Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-2_12-cv-00749/USCOURTS-azd-2_12-cv-00749-2/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1331 Fed. Question: Personal Injury

---

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

WO 

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

John D’Agnese and Barbara D’Agnese, 

Plaintiffs, 

v. 

Novartis Pharmaceuticals Corporation, 

Defendant. 

No. CV-12-00749-PHX-JAT

ORDER 

 Pending before the Court are: (1) Defendant’s Daubert Motion to Exclude 

Testimony of Plaintiffs’ Non-Retained Experts (Doc. 83); (2) Defendant’s Daubert 

Motion to Exclude Testimony of Dr. Mansfield (Doc. 84); (3) Defendant’s Daubert 

Motion to Exclude Testimony of Dr. Vogel (Doc. 85); (4) Defendant’s Daubert Motion to 

Exclude Testimony of Dr. Marx (Doc. 87); (5) Defendant’s Daubert Motion to Exclude 

Testimony of Dr. Skubitz (Doc. 88); (6) Defendant’s Daubert Motion to Exclude 

Testimony of Dr. Parisian (Doc. 89); (7) Defendant’s Daubert Motion to Exclude 

Testimony of Dr. Wayne Ray (Doc. 90); and (8) Defendant’s Daubert Motion to Exclude 

Testimony of Dr. Fletcher (Doc. 91). 

I. BACKGROUND 

 This case is part of “Wave III” of a multidistrict litigation in the United States 

District Court for the Middle District of Tennessee (the “MDL Court”). In their Second 

Amended Complaint (Doc. 1), Plaintiffs allege that Defendant Novartis Pharmaceuticals 

Corporation (“Defendant” or “NPC”) produces and markets the drugs Aredia® and 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 1 of 36
- 2 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

Zometa®. 

 Plaintiffs allege that Aredia® and Zometa® are classified as bisphosphonates and 

are prescribed for the management of metastatic disease to the bone and other bone 

diseases and conditions. Plaintiffs allege that Aredia® was the first generation version of 

Zometa®. Plaintiffs further allege that these drugs cause and precipitate osteonecrosis of 

the jaw or maxilla bone. Plaintiffs allege that osteonecrosis is bone death of an area of 

the bone, which is a permanently disfiguring and painful condition, which can result in 

the complete loss of the patient’s jaw bone. 

 Plaintiff John D’Agnese (“Mr. D’Agnese”) used Aredia® and Zometa® to treat 

multiple myeloma bone disease, a disease that Mr. D’Agnese was diagnosed with in 

1995. Mr. D’Agnese was also prescribed chemotherapy with cortiscosteroids, radiation 

treatments, and two stem cell implants to treat the multiple myeloma. Plaintiffs allege 

that Mr. D’Agnese suffered osteonecrosis of the jaw (“ONJ”)1

 as a result of taking 

Aredia® and Zometa®. Plaintiffs assert that Mr. D’Agnese was given forty-seven doses 

of Aredia® from December 3, 1998 to May 28, 2002 and forty-two doses of Zometa® 

from June 28, 2002 to October 11, 2005. 

 After completion of pretrial proceedings, this case was transferred from the MDL 

Court to this Court. 

 Defendant now moves to exclude the testimony of seven of Plaintiffs’ experts and 

the testimony of three of Plaintiffs’ treating physicians pursuant to Daubert v. Merrell 

Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) and Federal Rule of Evidence 702. The 

Court will discuss each Motion in turn. 

 

 

1

 The Parties also use the acronyms “BONJ,” “BRONJ,” and “BIONJ” to refer to 

bisphosphonate-related osteonecrosis of the jaw. In discussing the opinions of certain 

experts, the Court also uses those terms. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 2 of 36
- 3 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

II. LEGAL STANDARD 

Federal Rule of Evidence 702 

establishes several requirements for admissibility: (1) the 

evidence has to “assist the trier of fact” either “to understand 

the evidence” or “to determine a fact in issue”; (2) the witness 

has to be sufficiently qualified to render the opinion: 

If scientific, technical, or other specialized knowledge will 

assist the trier of fact to understand the evidence or to 

determine a fact in issue, a witness qualified as an expert by 

knowledge, skill, experience, training, or education, may 

testify thereto in the form of an opinion or otherwise, if (1) 

the testimony is based upon sufficient facts or data, (2) the 

testimony is the product of reliable principles and methods, 

and (3) the witness has applied the principles and methods 

reliably to the facts of the case. 

Primiano v. Cook, 598 F.3d 558, 563 -564 (9th Cir. 2010) (citing Fed. R. Evid. 702)). 

 The requirement that the opinion testimony “assist the 

trier of fact” “goes primarily to relevance.” For scientific 

opinion, the court must assess the reasoning or methodology, 

using as appropriate such criteria as testability, publication in 

peer reviewed literature, and general acceptance, but the 

inquiry is a flexible one. Shaky but admissible evidence is to 

be attacked by cross examination, contrary evidence, and 

attention to the burden of proof, not exclusion. In sum, the 

trial court must assure that the expert testimony “both rests on 

a reliable foundation and is relevant to the task at hand.” 

Id. at 564 (citing Daubert, 509 U.S. at 591-597). 

“[T]he test under Daubert is not the correctness of the 

expert’s conclusions but the soundness of his methodology.” 

Under Daubert, the district judge is “a gatekeeper, not a fact 

finder.” When an expert meets the threshold established by 

Rule 702 as explained in Daubert, the expert may testify and 

the jury decides how much weight to give that testimony. 

Id. at 565 (internal citations omitted). 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 3 of 36
- 4 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

 “[M]edicine is not a science but a learned profession, 

deeply rooted in a number of sciences and charged with the 

obligation to apply them for man’s benefit.” “Evidence-based 

medicine” is “the conscientious, explicit and judicious use of 

current best evidence in making decisions about the care of 

individual patients.” “Despite the importance of evidencebased medicine, much of medical decision-making relies on 

judgment-a process that is difficult to quantify or even to 

assess qualitatively. Especially when a relevant experience 

base is unavailable, physicians must use their knowledge and 

experience as a basis for weighing known factors along with 

the inevitable uncertainties” to “mak[e] a sound judgment.” 

 When considering the applicability of Daubert criteria 

to the particular case before the court, the inquiry must be 

flexible. Peer reviewed scientific literature may be 

unavailable because the issue may be too particular, new, or 

of insufficiently broad interest, to be in the literature. Lack of 

certainty is not, for a qualified expert, the same thing as 

guesswork. “Expert opinion testimony is relevant if the 

knowledge underlying it has a valid connection to the 

pertinent inquiry. And it is reliable if the knowledge 

underlying it has a reliable basis in the knowledge and 

experience of the relevant discipline.” “[T]he factors 

identified in Daubert may or may not be pertinent in 

assessing reliability, depending on the nature of the issue, the 

expert’s particular expertise, and the subject of his 

testimony.” Reliable expert testimony need only be relevant, 

and need not establish every element that the plaintiff must 

prove, in order to be admissible. 

 . . . 

 “A trial court should admit medical expert testimony 

if physicians would accept it as useful and reliable,” but it 

need not be conclusive because “medical knowledge is often 

uncertain.” “The human body is complex, etiology is often 

uncertain, and ethical concerns often prevent double-blind 

studies calculated to establish statistical proof.” Where the 

foundation is sufficient, the litigant is “entitled to have the 

jury decide upon [the experts’] credibility, rather than the 

judge.” 

Id. at 565-66 (internal citations omitted). 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 4 of 36
- 5 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

Finally, the District Court need only hold a Daubert hearing on medical evidence 

where the party challenging the expert’s testimony “raises a material dispute as to the 

admissibility of expert scientific evidence . . . [at which point, the Court must] consider 

the conflicting evidence and make findings about the soundness and reliability of the 

methodology employed by the scientific experts.” Daubert v. Merrell Dow 

Pharmaceuticals, Inc., 43 F.3d 1311, 1319 n.10 (9th Cir. 1995). 

 III. ANALYSIS 

Defendant requests Daubert hearings on each challenged expert. Plaintiffs insist 

that no Daubert hearings are necessary and claim that Defendant simply wants to 

increase the expense and resources that Plaintiffs must expend in this case. See Doc. 135. 

Plaintiffs further argue that the Court can decide these issues on the Record and the 

Parties’ briefs and that evidentiary hearings and oral argument are not necessary. See id. 

 A. Defendant’s Daubert Motion to Exclude Testimony of Plaintiffs’ 

 Non-Retained Experts (Doc. 83) 

Defendant moves to exclude the testimony of three of Mr. D’Agnese’s treating 

dental care providers from providing testimony that “Mr. D’Agnese’s use of BPs caused 

him to develop a long-resolved jaw condition that he claims was ONJ.” 

 The Court notes that much of Defendant’s challenge of Mr. D’Agnese’s treating 

physicians arises from the testimony Plaintiffs claimed the expert would make in their 

disclosure statement, rather than any actual opinions given by the treating physicians in 

this litigation. Defendant does not appear to dispute that these treating physicians may 

testify as percipient witnesses in this matter or that they may testify as to opinions formed 

during their treatment of Mr. D’Agnese. 

 Because it is undisputed that these treating physicians are able to offer some 

testimony in this matter and Defendant only challenges the expert’s ability to offer an 

opinion on causation, the Court questions the necessity of Daubert hearings for these 

experts, both because it is not clear to the Court that these experts actually intend to offer 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 5 of 36
- 6 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

the opinions that Defendant challenges2 and because, if Plaintiffs attempt to elicit 

testimony from these experts as to causation without laying the proper foundation for 

such testimony, a simple objection during trial would appear to serve the same purpose as 

a Daubert hearing while saving all Parties and the Court the expense of an evidentiary 

hearing to preview the testimony of witnesses that are going to testify despite the result of 

a Daubert hearing. Despite these reservations, the Court will consider whether 

Defendant has actually raised a material dispute as to the admissibility of actual opinions 

offered by these experts. 

