Earp et al v. Novartis Pharmaceuticals Corporation

Filing 100

ORDER: The court DENIES Plaintiffs' 55 Motion to Amend the Complaint, DENIES IN PART Defendant's 66 , 68 , 70 , 72 , 74 , 76 Motions to Exclude Expert Testimony, DENIES as moot 84 Plaintiffs' Cross-Motion regarding the moti on to exclude, and GRANTS IN PART AND DENIES IN PART 78 Defendant's Motion for Summary Judgment. The parties shall schedule and complete mediation no later than November 15, 2013. Signed by Chief Judge James C. Dever III on 9/11/2013. (Sawyer, D.)

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF NORTH CAROLINA
WESTERN DIVISION
No. 5:11-CV-680-D
JIMMY EARP and PATRICIA EARP,

Plaintiffs,

v.
NOVARTIS PHARMACEUTICALS
CORPORATION,
Defendant.

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ORDER

On September 1, 2006, Jimmy Earp ("Earp") and Patricia Earp (collectively, "plaintiffs") and
others filed a complaint alleging various claims against Novartis Pharmaceuticals Corporation
(''Novartis" or "defendant") arising from osteonecrosis of the jaw ("ONJ") allegedly caused by use
of Aredia and Zometa, two prescription bisphosphonate medications that Novartis produced and
sold. Ea.r;p v. Novartis Pharm. Corp., No. 5:06-CV-350-D, [D.E. 1] (E.D.N.C. Sept. 1, 2006). The
action was transferred to the United States District Court for the Middle District of Tennessee for
Multi-District Litigation ("MDL") proceedings. See id., [D.E. 11-12] (E.D.N.C. Nov. 6, 2006);
In re Aredia & Zometa Prods. Liab. Litig., No. 3:06-md-1760 (M.D. Tenn.). After discovery

proceedings and severance of the Earps' case, the MDL court transferred the case back to this court
for further proceedings, including (if needed) a trial [D.E. 44]. On November 19, 2012, the court
entered a scheduling order for pretrial motions [D.E. 60].
On November 8, 2012, plaintiffs moved to amend the complaint and filed a supporting
memorandum and exhibit [D.E. 55-56]. On December 3, 2012, Novartis responded in opposition
[D.E. 64]. On December 20, 2012, Novartis moved to exclude certain expert testimony as either

irrelevant or unreliable pursuant to Daubert v. Merrel Dow Pharm.. Inc., 509 U.S. 579 (1993). See
[D.E. 66, 68, 70, 72, 74, 76]. On January 22,2013, plaintiffs responded in opposition to the motions
to exclude expert testimony [D.E. 80, 82-83] and filed a cross motion seeking to collaterally estop
defendant's motions to exclude [D.E. 84]. Novartis replied on February 4, 2013 [D.E. 85-90] and
responded to plantiffs' estoppel request on February 15, 2013 [D.E. 93]. On December 20, 2012,
Novartis moved for summary judgment [D.E. 78] and filed a supporting memorandum and exhibits
[D.E. 79]. Plaintiffs responded in opposition [D.E. 81], and Novartis replied [D.E. 91]. As
explained below, the court denies plaintiffs' motion to amend, denies defendant's Daubert motions,
and grants in part and denies in part defendant's motion for summary judgment.
I.
As for plaintiffs' motion to amend the complaint, plaintiffs filed the motion on November
8, 2012, approximately 21 months after the close of fact discovery and 18 months after the deadline
for filing dispositive motions. See Scheduling Order [D.E. 27] 4. The scheduling order did not set
a deadline for filing amended pleadings. See id.
The court should freely give leave to amend ''when justice so requires." Fed. R. Civ. P.
15(a)(2). However, when a party seeks to amend a complaint after the date set forth in a scheduling
order for such motions, the party must establish good cause under Rule 16. See Nourison Rug Corp.
v. Parvizian, 535 F.3d 295, 298-99 (4th Cir. 2008); see Fed. R. Civ. P. 16(b)(4). Although the
scheduling order did not set a deadline for filing amended pleadings, the deadline for filing
dispositive motions necessarily implied a deadline for amended pleadings. After all, any new
pleadings would require the court to amend the scheduling order to allow Novartis to file responsive
dispositive motions and to conduct any necessary discovery. Thus, plaintiffs must meet the good
cause standard of Rule 16.
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Plaintiffs seek to add a claim under North Carolina,s Unfair and Deceptive Trade Practices
Act ("UDTPA,,), N.C. Gen. Stat.§ 75-1. Plaintiffs offer no explanation for the late addition of the
claim one and a half years after the deadline for dispositive motions even though the proposed new
claim allegedly is "based completely on previously plead[ed] and discovered facts.,, Pis., Mem.
Supp. Mot. Amend [D.E. 56] 2.
Plaintiffs have failed to show good cause under Ru1e 16. See Nourison Rug Com., 535 F.3d
at 298-99. Moreover, adding the UDTPA claim wou1d prejudice Novartis and further delay the case.
Thus, even if the court applied only Ru1e 15, the court wou1d still deny the motion due to prejudice.
See id. at 298 (describing Ru1e 15 standard). Accordingly, the court denies the motion to amend.

