MARK R. HORNAK, District Judge.
Plaintiffs Karen Rowland ("Ms. Rowland"), George Machen ("Mr. Machen"), Stacy Machen ("Mrs. Machen"), and Michelle Pratt Orr ("Mrs. Orr") bring strict liability, negligence, and breach of warranty claims against the Defendant, Novartis Pharmaceuticals Corporation ("NPC"), alleging that they or their spouse developed a painful and permanently disfiguring condition as a result of using NPC's prescription medication for the purpose of managing metastatic bone cancer. Pending before the Court is a deluge of Daubert motions filed by NPC to exclude opinion testimony from Plaintiffs' retained experts and to exclude causation testimony from Plaintiffs' case-specific retained and non-retained experts (their "treating physicians") under Federal Rule of Evidence 702 ("Rule 702"). Mrs. Orr has also filed a pending Daubert motion to exclude certain expert testimony from two of NPC's case-specific
The Court assumes the parties' familiarity with the factual background and wending procedural history of this case but will provide a brief review. These lawsuits involve Zometa, a Food and Drug Administration ("FDA") approved intravenous bisphosphonate ("IV BP") prescription drug designed, manufactured, marketed, distributed, and sold by NPC for patients with cancer that has metastasized to their bones. Rowland Compl. ¶ 6 ("RC"). Ms. Rowland received Zometa in conjunction with her treatment for metastatic breast cancer, Mr. Machen was prescribed Zometa in relation to his metastatic Stage IV-B Hodgkin's disease, and John Orr ("Mr. Orr"), Mrs. Orr's late husband
Ms. Rowland and the Machens originally filed suit in federal court in the District of Columbia. See RC, at 1 and Machen Compl. ("MC"), at ¶ 1. Mr. Orr initially filed suit in federal court in the Southern District of New York. See Orr Compl. ("OC"), at ¶ 1. All three cases were conditionally transferred to the Middle District of Tennessee ("the MDL court") for coordinated pretrial proceedings pursuant to the Multi-District Litigation Act, 28 U.S.C. § 1407. ECF No. 4. Along with the summary judgment motions it filed in the MDL court, NPC filed Daubert motions to exclude, for purposes of summary judgment, the expert testimony of Dr. Keith Skubitz ("Dr. Skubitz"), Dr. James Vogel ("Dr. Vogel"), Prof. Wayne Ray ("Prof. Ray"), Dr. Robert Marx ("Dr. Marx"), Dr. Suzanne Parisian ("Dr. Parisian"), and Dr. Robert Fletcher ("Dr. Fletcher")
Rule 702 provides:
Fed.R.Evid. 702. Rule 702 reflects "a liberal policy of admissibility." Kannankeril v. Terminix Int'l, Inc., 128 F.3d 802, 806 (3d Cir.1997), The Court acts as a gatekeeper and must screen purportedly scientific evidence to ensure that any and all such proffered evidence is both relevant and reliable. Daubert v. Merrell Dow Pharm., 509 U.S. 579, 589, 597, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). In determining the admissibility of expert testimony, courts have categorized the Rule 702 requirements as (1) the expert's qualifications, (2) the reliability of the expert's methods, and (3) the "fit" of the expert's methods to the facts of the case (i.e., whether the expert's methods are helpful to the fact finder).
Qualification "refers to the requirement that the witness possess specialized expertise." Schneider, 320 F.3d at 404. "A broad range of knowledge, skills, and training qualify an expert." Paoli, 35 F.3d at 741. An expert's opinion is reliable if it has "good grounds" in scientific methods and procedures and is not based on "subjective belief or unsupported speculation." Id. at 742. The reliability inquiry is flexible and focuses "on principles and methodology, not on the conclusions they generate." Daubert, 509 U.S. at 594-95, 113 S.Ct. 2786. Finally, an expert's testimony "fits" the issues in the case when it provides "a valid scientific connection to the pertinent inquiry." Id. at 591-92, 113 S.Ct. 2786.
