govinfo:USCOURTS-njd-1_08-cv-00008-5

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 UNITED STATES DISTRICT COURT 
DISTRICT OF NEW JERSEY 
 
 
 : 
IN RE: FOSAMAX (ALENDRONATE SODIUM) : 
PRODUCTS LIABILITY LITIGATION : 
 : 
_________________________________________ : 
 : 
BERNADETTE GLYNN and RICHARD GLYNN, : Civil Action No. 11-5304, 08-08 
 : 
 Plaintiffs, : OPINION 
 : 
 v . : 
MERCK SHARP & DOHME CORP, : 
 : 
 Defendant. : 
 : 
 
PISANO, District Judge 
 
  Plaintiffs Bernadette Glynn and Richard Glynn (“Plaintiffs”) brought this lawsuit against 
Defendant Merck, Sharp, & Dohme Corp. (“Defendant”), the manufacturer of Fosamax, which is 
a drug approved by the United States Food and Dr ug Administration (“FDA”) for the treatment 
and prevention of osteoporosis. This matter is part of the multi-district litigation concerning 
Fosamax and involves allegations that Fosa max causes atypical femur fractures (“AFFs 1”), it 
caused Plaintiff Mrs. Glynn’s femur fracture, a nd Defendant failed to warn physicians about 
Fosamax and AFFs. Presently before the Cour t is Defendant’s Motion for Summary Judgment 
on Plaintiffs’ failure to warn, breach of implied warranty of fitness for a particular purpose, and 
New York General Business Law cl aims as well as on Plaintiffs ’ request for punitive damages 
                                                             
1 The abbreviation of atypical femur fracture (singular) is “AFF.” PageID:
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[docket # 24]. 2 This Court heard oral argument on the Motion on March 8, 2013 and April 2, 
2013. See Fed. R. Civ. P. 78. For the reasons discusse d below, this Court will deny the Motion 
as to the failure to warn, breach of implied warranty of fitness for a particular purpose, and 
punitive damages claims and grant the Motion as to the New York General Business Law claims. 
I. BACKGROUND 
A. Fosamax and Label Change 
In September 2005, the FDA approved Fosama x for the treatment of osteoporosis in 
postmenopausal women, and in April 2007, the FDA approved Fosamax for the prevention of 
osteoporosis in postmenopausal women. Since this time, Fosamax has remained FDA approved 
for the treatment and prevention of postmenopausal osteoporosis. 
On June 13, 2008, a representative from the FDA e-mailed Defendant , stating that the 
FDA is “aware of reports regarding the occurrence of subtrochanteric hip fractures in patients 
using bisphosphonates” and is “concerned about this developing safety signal” [docket # 101, 
Declaration of James E. Cecchi in Support of the Memorandum of Law in Opposition to 
Defendant’s Motion for Summary Judgment (“C ecchi Dec.”), Ex. 82]. The FDA requested any 
investigations Defendant conducted “regarding the occurrence of at ypical fractures with 
bisphosphonate use as well as any investigational plans” and “all hip and femoral fracture case 
reports” Defendant received. Id. 
