MALACHY E. MANNION, District Judge.
Pending before the court is defendant Novartis Pharmaceuticals Corporation's ("NPC") motion to exclude the specific causation testimony of plaintiff's non-retained experts Drs. Patrick Adonizio, Timothy Atkinson, James Specter, Samuel A. Falcone, James R. Bruno, Witold B. Rybka, Mary Lou Decker, and Arthur Meyer, and of retained experts Drs. Robert Marx and Diane Stern. (Doc.
Throughout the country, cancer patients who have been treated with two of NPC's drugs, and who have afterwards developed osteonecrosis of the jaw, a debilitating and painful disease in which the jaw bone becomes exposed, have sued in product liability actions. Plaintiff John Bartoli is one of these patients. NPC is challenging the ability of Mr. Bartoli's treating physicians and medical experts to opine about whether his ONJ was caused by NPC's drugs.
Aredia® and Zometa® are two FDA-approved drugs, called intravenous bisphosphonates ("BP"), manufactured by Novartis. The drugs are administered for treatment of advanced cancers which affect the bones. Plaintiff John Bartoli was treated with Aredia® and Zometa® for multiple myeloma.
This case is a pharmaceutical products liability action in which the plaintiff brings claims for strict products liability, negligence, and breach of warranty. (Doc.
The admissibility of expert testimony is governed by Federal Rule of Evidence 702, which requires an expert witness to have "specialized knowledge" regarding the area of testimony. The Third Circuit has explained, "The basis of this specialized knowledge can be practical experience as well as academic training and credentials," and "[w]e have interpreted the specialized knowledge requirement liberally."
When faced with a proffer of expert testimony, the court must determine "whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue."
In performing its gatekeeping function to determine whether an expert's report is relevant and reliable under Daubert and Rule 702, "the court is not to weigh the evidence relied upon or determine whether it agrees with the conclusions reached therein.... Determinations regarding the weight to be accorded, and the sufficiency of, the evidence relied upon by the proffered expert are within the sole province of the jury."
As to the particulars of causation and diagnosis at issue in this motion, "performance of physical examinations, taking of medical histories, and employment of reliable laboratory tests all provide significant evidence of a reliable differential diagnosis," and "their absence makes it much less likely that a differential diagnosis is reliable."
Plaintiff indicates that he will not seek case-specific causation testimony from Drs. Adonizio, Bruno, Decker, Falcone, Rybka, and Specter, and withdraws his designation of those doctors as experts on causation. (Doc.
Dr. Atkinson was designated by plaintiff as a non-retained expert witness in this case. Dr. Atkinson is an oral and maxillofacial surgeon licensed to practice in Pennsylvania. He began to treat plaintiff in July of 2005, and was the primary doctor treating his ONJ. Defendant argues that Dr. Atkinson is not an expert on ONJ, and that his deposition testimony reflects that while he was under the working impression that BPs caused Mr. Bartoli's ONJ, he did not rule out other possible causes of ONJ.
Plaintiff argues that Dr. Atkinson did testify to doing a differential diagnosis. However, this argument lacks merit. Dr. Atkinson did testify that he performed a differential diagnosis as to what the nature of Mr. Bartoli's jaw issue was, determining that it was ONJ. But he did not do a differential diagnosis as to the cause of the ONJ. Indeed, he did not even come to a definitive opinion of what caused the ONJ. He specifically stated "no" upon being asked "you didn't in Mr. Bartoli's case determine the underlying cause of the jaw problem?" (Doc.
Dr. Atkinson's deposition as a whole does not reflect that he came to any certain conclusions about the cause of Mr. Bartoli's ONJ. Rather it reflects that he was treating Mr. Bartoli's ONJ symptoms and performing procedures to help with the ONJ regardless of the genesis of the problem. Indeed, his lawyer and Mr. Bartoli's lawyer both objected at his deposition on the grounds that he was being asked expert questions and that he was not an expert.
