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In Re: Fosamax (Alendronate Sodium Products Liability Litigation v. Merck Sharp & Dohme Corp

April 11, 2013


The opinion of the court was delivered by: 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 Drug Administration ("FDA") for the treatment and prevention of osteoporosis. This matter is part of the multi-district litigation concerning Fosamax and involves allegations that Fosamax causes atypical femur fractures ("AFFs*fn1 "), it caused Plaintiff Mrs. Glynn's femur fracture, and Defendant failed to warn physicians about Fosamax and AFFs. Presently before the Court 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 claims as well as on Plaintiffs' request for punitive damages [docket # 24].*fn2 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 discussed 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.


A. Fosamax and Label Change

In September 2005, the FDA approved Fosamax 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 ("Cecchi Dec."), Ex. 82]. The FDA requested any investigations Defendant conducted "regarding the occurrence of atypical 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 Precaution and Adverse Reaction/Post-Marketing Experience section[s] of the label to describe low-energy" femoral fractures of the subtrochanteric region [docket # 27, Declaration of Karen A. Confoy in Support of Defendant's Motion for Summary Judgment ("Confoy 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 "important to include an appropriate statement about them in the product label." Id. On April 15, 2009, an FDA representative e-mailed Defendant and stated that the proposed label change would be approved for inclusion 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 would work with Defendant to decide on language to include in the Warnings and Precautions section 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 shaft and subtrochanteric fractures" to the Adverse Reactions, Post-Marketing Experiences subsection of the label; however, the FDA did not approve the inclusion of AFFs in the Precautions section of the label because Defendant's "justification for the proposed PRECAUTIONS section language is inadequate" [docket # 26, Confoy Dec., Ex. 11].

In October 2010, the FDA issued a Drug Safety Communication, warning the public about the risk of AFFs in patients who take bisphosphonates, such as Fosamax, for the prevention and treatment of osteoporosis [docket # 26, Confoy Dec., Ex. 15]. The FDA noted that it would require all bisphosphonate manufacturers to add this information to the Warning and Precautions section of the drug labels and require a new Limitations of Use statement in the Indications and Usage section of the labels because "these atypical fractures may be related to 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 osteoporotic patients who have not been treated with bisphosphonates. Atypical femur fractures[*fn3 ] 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 Fosamax 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 Dec., Ex. 26, Mrs. Glynn Dep., at 175:10-13, 176:8-13]. She read the prescribing information that came with her prescription of 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 did not see any advertising for Fosamax. In July 2005, Dr. Acemoglu passed away.

After Dr. Acemoglu passed away, Mrs. Glynn received primary care treatment from Drs. Jessica Berman ("Dr. Berman") and Adrian Karatnycky ("Dr. Karatnycky") [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 August 31, 2005, and she refilled 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 testified that her decision to refill Mrs. Glynn's Fosamax prescription was appropriate [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 femur fractures, that information wouldn't have changed [her] decision to continue M[r]s. Glynn on Fosamax." Id. at 87:18-88:2. Although Dr. Berman continues to prescribe the generic, alendronate, to patients because "any risks are outweighed by the benefit of reducing 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.

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 managing 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 prescription for Fosamax, Dr. Costello evaluated Mrs. Glynn to determine whether the benefits of Fosamax outweighed the risks for her, and Dr. Costello found that they did. Id. at 97:6-21. Dr. Costello testified 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. Costello states that she "can't remember" going over the risk and benefit analysis 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 femur 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 specifically 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 ...

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