On September 15, 2008, Defendant submitted a Prior Approval Supplement to the FDA, 
proposing “to add language to both the Pr ecaution and Adverse Reaction/Post-Marketing 
                                                             
2 Defendant’s initially moved for Summary Judgment on several more causes of action [ see docket # 24], but 
Plaintiffs decided not to pursue certain claims and only th e failure to warn, breach of implied warranty of fitness for 
a particular purpose, New York General Busine ss Law, and punitive damages claims remain [ see docket # 95, p. 1, 
n. 1]. PageID:
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Experience section[s] of the label to desc ribe low-energy” femo ral fractures of the 
subtrochanteric region [docket # 27, Declaration of Karen A. C onfoy in Support of Defendant’s 
Motion for Summary Judgment (“C onfoy Dec.”), Ex. 8]. Defendant stated that “[i]t is not 
possible with the present data to establish whether treatment with” Fosamax increases the risk of 
these fractures, but because there is a temporal association between these fractures and Fosamax, 
Defendant thought that it was “impor tant to include an appropriate statement about them in the 
product label.” Id. On April 15, 2009, an FDA representa tive e-mailed Defendant and stated 
that the proposed label change would be approved for inclusi on in the Postmarketing Adverse 
events section of the label but not in the Precaution section of the label [docket # 101, Cecchi 
Dec., Ex. 83]. The FDA representative informed Defendant that it woul d work with Defendant 
to decide on language to include in the Warn ings and Precautions se ction of the label. Id. On 
May 22, 2009, the FDA formally responded to Defendant’s proposed label change, 
recommending that it add “low energy femoral sh aft and subtrochanteric fractures” to the 
Adverse Reactions, Post-Marketi ng Experiences subsection of th e label; however, the FDA did 
not approve the inclusion of AFFs in the Precau tions section of the la bel because Defendant’s 
“justification for the proposed PRECAUTIONS s ection language is inadequate” [docket # 26, 
Confoy Dec., Ex. 11]. 
In October 2010, the FDA issued a Drug Sa fety Communication, warning the public 
about the risk of AFFs in patients who ta ke bisphosphonates, such as Fosamax, for the 
prevention and treatment of osteoporosis [doc ket # 26, Confoy Dec., Ex. 15]. The FDA noted 
that it would require all bis phosphonate manufacturers to add th is information to the Warning 
and Precautions section of the drug labels and require a new Limita tions of Use statement in the 
Indications and Usage section of the labels because “these atypica l fractures may be related to PageID:
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long-term . . . bisphosphonate use.” Id. The current prescribing information for Fosamax 
includes the following information: “Atypical, low-energy, or low trauma fractures of the 
femoral shaft have been reported in bisphosphonate-treated patients. . . . Causality has not been 
established as these fractures also occur in oste oporotic patients who have not been treated with 
bisphosphonates. Atypical femur fractures[ 3] most commonly occur with minimal or no trauma 
to the affected area” [docket # 26, Confoy Dec., Ex. 20]. 
 B. Mrs. Glynn’s Treatment 
 In 2002, Mrs. Glynn’s primary care doctor, Dr. Murat Acemoglu (“Dr. Acemoglu”), 
requested that she undergo a DEXA scan to measure her bone mineral density. After reviewing 
the DEXA scan results, Dr. Acemoglu diagnosed her with “osteopenia – osteoporosis” [docket # 
27, Confoy Dec., Ex. 27 & 28]. Dr . Acemoglu prescribed Fosama x to Mrs. Glynn but did not 
give her anything to read about Fosamax at that time [docket # 26, Confoy Dec., Mrs. Glynn 
Deposition (“Dep.”), at 175:25-176:1; docket # 100, Cecchi Dec., Ex. 58]. Mrs. Glynn testified 
that Dr. Acemoglu told her to take Fosamax once a week, to drink a lot of water when taking it, 
and not to lie down after taking the pill [docket # 26, Confoy D ec., Ex. 26, Mrs. Glynn Dep., at 
175:10-13, 176:8-13]. She read the prescribing information that came with her prescription of 
                                                             
3  In 2010, the American Soci ety for Bone and Mineral Research (“ASBMR”) defined AFF by listing its Major 
Features, which are required to satisfy the definition of AFF, and Minor Features, whic h may be associated with 
AFFs but are not required characteristic s of them [docket # 26, Confoy Dec., Ex. 13]. The Major Features of an 
AFF are: (1) that it is “located anywhere along the femur from the distal to the lesser trochanter to just proximal to 
the supracondylar flare”; (2) “associated with no trauma or minimal trauma, as in a fall from a standing height or 
less”; (3) transverse or short oblique configuration; (4) noncomminuted; and (5) complete fractures extend through 
both cortices and may be associated w ith a medial spike, incomplete fractures involve only the lateral cortex. Id. 