 Defendant claims that the Court should exclude these treating physicians from 

offering such causation opinions under Daubert and Federal Rule of Evidence 702 for 

three reasons: (1) these treaters lack expertise regarding ONJ; (2) none of these treaters 

employed any methodology, let alone a scientifically reliable one, to conclude that Mr. 

D’Agnese’s jaw condition was actually ONJ, or, if so, that Mr. D’Agnese’s use of 

bisphosphonates actually caused his ONJ; and (3) the opinions Plaintiffs propose to offer 

from Drs. Green and Marischen do not fit Plaintiffs’ case and will only serve to confuse 

the jury. 

 Further, Defendant argues that, because Drs. Green, Lines, and Marischen did not 

produce a report pursuant to 26(a)(2)(B), they are limited to opining solely as to matters 

regarding their treatment of Mr. D’Agnese. The Court notes that Plaintiffs’ November 1, 

2011 Disclosure Statement purports to comply with an Order issued by the MDL Court 

governing Wave 1-A cases. (Doc. 20-19 at n. 1). That Order (Doc. 2040 in Middle 

District of Tennessee Case No. MD 06-1760) appears to waive the requirement of an 

expert report pursuant to 26(a)(2)(B) for opinions by a plaintiffs’ treating doctors 

concerning “the cause of the jaw problem allegedly experienced by plaintiff,” opinions 

that were formed by the doctor “outside the scope of [the doctor’s] treatment or 

 

2

 The Court is concerned that a ruling based on opinions that are not actually 

being offered by these witnesses would be an opinion on an issue that is not ripe and 

would be advisory. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 6 of 36
- 7 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

evaluation of plaintiff,” or for “use of the [doctor] at trial of that lawsuit to present 

evidence within the scope of Federal Rule of Evidence 702, 703, or 705” if Plaintiff 

disclosed to Defendant, in writing, the name and location of the doctor and stated the 

issues regarding which the disclosing party may elicit testimony from the doctor at trial 

(Id. at 1-2). In that Order, the MDL Court specifically stated that compliance with those 

rules, “shall constitute compliance with Rule 26(a)(2)(A).” (Id. at 2). 

 It is not clear to the Court whether this Order applied to Plaintiffs’ “Wave III” case 

in the MDL or whether the Order applied notwithstanding the amendment to Rule 26 

following the MDL Court’s January 26, 2009 Order, but before Plaintiffs’ 26(A)(2)(a) 

disclosure statement. Because the Parties have failed to brief these issues, this Court 

declines to address any possible issues regarding the sufficiency of Plaintiffs’ disclosures 

regarding Mr. D’Agnese’s treating doctors pursuant to Federal Rule of Civil Procedure 

26. Accordingly, the Court will limit its review of the admissibility of the testimony of 

Mr. D’Agnese’s treating doctors to issues identified by Defendant pursuant to Daubert

and Federal Rule of Evidence 702. For these reasons, the Court presumes for the 

purposes of this Order that Plaintiffs have properly disclosed all of the opinions of their 

treating physicians pursuant to Federal Rule of Civil Procedure 26. 

 1. Dr. Green 

In an August 15, 2011 disclosure statement, Plaintiffs stated that: 

 Dr. Green is one of Mr. D’Agnese’s dentists. His c.v. 

was produced at his deposition. He will testify to his 

treatment of Mr. D’Agnese and may use his expertise in this 

testimony. Dr. Green is expected to testify as to Mr. 

D’Agnese’s dental condition during the applicable period and 

will use his expertise to describe bone and tooth conditions. 

He is also expected to testify he had no reason to disagree 

with the opinion that Zometa® caused Mr. D’Agnese’s ONJ. 

Doc. 20-19 at 3. 

Defendant claims that Dr. Green should be precluded from offering causation 

opinions in this case because, during his May 19, 2010 deposition, he stated that (1) he 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 7 of 36
- 8 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

does not hold himself out to be an expert in causes of osteonecrosis of the jaw, (2) he 

conceded that he is unaware whether a cause and effect relationship between 

bisphosphonate exposure and ONJ has been reliably established, (3) he does not have the 

expertise to diagnose or treat ONJ; (4) he never observed any exposed necrotic bone in 

Mr. D’Agnese’s mouth or impaired healing ability in his jaw; and (5) he does not know 

whether Mr. D’Agnese ever had ONJ. 

 Defendant argues that Dr. Green cannot be permitted to testify that “he had no 

reason to disagree with the opinion that Zometa® caused Mr. D’Agnese’s ONJ.” 

Defendant argues that, because Dr. Green is not an expert on the causes of ONJ, any such 

statement, is outside his expertise and thus is inadmissible pursuant to Daubert and 

Federal Rule of Evidence 702. Defendant further argues that this statement should be 

excluded pursuant to Federal Rule of Evidence 403 because it is unhelpful and would 

serve no purpose other than to mislead and confuse the jury. 

 In response, Plaintiffs argue that Dr. Green should be permitted to testify to his 

opinions regarding Mr. D’Agnese’s medical condition. Plaintiffs point to testimony that 

Dr. Green gave during his May 19, 2011 deposition that (1) he was suspicious that Mr. 

D’Agnese had BIONJ, so he referred him to an oral surgeon; (2) he has been a dentist 

since 1963; (3) he reviewed the 2009 AAOMS guidelines on bisphosphonate related ONJ 

and Mr. D’Agnese’s x-rays and charts; (4) he is familiar with periodontal disease; (5) he 

would not do implants for Mr. D’Agnese because of his exposure to bisphosphonates; (6) 

he was suspicious of the radiograph and history of bisphosphonate use; (7) Mr. 

D’Agnese’s dental options are reduced because of his BIONJ; (8) as of March 2011, 

there was no multiple myeloma in Mr. D’Agnese’s jaw; (9) he has no reason to disagree 

with the diagnosis of BIONJ for Mr. D’Agnese; (10) he did not learn of the relationship 

between ONJ and bisphosphonates until 2004 or 2005; (11) in an implant discussion at a 

study club, he learned of the dangers of implants and oral bisphosphonates; and (12) he 

has learned in continuing medical education that intravenous bisphosphonates, such as 

Aredia® and Zometa®, are too big a risk for dental implants. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 8 of 36
- 9 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

 From this, Plaintiffs argue that Dr. Green has specialized knowledge that the jury 

is entitled to hear on the cause of Mr. D’Agnese’s disease. Specifically, Plaintiffs argue 

that Dr. Green can discuss periodontal disease, finding no myeloma in the jaw, and any 

other dental problems, and potentially rule them out as causes of ONJ. 

 Plaintiffs finally argue that the Court should allow all of Mr. D’Agnese’s “dental 

treaters” to testify as to their cause opinions. With regard to Dr. Green, the basis of 

Plaintiffs’ contention that the Court should allow Dr. Green to testify as to his “cause” 

opinion is unclear to the Court. At no time do Plaintiffs refer the Court to a disclosure or 

other testimony of Dr. Green that Aredia® and Zometa® caused Mr. D’Agnese’s ONJ. 

Further, Plaintiffs do not dispute Defendant’s contention that Dr. Green testified that he is 

not able to diagnose ONJ, or to identify the causes of ONJ, or to testify that 

bisphosphonates cause ONJ. Defendant specifically asks the Court to exclude Dr. 

Green’s opinion, that he had no reason to disagree with the opinion that Zometa® caused 

Mr. D’Agnese’s ONJ. Plaintiffs have failed to present any evidence that Dr. Green is 

qualified to make such an opinion. There is no question that, if Plaintiffs sought to elicit 

the statement that Dr. Green had reason to believe that Zometa® caused Mr. D’Agnese’s 

ONJ, they would have to establish that he has the requisite expertise to render that 

opinion. Plaintiffs have not done so and, thus, they cannot do the inverse. Further, 

Plaintiffs have failed to establish the relevance of any statement from Dr. Green that he 

has no reason to disagree with the opinion that Zometa® caused Mr. D’Agnese’s ONJ. 

 Accordingly, the Motion to Exclude the testimony of Plaintiffs’ non-retained 

experts is granted to the extent that it seeks to exclude Dr. Green’s opinion that he had no 

reason to disagree with the opinion that Zometa® caused Mr. D’Agnese’s ONJ. Because 

this is the only opinion actually given by Dr. Green that Defendant challenges, the Court 

limits its Order to such opinion. Defendant has not offered any evidence that Dr. Green 

indicated in his deposition testimony, or elsewhere, that he intends to testify that 

Plaintiffs had ONJ or that Zometa® or Aredia® caused ONJ. However, to the extent 

Plaintiffs attempt to elicit testimony from Dr. Green to that effect, Defendant may make 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 9 of 36
- 10 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

the appropriate objection at trial. This Order is not intended to limit any testimony of Dr. 

Green regarding the facts or other opinions that he may testify to as a percipient witness 

should the proper foundation for such facts be laid by Plaintiffs. See Primiano v. Cook, 

598 F.3d 558 (9th Cir. 2010) (“Where the foundation is sufficient, the litigant is ‘entitled 

to have the jury decide upon [the experts’] credibility, rather than the judge.’”) (internal 

citation omitted). 