Although Dr. Atkinson did come to a "working impression" that plaintiff was suffering from ONJ caused by BP treatment, plaintiff has failed to evince that Dr. Atkinson arrived at this conclusion through a reliable methodology such as a differential diagnosis. Accordingly, because he lacks a clear opinion about causation, and moreover because there has been no showing made that even his working impression regarding causation was arrived at through a reliable methodology, Dr. Atkinson may not testify as to specific causation in this case.
Dr. Meyer was also designated as a non-retained expert witness in the case. He is Mr. Bartoli's oncologist who has treated his multiple myeloma since 2000. He prescribed the BP drugs to plaintiff. Defendant argues that Dr. Meyer is not an expert in ONJ, and that he did not perform a differential diagnosis in coming to the conclusion that Mr. Bartoli's ONJ was caused by exposure to the BP drugs.
The court disagrees. While Dr. Meyer does state that he is not an expert in ONJ, that fact is not dispositive. As plaintiff reasonably points out, a doctor cannot be expected to be an "expert" in every disease, adverse medication side effect, or complication that his patients may ever experience. See
Defendant argues, citing Dr. Meyer's deposition, that he failed to rule out "actinomyces (a type of infection), osteomyelitis (another type of infection), herpes zoster (shingles), chemotherapy, steroids, anemia, and osteoporosis." But that is a forced reading of his testimony. He was asked about each of these possible causes, and responded with either a reason for ruling it out, or, for instance, in the case of the shingles, incredulity that he was even being asked because there was no reason to think it has anything to do with ONJ. (Doc.
Defendant finally argues that Dr. Meyer did not rule out the presence of multiple myeloma in plaintiff's jaw as the cause of the ONJ, and that he was unsure whether the myeloma or the ONJ appeared in the jawbone first. But he did explain why he considered that ONJ was the cause even while myeloma was present. (Doc.
Dr. Marx is a retained litigation-wide expert in the ongoing Aredia® and Zometa® cases around the country. He is a board-certified oral and maxillofacial surgeon at the University of Miami School of Medicine. He is involved in research concerning bisphosphonates and osteonecrosis of the jaw and was one of first doctors to allege a connection between BPs and ONJ.
Defendant argues that Dr. Marx may not testify as to specific causation in this case because he failed to rule out multiple myeloma as a cause of Mr. Bartoli's ONJ. Defendant also relies heavily on
Here, Dr. Marx reviewed extensive medical and dental records of Mr. Bartoli. He determined that the exposed bone in Mr. Bartoli's jaw, and its resistance to intense treatment such as antibiotics, hyperbaric oxygen treatment, and surgical debridements,
Dr. Stern is a retained expert in this litigation. She is an oral pathologist. She has held teaching positions at several medical schools. Unlike Dr. Marx, Dr. Stern's ability to testify as to specific causation has not been widely litigated in these proceedings throughout the country. Defendant objects to her opinion that the diagnosis of cancer in Mr. Bartoli's was incorrect because she did not look at the underlying slides, but only at the pathology report which found that Mr. Bartoli had cancer in his mouth.
Dr. Stern disputes the pathology report because the cancer in the jaw Mr. Bartoli was diagnosed with is "characterized by the proliferation of a single clone of cells," while the report shows that the cells in question are "polyclonal i.e. that these plasma cells did not develop from a single clone." (Case No. 3:06-0371, M.D. Tenn., Document 45-5). Dr. Stern thus believes that the cancer Mr. Bartoli was diagnosed with was not in fact present, and therefore not a possible cause of plaintiff's ONJ. Defendant argues that the cancer in question can appear in a polyclonal form. This dispute is not for the court to decide. Defendants can, of course, ask Dr. Stern about whether she looked at the underlying slides and whether that would have been a better method of reviewing the case, and can question her as to the scientific validity of her opinion regarding the existence of polyclonal multiple myeloma and the literature that indicates that it exists. But defendant's objections all go to the strength of her conclusion, not its admissibility. Dr. Stern may testify as to specific causation.
For the foregoing reasons, defendant's motion to exclude specific causation testimony, (Doc.