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In Re: Fosamax Products Liability Litigation v. Merck & Co.

August 30, 2011

IN RE: FOSAMAX PRODUCTS LIABILITY LITIGATION
SECREST
v.
MERCK & CO., INC.,



The opinion of the court was delivered by: John F. Keenan, United States District Judge

OPINION AND ORDER

This document relates to:

JOHN F. KEENAN, United States District Judge:

This is the fourth case selected for trial as a bellwether in the In re Fosamax Products Liability Litigation multidistrict litigation ("Fosamax MDL"). The Fosamax MDL involves claims that Fosamax, a drug designed and produced by defendant Merck Sharp & Dohme Corp. ("Merck"), caused users of Fosamax to suffer from a condition known as osteonecrosis of the jaw. In this case, plaintiff Linda Secrest ("Secrest" or "Plaintiff") brings strict liability and negligence claims on theories of design defect and failure to warn, in addition to claims for fraudulent misrepresentation and concealment, and breach of warranty. Plaintiff also seeks punitive damages.*fn1

Before the Court are four motions: (1) Merck's motion for summary judgment against Plaintiff on all claims; (2) Merck's motion to preclude Plaintiff's proposed expert testimony; (3) Plaintiff's motion to preclude Merck's proposed expert testimony; and (4) Merck's supplemental motion to preclude testimony of Dr. Epstein. For the reasons set forth below, Merck's motion for summary judgment is granted with respect to Plaintiff's claims for failure to warn, breach of warranty, fraudulent concealment, and punitive damages, but denied with respect to Plaintiff's claim for design defect. Merck's motions to preclude expert testimony are granted in part and denied in part. Plaintiff's motion to preclude expert testimony is granted in part and denied in part.

I. Background

The following facts are taken from the parties' Local Rule 56.1 Statements, the declarations submitted in connection with the instant motions, and the exhibits attached thereto. Unless otherwise noted, the facts are undisputed.*fn2

A. Fosamax*fn3

Defendant Merck is a New Jersey-based pharmaceutical company that makes and distributes the drug alendronate sodium under the brand name "Fosamax." Fosamax belongs to a class of drugs called "bisphosphonates," which are commonly used to treat metabolic and oncologic diseases related to abnormalities in the bone remodeling cycle. Fosamax is widely prescribed for the treatment and prevention of osteoporosis.*fn4

The first generation bisphosphonates were developed in the 1960s and 1970s. The United States Food and Drug Administration ("FDA") approved Fosamax for the treatment of osteoporosis and Paget's disease in 1995 and for the prevention of osteoporosis in 1997. Fosamax was the first of three nitrogen-containing bisphosphonates approved for oral administration to treat these conditions.

Some users of bisphosphonate drugs have developed a rare condition called osteonecrosis of the jaw ("ONJ"). ONJ is characterized clinically by an area of dead jaw bone that becomes exposed to the oral cavity. Symptoms can include pain, swelling, and purulent secretion. The condition has been observed to develop after invasive dental procedures, such as tooth extractions, but has presented spontaneously in some cases.

ONJ can occur in the absence of bisphosphonate use, but its background rate in the population is not known. It has been reported to occur in connection with radiation therapy to the head and neck, osteomyelitis (inflammation/infection of bone marrow), osteopetrosis, herpes zoster virus infection, chemotherapy, and major trauma. The risk of developing ONJ is increased by factors such as periodontal disease, poor oral hygiene, and trauma. See In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d at 170.

Merck and Plaintiff disagree about when Merck received notice of the possible association between Fosamax use and ONJ. Plaintiff contends that Merck was put on notice of the possible association when it received reports from "over a hundred patients who had developed 'dental pain' and/or 'dental infection' during clinical trials in 1995." (Pl.'s Rule 56 Statement ¶ 6.) Plaintiff also contends that a number of adverse event reports ("AERs") received by Merck in the mid- and late-1990's mentioned "reaction terms selected by Merck for coding ONJ reports" and other "adverse oral outcomes." (Id. ¶ 7.) According to Plaintiff, these reports should have triggered additional investigation by Merck notwithstanding the fact that the reports did not specifically mention ONJ. Merck maintains that the AERs that did not explicitly mention ONJ were insufficient to give notice of a possible association between Fosamax and ONJ.