 2. Dr. Lines 

In an August 15, 2011 disclosure statement, Plaintiffs stated that: 

 Dr. Limes [sic] is Mr. D’Agnese’s Oral and 

Maxillofacial surgeon who diagnosed him with 

Bisphosphonate Related ONJ. His c.v. was produced at his 

deposition. He will testify to his treatment of Mr. D’Agnese 

and may use his expertise in this testimony. He is expected to 

testify, inter alia, Mr. D’Agnese’s ONJ was caused and/or 

consistent with BONJ, and to his symptoms and side effects 

of treatment. He is further expected to testify that ONJ is 

treated differently from BONJ. 

(Doc. 20-19 at 2-3). 

Defendant claims that Dr. Lines should be precluded from offering causation 

opinions in this case because, during his May 25, 2011 deposition, he stated that (1) he 

does not hold himself out to be an expert in ONJ or intravenous bisphosphonates, (2) he 

has never researched ONJ, ONJ risk factors, bisphosphonates, published any articles, and 

does not know if a cause and effect relationship between bisphosphonate exposure and 

ONJ has been proven; (3) in his practice, he has never diagnosed the cause of ONJ in a 

bisphosphonate patient; (4) although, in his treatment of Mr. D’Agnese, he assumed Mr. 

D’Agnese had an issue with osteonecrosis, it was just an assumption; (5) Dr. Lines 

conceded that necrotic bone can be caused by infection, osteomyelitis and radiation and 

that loose teeth and bone loss can be caused by osteoporosis and periodontitis. Dr. Lines 

did not perform biopsies, histopathies, or cultures or attempt to rule out any alternative 

(non-BP) causes of Mr. D’Agnese’s jaw problem; (6) Dr. Lines testified that he is not 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 10 of 36
- 11 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

offering expert testimony on the causation of osteonecrosis, but his working assumption 

was that Mr. D’Agnese had osteonecrosis secondary to bisphosphonates; and (7) Dr. 

Lines agreed that Mr. D’Agnese’s presentation did not meet the American Association of 

Oral and Maxillofacial Surgeons’ (“AAOMS”) criteria for a clinical diagnosis of 

bisphosphonate-related ONJ. 

 Defendant argues that Dr. Lines’ testimony regarding whether Mr. D’Agnese had 

ONJ or what caused that ONJ should be excluded because (1) he disclaimed expertise in 

both osteonecrosis and BPs; and (2) Dr. Lines is not qualified to opine that BPs can 

generally cause ONJ because he has offered no evidence of academic or professional 

expertise regarding ONJ etiology and has never diagnosed the cause of ONJ in a 

bisphosphonate patient. 

 In response, Plaintiffs argue that (1) Dr. Lines is a board certified oral surgeon 

with over twenty-one years of experience as an oral/maxillofacial surgeon and has seen 

“a score” of cases of BIONJ; (2) he has given talks to other physicians on 

bisphosphonates and prevention of ONJ; (3) he testified that he knows that radiation is a 

cause of ONJ and there is an association between ONJ and bisphosphonates, but is not 

sure of all of the causes of ONJ, (4) he testified that of roughly 20 or 30 patients with 

ONJ, roughly 6 to 10 were taking bisphosphonates; and (5) he explained, in detail, his 

treatment of Mr. D’Agnese and the reasons for his treatment decisions. 

 From this, Plaintiffs argue that Dr. Lines must be able to testify that Mr. D’Agnese 

had ONJ and it was caused by bisphosphonates. Plaintiffs also argue, without citation to 

the record, that “Dr. Lines easily falls into the category of medical treaters who are 

experts in BIONJ.” (Doc. 98 at 14). 

 Neither Plaintiffs nor Defendant actually discuss any opinions by Dr. Lines that 

Mr. D’Agnese had ONJ or BIONJ. To the extent that Dr. Lines testified that he treated 

Mr. D’Agnese on the assumption that he had BIONJ or ONJ with specific reasons why he 

proceeded with treatment based on those assumptions, Defendant has not challenged Dr. 

Lines’ underlying methodology or scientific reasoning in making such assumptions. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 11 of 36
- 12 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

 Accordingly, the Court finds that Plaintiffs have failed to make a showing that Dr. 

Lines can testify that Mr. D’Agnese had ONJ or BIONJ. Defendant has failed to make a 

showing that Dr. Lines cannot testify as to the facts of his treatment of Mr. D’Agnese, 

including his working assumption that Mr. D’Agnese had ONJ and the further 

assumption that bisphosphonates caused that ONJ. Defendant has failed to argue or show 

that these assumptions were not based on reliable principles and methods. To the extent 

that Defendant challenges those opinions, such challenge goes to the weight of Dr. Lines’ 

testimony, as his failure to categorically determine Mr. D’Agnese’s condition and/or the 

cause of that condition does not render his working assumptions about that condition 

non-scientific speculation.3

 See Primiano, 598 F.3d at 564, 566 (“[T]he test under 

 

3

 Under similar facts, the Ninth Circuit Court of Appeals addressed this issue as 

follows: 

The law grants the district court the same broad 

latitude in determining how to determine reliability as it 

enjoys when deciding whether that expert’s relevant 

testimony is reliable. Kumho, 562 U.S. 137, 119 S.Ct 1167, 

1176. Furthermore, experts are permitted wide latitude to 

offer opinions, including those that are not based on firsthand 

knowledge or observations, so long as they have a reliable 

basis in the knowledge and experience of the discipline. 

Daubert, 509 U.S. at 592, 113 S.Ct. 2786. What is required is 

a “fit,” a determination that the proposed testimony is 

relevant to the task at hand, logically advancing a material 

aspect of the proposing party’s case. Daubert v. Merrell Dow 

Pharm., Inc., 43 F.3d 1311, 1315 (9th Cir.1999). Here, the 

trial court focused on the fact that Dr. Strange was Huff’s 

treating physician, with knowledge of Huff’s condition before 

the fall and after it. The district judge allowed Dr. Strange to 

testify in order to establish whether his medical findings were 

consistent with what was related to him by Huff. In 

concluding that Dr. Strange’s conclusions as to the cause of 

Huff’s fall would go to weight, and not to admissibility, the 

district judge pointed out that Dr. Strange clearly delimited 

his testimony, candidly admitting under cross-examination 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 12 of 36
- 13 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

Daubert is not the correctness of the expert’s conclusions but the soundness of his 

methodology”) (internal citation omitted). 

 Accordingly, the Motion to Exclude the testimony of Plaintiffs’ non-retained 

experts is denied as to Dr. Lines’ opinions. Defendant has not offered any evidence that 

Dr. Lines indicated in his deposition testimony, or elsewhere, that he intends to testify 

that Mr. D’Agnese had ONJ or that Zometa® or Aredia® caused ONJ. However, to the 

extent Plaintiffs’ attempt to elicit testimony from Dr. Lines to that effect, Defendant may 

make the appropriate objection at trial. This Order is not intended to limit any testimony 

of Dr. Lines regarding the facts or other opinions that he may testify to as a percipient 

witness should the proper foundation for such facts be laid by Plaintiffs. 

 3. Dr. Marischen 

In an August 15, 2011 disclosure statement, Plaintiffs stated that: 

 Dr. Marischen is one of Mr. D’Agnese’s dentists. His 

c.v. was produced at his deposition. He will testify to his 

treatment of Mr. D’Agnese and may use his expertise in this 

testimony. Dr. Marischen is expected to testify as to Mr. 

D’Agnese’s dental condition during the applicable period and 

will use his expertise to describe bone and tooth conditions. 

He is also expected to testify he had no reason to disagree 

with the opinion that Zometa® caused Mr. D’Agnese’s ONJ. 

 

that after an extensive differential diagnosis he could not 

point to an objective medical basis for Huff’s pain. The fact 

that all commonly accepted diagnostic tests-x-rays, lumbar 

CT scan, EMG, MRI, dermatomal distribution test-failed to 

reveal any precise physiological cause of Huff’s leg 

complaints does not reduce his conclusions based on that 

evidence to non-scientific “speculation.” Generating 

hypotheses and testing them to see if they can be falsified is 

the distinguishing characteristic of science. Daubert, 509 U.S. 

at 593, 113 S.Ct. 2786. The district judge’s ruling that the 

qualified conclusion reached by Dr. Strange would be left for 

the jury to believe or disbelieve was not an abuse of 

discretion. 

Huff v. Wal-Mart Stores, Inc., 203 F.3d 831, 1999 WL 1206845, at *2 (9th Cir. 1999). 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 13 of 36
- 14 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

Doc. 20-19 at 2. 

 Defendant argues that Dr. Marischen should be precluded from offering causation 

opinions in this case because Dr. Marischen was not deposed in this case and Plaintiffs 

cannot meet their burden to show that Dr. Marischen is an expert in diagnosing ONJ or 

the causes of ONJ. Defendant argues that, because he has no expertise, Dr. Marischen 

should be precluded from offering the opinion that “he had no reason to disagree with the 

opinion that Zometa® caused Mr. D’Agnese’s ONJ.” 

 In Response, Plaintiffs state that “Dr. Marischen is a prosthodontist whose medical 

records reflect he treated Mr. D’Agnese as a BIONJ patient.” (Doc. 98 at 10). Plaintiffs 

further state that Dr. Marischen has specialized knowledge that the jury is entitled to hear 

on the cause of Mr. D’Agnese’s disease. 

 Defendant specifically asks the Court to exclude Dr. Marischen’s opinion that he 

had no reason to disagree with the opinion that Zometa® caused Mr. D’Agnese’s ONJ. 

Plaintiffs have failed to present any evidence that Dr. Marischen is qualified to make 

such an opinion. There is no question that, if Plaintiffs sought to elicit the statement that 

Dr. Marischen had reason to believe that Zometa® caused Mr. D’Agnese’s ONJ, they 

would have to establish that he has the requisite expertise to render that opinion. 

