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Woniewala v. Merck & Co., Inc.

United States District Court, E.D. Pennsylvania

September 13, 2017

SAMUEL WONIEWALA, Plaintiff,
v.
MERCK & CO., INC., Defendants.

          OPINION

          Slomsky, J.

         I. INTRODUCTION

         In this action, Plaintiff Samuel Woniewala claims that MiraLAX®, an over-the-counter laxative, failed to warn the medical community about the risks associated with the product, which allegedly caused him to develop oxalate nephropathy, an acute renal injury characterized by calcium oxalate deposits in the kidneys. (Doc. Nos. 49 at ¶ 7; 74 at 8.) As a result of this injury, Plaintiff will require continued treatment and potentially a kidney transplant. (Doc. No. 74 at 8.) To support these claims, he seeks to admit the testimony of two causation experts: his nephrologist and a renal pathologist. A nephrologist is a physician who specializes in kidney function and a renal pathologist is a physician who studies the development of disease in the kidneys.

         Defendants move to preclude the testimony of these witnesses, relying on Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993), and Fed.R.Evid. 702 (Testimony By Expert Witness) (Doc. Nos. 67 and 76.) On May 10, 2017, the Court held a hearing on Defendants' Motion to Exclude Plaintiff's Causation Experts. For reasons that follow, the Court finds that Plaintiff's Causation Experts are qualified to testify in this case and that they have opinions which are the result of reliable methodologies. Accordingly, Defendants' Motion to Exclude Plaintiff's Causation Experts (Doc. No. 67) will be denied.

         II. FACTUAL BACKGROUND

         Plaintiff has lived with stable, Stage III chronic kidney disease for roughly thirteen years. (Doc. Nos. 49 at 4; 74 at 7.) His disease was managed by his primary care physician, Dr. Karen Bowles, M.D. and in later years, by a nephrologist, Dr. Michael Rudnick, M.D.. (Doc. No. 74 at 7.) By July 10, 2009, his disease was also being monitored by another nephrologist at the Hospital of the University of Pennsylvania. (Doc. No. 49 at 5.)

         Sometime in 2009, Plaintiff experienced problems with chronic constipation. (Id. at 4.) Both his primary care physician, Dr. Bowles, and his nephrologist, Dr. Rudnick, prescribed MiraLAX®-an over-the-counter laxative-to treat Plaintiff's constipation. (Id. at 4-5.) From 2009 until May 2013, Plaintiff continued using MiraLAX®, as his doctors advised. (Id. at 4-8.) On May 6, 2013, he was hospitalized with an acute kidney injury. (Id. at 7.) In June 2013, a renal biopsy revealed that Plaintiff had developed oxalate nephropathy. (Id.) Oxalate nephropathy is a condition in which calcium oxalate crystals are deposited in the kidneys, causing injury. (Doc. No. 67-1 at 9.)

         Plaintiff initiated this action alleging claims of negligence, strict product liability, and breach of express and implied warranties arising from his use of the laxative MiraLAX®. (Doc. No. 1-1.) In support of his claims, Plaintiff will offer at trial the expert testimony of his treating nephrologist Dr. Michael Rudnick, M.D., renal pathologist Dr. Glen Markowitz, M.D., and toxicologist Dr. Lawrence H. Lash, Ph.D.[1] (Doc. No. 74 at 6.) Both Dr. Rudnick and Dr. Markowitz opine that Plaintiff developed oxalate nephropathy as a result of his use of MiraLAX®. (Id.) The active ingredient in MiraLAX® is a form of polyethylene glycol with a molecular weight of 3350, referred to as PEG-3350. (Doc. No. 67-1 at 9.) Plaintiff claims that there is a “clear relationship between polyethylene glycol and the deposit of calcium oxalate in the kidneys” (Doc. No. 80 at 30:10-13) and submits that Dr. Rudnick and Dr. Markowitz will support these claims. The focal point of the overarching case, therefore, is whether MiraLAX®'s active ingredient, PEG-3350, caused Plaintiff's acute kidney injury.

         As noted, Defendants move to preclude the testimony of the proffered experts, Dr. Rudnick and Dr. Markowitz. (Doc. No. 67.) Defendants argue that Dr. Rudnick: (1) is not qualified to offer a “biological plausibility” opinion or a specific causation opinion, and (2) did not use reliable methodology in forming his opinions. (Doc. No. 67-1 at 13-28.) Similarly, Defendants argue that Dr. Markowitz: (1) is not qualified to offer a specific causation opinion, and (2) did not use reliable methodology in forming his opinions. (Id. at 28-34.) Relying upon Feit v. Great West Life & Annuity Ins. Co., 271 F. App'x 246, 254 (3d Cir. 2008), insofar as reliable methodology is concerned, Defendants claim that the experts improperly employed differential diagnosis[2] as a methodology because they did not consider all possible causes of Plaintiff's oxalate nephropathy and then rule out through the process of elimination all possible causes, leaving the remaining potential cause as the most likely cause. Defendants also challenge the fact that Dr. Markowitz relied on Dr. Rudnick's report without ever having met Plaintiff and merely formulated a “piggybacked opinion.” (Doc. No. 67-1 at 34.)

         A. Dr. Michael Rudnick's Report

         Dr. Michael Rudnick is Plaintiff's treating nephrologist. His expert report essentially is comprised of knowledge of his own treatment and medical records of Plaintiff. In order to prepare his expert report, [3] Dr. Rudnick also reviewed the following materials:

1. Medical Records of Michael Rudnick, M.D.
2. Medical Records of Karen Bowles, M.D.
3. Admission records at Mercy Hospital 5/6/13
4. Admission records at the Hospital of the University of Pennsylvania 5/13/13
5. Deposition of Dr. Sanjeev Sethi
6. Deposition of Samuel Woniewala
7. Deposition of Karen Bowles

(Doc. No. 67-9 at 1.)

         Dr. Rudnick led a team of physicians to uncover the cause of and treat Plaintiff's acute kidney injury. (Doc. No. 74 at 7.) He ordered the biopsy of Plaintiff's kidney, which was sent to the Mayo Clinic in Rochester, Minnesota. (Id. at 8.) There, Dr. Sanjeev Sethi, the renal pathologist at the Mayo Clinic, discovered the oxalate nephropathy and disclosed his findings to Dr. Rudnick. (Id.)

         Based upon the above information, Dr. Rudnick concluded that Plaintiff's kidney injury was due to oxalate nephropathy resulting from his ingestion of MiraLAX®.

         B. Dr. Glen Markowitz's Report

         Dr. Glen Markowitz is a renal pathologist and a professor of pathology and cell biology at Columbia University's College of Physicians and Surgeons. (Doc. No. 74-3.) Dr. Markowitz has given lectures and has written extensively on the pathology of drug-induced renal injury. (Id.)

         In order to prepare his expert report, [4] Dr. Markowitz reviewed the following materials:

1. Deposition transcript, Dr. Sanjeev Sethi
2. Deposition transcript, Samuel Woniewala
3. Expert report of treating nephrologist, Dr. Michael ...

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