Dr. Marx is a board certified oral and maxillofacial surgeon and a Professor of Surgery and Chief of the Division of Oral and Maxillofacial Surgery at the University of Miami Miller School of Medicine. ECF No. 73-2 at 2. Among his many qualifications listed in the record, see id., 2-93, Dr. Marx is well-known for helping to recognize BRONJ and notify NPC of its existence and for co-authoring the medical literature that first identified and described BRONJ. Id. NPC seeks to exclude Dr. Marx's opinions as to four issues: (1) whether certain patients in the Aredia/Zometa
With the exception of one case
All Zometa courts that have ruled on Dr. Marx's general causation testimony— based on adverse event reports submitted to the FDA or NPC about patients who allegedly developed ONJ after being treated with Zometa—have held his opinion admissible.
Zometa courts are similarly harmonious in their rulings on Dr. Marx's opinion regarding the biological mechanism by which IV BPs allegedly cause ONJ.
Zometa courts appear to be unanimous in concluding that Dr. Marx's expert opinion as to the efficacy of pre-Zometa dental screenings in preventing BRONJ is qualified and reliable.
NPC now argues beyond Daubert that Dr. Marx's opinion is irrelevant to these cases under Federal Rules of Evidence 401-403. It asserts that Ms. Rowland actually was advised by her oncologist to receive a dental examination before beginning Zometa treatment but failed to do so, that Mrs. Orr has submitted no dental records predating the start of Mr. Orr's IV BP treatment, and that Mr. Machen's alleged BRONJ was not caused by a dental procedure but occurred spontaneously. "The theoretical reason for the pretreatment dental examination is to enable an individual to have invasive dental procedures performed before starting bisphosphonates
Dr. Parisian is the founder of MD Assist, Inc., a regulatory and medical consulting firm specializing in matters regarding the FDA's regulation of products. ECF No. 77-13 at 2. She holds a medical degree and a Masters degree in biology and worked for many years for various regulatory agencies, including the FDA. Id. at 2-7. As a consultant, she provides information to individuals, manufacturers, and organizations with respect to various FDA requirements. Id. at 7. NPC seeks to exclude Dr. Parisian's opinions as to three issues: (1) NPC's compliance with FDA regulations; (2) the adequacy of the warnings NPC included in the Zometa labeling; and (3) regulatory causation.
Where, as here, plaintiffs have asserted claims based on violations of FDA regulations, Zometa courts have routinely allowed Dr. Parisian to testify as to the general FDA regulatory scheme governing pharmaceutical drugs due to her significant experience with the FDA and its regulations regarding new drug application, approval, monitoring, and labeling.
With the exception of one case
Pursuant to the consistent guidance of Zometa courts on this issue
Prof. Ray is a Professor of Preventive Medicine at Vanderbilt University School of Medicine, where he also serves as the Director of the Division of Pharmacoepidemiology and Master of the Public Health Program. ECF No. 79-7 at 2. He has extensive experience designing, conducting, and analyzing pharmacoepidemiologic studies. Id. at 2-3. For purposes of these cases, Prof. Ray performed a meta-analysis
Joining several of its sister courts
Dr. Vogel is a practicing oncologist and hematologist and an Associate Professor at the Mount Sinai School of Medicine, Division of Hematology/Medical Oncology. ECF No. 75-7 at 2. The MDL Court ruled that his testimony "concerning general causation and the scientific and medical accuracy of the warnings given by [NPC]" was admissible. ECF No. 75-2 at 4-5. NPC seeks to exclude Dr. Vogel's testimony on four issues; (1) whether pre-Zometa dental treatment measures reduce the risk of BRONJ; (2) the incidence rate of ONJ in IV BP patients; (3) the viability of alternative IV BP dosing durations and regimens; and (4) the biological mechanism by which IV BP drugs allegedly cause BRONJ.
Zometa courts have consistently found Dr. Vogel qualified to offer an opinion as to the effectiveness of pre-Zometa dental screenings in preventing BRONJ.
