceuticals Corporation ("NPC") drugs Aredia and Zometa. Aredia and Zometa are bisphosphonates prescribed to patients with multiple myeloma, hypercalcemia of malignancy, or certain kinds of cancer that has metastasized to the bones. Plaintiff Linda Ingram, as the personal representative of her deceased husband Rick Ingram's estate, brings this suit alleging claims for strict liability and negligence. Complaint, Doc. No. 1. This case was consolidated with similar cases in a multi-district litigation ("MDL") proceeding in the Middle District of Tennessee, and was remanded to this court for further proceedings on August 23, 2011. Doc. No. 37.
In January 1999, Mr. Ingram was diagnosed with multiple myeloma. He was prescribed Aredia in January 1999 and received it until January 2003, when he was switched to Zometa. He received Zometa until February 2004. Both medications were prescribed to treat Mr. Ingram's bone pain and decrease his risk for skeletal-related events. Mr. Ingram passed away in July of 2004. Joint Status Report, Doc. No. 43.
Plaintiff alleges that, as a result of taking these medications, Mr. Ingram developed osteonecrosis of the jaw ("ONJ"). Plaintiff alleges that NPC knew or should have known of the risk of ONJ from the use of Aredia and Zometa prior to January, 1999, but failed to provide a different or earlier warning. Plaintiff claims that Mr. Ingram would not have developed ONJ had NPC provided an adequate warning about the risks of Aredia and Zometa. Id.
This matter is before the court on NPC's Motion for Summary Judgment [Doc. No. 81]. Summary judgment is appropriate when the pleadings and supporting documents, viewed in the light most favorable to the nonmoving party, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Fed.R.Civ.P. 56(a) ("[T]he court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law."). Substantive law determines which facts are material. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The dispute must be genuine, that is, "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id.
The party opposing summary judgment may not rest upon the mere allegations or denials of the party's pleadings, but must set forth specific facts showing that there is a genuine issue for trial. Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586-87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Fed.R.Civ.P. 56(e)(3) ("If a party fails to properly support
To prevail on her claims, plaintiff must establish both that (1) Aredia and/or Zometa in fact caused Mr. Ingram's injury and (2) that NPC's failure to warn was the proximate cause of his injury. Eck v. Parke, Davis & Co., 256 F.3d 1013, 1017 (10th Cir.2001). Under Oklahoma law, a manufacturer of a prescription drug is required to warn not the ultimate consumer, but the prescribing physician, under the learned intermediary doctrine. Id. Even if the plaintiff establishes a duty to warn and a breach of that duty, she "must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided." Id. at 1018 (citations omitted). As stated by this court in Stafford v. Wyeth, 411 F.Supp.2d 1318, 1320 (W.D.Okla.2006), with respect to prescription drugs, Oklahoma' learned intermediary doctrine provides that:
Id., citing Edwards v. Basel Pharms., 933 P.2d 298, 300-01 (Okla.1997) (quoting Wooderson v. Ortho Pharm. Corp., 235 Kan. 387, 681 P.2d 1038, 1052, cert. denied, 469 U.S. 965, 105 S.Ct. 365, 83 L.Ed.2d 301 (1984)). Oklahoma's heeding presumption is that a prescribing physician given an adequate warning would have "heeded" the warning by incorporating that warning into his risk-benefit analysis in deciding whether to prescribe a given drug. Eck, 256 F.3d at 1021. This does not create a presumption that the drug would not have been prescribed, as plaintiff suggests, but rather assumes that the treating physician will incorporate the warnings into the risk/benefit analysis in deciding whether to prescribe a given drug. See Stafford, 411 F.Supp.2d at 1322.
Plaintiff is therefore entitled to a rebuttable presumption that Mr. Ingram's prescribing physician would have read and
NPC asserts that plaintiff cannot satisfy her ultimate burden of proving proximate causation because Mr. Ingram's prescribing oncologist, Dr. Khader Hussein, has testified that he would not have changed his course of treatment and would have prescribed Aredia even if he had been adequately warned. Dr. Hussein's sworn deposition testimony, given on March 18, 2011, is as follows:
Deposition of Dr. Hussein, Doc. No. 81-32, p. 49.
The court finds that this testimony is sufficient under Eck to rebut the above-described rebuttable presumption that arises under Oklahoma's learned intermediary doctrine. Dr. Hussein testified that had he known of Aredia's potential complication of osteonecrosis of the jaw, he would have prescribed it for Mr. Ingram anyway. This testimony establishes that although the prescribing physician, Dr. Hussein, would have read and heeded the warnings regarding Aredia and ONJ, this would not have changed Dr. Hussein's decision to prescribe it to Mr. Ingram. See Eck, 256 F.3d at 1019 (citing Woulfe v. Eli Lilly & Co., 965 F.Supp. 1478, 1485 (E.D.Okla. 1997)). Based on Dr. Hussein's unequivocal and undisputed testimony, the "burden shifts rather heavily back upon" the plaintiff to either "discredit the physicians' testimony or call into question the substance of the testimony, or otherwise demonstrate that the alleged failure to warn was the proximate cause" of Mr. Ingram's injuries. Eck, 256 F.3d at 1019.