The Minor Features of an AFF are: (1) localized periosteal reaction of the lateral cortex; (2) generalized increase in 
cortical thickness of the diaphysis; (3) prodromal symptoms such as dull or aching pain in the groin or thigh; (4) 
bilateral fractures and symptoms; (5) delayed healing; (6) comorbid conditions (e.g., vitamin D deficiency, 
rheumatoid arthritis, hypo sphosphotasia); and (7) us e of pharmaceutical agents (e.g., bisphosphonates, 
glucocorticoids, and proton pump inhibitors). Id. PageID:
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Fosamax, although she does not remember “word for word what it said” except that one should 
not lie down after taking the drug. Id. at 176:14-177:2. Mrs. Glynn di d not see any advertising 
for Fosamax. In July 2005, Dr. Acemoglu passed away. 
 After Dr. Acemoglu passed away, Mrs. Glynn r eceived primary care treatment from Drs. 
Jessica Berman (“Dr. Berman”) and Adrian Karatnycky (“Dr. Kara tnycky”) [docket #101, 
Cecchi Dec., Ex. 69, Dr. Karatnycky’s Deposition (“Dr. Karatnycky Dep.”), at 97:9-13), and 
Nurse Darlene Hoffman (“Nurse Hoffman”) at Troy Internal Medicine. Additionally, since 
1997, Dr. Laura Costello (“Dr. Costello”), an OB/ GYN, treated her. Drs. Berman, Costello, and 
Karatnycky, and Nurse Hoffman each prescribed Mrs. Glynn Fosamax, and she took the drug or 
a generic version of it until April 2009, when she fractured her femur [docket # 100, Cecchi 
Dec., Ex. 61 & 62]. 
Dr. Berman treated Mrs. Glynn once, on A ugust 31, 2005, and she refi lled Mrs. Glynn’s 
Fosamax prescription at that time [docket # 100, Cecchi Dec., Ex. 60, Dr. Berman’s Deposition 
(“Berman Dep.”), at 6:7-12, 9:1-2, 68:19-69:9]. Dr. Berman testif ied that her decision to refill 
Mrs. Glynn’s Fosamax prescription was appropria te [docket # 26, Ex. 31, Confoy Dec., Berman 
Dep., 87:11-14]. She testified that “had [she] known in 2005 when [she] continued M[r]s. Glynn 
on Fosamax what [she] know[s] today about femu r fractures, that information wouldn’t have 
changed [her] decision to conti nue M[r]s. Glynn on Fosamax.” Id. at 87:18-88:2. Although Dr. 
Berman continues to prescribe the generic, al endronate, to patients because “any risks are 
outweighed by the benefit of re ducing a fracture by 50 percent,” id. at 87:4-10, she no longer 
prescribes biphosphonates to patients to prevent osteoporosis; she made this change “between 
three to five years ago” [docket # 100, Cecchi Dec., Ex. 60, Berman Dep., at 36:4-12]. In 
addition, Dr. Berman now suggests a drug holiday to her patients after five years. Id. at 50:2-4. PageID:
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Dr. Costello wrote Mrs. Glynn prescriptions for Fosamax and the generic, alendronate, in 
2005, 2006, 2007, and 2009 [docket # 100, Cecchi Dec., Ex. 55, Dr. Costello’s Deposition 
(“Costello Dep.”), at 171:3-12; Ex. 60 & 61]. During this time, Dr. Costello still considered 
Mrs. Glynn’s primary care physician to be managi ng her bones, but Dr. Costello would write the 
Fosamax prescriptions as a matter of convenience [docket # 100, Cecchi Dec., Ex. 55, Costello 
Dep., at 108:3-17]. Prior to writing a prescripti on for Fosamax, Dr. Costello evaluated Mrs. 
Glynn to determine whether the benefits of Fo samax outweighed the risks for her, and Dr. 
Costello found that they did. Id. at 97:6-21. Dr. Costello te stified that she undertook this 
benefits and risk analysis several times when refilling Mrs. Glynn’s Fosamax prescription, see id. 
at 99:21-100:1; 103:12-19, but at one point in her testimony, Dr. Co stello states that she “can’t 
remember” going over the risk and benefit analys is of Fosamax with Mrs. Glynn, although it 
was something she typically did. Id. at 163:4-16. 
