WONIEWALA v. MERCK & CO., INC. et al
MEMORANDUM AND/OR OPINION. SIGNED BY HONORABLE JOEL H. SLOMSKY ON 8/7/2017. 8/8/2017 ENTERED AND COPIES E-MAILED.(sg, )
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
MERCK & CO., INC., et al.,
August 7, 2017
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. 1 (Doc. No. 49 at ¶ 7.) The
MiraLAX® label cautions against using the product if a patient, like Plaintiff, has kidney
disease, unless it is under the advisement and supervision of a physician. (Doc. No. 71-7 at 3.)
Defendants have filed a Motion for Partial Summary Judgment on the claims of failureto-warn, express warranty, and strict liability design defect. (Doc. No. 71.) Plaintiff has filed a
Response in Opposition (Doc. No. 73), and Defendants have filed a Reply. (Doc. No. 75.) The
Motion is now ripe for decision. For reasons that follow, the Motion for Partial Summary
Judgment (Doc. No. 71) will be denied without prejudice.
Oxalate nephropathy is an acute renal injury, a form of serious kidney damage, characterized
by deposits of ethylene glycol in the kidneys. (Doc. No. 49 at ¶¶ 7, 74, 79(c).)
Plaintiff Samuel Woniewala was diagnosed with Stage III chronic kidney disease. (Doc.
No. 49 at ¶ 22.) Back in 2009, Plaintiff experienced problems with constipation. (Id. at ¶ 23.)
On March 23, 2009, Plaintiff’s primary care physician, Dr. Karen Bowles, M.D., prescribed
MiraLAX® to treat the constipation. (Doc. No. 71-2 at ¶ 10.)
MiraLAX® is a laxative
containing polyethylene glycol 3350 (“PEG 3350”), which increases water in the colon to cause
bowel movements and unblock constipation. (Doc. No. 71-1 at 3.)
A. MiraLAX® Federal Drug Administration Approval and Label
In February 1999, the Federal Drug Administration (“FDA”) approved MiraLAX®’s
original application to be sold by prescription only. (Id. at 8.) In October 2006, the FDA
approved MiraLAX® to be sold over-the-counter. (Id. at 9.) MiraLAX® is used to treat
occasional constipation in adults. (Doc. No. 71-2 at ¶ 11.) The directions on the label instruct
the patient to dissolve 17 grams of powder in a beverage, and drink it once a day for no more
than seven days. (Doc. No. 71-7 at 3.) Additionally, MiraLAX®’s label advises patients with
kidney disease to take the laxative under medical supervision. (Id.) The label at issue provides
in full as follows:
Drug Facts (continued)
Active ingredient (in each dose)
Polyethylene Glycol 3350, 17 g………..Laxative
If pregnant or breast-feeding, ask a health
professional before use.
Keep out of reach of children. In case of
overdose, get medical help or contact a Poison
Control Center right away.
relieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to
do not take more than directed unless
advised by your doctor
adults and children 17 years of age and older:
stir and dissolve one packet of powder
(17 g) in any 4 to 8 ounces of beverage
(cold, hot or room temperature) then
use once a day
use no more than 7 days
children 16 years of age or under: ask a doctor
Allergy alert: Do no use if you are allergic to
Store at 20º - 25ºC(68º - 77ºF)
Tamper-Evident: Do not use if foil is open
Do not use if you have kidney disease, except Inactive ingredients none
under the advice and supervision of a doctor
Ask a doctor before use if you have
Questions or comments?
nausea, vomiting or abdominal pain
a sudden change in bowel habits that lasts
over 2 weeks
irritable bowel syndrome
Ask a doctor or pharmacist before use if you are
taking a prescription drug
When using this product you may have loose,
watery, more frequent stools
Stop use and ask a doctor if
you have rectal bleeding or your nausea,
bloating, cramping or abdominal pain gets
worse. These may be signs of a serious
you get diarrhea
you need to use a laxative for longer than 1
B. Plaintiff’s MiraLAX® Usage
Plaintiff took MiraLAX® every day from March 2009 until May 2013. (Doc. No. 71-11
at 2-3; Doc. No. 71-8 at 6:18-7:23.) As noted, in 2009, Plaintiff experienced problems with
constipation. (Doc. No. 49 at ¶ 23.) His primary care physician, Dr. Bowles, who was aware of
his history of chronic kidney disease and was monitoring his creatinine levels2, prescribed the
use of over-the-counter MiraLax® to treat Plaintiff’s constipation. (Id.) On July 10, 2009,
Plaintiff’s creatinine level was 1.47 mg/dl3 compared to a normal value level of 0.5 to 1.3 mg/dl.