The Court concurs with the uniform conclusions of other Zometa courts that have weighed the admissibility of Dr. Vogel's opinion on the rate of ONJ incidence in IV BP patients.
Plaintiffs seek to have Dr. Vogel testify that a reduced dosing schedule of Zometa is equally effective and presents less risk of BRONJ and that NPC failed to release information about possible alternative dosing schedules. NPC argues that Dr. Vogel's opinion is not sufficiently reliable because his suggested alternative Zometa regimen has not been approved by the FDA and was rejected as unreliable and medically inadvisable by the American Society of Clinical Oncology, and because he relies upon a single study and an article in support of his theory.
Pursuant to the well-reasoned opinions of other Zometa courts, which have found Dr. Vogel qualified by experience to testify as to the biological mechanism by which IV BPs affect jaw bones
Dr. Skubitz is a Professor of Medicine at the University of Minnesota Medical School, where he conducts research on basic biologic aspects of cancer and clinical cancer therapy and regularly sees patients in the oncology clinic. ECF No. 81-3 at 2. The MDL Court found him qualified to testify as to general causation and adequacy of warnings. ECF No. 81-2. NPC seeks to prevent Dr. Skubitz from testifying as an expert on (1) the viability of alternative IV BP dosing durations and regimens; (2) whether pre-Zometa dental treatment measures reduce the risk of BRONJ; and (3) the incidence rate of ONJ in IV BP patients.
Other Zometa courts have found Dr. Skubitz to be qualified to testify to the ONJ incidence rate in Zometa patients
NPC also pursues exclusion of the testimony of each of Plaintiffs' treating physicians that Plaintiffs have offered as expert witnesses on the topic of specific causation. Ms. Rowland has designated Dr. Marc Samuels ("Dr. Samuels"), her dentist, and Dr. William Chung ("Dr. Chung"), her oral surgeon, as such witnesses. However, Ms. Rowland has not presented any evidence that either physician is qualified to opine on the causation of ONJ. At his deposition, Dr. Samuels testified that he had no opinion as to whether Zometa causes ONJ, ECF No. 70-1 at 47-48. Dr. Chung stated at his deposition that he did not consider himself an expert in BRONJ. ECF No. 70-2 at 16.
Mr. Machen designates Dr. Derek Kelly ("Dr. Kelly"), his oral surgeon, and Dr. Mark Stein ("Dr. Stein"), his dentist, as experts testifying on the issue of causation. Much like Ms. Rowland, Mr. Machen has presented no concrete qualifications for either physician to present such testimony. Dr. Stein testified at his deposition that he does not consider himself an expert on ONJ, ECF No. 96-1 at 7, and that he had no opinion as to whether Mr. Machen had ONJ. ECF No. 71-1 at 44. At his deposition, Dr. Kelly also testified that he did not consider himself an expert on ONJ or its
Mrs. Orr offers Dr. Joseph Cillo ("Dr. Cillo"), Mr. Orr's oral surgeon, and Dr. David Roodman ("Dr. Roodman"), his oncologist, as expert witnesses on causation. Both physicians at least believe themselves to be experts on ONJ and appear to have some expertise to support that assertion. ECF No. 90-2 at 172-73, 206. Dr. Cillo completed a fellowship with Dr. Marx where he treated and managed patients with BRONJ. He has treated in total at least 50 patients suffering from BRONJ and has lectured on and written a peer-reviewed article on BRONJ. Id. at 69-76. Dr. Roodman has lectured on BRONJ and co-authored the American Society of Clinical Oncology guidelines for use of bisphosphonates in multiple myeloma patients. Id. at 231-88. However, Dr. Cillo was never deposed in this case, and Dr. Roodman never unequivocally testified at deposition that he believed to a reasonable degree of medical certainty that Mr. Orr's condition was caused by his Zometa use. Id. at 192.