Dr. Costello further testified that she still prescribes Fosamax to her patients for the 
treatment and prevention of osteoporosis. Id. at 50:14-24; 130:14-21. She continues to prescribe 
Fosamax because she “believe[s] that the slight risk of an atypical femu r fracture is outweighed 
by [the] overall benefit of reducing all the other types of fractures.” Id. at 131:15-24; see also id. 
at 53:16-54:1. She does not specif ically tell her patients the risk of AFF, however, because they 
are a “very low risk.” Id. at 61:6-18. Yet, Dr. Costello then stated that she does discuss AFFs “if 
a woman has been on Fosamax for [a] period of time” because they are a “serious adverse effect” 
and “it’s something important for them to know so they can make an informed decision.” Id. at 
178:1-18. She testified that she relies on the FDA’s approved label of a drug when deciding 
whether to prescribe the drug to her patients and she familiarizes herself with the risk 
information contained in the label; she also tries to keep up with the FDA’s changes to the label. PageID:
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Id. at 30:17-31:9; 14-:8-24. Dr . Costello’s prescribing pract ices regarding Fosamax have 
changed; in fact, her prescrip tions decreased, and she is pres cribing “calcium and vitamin D 
more than Fosamax.” Id. at 51:1-7. She explained that she changed her behavior because 
“atypical fractures . . . raised a flag.” Id. at 52:7-11. 
It appears that Dr. Karatnycky prescribed Fosamax to Mrs. Glynn in 2006 and wrote 
three refill prescriptions for Fosamax in 2007 [docket # 101, Cecchi Dec., Ex. 61; Ex. 69, Dr. 
Karatnycky’s Deposition (“Karatnycky Dep.”), at 62:24-63:9; Ex. 70]. In 2006, a DEXA bone 
scan revealed that Mrs. Glynn’s bone mineral density improved. Based on these results, he 
opined that “Fosamax was having a beneficial e ffect for Mrs. Glynn in terms of increasing her 
bone mass” [docket # 26, Confoy Dec., Ex. 32, Karatnycky Dep., at 89:2-21]. He finds Fosamax 
effective for treatment of patients with osteoporo sis, and he “assume[s] . . . that . . . improving 
the bone density with . . . Fosamax would naturally reduce the risk of osteoporotic fractures.” Id. 
at 59:14-60:18. Dr. Karatnycky te stified that if there “was a warning saying that Fosamax was 
associated with femur fractures,” then that “would have possibly trig gered a communication” 
with Mrs. Glynn, especially if he had seen her for an office visit [docket # 101, Cecchi Dec., Ex. 
69, Karatnycky Dep., at 206:5-18]. He states that if the information was in the label’s warning 
section, he would have “passed that [infor mation] along” and “possibly even stopped the 
Fosamax at that point.” Id. at 82:15-83:8; 207: 2-5. He relies on the information in the label to 
inform him about the risk and benefits of a drug. Id. at 18:15-20. 
Dr. Karatnycky changed his prescribing hab its in 2011 and now has a “conversation with 
. . . patients after five years or three to five years about whether they should take the medication.” 
Id. at 184:20-185:6. This change in prescribin g habits was based on the published data on the 
“increased risk of atypical fractures.” Id. at 185:13-186:4. Dr. Karatnycky testified that he PageID:
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would take patients off Fosamax if they are “no longer severely osteopenic” but will continue the 
drug if the patient continues to be osteopenic. Id. at 186:16-187:10. 