It is undisputed that on October 3, 2003, Merck received for the first time an adverse event report expressly stating that a Fosamax patient had developed ONJ. Merck received two additional reports of ONJ in Fosamax users in January and March 2004. By April 2004, Merck had also been notified that Dr. Salvatore Ruggiero of the Long Island Jewish Medical Center in New Hyde Park, NY, was planning to publish an article in the Journal of Oral and Maxillofacial Surgery about sixty-three bisphosphonate patients who developed ONJ. Six of the patients in Dr. Ruggiero's study had taken Fosamax.

Merck alleges that these reports were reviewed by its Adverse Event Review Team ("AERT") in July 2004, and its Regulatory, Clinical, Epidemiology, Clinical Risk Management and Basic Research teams in September 2004. According to Merck, its various research teams at first recommended that it research the incidence rate of ONJ in Fosamax users. However, as additional reports of ONJ in Fosamax users came to Merck's attention in January 2005, its Label Evaluation and Development ("LEAD") Team recommended that Merck include a warning about these reports in the "Adverse Reactions" section of the Fosamax label.

Plaintiff challenges Merck's account of its reaction to the reports of ONJ, claiming that Merck's AERT recommended including an ONJ warning in the Fosamax label as early as January 2004. Plaintiff bases this allegation on the October 22, 2010, deposition of Dr. Diane Benezra-Kurshan, a former member of the AERT. At this deposition, Dr. Benezra-Kurshan testified that the AERT first recommended inclusion of information about ONJ in the Fosamax label in January 2004. However, Merck, pointing to a statement made later in Dr. Benezra-Kurshan's deposition giving January 2005 as the date AERT first recommended including an ONJ warning on the Fosamax label, argues that Dr. BenezraKurshan was mistaken when she gave the earlier, January 2004 date.

It is undisputed that on January 31, 2005, Merck received a letter from the FDA requesting that Merck include the following precautionary language in the Fosamax label:

Osteonecrosis, primarily in the jaw, has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally.

For patients who develop osteonecrosis of the jaw (ONJ) while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. (Df.'s Decl. in Supp. of S.J. Mot., Ex. 31, Letter from David Orfloff to Merck 1.) This letter requested that Merck submit a revised label within six months. On March 1, 2005, Merck proposed different precautionary language, which it had been preparing prior to receiving the FDA's January 2005 letter. By letter dated June 21, 2005, the FDA requested that Merck use the exact language provided in its January 2005 letter. Communications between Merck and the FDA continued, and on July 12, 2005, both Merck and the FDA agreed that the following language was appropriate for the Fosamax label:

Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported in patients taking bisphosphonates. Most reported cases of bisphosphonate-associated osteonecrosis have been in cancer patients treated with intravenous bisphosphonates, but some have occurred in patients with postmenopausal osteoporosis. Known risk factors for osteonecrosis include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), poor oral hygiene, and co-morbid disorders (e.g., pre-existing dental disease, anemia, coagulopathy, infection).

Patients who develop osteonecrosis of the jaw (ONJ) while on bisphosphonate therapy should receive care by an oral surgeon. Dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk for ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. (Df.'s Decl. in Supp. of S.J. Mot., Ex. 33, E-mail from Helen Durand, July 12, 2005.) This label was posted on Merck's website and distributed to physicians by sales representatives in August 2005. A number of additional revisions were made after the July 2005 label change, but these revisions are not relevant to this case.