II.
Novartis has filed a number ofmotions seeking to exclude the testimony of plaintiffs, experts
under Daubert and Federal Ru1e of Evidence 702. Specifically, Novartis filed motions to exclude
( 1) testimony of Dr. Robert Marx regarding causation, Novartis' s state ofmind, N ovartis' s operation
of clinical trials, and the efficacy of certain dental treatments [D .E. 66]; (2) testimony of plaintiffs'
regulatory expert Dr. Suzanne Parisian [D.E. 68]; (3) testimony ofDr. Keith Skubitz about ONJ, the
drafting and approval of Aredia and Zometa labels, FDA dosing information, and the efficacy of
preventative dentistry for patients using Aredia and Zometa [D.E. 70]; (4) testimony of Dr. James
Vogel [D.E. 72]; (5) testimony regarding specific causation of plaintiff Earp's ONJ by retained
expert Dr. Frederick Nance and plaintiff Earp's treating physicians Dr. George Blakey, Dr. Mark
Yoffe, Dr. Alan Kritz, Dr. Daniel Petrocella, and Dr. Steven Davis [D.E. 74]; and (6) general
causation testimony of Dr. Wayne Ray [D.E. 76].
Ru1e 702 provides:
A witness who is qualified as an expert by knowledge, skill, experience, training, or