(Id. at ¶ 24.) Both his primary care physician, and his nephrologist, Dr. Michael Rudnik,
continued to prescribe and recommend MiraLAX® to be taken as needed for Plaintiff’s chronic
constipation. (Id. at ¶ 26.) Plaintiff continued to use MiraLAX® at the advice of, and under the
supervision of, his physicians. (Id.) Throughout 2010, Plaintiff’s doctors tested and documented
his creatinine levels, which ranged between 1.31 to 1.81 mg/dl. (Id. at ¶ 28.)
In 2011, Plaintiff continued to experience problems with constipation, and his
nephrologist continued to prescribe over-the-counter MiraLAX® to treat this condition. (Id. at ¶
29.) The MiraLAX® label instructs adults to fill the bottle cap to the indicated line, which
measures to 17 grams of powder, dissolve the powder in four to eight ounces of liquid, and drink
the mixture once a day. From 2009 until approximately December 2012, Plaintiff ingested one
capful of MiraLAX® daily. (Doc. No. 71-8 at 6:18-7:2.) From December 2012 until May 2013,
“Creatinine is a waste product in your blood that comes from muscle activity. It is normally
removed from your blood by your kidneys, but when kidney function slows down, the
creatinine level rises.” (Doc. No. 73 at 3 n.3 (citing National Kidney Foundation Website at
www.kidney.org/atoz/content/understanding-your-lab-values).) “Generally, a high creatinine
level means that your kidneys aren’t working well.” Creatinine test, MAYO FOUNDATION FOR
MEDICAL EDUCATION AND RESEARCH (Jan. 27, 2016), http://www.mayoclinic.org/testsprocedures/creatinine-test/details/results/rsc-20179431.
“mg/dl” is an abbreviation for milligrams per deciliter.
his physician increased his daily dosage to one and one-half to two capfuls of MiraLAX®. (Id.
“Beginning in February 2013, Plaintiff noted some left-sided abdominal flank pain,” and
on March 15, 2013, he told his primary care physician about the pain. (Id. at ¶ 38.) On May 6,
2013, Plaintiff was admitted to Mercy Hospital in Philadelphia, Pennsylvania, complaining of
various symptoms, including nausea and abdominal pain. (Id. at ¶ 39.) When Plaintiff was
admitted to the hospital, his creatinine level was measured at 8.3 mg/dl, which is about eight
times the normally accepted level. (Id. at ¶ 40.)
On May 13, 2013, Plaintiff was transferred to the Hospital of the University of
Pennsylvania. (Id. at ¶ 41.) There, Plaintiff’s creatinine level at admission was 7.68 mg/dl. (Id.
at ¶ 42.) Plaintiff was diagnosed with an acute kidney injury, and the doctors noted during his
admission that he had been taking MiraLAX® daily to treat his chronic constipation. (Id. at ¶
43.) Plaintiff continued to experience constipation while an inpatient at the Hospital of the
University of Pennsylvania. (Id. at ¶ 44.) During that time, the hospital continued to prescribe
MiraLAX® and administer the laxative to him to treat his continuing constipation. (Id.) In June
2013, a renal biopsy was performed, and the specimens were submitted to the Mayo Clinic for
examination. (Id. at ¶ 46.) The Mayo Clinic reported that the specimens confirmed the presence
of oxalate nephropathy.4 (Id. at ¶ 47.)
C. Procedural History
Plaintiff Samuel Woniewala initiated this suit in state court, alleging negligence, strict
product liability, and breach of express and implied warranties in connection with his use of
As noted, oxalate nephropathy is an acute renal injury, a form of serious kidney damage,
characterized by deposits of ethylene glycol in the kidneys. (Doc. No. 49 at ¶¶ 7, 74, 79(c).)