Nurse Hoffman wrote Fosamax or alendrona te sodium prescriptions for Mrs. Glynn 
beginning in 2008. She testified th at her decision to continue Mrs. Glynn on Fosamax in 2008 
was appropriate [docket # 101, Cecchi Dec., Ex. 71, Nurse Hoffman’s Deposition (“Hoffman 
Dep.”) at 122:16-19]. Nurse Hoffman has found Fo samax to be effective for the treatment and 
prevention of osteoporosis, and she relies on a drug’s labeling “in considering whether to 
prescribe medication for a patient.” Id. at 39:11-14; 70:8-14. Add itionally, she testified that 
“had [she] known then what [s he] know[s] today about this issu e of fracture,” she would have 
probably had “a different discussion with” Mrs. Glynn regarding Fosamax. Id. at 122:20-123:4. 
A couple of years ago, Nurse Hoffman began r ecommending that patients consider going off 
Fosamax after five years. Id. at 76:12-17. 
 C. Mrs. Glynn’s Femur Fracture 
On April 17, 2009, Mrs. Glynn sustained a fractur e to her right femur. Final Pretrial 
Order ¶ 3. An ambulance took Mrs. Glynn to St. Mary’s Hospital in Troy, New York where Dr. 
Frederick Fletcher operated on her [docket # 26, Confoy Dec., Ex. 41, Dr. Fletcher’s Deposition 
at 48]. About a year after the fracture, Dr. Flet cher examined Mrs. Glynn and said the fracture 
“healed beautifully,” although he noted that she wa s still complaining of some pain. Id. at 80:1-
19. In August 2009, approximately four months after her surger y, Mrs. Glynn began biking and 
swimming again. [docket # 27, Confoy Dec., Ex. 42]. PageID:
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 D. Plaintiffs’ Complaint 
On September 15, 2011, Mrs. Gl ynn directly filed a Complaint in this Court against 
Defendant, alleging causes of act ion for: (1) failure to warn; (2) defective design; (3) 
negligence; (4) negligent misrepresentation; (5 ) breach of express warranty; (6) breach of 
implied warranty of fitness for a particular purpose; (7) breach of implied warranty of 
merchantability; (8) violation of the Consumer Fra ud Act, N.J.S.A. 56:8-2 et seq.; (9) violations 
of the New York General Business Law (N.Y. Gen. Bus. Law §§ 349 et seq. and 350 et seq.); 
(10) unjust enrichment; (11) punitive damage s pursuant to the N.J. Product Liability Act 
(N.J.S.A. 2A:58C-1 et seq.) an d the N.J. Punitive Damages Ac t (N.J.S.A. 2A:15-5.10, et seq.); 
and (12) loss of consortium on behalf of Plai ntiff Richard Glynn [docket # 1]. Defendant moved 
for summary judgment on January 15, 2013 [docket #24] . Subsequently, Plaintiffs decided to 
pursue only the following claims: (1) failure to warn; (2) breach of the implied warranty of 
fitness for a particular purpose; (3) violations of the New York General Business Law; and (4) 
punitive damages; therefore, Defendant’s Motion for Summary Judgment applies to these claims 
only. 
II. DISCUSSION 
A. Summary Judgment Standard 
To prevail on a motion for summary judgment, the moving party must establish “that 
there is no genuine dispute as to any material fact and the movant is entitled to judgment as a 
matter of law.” Fed. R. Civ. P. 56(a). In determ ining whether a genuine dispute of material fact 
exists, the court must view the facts in the light most favorable to the nonmoving party and 
extend all reasonable inferences to that party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., PageID:
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475 U.S. 574, 587 (1986); Stephens v. Kerrigan , 122 F.3d 171, 176–77 (3d Cir. 1997). The 
Court is not required to “weigh the evidence and determine the truth of the matter” but instead 
need only determine whether a genuine issue necessitates a trial. Anderson v. Liberty Lobby, 
Inc., 477 U.S. 242, 249 (1986). A materi al fact raises a “g enuine” issue “if the evidence is such 
that a reasonable jury could return a verdict for the nonmoving party.” Id. at 248. 
On a summary judgment motion, the moving party bears the initial burden of 
demonstrating the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 
317, 323 (1986). If the moving party makes this showing, the burden shifts to the nonmoving 
party to present evidence that a ge nuine fact issue compels a trial. Id. at 324. The nonmoving 
party must then offer admissible evidence that establishes a genuine i ssue of material fact, id., 
not just “some metaphysical doubt as to the material facts.” Matsushita Elec. Indus. Co. , 475 
U.S. at 586. 