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education may testifY in the form of an opinion or otherwise if:
(a) the expert's scientific, technical, or other specialized knowledge will help
the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts of
the case.
Fed. R. Evid. 702. Daubert clarifies that Ru1e 702 "assign[s] to the trial judge the task of ensuring
that an expert's testimony both rests on a reliable foundation and is relevant to the task at hand." 509
U.S. at 597. The court recognizes that "Ru1e 702 was intended to liberalize the introduction of
relevant expert evidence," but that "expert witnesses have the potential to be both powerful and quite
misleading." Cooper v. Smith & Nephew. Inc., 259 F.3d 194, 199 (4th Cir. 2001) (quotation
omitted).
The proponent of the expert testimony bears the burden of establishing its admissibility by
a preponderance of the evidence. ld. A district court has broad latitude in determining whether to
admit proposed expert testimony. United States v. Gastiaburo, 16 F.3d 582, 589 (4th Cir. 1994).
Courts have distilled Ru1e 702' s requirements in two crucial inquiries: whether the proposed
experttestimonyisrelevantand whetheritisreliable. Kumho Tire Co. v. Carmichael, 526 U.S. 137,
141 (1999); Daubert, 509 U.S. at 589; United States v. Forrest, 429 F.3d 73, 80 (4th Cir. 2005). To
be relevant, the proposed expert testimony must be helpful to the trier of fact. See Daubert, 509 U.S.
at 591-92. "Testimony from an expert is presumed to be helpful unless it concerns matters within
the everyday knowledge and experience of a lay juror." Kopf v. Sk;ynn, 993 F .2d 3 74, 377 (4th Cir.
1993); accord Koger v. Norfolk S. Ry. Co., No. 1:08-0909,2010 WL 692842, at *1 (S.D. W.Va.
Feb. 23, 2010) (unpublished).
"[T]he test of reliability is flexible and the law grants a district court the same broad latitude
when it decides how to determine reliability as it enjoys in respect to its u1timate reliability
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determination." United States v. Wilson, 484 F.3d 267,274 (4th Cir. 2007) (quotation omitted); see
Kumho Tire, 526 U.S. at 141-42. A witness may qualify to render expert opinions in any one of the
five ways listed in Rule 702: knowledge, skill, experience, training, or education. See Kumho Tire,
526 U.S. at 147. When a party challenges an expert's qualifications, "'the test for exclusion is a
strict one, and the purported expert must have neither satisfactory knowledge, skill, experience,
training nor education on the issue for which the opinion is proffered."' Kopf, 993 F .2d at 377
(quoting Thomas J. Kline. Inc. v. Lorillard. Inc., 878 F.2d 791,799 (4th Cir. 1989)). "In making its
initial determination of whether proffered testimony is sufficiently reliable, the court has broad
latitude to consider whatever factors bearing on validity that the court finds to be useful; the
particular factors will depend upon the unique circumstances of the expert testimony involved."
Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir. 1999). In analyzing reliability, a
court should consider factors such as:
(1) whether a theory or technique can be or has been tested; (2) whether it has been
subjected to peer review and publication; (3) whether a technique has a high known
or potential rate oferror and whether there are standards controlling its operation; and
(4) whether the theory or technique enjoys general acceptance within a relevant
scientific community.
Cooper, 259 F.3d at 199; see Daubert, 509 U.S. at 592-94.
Much ofthe parties' dispute regarding expert testimony concerns whether each ofthe various
experts is qualified and has a reliable basis to offer testimony as to the alleged causal connection
between Aredia and Zometa and ONJ. The court analyzes the arguments seriatim.
As for Dr. Marx, Dr. Marx is a qualified expert and has a reliable basis to offer testimony
regarding the efficacy of certain treatments in preventing bisphosphonate-induced ONJ ("BIONJ"),
general causation based on adverse event reports, and the biological mechanism by which
bisphosphonates may cause BIONJ. To the extent plaintiffs seek to introduce Dr. Marx's opinion
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on whether Novartis acted in "bad faith," the court agrees with Novartis that Dr. Marx lacks a basis
to testify on the subject, and such testimony will be excluded. Likewise, the court will not permit
Dr. Marx to criticize Novartis's clinical trials or opine on patients in those trials given his lack of
expertise or any reliable methodology.
As for Dr. Parisian, Dr. Parisian is an expert whose testimony may be helpful to a jury
regarding the FDA drug-approval process including regulations governing the approval, advertising,
and marketing of pharmaceuticals. To the extent she also seeks to opine on whether Novartis
complied with the regulations, industry ghostwriting or funding of scientific studies, causation,
whether the labels provided adequate warnings in this case, state of mind, or to provide other
testimony that would unduly prejudicial, irrelevant, or outside the scope of her expertise, the court
will not allow her to do so.
As for Dr. Skubitz, Dr. Skubitz is a qualified expert and has a reliable basis to offer testimony
regarding the efficacy of pretreatment dental screening in preventing BIONJ. The court, however,
will not permit him to testify about alternative dosing or labeling.
As for Dr. Vogel, Dr. Vogel is a qualified expert and has a reliable basis to offer testimony
regarding the efficacy of pretreatment dental screening in preventing BIONJ, the incidence rate of
ONJ, the efficacy of reduced dosing schedules, and general causation. The court, however, will not
permit him to testify about corporate conduct, labeling, or the biological mechanism by which
bisphosphonates may cause BIONJ.
As for Doctors Nance and Blakey, these witnesses are qualified experts and each has a
reliable basis to offer testimony regarding specific causation of plaintiff Earp's ONJ. Plaintiffs do
not appear to contend that Doctors Yoffe, Kritz, Petrocella, and Davis will testify that Aredia or
Zometa specifically caused plaintiff Earp's ONJ, and plaintiffs do not argue that these treating