Here, plaintiff has not discredited Dr. Hussein's testimony, nor has she called into question the substance of his testimony. In an apparent attempt to "otherwise demonstrate" that the failure to warn was the proximate cause of Mr. Ingram's injuries, plaintiff has pointed out that Dr. Hussein additionally testified at his deposition that his prescribing practices for bisphosphonates have changed over time. These changes are: (1) he advises his patients to have a dental exam before starting treatment (Deposition of Dr. Hussein, Doc. No. 94-13, pp. 48-49); (2) he advises his patients to have any dental issues resolved before starting the drug (Doc. No. 94-13, pp. 48-49); (3) he advises his patients to tell their dentist or oral healthcare provider they are receiving the drugs (Doc. No. 94-13, p. 46); (4) he advises his patients to avoid dental manipulations (Doc. No. 94-13, p. 46); and (5) when a problem develops the drug is generally stopped (Doc. No. 94-13, pp. 46-47). Plaintiff argues that:
Plaintiff asserts that her summarization of this "evidence" demonstrates an issue of fact as to whether NPC's breach of duty proximately caused Mr. Ingram's jaw injury.
In determining whether plaintiff has established that the noted changes in Dr. Hussein's prescribing practices would have prevented Mr. Ingram's jaw injuries, the court finds that, based on the undisputed summary judgment evidence, the appropriate date for considering NPC's duty to warn is January of 1999, when Mr. Ingram was prescribed Aredia by Dr. Hussein. The court notes that plaintiff's expert, Dr. Robert Marx, has testified in this case that Mr. Ingram already had ONJ when he began taking Zometa in January of 2003. Deposition of Dr. Marx, Doc. No. 101-1, p. 51. Dr. Marx testified that Mr. Ingram's case "seems to be related to Aredia" and that the Zometa in 2003 "just perpetuated the osteonecrosis of the jaw in this case." Id. Since any NPC warning concerning ONJ when Mr. Ingram was changed over to Zometa would not have prevented ONJ, the adequacy of NPC's warnings at that time, i.e., January of 2003, is not relevant. When this finding is kept in mind, it is clear that plaintiff's arguments regarding Dr. Hussein's changed prescribing practices are insufficient to discharge her burden of proof on proximate causation. As demonstrated above, Dr. Hussein has unequivocally testified that had he known in January of 1999 that Aredia had the potential complication of ONJ, he would have prescribed it for Mr. Ingram anyway.
Additionally, the court notes that plaintiff's expert Dr. Marx has testified at his deposition in this case that he does not believe that the extraction of tooth #30
The court concludes that plaintiff has failed to meet her burden of proof on the issue of proximate cause, a burden which the Tenth Circuit has explained in Eck shifts "rather heavily" back upon plaintiff, not NPC or the court. Plaintiff has not demonstrated, by reference to evidence in the summary judgment record, that any of the changed prescribing practices described by Dr. Hussein would have prevented Mr. Ingram's injury. This conclusion is based on the undisputed timeline of events concerning Mr. Ingram's oncological and dental care, the lack of any evidence that the changed prescribing practices would have prevented Mr. Ingram's injury, and plaintiff's failure to
NPC is also entitled to summary judgment on plaintiff's claim for wrongful death. A review of plaintiff's Complaint, Doc. No. 1, reveals that it contains two counts, neither of which is wrongful death. Thus, it appears that plaintiff has failed to state a claim for wrongful death. Even were the court to assume for the sake of argument that a wrongful death claim exists given other allegations in the Complaint, such a claim cannot withstand summary judgment. NPC argues that it is entitled to summary judgment on the wrongful death claim because plaintiff has failed to present expert testimony establishing that NPC's product caused Mr. Ingram's death.
Plaintiff's response makes reference to the following deposition testimony given by Mr. Ingram's oncologist, Dr. Hussein, after defense counsel inquired into the cause of Mr. Ingram's death:
Deposition of Dr. Hussein, Doc. No. 94-13, pp. 41-43.
Relying only on the deposition testimony of Dr. Hussein set forth above, plaintiff states in a conclusory fashion that "Mr. Ingram had been on long-term broad spectrum antibiotics as a result of his ONJ[,]" and that "[t]his evidence is sufficient to create a jury issue on the wrongful death claim." However, the cited testimony of Dr. Hussein does not provide sufficient evidentiary support at the summary judgment stage for plaintiff's contention that Mr. Ingram "had been on long-term broad spectrum antibiotics as a result of his ONJ." Indeed, the cited testimony of Dr. Hussein does not specifically tie the broad spectrum antibiotics Mr. Ingram may have received to ONJ or any NPC product. This is clearly a case where the causes of Mr. Ingram's medical conditions and death cannot be determined absent expert testimony. See Christian v. Gray, 65 P.3d 591, 601-02 (Okla.2003) ("When an injury is of
Plaintiff has failed to demonstrate that there is a genuine dispute for trial. Accordingly, summary judgment in favor of NPC on all claims is appropriate. Therefore, for the reasons stated above, Novartis Pharmaceuticals Corporation's Motion for Summary Judgment
It is so ordered.