In the Third Circuit, treating physicians' opinions on prognosis and causation are inherently expert testimony. Pease v. Lycoming Engines, 2012 WL 162551, at *12 (E.D.Pa. Jan. 19, 2012). However, when a treating physician's causation conclusion is excluded as unreliable, he may still be permitted to testify about his examination of the plaintiff, the tests he conducted, and any diagnosis he reached. Heller v. Shaw Indus., 167 F.3d 146, 159 n. 8 (3d Cir.1999) (citation omitted). Plaintiffs' treating physicians are therefore free to testify as to personal knowledge they gained from their examinations of Plaintiffs—statements made to them by Plaintiffs during care and treatment, their own examinations, diagnoses, and course of treatment, and Plaintiffs' prognoses based on their observations during treatment. Damiani v. Momme, 2012 WL 1657920, at *4 (E.D.Pa. May 11, 2012). "What these treating physicians may not do is offer independent opinions as to the cause of [p]laintiff's injuries." Id.
The Court will not allow the treating physicians for Ms. Rowland or Mr. Machen to testify as to causation in any respect given their deposition testimony. They may, however, testify about their care and treatment of Plaintiffs based on their personal knowledge and examinations. The Court will allow Mr. Orr's treating physicians to opine on causation due to their experience with BRONJ, but only to the extent that they formed any such opinion from their treatment of Mr. Orr and not at the request of counsel.
Dr. Najjar is a board certified oral pathologist and oral and maxillofacial surgeon. ECF No. 70-3 at 15-30. He is a specialist in jaw disease, has treated patients with BRONJ, and has researched ONJ in rats. Id. Two other Zometa courts have allowed Dr. Najjar to give expert testimony on the topic of causation.
As to Ms. Rowland, the Court concludes that Dr. Najjar may testify regarding causation of her ONJ. NPC's main objections to Dr. Najjar's testimony are that he did not rule out osteomyelitis as a possible cause in his differential diagnosis and that he only reviewed Ms. Rowland's medical records in making his determination. A medical expert's causation conclusion should not be excluded because he failed to rule out every possible alternative cause of injury or illness. Heller, 167 F.3d at 156. Only "where a defendant points to a plausible alternative cause and the doctor offers no explanation for why he or she has concluded that was not the sole cause" is that doctor's methodology unreliable. Paoli, 35 F.3d at 759 n. 27 (emphasis in original). Dr. Najjar considered osteomyelitis and a number of other possible causes in his expert report and concluded that they were not probable or were secondary causes to BRONJ. ECF No. 70-3 at 3, Once a defendant's suggested alternative causes are adequately addressed by the expert, they go to the weight of his testimony, not its admissibility. Kannankeril, 128 F.3d at 808. Additionally, evaluation of a plaintiffs medical records is a reliable method even in the absence of a physical examination. Paoli, 35 F.3d at 762. Therefore, Dr. Najjar's causation opinion as to Ms. Rowland is admissible for Rule 702 purposes, and NPC's objections may properly be addressed with cross-examination.
NPC raises different issues with respect to Dr. Najjar's causation opinion on Mr. Machen. NPC argues that since Dr. Najjar found no necrotic or exposed jawbone during his examination of Mr. Machen, he could not credibly diagnose him with osteonecrosis of the jaw (literally, dead jawbone). The American Association of Oral and Maxillofacial Surgeons ("AAOMS") criteria for diagnosing Stage I BRONJ requires that the patient have exposed bone or exposed necrotic bone for a period of 6-8 weeks. ECF No. 71-6 at 4. Dr. Najjar admitted during his deposition that Mr. Machen's symptoms did not meet those recognized diagnostic BRONJ criteria, ECF No. 71-5 at 12, but testified that he believed Mr. Machen suffered from a "BRONJ-like lesion," ECF No. 92-2 at 176, or bony defect in his jaw that was in fact Stage I BRONJ pursuant to his own criteria. Id. at 143. Plaintiff argues that this diagnosis is akin to "Stage 0" BRONJ, which the AAOMS defined in a 2009 position paper as found in "patients with no clinical evidence of necrotic bone, but present with non-specific symptoms or clinical and radiographic findings." Id. at 82.