Plaintiffs have not done so and, thus, they cannot do the inverse. Further, Plaintiffs have 

failed to establish the relevance of any statement from Dr. Marischen that he has no 

reason to disagree with the opinion that Zometa® caused Mr. D’Agnese’s ONJ. 

 Accordingly, the Motion to Exclude the testimony of Plaintiffs’ non-retained 

experts is granted to the extent that it seeks to exclude Dr. Marischen’s opinion that he 

had no reason to disagree with the opinion that Zometa® caused Mr. D’Agnese’s ONJ. 

However, because Dr. Marischen was not deposed in this case, and Plaintiffs have not 

presented any affidavit or other evidence containing Dr. Marischen’s proposed testimony, 

the Court is unable to ascertain what Dr. Marischen’s opinions actually are or the basis 

for those opinions. Neither party has offered any evidence that Dr. Marischen intends to 

testify that Mr. D’Agnese had ONJ or that Zometa® or Aredia® caused ONJ. However, 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 14 of 36
- 15 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

to the extent Plaintiffs attempt to elicit testimony from Dr. Marischen to that effect, 

Defendant may make the appropriate objection at trial. This Order is not intended to 

limit any testimony of Dr. Marischen regarding the facts or other opinions that he may 

testify to as a percipient witness should the proper foundation for such facts be laid by 

Plaintiffs. 

 B. Defendant’s Daubert Motion to Exclude Testimony of Dr. 

 Mansfield (Doc. 84) 

 Dr. Mansfield is an oral/maxillofacial specialist, who was retained by Plaintiffs to 

offer expert testimony in this case. Dr. Mansfield’s proposed testimony is based on his 

thirty years of experience as an oral/maxillofacial surgeon, his examination of Mr. 

D’Agnese’s medical records, scientific literature, and his own examination of Mr. 

D’Agnese. Dr. Mansfield wrote a letter to Mr. D’Agnese’s counsel summarizing his 

opinions regarding Mr. D’Agnese’s condition. Plaintiffs assert that this letter is Dr. 

Mansfield’s “Rule 26 report.” (Doc. 98 at 4). Dr. Mansfield was also deposed in this 

case. 

 Defendant argues that Dr. Mansfield’s opinion that Aredia® and Zometa® caused 

Mr. D’Agnese’s ONJ must be excluded under Federal Rule of Evidence 702 and Daubert

because: (1) Dr. Mansfield admitted that Mr. D’Agnese’s jaw condition is most likely 

something other than ONJ; (2) Dr. Mansfield failed to consider admittedly plausible 

alternative causes, let alone reliably rule them out, so he did not employ a differential 

diagnosis or any other reliable methodology for determining the cause of Mr. D’Agnese’s 

jaw condition; and (3) Dr. Mansfield conceded that the purported basis for his opinion 

that bisphosphonates caused Mr. D’Agnese’s alleged ONJ is scientifically unreliable. 

 It is undisputed that, at the time Dr. Mansfield examined Mr. D’Agnese, in July 

2011, there was no clinical evidence that he had ONJ on that date. It is disputed whether 

Mr. D’Agnese suffered from ONJ from 2005 to 2007. 

 In his September 1, 2011 deposition, Dr. Mansfield testified that he has treated 

150 to 200 cases of ONJ and has diagnosed approximately 10 to 12 of those cases as 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 15 of 36
- 16 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

being caused by bisphosphonates. Dr. Mansfield further testified that determining that 

ONJ is caused by bisphosphonates is a diagnosis by exclusion because the disease and the 

process cannot be biopsied. Dr. Mansfield testified that he makes a diagnosis of ONJ 

caused by bisphosphonates based on exclusion, history, and presentation. Dr. Mansfield 

testified that a proper diagnosis of BIONJ has three criteria: (1) exposure to 

bisphosphonates; (2) exposed bone for more than eight weeks in the jaw; and (3) no 

history of radiation therapy to the jaw. When questioned as to whether Mr. D’Agnese 

had exposed bone for more than eight weeks in the jaw, Dr. Mansfield explained that by 

Mr. D’Agnese’s own verbal history, he had exposed bone for close to eight weeks, but 

there was no evidence of necrotic bone for eight weeks in the medical records. 

 Dr. Mansfield further explained that it was not clear from the medical records 

whether Mr. D’Agnese had radiation to the jaw when he was given radiation eight years 

before developing his jaw problems. Dr. Mansfield did opine that the quantity of 

radiation given to Mr. D’Agnese eight years before he developed problems with his jaw 

likely did not have a significant impact on Mr. D’Agnese’s jaw when he developed those 

issues. 

 Defendant’s first two challenges to Dr. Mansfield’s testimony as to causation are 

that Dr. Mansfield admitted that Mr. D’Agnese’s jaw condition is most likely something 

other than ONJ and that Dr. Mansfield failed to consider admittedly plausible alternative 

causes, let alone reliably rule them out, so he did not employ a differential diagnosis or 

any other reliable methodology for determining the cause of Mr. D’Agnese’s jaw 

condition. 

 With regard to their first argument, Defendant cites to testimony by Dr. Mansfield 

indicating that Mr. D’Agnese’s jaw condition would have been consistent with an 

infection. With regard to their second argument, Defendant cites to testimony that Dr. 

Mansfield did not rule out every other possible cause identified by Defendant of Mr. 

D’Agnese’s condition. Nothing in this testimony renders Dr. Mansfield’s opinion that 

Mr. D’Agnese’s jaw condition was consistent with bisphosphonate-related ONJ 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 16 of 36
- 17 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

unreliable. Dr. Mansfield’s failure to definitively conclude that Mr. D’Agnese’s jaw 

condition was caused by bisphosphonates does not convert his opinions that Mr. 

D’Agnese’s jaw condition could have been caused by bisphosphonates and that Mr. 

D’Agnese’s case meets the three criteria for bisphosphonate-related ONJ to non-scientific 

“speculation.” 

Dr. Manfield’s proposed testimony is relevant to the issue of causation in this case 

and advances a material aspect of Plaintiffs’ case. Although Defendant may disagree 

with Dr. Mansfield’s opinions, Defendant can cross-examine Dr. Mansfield and the jury 

can decide on his credibility. See Primiano, 598 F.3d at 566 (“Reliable expert testimony 

need only be relevant, and need not establish every element that the plaintiff must prove, 

in order to be admissible.”). 

 Finally, Defendant asserts that Dr. Mansfield should not be permitted to testify as 

to causation because “Dr. Mansfield conceded that the purported basis for his opinion 

that bisphosphonates caused Mr. D’Agnese’s alleged ONJ is scientifically unreliable.” In 

fact, Defendant challenges Dr. Mansfield’s reliance on Mr. D’Agnese’s statement that he 

had exposed bone for more than eight weeks in his jaw in establishing the second element 

of a BIONJ diagnoses. Defendant appears to suggest that doctors can only make a 

diagnosis based on medical phenomena that the doctor himself witnesses and may not 

take their patient’s subjective complaints into account when making a diagnosis. This 

simply cannot be the case. “A trial court should admit medical expert testimony if 

physicians would accept it as useful and reliable, but it need not be conclusive because 

medical knowledge is often uncertain.” Primiano, 598 F.3d at 565-66 (internal quotation 

omitted). Certainly, physicians often rely on their patient’s subjective complaints in 

making a diagnosis of their ailments. To the extent that Defendant seeks to challenge Mr. 

D’Agnese’s credibility in the information that he gave to Dr. Mansfield, which resulted in 

a “diagnosis” that Mr. D’Agnese’s symptoms were consistent with BIONJ, such 

challenge can be made before the jury. 

 The Court finds that Defendant has failed to raise a genuine dispute as to the 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 17 of 36
- 18 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

admissibility of Dr. Mansfield’s testimony and, thus, their request for a Daubert hearing, 

and their Motion to Exclude Dr. Mansfield’s testimony is denied. 

 C. Defendant’s Daubert Motion to Exclude Testimony of Dr. Vogel 

 (Doc. 85) 

Dr. Vogel is an oncologist and hematologist who practiced medicine for more than 

thirty-five years and is an Associate Professor at the Mount Sinai School of Medicine. 

 In deciding Motions for Summary Judgment in the MDL, the MDL Court found 

that Dr. Vogel’s testimony concerning general causation and the scientific and medical 

accuracy of warnings given by Novartis were admissible under Federal Rule of Evidence 

702 and Daubert. (See Doc. 85-7 and Doc. 85-8). Defendant does not challenge those 

rulings, but rather argues that Dr. Vogel’s proposed testimony concerning (1) the alleged 

corporate behavior of Novartis, (2) the delay and failure in transmission of certain 

information impacting a large number of patients, and (3) the benefit of pretreatment 

dental screening should be precluded under Rule 702 and Daubert. The MDL Court 

declined to rule on whether such testimony should be admitted under Rule 702 and 

Daubert. 

 Defendant argues that, “[b]ased on his review of a select few corporate documents 

that plaintiffs’ counsel provided him, Dr. Vogel criticizes NPC’s response to reports of 

ONJ in patients receiving Zometa®, including how it revised its labeling.” Defendant 

argues that these opinions should be excluded because Dr. Vogel has no first-hand 

knowledge of the circumstances and brings no scientific or other technical expertise to 

bear on the testimony. Defendant argues that this opinion is both subjective and 

speculative. Defendant further argues that these opinions would not assist the jury 

because the opinions merely reiterate arguments based on inferences that can be drawn 

by laypersons. 