MiraLAX®. (Doc. No. 1-1.) Defendants removed the action to this Court from the Court of
Common Pleas of Philadelphia County. (Doc. No. 1.)
The parties thereafter proceeded to discovery. On February 8, 2016, at the request of the
parties, discovery was bifurcated—or split—into two phases. (Doc. No. 58.) “Phase I” was
limited to the issue of proof of injury and medical causation.5 (Id. at ¶ 1.) “Phase II” will
address liability issues including pre-emption, adequacy of the warning, breach of warranty, and
design and manufacturing defects. (Id.) To date, the parties have not yet entered “Phase II” of
the discovery plan. (See Doc. No. 80 at 45:19-47:2.)
On February 13, 2017, Defendants filed a Motion for Partial Summary Judgment on
Plaintiff’s failure-to-warn, express warranty, and strict liability design defect claims. (Doc. No.
71.) On February 23, 2017, Plaintiff filed a Response in Opposition. (Doc. No. 73.) On March
2, 2017, Defendants filed a Reply. (Doc. No. 75.)
STANDARD OF REVIEW
Granting summary judgment is an extraordinary remedy.
Summary judgment is
appropriate “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.” Fed. R. Civ. P. 56(a). In reaching this
decision, the court must determine whether “the pleadings, depositions, answers to
interrogatories, admissions, and affidavits show there is no genuine issue of material fact and that
the moving party is entitled to judgment as a matter of law.” Favata v. Seidel, 511 F. App’x 155,
158 (3d Cir. 2013) (quoting Azur v. Chase Bank, USA, Nat’l Ass’n, 601 F.3d 212, 216 (3d Cir.
2010) (quotation omitted)). A disputed issue is “genuine” only if there is a sufficient evidentiary
basis on which a reasonable jury could find for the non-moving party. Kaucher v. Cnty. of
The parties agreed that “[m]edical causation is the threshold issue in this case.” (Doc. No. 55
at 1.) At oral argument, the parties explained that the “Phase I” question is therefore “Did the
drug cause the harm?” (Doc. No. 80 at 7:5-6.)
Bucks, 455 F.3d 418, 423 (3d Cir. 2006) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
248 (1986)). For a fact to be considered “material,” it “must have the potential to alter the
outcome of the case.” Favata, 511 F. App’x at 158. Once the proponent of summary judgment
“points to evidence demonstrating no issue of material fact exists, the non-moving party has the
duty to set forth specific facts showing that a genuine issue of material fact exists and that a
reasonable factfinder could rule in its favor.” Id. (quoting Azur, 601 F.3d at 216 (internal
quotation marks omitted)).
In deciding a motion for summary judgment, “[t]he evidence of the nonmovant is to be
believed, and all justifiable inferences are to be drawn in his favor.” Id. (quoting Chambers ex
rel. Chambers v. Sch. Dist. of Philadelphia Bd. of Educ., 587 F.3d 176, 181 (3d Cir. 2009)
(quotation omitted)). The Court’s task is not to resolve disputed issues of fact, but to determine
whether there exist any factual issues to be tried. Anderson, 477 U.S. at 247-49. Whenever a
factual issue arises which cannot be resolved without a credibility determination, at this stage the
Court must credit the non-moving party’s evidence over that presented by the moving party. Id.
at 255. If there is no factual issue, and if only one reasonable conclusion could arise from the
record regarding the potential outcome under the governing law, summary judgment must be
awarded in favor of the moving party. Id. at 250.
Defendants contend that partial summary judgment is warranted on Plaintiff’s design
defect claims, which include failure to warn, express warranty, and strict liability claims. (Doc.
No. 71-1.) In particular, Defendants argue that Plaintiff cannot satisfy his burden of proving that
any alleged inadequacy of MiraLAX®’s warnings proximately caused his injuries because
Plaintiff admitted he never read the MiraLAX® label. (Id. at 9.) Additionally, Defendants argue
that Plaintiff’s express warranty claim fails because no express warranty was a “benefit of the
bargain” when Plaintiff purchased MiraLAX®. (Id. at 12.) Finally, Defendants argue that
Plaintiff’s design defect and warranty claims are preempted by federal law. (Id. at 13.)