The Court concludes that Dr. Najjar may testify to the causation of Mr. Machen's ONJ. Dr. Najjar is eminently qualified by experience as an expert in ONJ and BRONJ and used a differential diagnosis to come to his causation conclusion. He utilized reliable scientific methods, including a physical examination of
The court in Bessemer v. Novartis Pharm. Corp., No. MID-L-1835-08, slip op. at 6-7, 11 (N.J.Super.Ct. Law Div. Apr. 30, 2010), confronted a similar Daubert challenge. NPC sought to exclude the case-specific causation testimony of one of the plaintiffs experts on the grounds that the plaintiff had no history of exposed bone and therefore, under the AAOMS criteria, could not reliably be diagnosed with BRONJ. Id. at 7. The expert diagnosed the plaintiff with Stage 0 BRONJ, which NPC alleged is "not meant to assess a causal relationship between bisphosphonates and ONJ but rather serves as a treatment guideline." Id. The Court disagreed with NPC, writing:
Id. The Court concurs with the Bessemer court's conclusion and finds it to be consistent with Third Circuit guidance—the crux of the admissibility question is reliable methodology, not the acceptability of the conclusion itself. See Paoli, 35 F.3d at 744. Because Dr. Najjar is qualified to testify as to ONJ causation and used reliable methodology to come to his conclusion about what caused Mr. Machen's injuries, his expert causation opinion is admissible under Rule 702.
Dr. Atallah is Director of Oral and Maxillofacial Surgery at Miami VA Medical Center and Assistant Professor of Clinical Surgery in the Division of Oral and Maxillofacial Surgery at Miami University Miller School of Medicine. ECF No. 69-1 at 22. He has experience regularly evaluating and treating patients with BRONJ and was a resident under Dr. Marx at the time BRONJ cases first became frequent. Id. His expert report concludes to a reasonable degree of medical certainty that Mr. Orr developed BRONJ as a result of his Zometa treatment. NPC seeks to exclude his causation testimony primarily on the basis that the differential diagnosis Dr. Atallah conducted with respect to Mr. Orr did not properly rule out several alternative causes documented in Mr. Orr's medical records, including chemotherapy, corticosteroid use, and osteomyelitis.
The Court concludes that Dr. Atallah may testify on the issue of the causation. He is qualified as an expert through his experience treating BRONJ patients, and it is axiomatic that when conducting a differential diagnosis, a physician cannot and need not eliminate all possible causes of the patient's injury for his causation opinion to become admissible; he merely must rule out obvious alternative causes. Heller, 167 F.3d at 156. Dr. Atallah considered a number of other possible explanations for Mr. Orr's injury and specifically ruled out numerous alternative causes including cancer, chemotherapy, corticosteroid use, radiation, and osteomyelitis for reasons that he explained in his expert report and further at his deposition. ECF No. 69-1 at 22-27; ECF No. 90-2 at 21-67. The Court therefore will allow him to testify as an expert witness on case-specific
Dr. Pickens is a Clinical Professor of Medicine at the Temple University School of Medicine. Orr v. Novartis Pharm. Corp., MDL No. 3:06-MD-1760, 3;07-cv-00472, ECF No. 37-2 at 2 (M.D.Ten. filed July 16, 2012). He has extensive experience with metastatic bone cancer, including multiple myeloma. Id. Mrs. Orr seeks to exclude Dr. Pickens from testifying that he found the information about ONJ provided in the Zometa labels and warnings adequate to perform a proper risk/benefit analysis prior to prescription, arguing that he is not qualified to offer such an opinion.