 To support this argument, Defendant points to testimony that Dr. Vogel gave 

during his April 2, 2009 deposition that he is not an expert regarding drug labeling, he is 

not an expert in FDA regulation of pharmaceutical companies, he did not review and is 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 18 of 36
- 19 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

not familiar with the relevant FDA regulations, and he was not aware of certain 

communications between the FDA and Defendant regarding the Zometa® label. 

Accordingly, Defendant requests that the Court preclude “Dr. Vogel from criticizing 

NPC’s labeling.” 

 Defendant next argues that Dr. Vogel’s opinions regarding NPC’s corporate 

conduct, including NPC’s knowledge and intent are not the proper subject of expert 

testimony. Specifically, Defendant argues that the Court should preclude Dr. Vogel from 

offering any of the following opinions: (1) Defendant misrepresented causation evidence, 

(2) Defendant referenced corticosteroids as potential risk factors for ONJ in the warnings 

on its label to misdirect the focus of medical attention away from the jaw area; (3) 

Defendant minimized the incidence rate of ONJ; (4) Defendant knew and failed to 

communicate that ONJ occurs in a patient after fewer infusions of Zometa® than of 

Aredia® and (5) Defendant knew and failed to communicate that a decrease in the 

duration, dose, and/or frequency of therapy decreases the incidence of ONJ. 

 Defendant argues that these opinions must be precluded because they are not 

based on scientific, technical, or other specialized knowledge, Dr. Vogel has no 

experience that would qualify him to opine on the conduct of a pharmaceutical company 

and is no more competent than the jury to evaluate the emails cited in his reports. 

 Defendant next argues that Dr. Vogel’s opinion that preventative dental measures 

taken prior to initiating Aredia® and Zometa® therapy would reduce the incidence of 

ONJ. First, Defendant argues the opinion is irrelevant because it does not “fit” the facts 

of this case. Defendant argues that, because Mr. D’Agnese’s medical oncologist, Dr. 

Olshan performed a dental examination on Mr. D’Agnese before bisphosphonate therapy 

began and Dr. Mansfield testified that a warning was irrelevant in Mr. D’Agnese’s case 

because Dr. Olshan conducted a thorough medical examination. 

 Second, Defendant argues that Dr. Vogel’s methodology in support of this opinion 

is not scientifically reliable because (1) the sole basis for his opinion was a publication 

regarding a retrospective study attempting to analyze the benefits of dental monitoring of 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 19 of 36
- 20 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

patients while on bisphosphonates, which is not the type of evidence that experts in the 

field would rely upon to determine the effectiveness of pretreatment dental screenings, 

(2) Dr. Vogel’s opinion conflicts with Dr. Marx’s opinion that it is not clear whether 

pretreatment dental screenings are effective in reducing the incidence of ONJ. 

 Defendant next argues that Dr. Vogel’s opinions regarding the incidence of ONJ 

are irrelevant and are based on insufficient facts and data. Defendant argues that Dr. 

Vogel’s opinion that, in publications and correspondence, Defendant minimized the 

incidence of ONJ in patients on Aredia® and Zometa® because the incidence rate is 

generally five percent or above should be precluded because: (1) it is not relevant as the 

correspondence and publications that Dr. Vogel relies on post-date 2005, the year that 

Mr. D’Agnese received his last infusion of Zometa® and thus, this evidence did not exist 

when Mr. D’Agnese was being prescribed Zometa®; (2) even if this information were 

relevant, it is based on insufficient facts and data and is false based on randomized, 

double blind, controlled studies that find the incidence rate of ONJ in Zometa® patients 

is one percent that Dr. Vogel failed to account for in his conclusions; (3) the publications 

that Dr. Vogel relies on do not support his conclusion, (4) Dr. Vogel’s methodology is 

internally inconsistent because he selectively relies on certain studies and personal 

experience while disregarding studies that clearly undermine his conclusions. 

 Defendant next argues that Dr. Vogel’s opinion that “a reduced dosing schedule 

has shown equal efficacy and less risk” and Dr. Vogel’s suggestion that Defendant 

improperly failed to disseminate information about alternative dosing schedules should 

be precluded because (1) Dr. Vogel is not qualified to offer an opinion on this issue as he 

admittedly lacks knowledge of the FDA’s role in the regulation and labeling of 

prescription drugs because he does not know what information the FDA permits 

Defendant to provide to the medical community about Aredia® and Zometa®; and (2) 

Dr. Vogel’s opinions are not relevant because he relies on a single retrospective study 

that involved only 106 myeloma patients, which was published a year and a half after Mr. 

D’Agnese stopped taking Zometa®, and does not address whether Defendant should have 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 20 of 36
- 21 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

advised prescribing physicians of a different dosing schedule in 2002 through 2005. 

 Finally, Defendant argues that Dr. Vogel is unqualified to offer the opinion that 

BPs are more likely to accumulate in the jaw than in other bones due to higher 

remodeling rates and higher uptake of bisphosphonates because (1) Dr. Vogel is not a 

bone biologist or pathologist; and (2) Dr. Vogel concedes he does not have the expertise 

to explain his mechanism hypotheses to the jury. 

 In Response,4

 Plaintiffs argue that other courts in other districts have ruled on 

 

4

 Plaintiffs filed one Response to Defendant’s Daubert motions regarding Dr. 

Marx, Dr. Fletcher, Dr. Ray, Dr. Skubitz, and Dr. Vogel. In that Response, Plaintiffs 

attempt to “incorporate by reference” “the entirety of the Daubert opposition briefs and 

all exhibits filed in [the MDL case] in the ‘Wave I-A’ cases, filed on September 1, 2010, 

in the ‘Wave I-B’ cases, filed on November 22, 2010 in the ‘Wave I-C’ cases, filed on 

June 20, 2011 in the ‘Wave II’ cases, filed on November 30, 2011 in the Wave ‘III’ cases 

filed on September 16, 2012 in the Wave ‘IV’ cases, and oppose [Defendant’s] current 

motion to exclude these witnesses for those and the following reasons.” (Doc. 104 at 2). 

Plaintiffs have not attached any of these “oppositions” to their Response. Plaintiffs rely 

on Federal Rule of Civil Procedure 10(c) for this “incorporation by reference.” 

First, Federal Rule of Civil Procedure 10(c) does not apply to arguments in certain 

motions being incorporated by reference into new motions. Rather, Federal Rule of Civil 

Procedure 10(c) allows statements in pleadings to be adopted by reference in any other 

pleadings or motions. See Fed.R.Civ.P. 10(c); Fed.R.Civ.P. 7(a) (defining pleadings as a 

complaint, answer to a complaint, answer to a counterclaim designated as a counterclaim, 

an answer to a crossclaim, a third-party complaint, an answer to a third-party complaint 

and a reply to an answer). 

Second, this attempt to incorporate various documents by reference that include 

arguments related and unrelated to the current issues before the Court circumvents this 

Court’s local rules governing page limits. 

Finally, this Court is not going to dig through various documents (copies of which 

have not even been provided by Plaintiffs) in order to determine what arguments in those 

other oppositions Plaintiffs believe may or may not be relevant to the issues currently

before the Court. It is Plaintiffs obligation to oppose Defendant’s arguments and not this 

Court’s obligation to attempt to ascertain what arguments from other motions Plaintiffs 

may be trying to make again. See Orr v. Bank of America, 285 F.3d 764, 775 (9th Cir. 

2002) (internal quotation omitted) (“Judges need not paw over the files without assistance 

from the parties.”)); Indep. Towers of Wash. v. Washington, 350 F.3d 925, 929 (9th Cir. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 21 of 36
- 22 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

Daubert motions in other cases that were part of the MDL and have admitted at least 

some of the testimony challenged by Defendant in the motions before this Court.5

 

Plaintiffs do not make any arguments in response to Defendant’s challenges to Dr. 

Vogel’s testimony nor do they explain why Dr. Vogel’s testimony should be admitted 

under Federal Rule of Evidence 702. 

 Accordingly, Defendant has raised material disputes as to the admissibility of the 

challenged testimony of Dr. Vogel and, thus, the Court must hold a Daubert hearing to 

determine if Dr. Vogel’s opinions on the matters challenged by Defendant are admissible 

under Federal Rule of Evidence 702. If Plaintiffs do not intend to offer the challenged 

testimony of Dr. Vogel, Plaintiffs shall file a notice with the Court stating that such 

challenged testimony is not offered within 5 days of the date of this Order and the 

Daubert hearing regarding Dr. Vogel’s testimony will be vacated, Dr. Vogel will not be 

permitted to testify on the challenged subjects at trial, and the Daubert motion will be 

denied as moot. 

 

2003) (“[J]udges are not like pigs, hunting for truffles buried in briefs.’”) (citation 

omitted). 

If Plaintiffs required a page extension to respond to Defendant’s argument on the 

current Motions pending before the Court, they could have either filed separate responses 

to each Daubert Motion or could have requested a page extension from the Court. 

Plaintiffs chose to do neither and erroneously relied on Federal Rule of Civil Procedure 

10(c) to incorporate arguments in various other oppositions that are not in this Court’s 

record by reference into the current Response. 

Accordingly, the Court has not considered any of the oppositions that Plaintiffs 

attempted to “incorporate by reference” that were filed in the MDL. 

