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In re Fosamax Products Liability Litigation

August 5, 2009


The opinion of the court was delivered by: John F. Keenan, United States District Judge*fn1


Before the Court is Defendant Merck & Co., Inc.'s ("Merck") motion for summary judgment against Plaintiff Shirley Boles ("Boles"). This case is the first of three bellwether trials in a multi-district products liability litigation concerning the osteoporosis drug Fosamax. For the reasons set forth below, the motion is granted in part and denied in part.


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

A. Fosamax*fn2

Fosamax is an oral bisphosphonate manufactured by Defendant Merck for the treatment of osteoporosis. The Food and Drug Administration ("FDA") approved this use of Fosamax on September 29, 1995. On April 25, 1997, the FDA approved a labeling indication for Fosamax's use for the prevention of osteoporosis.

The parties dispute when the first report linking bisphosphonate use with development of osteonecrosis of the jaw ("ONJ") was published in the medical literature. Plaintiff points to a textbook by Dr. Robert Marx, a professor of surgery at the University of Miami School of Medicine, which was apparently published in November 2002.*fn3 The textbook reads, in relevant part,

The most common bisphosphonates used for osteoporosis, such as alendronate [Fosamax] . . . , are without serious bone necrosis complications when used according to their recommended dosages. However, pamidronate (Aredia, Novartis), used to treat hypercalcemia related to malignancies in the dosage range of one 60- to 90-mg dose intravenously every 1 week to 1 month, produces a significant incidence of exposed nonvital bone in the mandible and/or maxilla. (Def.'s Ex. 4.) Merck claims that the earliest report was actually a September 2003 letter to the editor, also written by Dr. Marx. The letter was published in the Journal of the Oral and Maxillofacial Surgery and concerned the occurrence of ONJ in patients who took intravenous -- as opposed to oral -- bisphosphonates. It was not until the spring of 2004 that a published scientific article linked oral bisphosphonate use to the development of ONJ.*fn4

In July 2005, Merck made the following FDA-approved addition to Fosamax's 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. (Def.'s Ex. 9 at 13.)

B. Shirley Boles

Plaintiff Shirley Boles is a 71-year-old Florida resident who alleges that she developed ONJ as a result of taking Fosamax. In early July 1997, Dr. James Mills, a board-certified obstetrician and gynecologist, found that Boles suffered from osteoporosis in her hip and osteopenia -- lower than normal bone density that is not low enough to be classified as osteoporosis -- in her spine.*fn5 (Def.'s Ex. 10 at 52:11-16.) He prescribed Fosamax for Boles on July 10, 1997. Boles continued to take the drug, with occasional gaps in usage, up through at least February 2006 and possibly as late as October 2006.

On June 13, 2002, a few days after Boles complained to her dentist that she had a loose tooth, two of Boles's teeth were extracted. An infection developed on the left side of Boles's mandible near the site of the extraction. On August 16, 2002, Dr. Charles Elwell, an oral surgeon, performed a debridement of the infected site and curettage of necrotic bone from the area of extraction. In May 2003, Boles complained of swelling under her chin and then, that summer, developed a draining fistula.

According to Dr. Elwell -- who has treated Boles's related, ongoing infections since the summer of 2002 -- his last evaluation of Boles in December 2007 revealed that she still had an infection. Around that time, he concluded that Boles's "bony changes" and "lack of bone healing" were correlated to the "use of bisphosphonate therapy over a long-term period." (Pl.'s Ex. 12 at 104:12-18.) Dr. Patrick Anastasio, an infectious disease specialist who examined Plaintiff a month earlier in November 2007, reached the same conclusion independently. (Id. at 104:25-105:6.)

Dr. John Hellstein, a clinical professor at the University of Iowa College of Dentistry who specializes in oral and maxillofacial pathology, is Boles's expert on the alleged causal link between her bisphosphonate use and her ONJ. After examining Boles and her medical records in January 2009, Dr. Hellstein diagnosed her, "to a level of medical certainty," as having "Stage 3 Bisphosphonate Osteonecrosis."*fn6 (Pl.'s Ex. 6 App. B.) Under questioning from Merck at his March 25, 2009, deposition, Dr. Hellstein admitted that Plaintiff's symptoms in 2003 could be explained by other possible causes, such as denture irritation or an infection.