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physicians have any basis for so opining. See Pis.' Mem. Opp. Mot. Exclude [D.E. 80] 24-25.
Accordingly, any such testimony will be excluded. However, Doctors Petrocella and Davis are
experts qualified to discuss how bisphosphonate-related ONJ causes difficulty in treatment and how
their profession's understanding ofAredia and Zometa and its links to ONJ would have affected their
treatment of plaintiff Earp.
In accordance with the foregoing conclusions, the court denies in part Novartis's motions to
exclude expert testimony [D.E. 66, 68, 70, 72, 74, 76]. The court notes that many ofNovartis's
objections go to the weight of the experts' testimony and not to its admissibility. "Vigorous crossexamination, presentation of contrary evidence, and careful instruction on the burden of proof are
the traditional and appropriate means of attacking shaky but admissible evidence." Daubert, 509
U.S. at 596. The court will further consider as part of the motions in limine or at trial whether the
testimony of any expert should be limited as irrelevant, unduly prejudicial, or outside the scope of
his or her expertise. The court denies plaintiffs' cross-motion [D.E. 84] regarding the motions to
exclude as moot.

m.
Next, the court considers N ovartis' s motion for summary judgment [D .E. 15, 78]. The court
reviews Novartis' s motion for summary judgment under the familiar standard ofRule 56. Summary
judgment is appropriate when, after reviewing the record taken as a whole, no genuine issue of
material fact exists, and the moving party is entitled to judgment as a matter oflaw. Fed. R. Civ. P.
56(a); Anderson v. Liberty Lobby. Inc., 477 U.S. 242,247-48 (1986). The party seeking summary
judgment bears the initial burden of demonstrating the absence of a genuine issue of material fact.
Celotex Com. v. Catrett, 477 U.S. 317, 325 (1986). Once the moving party has met its burden, the
nonmoving party may not rest on the allegations or denials in its pleading, Anderson, 477 U.S. at
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248-49, but "must come forward with specific facts showing that there is a genuine issue for trial."
Matsushita Elec. Indus. Co. v. Zenith Radio Com., 475 U.S. 574, 587 (1986) (emphasis and
quotation omitted). A trial court reviewing a motion for summary judgment should determine
whether a genuine issue of material fact exists for trial. Anderson, 477 U.S. at 249. In making this
determination, the court must view the evidence and the inferences drawn therefrom in the light most
favorable to plaintiffs. Scott v. Harris, 550 U.S. 372, 378 (2007).
Novartis argues that (1) plaintiffs' claims are barred by North Carolina's statute of
limitations; (2) plaintiffs have presented no admissible evidence of causation; (3) plaintiffs have
failed to show that Novartis failed to provide a timely or adequate warning, or that a different
warning would have prevented Earp's jaw injury; (4) plaintiffs fail to provide evidence of any
express warranty that Novartis violated; ( 5) plaintiffs have no evidence that Aredia and Zometa were
not fit and effective for their intended purpose; (6) plaintiffs' strict liability, negligent manufacturing,
and negligent design claims fail as a matter of law; and (7) Patricia Earp's claim for loss of
consortium fails because it is derivative of the other claims. Def.'s Mem. Supp. Mot. Summ. J.
[D.E. 79] 1-2.
North Carolina's statute oflimitations for personal injury provides a three-year limitations
period that does not "accrue until bodily harm to the claimant . . . becomes apparent or ought
reasonably to have become apparent to the claimant." N.C. Gen. Stat. § 1-52(16). In the case of
diseases, the limitations period does not begin until a medical diagnosis reveals the nature of
plaintiff's disease. See Wilder v. Amatex Com., 314 N.C. 550, 559--61, 336 S.E.2d 66, 71-72
(1985); cf. Wilson v. McLeod Oil Co., 327 N.C. 491, 512, 398 S.E.2d 586, 596-97 (1990); Black
v. Littlejohn, 312 N.C. 626,643-45,325 S.E.2d469, 480-82 (1985); Crawford v. Boyette, 121 N.C.
App. 67, 70-72, 464 S.E.2d 301, 304 (1995). Viewing the evidence in the light most favorable to

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plaintiffs, Earp's jaw condition was not diagnosed as bisphosphonate-related ONJ until October 11,
2005. E.g., Blakey Dep. [D.E. 80-14] 113-14. Therefore, viewing the evidence in the light most
favorable to plaintiffs, plaintiffs' September 1, 2006 complaint was timely filed.
Next, Novartis argues that plaintiffs lack evidence of causation. Plaintiffs, however, have
proffered sufficient, admissible expert testimony concerning causation to create a genuine issue of
fact for trial.
As for the adequacy of the warnings concerning Aredia and Zometa, numerous material
factual issues remain, such as what Novartis knew about the risks ofbisphosphonates, when it knew
or should have known those risks, and whether it adequately conveyed the risks to physicians.
Furthermore, viewing the evidence in the light most favorable to plaintiffs, plaintiffs have produced
evidence that creates a genuine issue as to whether Earp's treatment would have been different if
Novartis had provided adequate warning.
[D.E. 80-24] 96; Kritz Dep. [D.E. 80-27]

See,~'

Yoffe Dep. [D.E. 80-16] 119-20; Davis Dep.