5

 Although the Court gave Plaintiffs the opportunity to explain whether or not res 

judicata would somehow apply to the challenged testimony of Dr. Vogel, Plaintiffs have 

not made any argument that res judicata would apply to the opinions challenged by 

Defendant. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 22 of 36
- 23 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

 D. Defendant’s Motion to Exclude Testimony of Dr. Marx (Doc. 87) 

Dr. Marx is Chief of Oral and Maxillofacial Surgery at the University of Miami 

Health System and is involved in ongoing research concerning bisphosphonates and 

osteonecrosis of the jaw. He was one of the earliest physicians to allege a connection 

between bisphosphonates and ONJ and, in 2003, was invited by Defendant to participate 

in more than one advisory board meeting on ONJ. (Doc. 87-6). Plaintiffs intend to 

present testimony of Dr. Marx as a case-wide general expert and do not intend to present 

case specific opinions of Dr. Marx regarding Mr. D’Agnese’s jaw problems. 

 In the MDL, Defendant filed a Motion to Exclude Litigation-Wide Testimony of 

Plaintiffs’ Expert Dr. Robert Marx. (Doc. 87-6) In that Motion, Defendant challenged 

Dr. Marx’s testimony regarding (1) the causal connection between Aredia® and 

Zometa® and ONJ, (2) treatment and preventative measures for ONJ, (3) alleged 

misconduct by Defendant, which Dr. Marx considers to be taken in “bad faith,” (4) 

whether certain patients in the Aredia®/Zometa® clinical trials likely had 

bisphosphonate-induced ONJ, and (5) criticisms of certain aspects of those clinical trials. 

(Id.). 

 The MDL Court ruled, that for the purposes of deciding summary judgment, Dr. 

Marx’s testimony regarding the causal connection between Aredia® and Zometa® and 

ONJ and treatment and preventive measures for ONJ should be admitted pursuant to 

Federal Rule of Evidence 702. (Id.). The MDL Court declined to rule on whether Dr. 

Marx’s opinions regarding Defendant’s bad faith or his opinions concerning clinical trials 

should be precluded pursuant to Rule 702. (Id.). 

Defendant argues that Dr. Marx’s testimony regarding the adequacy of 

Defendant’s warnings are irrelevant and do not fit the facts of Mr. D’Agnese’s case 

because (1) Mr. D’Agnese was first prescribed Aredia® in 1998 before any associations 

between ONJ and BPs became known or knowable according to Dr. Marx and (2) even 

after he was warned of the potential risk of ONJ by his prescribing oncologist, Dr. 

Olshan, Mr. D’Agnese opted to continue using Zometa®. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 23 of 36
- 24 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

 Defendant next argues that Dr. Marx’s opinions regarding preventive dental 

measures should be excluded because they do not fit the facts of Mr. D’Agnese’s case 

because prior to initiating Zometa® therapy, Dr. Olshan performed a detailed 

examination of Mr. D’Agnese’s oral cavity and, from that examination, Dr. Olshan 

determined that there was no need for Mr. D’Agnese to undergo an invasive surgery. 

Defendant argues that Dr. Mansfield testified that a warning regarding a pre-prescription 

dental exam is irrelevant in Mr. D’Agnese’s case given Dr. Olshan’s examination. 

Defendant argues that, based on this, a warning to avoid invasive dental procedures while 

on BP therapy is also irrelevant. Defendant argues that Dr. Marx’s opinions regarding 

preventative dental measures should also be excluded because Dr. Marx has no 

scientifically reliable basis upon which to opine that dental treatment measures actually 

prevent BP patients from developing ONJ because he stated that the jury is still out in 

terms of controlled data on that issue. 

 Defendant next argues that Dr. Marx offers the opinion that Defendant ignored 

evidence that bisphosphonates caused ONJ and, thus acted in bad faith. Defendant 

argues that this opinion about Defendant’s state of mind is outside the bounds of his 

expertise and is inadmissible speculation. 

 Defendant next argues that Dr. Marx offers the opinion that NPC’s clinical trials 

were a serious deviation of proper research data recording and jaw and mouth 

examinations were not routinely performed as part of the trial. Defendant argues that this 

opinion should be precluded because Dr. Marx lacks the expertise to evaluate the design 

and conduct of these trials and admits that he used hindsight in reaching the opinions. 

Defendant argues that Dr. Marx lacks the relevant expertise because he admits that he 

never planned or managed any clinical trials relating to bisphosphonates, is not an expert 

in the FDA’s regulation of drug companies, and has never been involved in putting 

together a New Drug Application for submission to FDA. Defendant further argues that 

Dr. Marx is unqualified to offer this opinion because he is not a medical doctor, does not 

prescribe BPs and does not treat patients who require BPs. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 24 of 36
- 25 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

 Defendant next argues that this opinion regarding clinical trials should be 

excluded because Dr. Marx does not offer any evidence that before or during the period 

when the trials were designed or conducted Defendant knew or had reason to know that 

ONJ was a possible side effect of Aredia® or Zometa® therapy. 

 Defendant next argues that Dr. Marx’s opinion that five patients in the clinical 

trials had bisphosphonate-related ONJ are post-hoc diagnoses that do not satisfy one of 

the factors of a BIONJ diagnoses, namely that the patient had exposed bone lasting more 

than eight weeks. Defendant argues that this demonstrates that Dr. Marx’s methodology 

in reaching a diagnosis of ONJ is applied inconsistently and is unreliable. 

 Defendant finally argues that Dr. Marx’s general causation testimony is unreliable 

and that Dr. Marx’s opinions about the biological mechanism by which BP drugs 

allegedly cause ONJ fails because Dr. Marx lacks necessary expertise and the testimony 

is unreliable. With regard to these latter two challenged opinions, the Court finds that the 

MDL Court has already considered these issues and ruled that such testimony is 

admissible when it stated that Dr. Marx’s testimony regarding the causal connection 

between Aredia® and Zometa® and ONJ and treatment and preventive measures for ONJ 

should be admitted pursuant to Federal Rule of Evidence 702. Defendant has failed to 

present any evidence to the Court that the MDL Court did not consider the challenges 

Defendant now makes, or if the MDL Court did not consider those challenges, the 

reasons Defendant did not make such challenges in its earlier motion. These challenges 

do not appear to be specific to Mr. D’Agnese’s case, but rather appear to challenge Dr. 

Marx’s case wide testimony regarding the causal connection between bisphosphonates 

and ONJ. Accordingly, Defendant has presented no convincing reason for this Court to 

reconsider the MDL Court’s decision regarding the admissibility of Dr. Marx’s testimony 

regarding the causal connection between Aredia® and Zometa® and ONJ and treatment 

and preventive measures for ONJ and such testimony should be admitted pursuant to 

Federal Rule of Evidence 702. 

 With regard to the other challenged portions of Dr. Marx’s testimony, Plaintiffs 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 25 of 36
- 26 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

argue that other courts in other districts have ruled on Daubert motions in other cases that 

were part of the MDL and have admitted at least some of the testimony challenged by 

Defendant in the motions before this Court.6

 Plaintiffs do not make any arguments in 

response to Defendant’s challenges to Dr. Marx’s testimony nor do they explain why Dr. 

Marx’s testimony should be admitted under Federal Rule of Evidence 702. 

 Accordingly, Defendant has raised material disputes as to the admissibility of the 

challenged testimony of Dr. Marx, with the exception of the challenged testimony 

concerning general causation and biological mechanism, and, thus, the Court must hold a 

Daubert hearing to determine if Dr. Marx’s opinions on the matters challenged by 

Defendant are admissible under Federal Rule of Evidence 702. If Plaintiffs do not intend 

to offer the challenged testimony of Dr. Marx, Plaintiffs shall file a notice with the Court 

stating that such challenged testimony is not offered within 5 days of the date of this 

Order and the Daubert hearing regarding Dr. Marx’s testimony will be vacated, Dr. 

Marx will not be permitted to testify on the challenged subjects at trial, and the Daubert 

motion will be denied as moot. 

 E. Defendant’s Motion to Exclude Testimony of Dr. Skubitz (Doc. 88) 

Dr. Skubitz is a medical oncologist on the faculty of the University of Minnesota 

Medical School. Plaintiffs intend to present testimony of Dr. Skubitz as a case-wide 

general expert and do not intend to present case specific opinions of Dr. Skubitz 

regarding Mr. D’Agnese’s jaw problems. 

 In the MDL, Defendant filed a Motion to Exclude Testimony of Plaintiffs’ Expert 

Dr. Keith Skubitz. (Doc. 104-15) In that Motion, Defendant challenged Dr. Skubitz’s 

testimony regarding (1) general causation, (2) scientific and medical accuracy of 

warnings given by Defendant (3) extending the dosing interval for patients with 

 

6

 Although the Court gave Plaintiffs the opportunity to explain whether or not res 

judicata would somehow apply to the challenged testimony of Dr. Marx, Plaintiffs have 

not made any argument that res judicata would apply to the opinions challenged by 

Defendant. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 26 of 36
- 27 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

Zometa®, and (3) recommending that patients treated with Aredia® and Zometa® 

receive pre-treatment preventative dentistry to reduce the incidence of ONJ. 

 The MDL Court ruled, that for the purposes of deciding summary judgment, Dr. 

Skubitz’s testimony regarding a general causation connection between Aredia® and 

Zometa® and osteonecrosis of the jaw and the adequacy of Defendant’s warnings about 

that connection should be admitted pursuant to Federal Rule of Evidence 702. (Id.). The 

MDL Court declined to rule on whether Dr. Skubitz’s opinions regarding extending the 

dosing interval for patients treated with Zometa® or recommending that patients treated 

with Aredia® and/or Zometa® receive pre-treatment preventative dentistry to reduce the 

incidence of ONJ should be precluded under Rule 702. (Id.). 