Plaintiff has also identified a regulatory expert, Dr. Susan Parisian, a former officer of the FDA, who has opined on when Merck should have warned about the risks posed by Fosamax.*fn7

The parties strongly dispute Dr. Parisian's true position on when Merck should have made such a warning. Specifically, Merck maintains that Dr. Parisian does not believe Merck had a duty to warn prior to October 2003, while Plaintiff claims Dr. Parisian believes Merck's duty to warn may have existed as early as the mid-1990s. In light of the importance of Dr. Parisian's expert opinion and the contrary interpretations thereof, the Court reproduces the relevant testimony in full.

At her deposition, Dr. Parisian offered the following testimony relevant to Merck's duty to warn:

Q: Can you identify for me any label for Fosamax -- and I'm talking about an FDA-approved label, because all of the labels that accompany a marketed drug have in fact been FDA approved, have they not?

A: Yes.

Q: Can you identify for me any label that you consider to be inadequate to advise physicians of the risks and benefits of Fosamax?

A: Well, in terms of when should they have -- if we're talking about osteonecrosis, for example, when was the company aware of osteonecrosis of the jaw, and you could take October of 2003, they were aware and they put that they knew that they were receiving reports, it was in the literature. So at that particular time they were aware of ONJ, so they could have updated their labeling to have included information about that. They didn't. So it would be that if you're thinking about when were they aware of ONJ and where does it not appear in the labeling, it does not appear in the labeling at that point in time.

Q: That's not really my question, Doctor. Here's my question: I have read through your report, and it's a lengthy report. And I do not see in that report any statement that says: I believe that the labeling that accompanied Fosamax was inadequate to advise physicians of the risks associated with the drug at any particular time.

[PLAINTIFF'S COUNSEL]: Object to the --


[DEFENSE COUNSEL]: The question -- the document speaks for itself. My question very simply is: Is there a time or are there labels that you believe are inadequate? And if so, can you identify them for me first. So I know what time -- if we're talking about 2003 and everything before 2003 is fine, I just need to know that, and we can go from there.

A: All right. Well, I used the 2003 [sic]. But if you take, for example, there are reports of exostosis going back in the '90s, which are discussed in here, none of that type of a risk appears in the literature -- in the labeling. But I use the 2003 as when we all -- the company has agreed that they were aware of ONJ in October 2003, and they didn't change the label.

In here, I do discuss the labeling negotiation that occurred in 2005. And that's -- I was trying to go to that.

[DEFENSE COUNSEL]: Let me see if I -- I'm going to move to strike the comments as non-responsive to the last answer.

[BY DEFENSE COUNSEL]: And let me ask this question, Doctor: Do you have an opinion as you sit here today and one which you intend to offer as to when osteonecrosis of the jaw should have been incorporated in the Fosamax label?

A: I did. I said October 2003.

Q: All right. Now, as of October 2003, you base that upon the letter to the editor that Marx published showing osteonecrosis of the jaw in bisphosphonate users, correct?


THE WITNESS: That would be one of the things. But I believe also I'm looking at the adverse event reports that they had had for exostosis since 1996.

[DEFENSE COUNSEL]: Let me separate out the adverse event reports for a second and let me ask you about the Marx report. Okay?

A: All right. You want to ask me about the Marx report.

Q: When the Marx report was published in 2003, were there any oral bisphosphonate osteonecrosis cases reported?

A: In terms of the medical literature?

Q: In terms of the letter to the editor in 2003.

A: Okay. That's what I'm saying. In terms of label, what could be on the label, the exostosis -- the ONJ term --

[PLAINTIFF'S COUNSEL]: Let her finish.

[THE WITNESS]: The ONJ term didn't exist before that. So it would have been under the category of exostosis, which was occurring in the report since 1996, I believe it has been in there.

[DEFENSE COUNSEL]: I move to strike as non-responsive.

[DEFENSE COUNSEL]: Is it your -- do I understand correctly it to be your testimony that as of October 2003, the Fosamax label should have included a reference to osteonecrosis of the jaw?

[PLAINTIFF'S COUNSEL]: Asked and answered.


[DEFENSE COUNSEL]: And that is based upon what?

A: If you go to paragraph 215 [of my expert report], in their first -- Merck is representing to the FDA that its first report of ONJ was October 2003. So that's the number that Merck has gone forth and said that we knew -- we gave our first report of ONJ to the FDA on October 2003. Actually, their adverse event reports are before that. But the one that Merck has said over and over is that it was October 2003. (Pl.'s ...

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