B. Linda Secrest's Fosamax Use and Medical Treatment

Linda Secrest is a resident of Florida. She worked for United Airlines as a flight attendant for 34 years and at one point was based in San Francisco, California. At various times over the past thirty-nine years, Secrest's primary care physician was Dr. Lawrence Epstein, who practices medicine in Mountain View, California.

Secrest first used Fosamax in June 1998, and continued to use Fosamax until April 2005. Over this period of time, Secrest's bone density was measured several times. In June 1998, Ms. Secrest had a femoral neck (hip) t-score of -0.3 SD and a combined lumbar spine t-score of -2.26 SD. A scan taken in September 2001 showed that Ms. Secrest had a femoral neck (hip) t-score of -0.3 SD and a combined lumbar spine t-score of -1.8 SD. An additional scan taken in February 2005 showed that Ms. Secrest had a femoral neck (hip) t-score of -0.5 SD and a combined lumbar spine t-score of -1.9 SD. (Pl.'s Rule 56.1 Statement ¶¶ 22-24.) These bone scans indicate that Ms. Secrest was osteopenic under current standards--and potentially at risk of developing osteoporosis--throughout the time she used Fosamax.

Dr. Epstein first prescribed Fosamax for Secrest in June 1998, but the parties dispute the precise amount and duration of Secrest's subsequent Fosamax use. Between June 1998 and April 2005, Secrest received Fosamax prescriptions from four different physicians: Drs. Epstein, Martin, Osborn, and Hidlebaugh. Dr. Epstein prescribed Fosamax to Secrest between June 1998 and March 2003, but according to Merck, Secrest had no Fosamax prescription during an eleven-month period between March 2000 and February 2001, a five-month period between early May 2001 and September 2001, a fifteen-month period between February 2002 and May 2003, or the period between late August 2003 and late December 2003. (See Df.'s Decl. in Supp. of Daubert Mot. Ex. 4.) Merck claims that the only prescription written by Dr. Osborn, one written in May 2002, was never filled by a pharmacy. (Df.'s Reply Mem. in Supp. Daubert Mot. 5 n.4.) Secrest claims that, according to her medical records, she used Fosamax continuously between May 1998 and April 2005, with the exception of a single four-month gap between September 2000 and January 2001. (See Pl.'s Mem. in Supp. of Daubert Mot. 11-15.)

This case primarily concerns the allegation that Secrest's use of Fosamax caused her to develop ONJ, but at various points in time, Secrest has suffered a number of other injuries in her jaw and oral cavity. Secrest suffers from xerostomia, or dry mouth; this placed her at a higher than average risk for infection in the oral cavity. In 2000, Dr. Marciano performed a number of dental implant surgeries on Secrest, in which five of thirteen dental implants failed to integrate. Secrest suffered from a tooth infection in April 2002 and a pseudomonas infection in December 2002, but these infections responded to treatment. (Marciano Dep. 27-28, 31-34, 37-38, 41-43.)

In her Plaintiff Profile Form ("PPF"), Secrest originally claimed an injury date of December 1999. However, Mrs. Secrest now alleges that she did not develop ONJ until March 2004. In March 2004, Secrest had an infection in the submental area of her jaw, which is "the area below [one's] chin." (Pl.'s Mem. Opp. Df.'s Daubert Mot. Ex. 3, 45:21-23.) Dr. Marciano tentatively diagnosed this infection as osteomyelitis but later referred Secrest to Dr. Marx because the suspected infection failed to respond to treatment. (Pl.'s Mem. in Opposition to Df.'s Daubert Mot. Ex. 3, Deposition of Dr. Marciano 62-63.)

Dr. Marx later diagnosed Secrest's condition as ONJ with an associated infection secondary to Fosamax use. (Id. at 73.) Dr. Marx recommended that Secrest stop taking Fosamax in April 2005, and her ONJ allegedly resolved by August 2005.