 Defendant argues that Dr. Skubitz’s opinion that reduced dosing may be 

efficacious should be precluded because his belief that reduced dosing may be efficacious 

is supported by nothing except one study, which is not scientifically-reliable evidence 

because it retrospectively reviews a single institution’s records without a control group 

and it is unclear whether ONJ cases described in the study meet Dr. Skubitz’s definition 

of ONJ and is not scientifically reliable evidence on dosing in the multiple myeloma 

population. 

 Defendant next argues that Dr. Skubitz’s opinion that the implementation of 

stronger warnings and preventative measures has reduced the incidence of ONJ is not 

relevant because it does not fit the facts of Mr. D’Agnese’s case. Defendant argues that 

any claim that Mr. D’Agnese would have avoided his alleged ONJ if he had undergone a 

comprehensive dental exam prior to undergoing bisphosphonate therapy is belied by the 

fact that, prior to initiating Zometa® therapy, Dr. Olshan performed a detailed 

examination of Mr. D’Agnese’s oral cavity and, from that examination, Dr. Olshan 

determined that there was no need for Mr. D’Agnese to undergo an invasive surgery. 

Defendant argues that Dr. Mansfield testified that a warning regarding a pre-prescription 

dental exam is irrelevant in Mr. D’Agnese’s case given Dr. Olshan’s examination. 

Defendant further argues that this opinion should be excluded because Dr. Skubitz offers 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 27 of 36
- 28 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

no scientifically reliable evidence to support it. 

 Defendant next argues that Dr. Skubitz’s opinions about labels are not relevant to 

Mr. D’Agnese’s case because Dr. Skubitz testified that he would not offer any opinions at 

trial suggesting that Defendant should have communicated information on ONJ to 

prescribing physicians prior to September 2003. Defendant argues that this does not 

apply to Mr. D’Agnese taking the drugs between 1998 and 2005. 

 Defendant next argues that Dr. Skubitz should not be permitted to testify regarding 

osteopetrosis, pycnodysostosis, or phossy jaw because he testified that he would not 

opine that osteopetrosis and pycnodysotosis should have alerted Defendant to the alleged 

association between Zometa® and ONJ. With regard to this category, the Court cannot 

exclude testimony that Dr. Skubitz does not intend to offer and, thus, Defendant’s request 

for a Daubert hearing on this testimony is denied without prejudice to Defendant making 

any appropriate objections to such testimony at trial. 

 Defendant next argues that Dr. Skubitz should not be permitted to offer the 

opinion that Aredia® and Zometa® labels should have included information regarding 

the incidence rate of ONJ because (1) he cannot say when he believes a five percent rate 

should have appeared on labels, (2) he conceded he would not opine that either the 2003 

Aredia® or Zometa® labels or the March 2004 labels should have included information 

regarding the incidence of ONJ, and (3) he admitted that the only randomized controlled 

studies studying the incidence of ONJ in Zometa® users demonstrated a rate of about one 

percent. 

 Defendant next argues that Dr. Skubitz lacks any qualifications or expertise on 

FDA labeling and should not be permitted to opine on the adequacy of the labeling or 

Defendant’s participation with the FDA regarding the labels. 

 Defendant next argues that Dr. Skubitz should not be permitted to offer opinions 

on general causation. The MDL Court has already considered this issue and ruled that 

such testimony is admissible when it stated that, Dr. Skubitz’s testimony regarding a 

general causation connection between Aredia® and Zometa® and osteonecrosis of the 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 28 of 36
- 29 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

jaw and the adequacy of Defendant’s warnings about that connection should be admitted 

pursuant to Federal Rule of Evidence 702. Defendant has failed to present any evidence 

to the Court that the MDL Court did not consider the challenges Defendant now makes, 

or, if the MDL Court did not consider those challenges, the reasons Defendant did not 

make such challenges in its earlier motion. These challenges do not appear to be specific 

to Mr. D’Agnese’s case, but rather appear to challenge Dr. Skubitz’s case wide testimony 

regarding the causal connection between bisphosphonates and ONJ. Accordingly, 

Defendant has presented no convincing reason for this Court to reconsider the MDL 

Court’s decision regarding the admissibility of Dr. Skubitz’s testimony regarding the 

general causation connection between Aredia® and Zometa® and osteonecrosis of the 

jaw and the adequacy of Defendant’s warnings about that connection and, thus, that 

testimony should be admitted pursuant to Federal Rule of Evidence 702. 

 With regard to the other challenged portions of Dr. Skubitz’s testimony, Plaintiffs 

argue that other courts in other districts have ruled on Daubert motions in other cases that 

were part of the MDL and have admitted at least some of the testimony challenged by 

Defendant in the motions before this Court.7

 Plaintiffs do not make any arguments in 

response to Defendant’s challenges to Dr. Skubitz’s testimony nor do they explain why 

Dr. Skubitz’s testimony should be admitted under Federal Rule of Evidence 702. 

 Accordingly, Defendant has raised material disputes as to the admissibility of the 

challenged testimony of Dr. Skubitz, with the exception of the challenged testimony 

concerning osteopetrosis, pycnodysostosis, or phossy jaw and general causation 

connection between Aredia® and Zometa® and osteonecrosis of the jaw and the 

adequacy of Defendant’s warnings, and, thus, the Court must hold a Daubert hearing to 

determine if Dr. Skubitz’s opinions on the matters challenged by Defendant are 

 

7

 Although the Court gave Plaintiffs the opportunity to explain whether or not res 

judicata would somehow apply to the challenged testimony of Dr. Skubitz, Plaintiffs have 

not made any argument that res judicata would apply to the opinions challenged by 

Defendant. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 29 of 36
- 30 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

admissible under Federal Rule of Evidence 702. If Plaintiffs do not intend to offer the 

remaining challenged testimony of Dr. Skubitz, Plaintiffs shall file a notice with the 

Court stating that such challenged testimony is not offered within 5 days of the date of 

this Order and the Daubert hearing regarding Dr. Skubitz’s testimony will be vacated, Dr. 

Skubitz will not be permitted to testify on the challenged subjects at trial, and the 

Daubert motion will be denied as moot. 

 F. Defendant’s Daubert Motion to Exclude Testimony of Dr. 

 Wayne Ray (Doc. 90) 

Dr. Ray is a statistics/epidemiology professor, who Plaintiffs have retained to give 

the opinion that Aredia® and Zometa® cause ONJ. Defendant seeks to preclude Dr. 

Ray’s testimony in its entirety pursuant to Daubert and Rule 702 because Dr. Ray used 

an unreliable, untested, and non-peer-reviewed methodology. 

 Plaintiffs argue that other courts in other districts have ruled on Daubert motions 

in other cases that were part of the MDL and have admitted at least some of the testimony 

challenged by Defendant in the motions before this Court.8

 Plaintiffs do not make any 

arguments in response to Defendant’s challenges to Dr. Ray’s testimony nor do they 

explain why Dr. Ray’s testimony should be admitted under Federal Rule of Evidence 

702. 

 Accordingly, Defendant has raised material disputes as to the admissibility of Dr. 

Ray’s testimony and, thus, the Court must hold a Daubert hearing to determine if Dr. 

Ray’s opinions are admissible under Federal Rule of Evidence 702. If Plaintiffs do not 

intend to offer testimony of Dr. Ray, Plaintiffs shall file a notice with the Court stating 

that such challenged testimony is not offered within 5 days of the date of this Order and 

the Daubert hearing regarding Dr. Ray’s testimony will be vacated, Dr. Ray will not be 

 

8

 Although the Court gave Plaintiffs the opportunity to explain whether or not res 

judicata would somehow apply to the challenged testimony of Dr. Ray, Plaintiffs have 

not made any argument that res judicata would apply to the opinions challenged by 

Defendant. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 30 of 36
- 31 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

permitted to testify at trial, and the Daubert motion will be denied as moot. 

 G. Defendant’s Daubert Motion to Exclude Testimony of Dr. 

 Parisian (Doc. 89) 

Dr. Parisian is an FDA regulatory expert. Defendant argues that Dr. Parisian seeks 

to testify (1) that Defendant has violated FDA statutes, regulations, guidance documents 

and industry standards, and (2) about Defendant’s corporate conduct, knowledge, and 

communications regarding Aredia® and Zometa® between Defendant and the FDA and 

physicians. Defendant argues that Dr. Parisian’s testimony is inadmissible under 

Daubert and Rule 702 because (1) she is unqualified to opine abut NPC’s compliance 

with drug regulations because her experience at the FDA was solely in the device 

division; (2) her opinions that NPC violated various drug regulations or pharmaceutical 

industry standards are improper legal conclusions; (3) her personal interpretations and 

regurgitation of corporate documents invades the province of the jury and exceeds the 

scope of proper expert testimony, (4) her speculation about NPC’s intent and state of 

mind is improper; (5) her testimony about NPC’s labeling regarding Aredia® and 

Zometa® is irrelevant given the particular facts of this case and (6) she tries to give 

causation testimony, though she admits that she is unqualified to do so. 

 In Response, Plaintiffs argue that Defendant has failed to identify the opinions that 

Dr. Parisian seeks to give in this case, because, although Defendant purports to inform 

the Court what those opinions are, it has not put those opinions in the Record. Indeed, in 

its Motion to Exclude Dr. Parisian’s testimony, Defendant cites to a Report that was 

lodged and attached to a Motion to Seal. However, this Court denied the Motion to Seal 

and, thus, the Report was never filed. This Court cannot rely on documents that are not 

in the Record and cannot rely on Defendant’s regurgitation of Dr. Parisian’s opinions to 

determine if Dr. Parisian’s actual opinions, in this case, are admissible under Daubert or 

Federal Rule of Evidence 702. 