 B. Failure to Warn 4 
 Defendant argues that summary judgment must be granted because Plaintiffs are unable 
to establish the proximate cause element of failure to warn since none of Mrs. Glynn’s 
prescribing doctors testified that a different warning would have changed their decision to 
prescribe Fosamax. Plaintiffs, however, assert that summary judgment should be denied because 
material issues of fact exist regarding whether Defendant’s failure to warn Mrs. Glynn’s doctors 
about AFFs was a proximate cause of her injuri es. Plaintiffs contend that proximate cause 
requires them to show that an appropriate warn ing would have changed the manner in which the 
drug was prescribed and not that it would have changed a doct or’s decision to prescribe 
                                                             
4 The parties agree that New York law go verns Plaintiffs’ substantive claims. See Final Pretrial Order at 32 [docket 
# 150]. PageID:
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Fosamax. For example, Plaintiffs claim that pr escribing the drug in a different manner includes 
the doctor passing on new warnings, having a detailed discussion with the patient, 
recommending a drug holiday, and engaging in an individual patient analysis. Moreover, 
Plaintiffs argue that New York’s heeding pr esumption applies, meaning if a warning was 
provided to the prescribing doctor, he or she woul d have heeded that warning. Lastly, Plaintiffs 
point out that to the extent he r prescribing doctors provided conflicting testimony, the testimony 
should be assessed by a trier of fact. Defendant s replied, arguing that Pl aintiffs cannot prove 
failure to warn where a different warning would not have changed Mrs. Glynn’s doctors’ 
prescribing decisions. Defendants point out that none of Mrs. Glynn’ s doctors testified that they 
would not have prescribed Fosamax to Mrs. Glynn if the label contained its current warnings. 
 “Under New York law, a failur e to warn claimant must show (1) that a manufacturer has 
a duty to warn (2) against dangers resulting from foreseeable uses about which it knew or should 
have known and (3) that failure to do so was the proximate cause of harm.” In re Fosamax 
Products Liab. Litig. (Scheinberg v. Merck & Co.) , 2013 WL 76140, *3 (S.D.N.Y. Jan. 7, 2013). 
To “establish proximate causation in a failure to warn claim resulting from a pharmaceutical 
product, a plaintiff must show th at an appropriate warning would have affected the course of 
treatment of the plaintiff’s physician.” Id. at *4. Stated differently, th e plaintiff must show that 
“had a different, more accurate warning[] been given, his physician woul d not have prescribed 
the drug in the same manner.” Alston v. Caraco Pharmaceutical, Inc., 670 F. Supp. 2d 279, 285 
(S.D.N.Y. 2009). New York’s learned intermediary doctrine provides that “the duty to warn is 
met by providing information to the prescribing physic ian, not to the pa tient directly.” Id. at 
284; see also Mulhall v. Hannafin, 45 A.D.3d 55, 58, 841 N.Y.S.2d 282 (N.Y. App. Div. 2007). PageID:
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 Here, the Court has reviewed the testimony of Drs. Berman, Costello, Karatnycky, and 
Nurse Hoffman and finds conflicting testimony regarding whether an appropriate Fosamax 
warning would have affected the course of treatment of Mrs. Gl ynn’s prescribing physicians or 
changed the manner in which they prescribed the drug to her. Although Drs. Berman, Costello, 
Karatnycky, and Nurse Hoffman have testified that they changed the manner in which they 
prescribe Fosamax, they have not definitively st ated, with the exception of Dr. Berman who saw 
Mrs. Glynn once, whether an appropriate warning would have affected the doctors’ prescribing 
practices regarding Mrs. Glynn. See docket # 26, Confoy Dec., E x. 31, Berman Dep., at 87:18-
88:2; docket # 100, Cecchi Dec., Ex. 55, Costel lo Dep., at 52:7-11, 132:1-10; docket # 100, 
Cecchi Dec., Ex. 60, Berman Dep., at 36:4-12, 50:2-4; docket # 101, Cecchi Dec., Ex. 69, 
Karatnycky Dep., at 82:15-83:8, 184:20-185:6, 206:5-18, 207:2-5; docket # 101, Cecchi Dep., 
Ex. 71, Hoffman Dep., at 76:12-17, 122: 16-123:4. As a result, “[i] t is for the jury to decide 
which of [the doctors’ statements] to credit.” In re Fosamax Products Liab. Litig. , 2013 WL 
76140, at *4. Therefore, this Court will de ny Defendant’s Motion for Summary Judgment 
without prejudice as to failure to warn. 