In contrast, Plaintiff contends that the Motion for Partial Summary Judgment is
premature. (Doc No. 73.) Specifically, Plaintiff argues that the parties have not completed the
necessary discovery on these claims to determine whether a genuine issue of material fact exists.
(Id. at 6.) Plaintiff proffers that any decision on the Motion should be deferred until the
conclusion of the next phase of the litigation, since “Phase I” is limited to “the issue of medical
causation.” (Id.) The court agrees with Plaintiff.
Defendants’ Motion for Partial Summary Judgment is premature in “Phase I” because the
parties stipulated to a bifurcated discovery plan that included two phases. (See Doc. No. 55-1 at
1.) Pursuant to a scheduling order, “Phase I” is “limited to only the issue of proof of injury and
medical causation.” (Doc. No. 58 at ¶ 1.) Under Federal Rule of Civil Procedure 29, parties
may agree to separate discovery into phases. Rule 29 allows for stipulations about discovery
Unless the court orders otherwise, the parties may stipulate that: (a) a deposition
may be taken before any person, at any time or place, on any notice, and in the
manner specified—in which event it may be used in the same way as any other
deposition; and (b) other procedures governing or limiting discovery be
modified—but a stipulation extending the time for any form of discovery must
have court approval if it would interfere with the time set for completing
discovery, for hearing a motion, or for trial.
Fed. R. Civ. P. 29.
Here, the parties previously agreed to bifurcate discovery to promote judicial economy.
(Doc. No. 55-1 at 1.) In the Joint Rule 26(f) Report, the parties represented as follows:
The Parties propose that discovery in this case shall proceed in two distinct
phases. Discovery in Phase 1 would address whether Mr. Woniewala had oxalate
nephropathy and, if so, whether the laxative drug, MiraLax®, caused the disease.
Phase 1 would consist of fact and expert discovery, followed by potentially
dispositive and Daubert motions, all limited to the issue of proof of injury and
medical causation. Assuming the case cannot be resolved at the conclusion of
Phase 1, the case would proceed to Phase 2, followed by trial if necessary.
Discovery in Phase 2 would cover issues of liability, including negligence and
proximate cause. While there may be some degree of minor overlap in the issues
pertaining to liability and causation, the parties believe that bifurcation of this
case will promote judicial economy. Irrespective of the outcome of “Phase 1”, all
parties agree that resolving the causation issues prior to the liability issues will
likely expedite resolution of the case.
(Id. (emphasis added).)
At this stage, the parties should adhere to the stipulated bifurcated schedule of discovery.
“The rule in this circuit since 1972 has been that the decision to bifurcate vel non is a matter to
be decided on a case-by-case basis and must be subject to an informed discretion by the trial
judge in each instance.” Lis v. Robert Packer Hosp., 579 F.2d 819, 824 (3d Cir. 1978) (citing
Idzojtic v. Pennsylvania Railroad Co., 456 F.2d 1228, 1230 (3d Cir. 1971)).
“Phase I” of discovery is limited to the issue of proof of injury and medical causation.
(Doc. No. 56.) Pursuant to the Court’s Order “Phase II” will address liability issues including
pre-emption, adequacy of the warning, proximate cause, design and manufacturing defects, and
breach of warranty. (Doc. No. 58.) Plaintiff will be afforded the opportunity to take discovery
and produce expert reports in support of his causation claims. (Doc. No. 73 at 2.)
The instant Motion would be more appropriate when the record is fully developed at the
conclusion of “Phase II” of discovery because “Phase II” will address the adequacy of the
warning, design and manufacturing defects, and breach of warranty. Therefore, the Motion for
Partial Summary Judgment (Doc. No. 71) will be denied without prejudice.
For the foregoing reasons, Defendants’ Motion for Partial Summary Judgment (Doc. No.
71) will be denied without prejudice. An appropriate Order follows.
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