 Accordingly, Defendant has failed to show that there is a material dispute as to the 

admissibility of Dr. Parisian’s opinions and the request for a Daubert hearing and Motion 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 31 of 36
- 32 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

to Exclude Dr. Parisian’s testimony is denied without prejudice to Defendant making 

appropriate objections at trial. 

 H. Defendant’s Daubert Motion to Exclude Testimony of Dr. 

 Fletcher (Doc. 91) 

Although the Daubert Motion regarding the exclusion of testimony of Dr. Fletcher 

has been fully briefed, in their supplement to the Court, Plaintiffs state that “Dr. Fletcher 

is withdrawn and is moot.” (Doc. 137 at 3). Because Plaintiffs do not intend to offer any 

testimony of Dr. Fletcher, Defendant’s Motion to Exclude Dr. Fletcher’s testimony is 

denied as moot. 

 IV. CONCLUSION 

Based on the foregoing, 

IT IS ORDERED that Defendant’s Daubert Motion to Exclude Testimony of 

Plaintiffs’ Non-Retained Experts (Doc. 83) is granted in part and denied in part as 

follows: 

 Defendant’s Daubert Motion to Exclude Testimony of Plaintiffs’ Non-Retained 

Experts (Doc. 83) is granted to the extent it seeks to exclude Dr. Green’s opinion that he 

had no reason to disagree with the opinion that Zometa® caused Mr. D’Agnese’s ONJ. 

With regard to Dr. Green, the Motion is denied in all other respects without prejudice to 

Defendant making appropriate objections at trial. 

 Defendant’s Daubert Motion to Exclude Testimony of Plaintiffs’ Non-Retained 

Experts (Doc. 83) is denied as to the challenges to Dr. Lines’ opinions without prejudice 

to Defendant making appropriate objections at trial. 

 Defendant’s Daubert Motion to Exclude Testimony of Plaintiffs’ Non-Retained 

Experts (Doc. 83) is granted to the extent that it seeks to exclude Dr. Marischen’s opinion 

that he had no reason to disagree with the opinion that Zometa® caused Mr. D’Agnese’s 

ONJ and is denied in all other respects without prejudice to Defendant making 

appropriate objections at trial. 

IT IS FURTHER ORDERED that Defendant’s Daubert Motion to Exclude 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 32 of 36
- 33 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

Testimony of Dr. Mansfield (Doc. 84) is denied. 

IT IS FURTHER ORDERED that the Court will hold a Daubert hearing on 

Defendant’s Daubert Motion to Exclude Testimony of Dr. Vogel (Doc. 85). Such 

hearing will be limited solely to the challenges made in that Motion. Namely, Dr. Vogel’s 

testimony regarding (1) the adequacy of Defendant’s drug labeling; (2) opinions that 

Defendant misrepresented causation evidence, attempted to misdirect the focus of 

medical attention away from the jaw area by referencing corticosteroids, minimized the 

incidence rate of ONJ, knew and failed to communicate that ONJ occurs in patients after 

fewer infusions of Zometa® than Aredia®, knew and failed to communicate that a 

decrease in the duration, dose, and/or frequency of therapy decreases the incidence of 

ONJ; (3) whether Dr. Vogel’s opinions regarding preventive dental measures fit the facts 

of Mr. D’Agnese’s case; (4) that the incidence rate of ONJ in patients on Aredia® and 

Zometa® is generally five percent; (5) that a reduced dosing schedule has shown equal 

efficacy and less risk and that Defendant improperly failed to disseminate information 

about alternative dosing schedules, and (6) that BPs are more likely to accumulate in the 

jaw than in other bones due to higher remodeling rates and higher uptake of 

bisphosphonates. 

 If Plaintiffs do not intend to offer the challenged testimony of Dr. Vogel, IT IS 

ORDERED that Plaintiffs shall file a notice with the Court stating that such challenged 

testimony is not offered within 5 days of the date of this Order and the Daubert hearing 

regarding Dr. Vogel’s testimony will be vacated, Dr. Vogel will not be permitted to 

testify on the challenged subjects at trial, and the Daubert motion will be denied as moot. 

 IT IS FURTHER ORDERED that Defendant’s Motion to Exclude the 

Testimony of Dr. Marx (Doc. 87) is denied in part as follows: 

 Defendant’s Motion to Exclude the Testimony of Dr. Marx (Doc. 87) is denied to 

the extent it seeks to preclude Dr. Marx’s general causation opinions and Dr. Marx’s 

opinions about the biological mechanism by which BP drugs allegedly cause ONJ. 

IT IS ORDERED that the Court will hold a Daubert hearing on the remainder of 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 33 of 36
- 34 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

Defendant’s Motion to Exclude the Testimony of Dr. Marx (Doc. 87) as follows: 

Such hearing will be limited to the following portions of Dr. Marx’s testimony (1) 

whether Dr. Marx’s opinions regarding the adequacy of Defendant’s warnings fit the 

facts of Mr. D’Agnese’s case; (2) whether Dr. Marx’s opinions regarding preventative 

dental measures fit the facts of Mr. D’Agnese’s case; (3) Dr. Marx’s opinion that 

Defendant ignored evidence that bisphosphonates caused ONJ and, thus, acted in bad 

faith; (4) Dr. Marx’s opinion that NPC’s clinical trials were a serious deviation of proper 

research data recording and jaw and mouth examinations were not routinely performed as 

part of the trial; and (5) Dr. Marx’s opinion that five patients in the clinical trials had 

bisphosphonate-related ONJ. 

 If Plaintiffs do not intend to offer the remaining challenged testimony of Dr. Marx, 

IT IS ORDERED that Plaintiffs shall file a notice with the Court stating that such 

challenged testimony is not offered within 5 days of the date of this Order and the 

Daubert hearing regarding Dr. Marx’s testimony will be vacated, Dr. Marx will not be 

permitted to testify on the remaining challenged subjects at trial, and the Daubert motion 

will be denied as moot. 

IT IS FURTHER ORDERED that Defendant’s Motion to Exclude the 

Testimony of Dr. Skubitz (Doc. 88) is denied in part as follows: 

 Defendant’s Motion to Exclude the Testimony of Dr. Skubitz (Doc. 88) is denied 

to the extent it seeks to preclude Dr. Skubitz’s general causation opinions and denied to 

the extent it seeks to preclude testimony not offered by Dr. Skubitz. 

IT IS ORDERED that the Court will hold a Daubert hearing on the remainder of 

Defendant’s Motion to Exclude the Testimony of Dr. Skubitz (Doc. 88) as follows: 

Such hearing will be limited to the following portions of Dr. Skubitz’s testimony: 

(1) Dr. Skubitz’s opinion that reduced dosing may be efficacious; (2) whether Dr. 

Skubitz’s opinion that the implementation of stronger warnings and preventative 

measures has reduced the incidence of ONJ fits the facts of Mr. D’Agnese’s case; (3) Dr. 

Skubitz’s opinion that Aredia® and Zometa® labels should have included information 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 34 of 36
- 35 - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

regarding the incidence rate of ONJ; and (4) Dr. Skubitz’s opinions regarding the 

adequacy of labeling or Defendant’s participation with the FDA regarding labels. 

 If Plaintiffs do not intend to offer the remaining challenged testimony of Dr. 

Skubitz, IT IS ORDERED that Plaintiffs shall file a notice with the Court stating that 

such challenged testimony is not offered within 5 days of the date of this Order and the 

Daubert hearing regarding Dr. Skubitz’s testimony will be vacated, Dr. Skubitz will not 

be permitted to testify on the remaining challenged subjects at trial, and the Daubert 

motion will be denied as moot. 

 IT IS FURTHER ORDERED that Defendant’s Daubert Motion to Exclude the 

Testimony of Dr. Parisian (Doc. 89) is denied without prejudice to Defendant making 

appropriate objections at trial. 

IT IS FURTHER ORDERED that the Court will hold a Daubert hearing on 

Defendant’s Daubert Motion to Exclude the Testimony of Wayne Ray (Doc. 90). 

 If Plaintiffs do not intend to offer the testimony of Dr. Ray, IT IS ORDERED 

that Plaintiffs shall file a notice with the Court stating that such challenged testimony is 

not offered within 5 days of the date of this Order and the Daubert hearing regarding Dr. 

Ray’s testimony will be vacated, Dr. Ray will not be permitted to testify at trial, and the 

Daubert motion will be denied as moot. 

IT IS FURTHER ORDERED that Defendant’s Daubert Motion to Exclude the 

Testimony of Dr. Fletcher (Doc. 91) is denied as moot. 

 

/// 

// 

/ 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 35 of 36
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

M

th

D

W

W

IT IS

Motion to E

he Testimon

Dr. Skubitz 

Wayne Ray

Washington 

Dated

S FINALLY

Exclude Tes

ny of Dr. M

(Doc. 88),

y (Doc. 90

Street, in C

d this 28th d

Y ORDER

stimony of 

Marx (Doc. 

, and Defen

0) for Thu

Courtroom 5

day of Janu

- 36

RED setting

Dr. Vogel 

87), Defen

ndant’s Da

ursday, Feb

503, in Pho

uary, 2013.

6 - 

g a Daubert

(Doc. 85),

ndant’s Mo

aubert Moti

bruary 14, 

oenix, Arizo

t hearing on

, Defendan

tion to Exc

ion to Excl

2013 at 9

ona. 

n Defendan

nt’s Motion 

clude the Te

lude the Te

9:00 a.m. 

nt’s Dauber

to Exclude

estimony o

estimony o

at 401 W

rt 

e

f 

f 

W. 

Case 2:12-cv-00749-JAT Document 139 Filed 01/28/13 Page 36 of 36