C. Procedural History of this Case

Plaintiff filed her complaint in the Middle District of Florida on April 10, 2006. On August 16, 2006, the Judicial Panel on Multidistrict Litigation designated this Court as the transferee forum for consolidated pretrial litigation of all federal court cases involving allegations that ingestion of Fosamax causes injurious side effects to the jaw, including osteonecrosis of the jaw, and transferred this case from the Middle District of Florida to this Court. See In re Fosamax Products Liability Litigation, 444 F. Supp. 2d 1347 (J.P.M.L. 2006). Pursuant to Fosamax MDL Case Management Orders 3, 9,*fn5 and 10, Merck and the Plaintiffs Steering Committee ("PSC") selected twenty-five cases to be worked up through expert discovery. This group of twenty-five cases, as modified, has served as the pool from which cases have been selected for bellwether trial. Originally, the Court and the parties contemplated holding three bellwether trials, but the total number was expanded to five on September 9, 2010, and this case was selected for trial on September 23, 2010. On February 4, 2011, the PSC and Merck were directed to select two additional cases, bringing the total number of bellwether trials in the Fosamax MDL to seven.

Pursuant to Case Management Order No. 3 and Case Management Order No. 8, each plaintiff in the Fosamax MDL has been required to complete a form referred to as a "Plaintiff Profile Form" or "PPF." Secrest completed her original PPF in February 2007, and later submitted a supplemental PPF in December 2010.

In advance of an anticipated trial date of March 14, 2011, the Court heard oral argument on February 15, 2011, concerning Merck's motion for summary judgment, Merck's Daubert motion concerning Drs. Marx and Marciano, and Secrest's Daubert motion. On March 1, Merck filed its Daubert motion concerning Dr. Epstein, and the Court granted Secrest's request for an adjournment of the trial.

On July 13, 2011, Mrs. Secrest filed the Third Supplemental Disclosures of Robert E. Marx, DDS, which notified the Court of articles published by Dr. Marx while the motions addressed herein were sub judice.

The trial in this case is now scheduled to begin on September 7, 2011.

D. Proposed Expert Witnesses

Each party moves under Rule 702 of the Federal Rules of Evidence and Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993), to exclude certain expert testimony that the other party intends to present at trial. Merck seeks to exclude certain testimony of Drs. Robert Marx, Philip Marciano, and Lawrence Epstein, and Plaintiff seeks to exclude certain testimony of Drs. Norman Betts and Barry Gruber. Background on each of the proposed expert witnesses is provided below.

1. Dr. Robert MarX

Dr. Marx is a Professor of Surgery and the Chief of Oral and Maxillofacial Surgery at the University of Miami. In ruling on the parties' omnibus Daubert motions concerning general causation testimony, the Court found the testimony of Dr. Marx admissible under Rule 702 on the issue of general causation, In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d at 176, but later granted Merck's motion to exclude Dr. Marx from testifying "that Fosamamx can cause [ONJ] before three years of continuous use," in part due to the discrepancy between his proposed testimony and the articles he has published on the subject. In re Fosamax Prods. Liab. Litig., No. 06 MD 1789, 2009 WL 2878439, at *1 (S.D.N.Y. Sept. 9, 2009).

Dr. Marx has previously testified at bellwether trials in the Fosamax MDL. Now, as in prior bellwether trials, Dr. Marx states that he "no longer believe[s] that three years is an absolute threshold for the development of bisphosphonate-induced [ONJ]." (Id. at 3.)

In this case, Dr. Marx has opined that, based on his treatment of Secrest, Secrest suffered from "Stage 1 bisphosphonate-induced [ONJ] in or around mid-2004," that her use of Fosamax after mid-2004 continued to exacerbate her condition, and that her ONJ healed because she stopped taking Fosamax. (Df.'s Decl. in Supp. of Df.'s Daubert Mot., Ex. 14, Supp. Expert Discls. of Robert E. Marx, DDS Regarding Patient Linda Secrest ("Marx Supp. Discls.") 1-2.) Dr. Marx believes that Secrest continues to suffer from ...


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