As an oncologist, Dr. Pickens has had many multiple myeloma patients and often prescribes medications to such patients. Under Pennsylvania law, prescribing physicians have a duty to be fully aware of the characteristics of the drug they are prescribing and to advise patients of any dangers or side effects associated with use of the drug. Coyle by Coyle v. Richardson-Merrell, Inc., 526 Pa. 208, 584 A.2d 1383, 1385 (1991) (quoting Makripodis by Makripodis v. Merrell-Dow Pharm., Inc., 361 Pa.Super. 589, 523 A.2d 374, 378 (1987)). As a result, the warnings that accompany prescription drugs are directed to the physician, who then uses his independent medical judgment, data supplied by the manufacturer, medical literature, and other sources to decide whether to prescribe the drug to a particular patient. Id. Dr. Pickens has examined the Zometa labels and warnings and may testify as to their adequacy in the context of his own experience as a prescribing oncologist. See Deutsch, 768 F.Supp.2d at 440 (excluding opinions from Drs. Vogel and Skubitz that Zometa labels and warnings were inadequate because they failed to comply with FDA regulations, but allowing them to testify as to the adequacy of the labels from the perspective of oncologists and prescribing physicians).
Dr. Mega is an Associate Professor of Medicine at the Warren Alpert School of Medicine at Brown University in the Division of Hematology/Oncology. Orr, MDL No. 3:06-MD-1760, 3:07-cv-00472, ECF No. 37-3 at 2 (M.D. Ten., filed July 16, 2012), He has over a decade of experience prescribing and using Zometa and estimates that 30 patients in his practice receive monthly injections of either Aredia or Zometa. Id. Over eleven years, Dr. Mega has personally treated four patients who developed ONJ while using IV BPs. Id. Mrs. Orr seeks to exclude his expert testimony related to (1) general causation of ONJ, (2) Mr. Orr's dental condition, and (3) the adequacy of the Zometa warnings and labels, on the basis that he is not qualified to give such testimony.
For the same reasons the Court allowed Dr. Perkins to opine on the adequacy of the Zometa warnings and labels, the Court will allow Dr. Mega's testimony as to that issue from the perspective of a prescribing oncologist. Dr. Mega primarily bases his general ONJ causation opinion on his review of the relevant medical literature and his handful of personal experiences as a treating physician. Id. at 6-7. The Third Circuit has articulated a liberal policy of admissibility under Rule 702—an expert may be qualified by a broad range of knowledge, skills, and training. Paoli, 35 F.3d at 741. Dr. Mega meets that standard by virtue of his standing as an
Mrs. Orr also claims that Dr. Mega will testify about her late husband's dental condition and identify it as osteomyelitis
In any event, despite the Third Circuit's liberal policy of admissibility, the Court can imagine no reason why Dr. Mega, an oncologist, should be permitted to testify about Mr. Orr's general dental condition or about osteomyelitis. The disputed portion of Dr. Mega's report states, "Mr. Orr was significantly immunocompromised. As a result he developed osteomyelitis of the jaw, which responded favorably to the prescribed antibiotic therapy." Orr, MDL No. 3:06-MD-1760, 3:07-cv-00472, ECF No. 37-3 at 9. The record reflects that Dr. Nalini Rao, an infectious disease specialist, diagnosed Mr. Orr with "acute and chronic osteomyelitis." 2:12-cv-01715-MRH, ECF No. 8-25 at 44. NPC may choose to offer Dr. Rao as an expert to testify about his diagnosis, but it cannot transmogrify Dr. Mega's testimony into an admissible expert opinion on Mr. Orr's dental condition by offering the diagnosis or other medical opinions of Dr. Rao or any other physician through Dr. Mega. See Hartle v. FirstEnergy Generation Corp., 2014 WL 1235826, at *6 (W.D.Pa. Mar. 25, 2014) (while an expert may rely on other experts, he may not be the mouthpiece of the medical opinions of an expert in a different specialty). The Court will accordingly grant Mrs. Orr's motion to exclude any expert testimony from Dr. Mega on the subject of Mr. Orr's dental condition.
For the reasons stated in this Opinion, the Court will:
An appropriate Order will follow.