 C. Breach of Implied Warranty of Fitness for a Particular Purpose 
 Defendant argues that summary judgment should be granted because it did not breach an 
implied warranty of fitness for a pa rticular purpose. Defendant as serts that Fosamax is intended 
and FDA approved for the particular purpose of treating and preventing osteoporosis, and there 
is no evidence that its statem ents about Fosamax’s efficacy, which are approved by the FDA, 
were false, misleading, and inaccurate. In addi tion, Defendant contends that it never warranted 
that Fosamax was without risk to a person’ s body and health and notes that prescription 
medications have known risks. PageID:
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 Plaintiffs argue that Mrs. Glynn and her prescribing doctors relied on Defendant’s 
representations that Fosamax was an appropriate treatment for her osteopenia, and they expected 
that Fosamax would improve her bone density a nd prevent fractures; instead, the drug allegedly 
caused Mrs. Glynn’s AFF. 
 Defendants replied, arguing that using Fosama x for the purpose of tr eating or preventing 
osteoporosis, its FDA approved use, is not a pa rticular purpose, but th e “normal, regular, 
expected purpose” of the drug (Drb7) 5 . Defendants contend that if using Fosamax to treat or 
prevent osteoporosis is a particular purpose, then Fosamax is fit for that purpose because of its 
continued FDA approval. Lastl y, Defendant argues that this claim stems from Mrs. Glynn’s 
misunderstanding of what the Fosamax label said regarding the drug’s benefits; Defendant never 
communicated to Mrs. Glynn’s “doctors that Fosamax prevents all fractures at all sites of the 
body in all patient populations (both osteoporotic and osteopenic)” (Drb7). 
 To establish a breach of an implied warrant y of fitness for a part icular purpose, “the 
buyer must establish that the se ller had reason to know, at the ti me of contracting, the buyer’s 
particular purpose for which the goods are require d and that the buyer was justifiably relying 
upon the seller’s skill and judgment to select and furnish suitable goods, and that the buyer did in 
fact rely on that skill . . . .” Saratoga Spa & Bath, Inc. v. Beech Sys. Corp. , 656 N.Y.S.2d 787, 
790 (N.Y. App. Div. 1997). Thus, the “existence of this warranty . . . depends in part upon the 
comparative knowledge and skill of the parties.” Id. 
 Here, the Court finds that material issues of fact exist regardi ng the particular purpose 
element of Mrs. Glynn’s claim. Defendant argues that the particular purpose, if there is one, is 
                                                             
5 Any citations to Drb7 mean Defendant’s reply brief at page 7. Likewise, any citations to “Db” and a number or 
“Pb” and a number mean Defendant or Plaintiffs’ brief at a page number. PageID:
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the treatment and prevention of os teoporosis while Plaintiffs argue that the purpose was to treat 
osteoporosis and reduce fractures. In addition, it is unclear ex actly what implied warranty, if 
any, Defendant communicated to the prescribi ng physicians. Because Defendant has not 
demonstrated the absence of a genuine issue of material fact and it is unclear whether it is 
entitled to judgment as a matter of law on this claim, this Court will deny summary judgment 
without prejudice. 