9~92.

As for plaintiffs' claim for breach of express warranty, "[a] claim for breach of express
warranty ... requires proof of (1) an express warranty as to a fact or promise relating to the goods,
(2) which was relied upon by the plaintiff in making his decision to purchase, (3) and that this
express warranty was breached by the defendant." Harbor Point Homeowners' Ass'n ex rei. Bd. of
Dirs. v. DJF Enters .. Inc., 206 N.C. App. 152, 162,697 S.E.2d 439,447 (2010). Plaintiffs have not
provided evidence of any express warranty Novartis or its agents made or violated. See Pis.' Mem.
Opp. Summ. J. [D.E. 81] 27-28. Accordingly, the court grants summary judgment to Novartis on
this claim.
As for plaintiffs' claim for breach of implied warranty, Novartis argues that plaintiffs' claim
"is actually a failure to warn claim under a different name." Def.'s Mem. Supp. Mot. Summ. J. 22.

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However, "a failure to warn of dangerous propensities concerning a product may create an action of
breach of implied warranty of merchantability." Bryant v. Adams, 116 N.C. App. 448, 468, 448
S.E.2d 832, 843 (1994); see Nicholson v. Am. Safety Util. Corp., 124 N.C. App. 59, 69,476 S.E.2d
672, 678 (1996). Viewing the evidence in the light most favorable to plaintiffs, genuine issues of
material fact remain concerning this claim. Thus, the court denies summary judgment on this claim.
As for plaintiffs' claims for strict liability and manufacturing defect, plaintiffs "are not
pressing" either claim in this case. Pis.' Mem. Opp. Summ. J. 28. Accordingly, the court grants
summary judgment to Novartis on these claims.
As for plaintiffs' design defect claim, plaintiffs must prove, among other things, either one
of the following:
(1) At the time the product left the control of the manufacturer, the manufacturer
unreasonably failed to adopt a safer, practical, feasible, and otherwise reasonable
alternative design or formulation that could then have been reasonably adopted and
that would have prevented or substantially reduced the risk of harm without
substantially impairing the usefulness, practicality, or desirability of the product.
(2) At the time the product left the control of the manufacturer, the design or
formulation of the product was so unreasonable that a reasonable person, aware of
the relevant facts, would not use or consume a product of this design.
N.C. Gen. Stat.§ 99B-6(a); see DeWitt v. Eveready Battery Co., 144 N.C. App. 143, 154-55, 550
S.E.2d 511, 518-19 (2001), aff'd, 355 N.C. 672,565 S.E.2d 140 (2002). Plaintiffs have not alleged
or produced evidence of any safer alternative design that would have prevented or substantially
reduced the risk of harm of using Aredia or Zometa. Furthermore, plaintiffs' evidence shows that
physicians continue to prescribe and use Aredia and Zometa after becoming aware of the allegedly
defective design of the products. E.g., Yoffe Dep. 118-19. Thus, plaintiffs have not shown that the
formulation of these medications was so unreasonable that a reasonable person would not use or
consume them. Accordingly, the court grants summary judgment to Novartis on this claim.
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Finally, the parties agree that Patricia Earp's loss of consortium claim rises or falls with
plaintiffs' other claims. Accordingly, the court denies summary judgment on this claim.

IV.
In sum, the court DENIES plaintiffs' motion to amend the complaint [D.E. 55], DENIES in
part defendant's motions to exclude expert testimony [D .E. 66, 68, 70, 72, 74, 76], DENIES as moot
plaintiffs' cross-motion regarding the motion to exclude [D.E. 84], and GRANTS IN PART AND
DENIES IN PART defendant's motion for summary judgment [D.E. 78]. The parties shall schedule
and complete mediation no later than November 15, 2013.
SO ORDERED. This _ll_ day of September 2013.

OJsc.DEVERill
Chief United States District Judge

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