 C. Violations of New York General Business Law 
 In their Complaint, Plaintiffs allege that Defendant violated tw o sections of the New 
York General Business Law: § 349 and § 350. Defendant argues that summary judgment should 
be granted because (1) Plaintiffs cannot show re liance on any Fosamax advertising or marketing, 
meaning the § 350 claim fails; and (2) Plaintiffs § 349 claim is preempted by federal law. 
 Section 349 of the New York General Busine ss Law provides that “[d]eceptive acts or 
practices in the conduct of any business, trade or commerce or in the furnishing of any service in 
this state are hereby declared unlawful.” N.Y. GEN. BUS. LAW § 349(a). Section 350 states 
“[f]alse advertising in the conduct of any business, trade or commerce or in the furnishing of any 
service in this state is hereby declared unlawful.” N.Y. GEN. BUS. LAW § 350. “These statutes 
on their face apply to virtually all economi c activity, and their a pplication has been 
correspondingly broad.” Goldych v. Eli Lilly & Co. , 2006 WL 2038436, *6 (N.D.N.Y. Jul. 19, 
2006). The “elements for both of these causes of action are (i) that defendants engaged in 
conduct that was misleading in a material resp ect; (ii) the deceptive conduct was ‘consumer 
oriented’; and (iii) that the plaintiff was injured ‘by reason of’ defendant’s conduct.” Id. 
“[C]ompliance with FDA warning requirements is a complete defense” to both of these statutes. PageID:
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Am. Home Products Corp. v. Johnson & Johnson , 672 F. Supp. 135, 144 (S.D.N.Y. 1987); see 
also N.Y. GEN. BUS. LAW §349(d) (providing “it shall be a co mplete defense that the act or 
practice is . . . subject to and complies with the rules and regulations of, and the statutes 
administered by, the federal trade commission or any official department , division, commission 
or agency of the United States”); N.Y. GEN. BUS. LAW §350-c (stating it shall be a complete 
defense if an individual presents “evidence that the advertisement is subject to and complies with 
the rules and regulations of, and the statutes administered by, the Federal Trade Commission”); 
Am. Home Products Corp. , 672 F. Supp. at 144 (recognizing th at “New York courts have 
construed” § 350-c “to cover regul ations by other federal agencies ” as well as the Federal Trade 
Commission). 
 The Court will grant Defendant’s Motion fo r Summary Judgment as to §§ 349 and 350. 
Fosamax is approved by the FDA, and therefore, this approval is a comp lete defense to a § 349 
claim. See Cytyc Corp. v. Neuromedical Sys., Inc. , 12 F. Supp. 2d 296, 301 (S.D.N.Y. 1998); 
Am. Home Products Corp. v. Johnson & Johnson, 672 F. Supp. 135, 144 (S.D.N.Y. 1987). 
Regarding § 350, Plaintiffs cannot bring an action for false advertising because the 
parties have stipulated that “Mrs. Glynn does not claim to ha ve seen any advertising for 
Fosamax.” Final Pretrial Order, p. 3. 
Because there is no genuine issue of material fact regarding these claims, Defendant is 
entitled to judgment as a matter of law, and its Motion for Summar y Judgment is granted as to 
Plaintiffs’ New York General Business Law claims. PageID:
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16 
 
 D. Punitive Damages 
 The parties dispute the choice of law standard that applies to punitive damages. Plaintiffs 
argue that New York or Pennsylvania law applie s while Defendant asserts that New Jersey law 
applies. This Court denies summary judgment b ecause it needs a trial re cord to decide which 
states’ law applies to punitive damages. The Motion may be renewed at the close of Plaintiffs’ 
case. 
III. CONCLUSION 
For these reasons, the Court denies Defenda nt’s Motion for Summar y Judgment without 
prejudice as to failure to warn, breach of implied warranty of fitness for a particular purpose, and 
punitive damages and grants the Motion as to New York General Business Law §§ 349 and 350. 
An Order accompanies this Opinion. 
Dated: April 11, 2013 
/s/ Joel A. Pisano 
JOEL A. PISANO 
United States District Judge PageID:
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