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In re Fosamax Products Liability Litigation

United States District Court, S.D. New York

January 7, 2013

In re: FOSAMAX PRODUCTS LIABILITY LITIGATION. This document relates to: Scheinberg
v.
Merck & Co., Inc., No. 08 Civ. 4119 (JFK).

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Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A., by: Timothy M. O'Brien, Esq., Brandon L. Bogle, Esq., for Plaintiff Rhoda Scheinberg.

Hughes Hubbard & Reed LLP, by: Theodore V.H. Mayer, Esq., William J. Beausoleil, Esq., Julia R. Zousmer, Esq., for Defendant Merck Sharp & Dohme Corporation.

Venable LLP, by: Paul F. Strain, Esq., David J. Heubeck, Esq., Stephen E. Marshall, Esq., for Defendant Merck Sharp & Dohme Corporation.

OPINION & ORDER

JOHN F. KEENAN, District Judge.

I. The Motions

This is the fifth case selected for trial as a bellwether in the In re Fosamax Products Liability Litigation multidistrict litigation. This MDL involves claims that Fosamax, a drug designed and produced by defendant Merck Sharp & Dohme Corp. (" Merck" ), caused users of Fosamax

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to suffer from a condition known as osteonecrosis of the jaw (" ONJ" ). In the instant case, plaintiff Rhoda Scheinberg (" Scheinberg" 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 express and implied warranty. Plaintiff also seeks punitive damages.

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 of Dr. Suzanne Parisian; (3) Merck's motion to preclude Plaintiff's proposed expert testimony of Drs. Sanford Buch and Andrew Breiman; and (4) Plaintiff's motion to preclude Merck's proposed expert testimony from Drs. Barry Gruber and Robert Glickman. For the reasons set forth below, Merck's motion for summary judgment is granted with respect to Plaintiff's claims for breach of warranty, fraudulent misrepresentation and concealment, and punitive damages, but denied with respect to Plaintiff's claim for design defect and failure to warn. 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.

II. Background

Defendant Merck is a New Jersey-based pharmaceutical company that makes and distributes the drug alendronate sodium under the brand name Fosamax. Fosamax is one of several drugs known as " bisphosphonates," and is taken orally, rather than intravenously as are some other bisphosphonates. Fosamax was originally approved by the FDA for the treatment of postmenopausal osteoporosis and Paget's disease in 1995, and the FDA has since approved it for additional uses.

Plaintiff contends that Merck has long known of reports linking bisphosphonate use with the development of ONJ. According to Plaintiff, Merck was aware that Fosamax could cause ONJ before Scheinberg suffered her injuries, and Merck failed adequately to warn the medical community of this risk. Plaintiff references various adverse event reports suggesting complications allegedly related to ONJ in persons being treated with Fosamax, as well as twenty later, more definitive reports in the 2003-2005 timeframe that Fosamax users were experiencing symptoms of ONJ.

Merck claims that after receiving reports that Fosamax users were developing ONJ, its various research teams began to investigate the reports by calling physicians and attempting to ascertain " background rates" for the incidence of ONJ in the population of those who do not use Fosamax. These research teams first recommended that Merck change its label to include an ONJ warning in January 2005. Eventually, after seeking FDA approval, Merck modified its label in July 2005, to inform the public that: " Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported in patients taking bisphosphonates."

Scheinberg began taking Fosamax in 2000, and continued taking it through 2006. Her prescribing physician between 2004 and 2006 was Dr. Dunn. (Def. 56.1 ¶ 1.) On October 30, 2006, Plaintiff had a tooth extraction, after consultation with her dentist, Dr. Rinaudo and an oral surgeon, Dr. Buch. ( Id. ¶¶ 3-4.) Plaintiff's proffered expert, Dr. Richard Kraut, has opined that the delay Plaintiff experienced in healing from the tooth extraction was ONJ, and that her use of Fosamax " was a major contributing factor to her development of ONJ." (Kraut Report at 8.) Dr. Kraut also

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stated that to avoid the onset of ONJ, Scheinberg would have needed to stop taking Fosamax at least six months before her tooth extraction, or April 30, 2006. (Kraut Depo. at 141:2-25, 148:25-149:7.)

III. Defendant's Motion for Summary Judgment

The parties do not dispute that Plaintiff's claims are governed by New York law. The Court notes that Scheinberg is a resident of New York. (Compl. ¶ 1.)

A. Design Defect

Merck argues that summary judgment is warranted on Scheinberg's design defect claim because she has not presented any expert testimony that there was a feasible design alternative.

In response, Plaintiff suggests that under New York law, a feasible design alternative is only one of many factors for a jury to consider in a design defect claim. Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102, 463 N.Y.S.2d 398, 450 N.E.2d 204, 208-09 (1983). In any event, Plaintiff states, she has adduced evidence of two alternative designs that Merck could have employed. First, Plaintiff avers that for patients like Scheinberg, whose T-scores were better than -2.5, the placebo is just as effective, and therefore it could constitute a feasible alternative design. Second, Plaintiff asserts that Dr. Parisian has testified that Merck should have included a warning about ONJ on its packaging. As such, Plaintiff proffers that a feasible design alternative could be the same product (Fosamax), repackaged to include a much stronger warning.

Under New York law, a plaintiff may recover for a design defect by showing that the product, as designed, was not reasonably safe and that the defective design was a substantial factor causing the plaintiff's injury. See id. at 108-09, 463 N.Y.S.2d 398, 450 N.E.2d 204. To recover under a theory of strict products liability for sale of a defectively designed product, " it is well established that a plaintiff must plead and prove that there was a feasible design alternative that would have made the product safer." Daley v. McNeil Consumer Products Co., a Div. of McNeil-PPC, Inc., 164 F.Supp.2d 367, 374 (S.D.N.Y.2001).

Despite Plaintiff's assertion that he is not required to prove evidence of alternative machine designs, the Second Circuit case which she cites for that proposition specifically provides that " it is true that the plaintiff carries the burden of showing that an alternative design was feasible and safer," in connection with a claim for design defect. Urena v. Biro Manu. Co., 114 F.3d 359, 365 (2d Cir.1997). Indeed, Urena held only that the plaintiff in that case was able to meet the burden without considering the testimony of his proposed expert. Id.

Plaintiff has misinterpreted the law as to whether evidence of a feasible alternative design is a prerequisite for a design defect claim. However, she is correct in asserting that a different label on the outside of the Fosamax container would be a sufficient " feasible alternative design," the adequacy of which is for the jury to decide. Indeed, the Second Circuit has held that testimony as to whether a manufacturer could " have added a sticker or other warning to the machine which would have made clear" the risk associated with using the product is sufficient evidence of a feasible alternative design. Urena, 114 F.3d at 365. Therefore, summary judgment as to the design defect claim is denied.

B. Failure to Warn

Merck next argues that it is entitled to summary judgment on Scheinberg's failure to warn claim because (1) no warning would have changed Scheinberg's doctors'

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prescribing decisions and (2) Merck's warnings were sufficient as a matter of law. In support of this argument, Merck points to Dr. Dunn's statements that Merck's 2005 label change " apprised" her of the " possible risk of necrosis of the jaw for patients [who] take Fosamax." (Dunn Depo. 138, 246.) Dr. Dunn also stated that even the 2012 Fosamax label " would not have changed [her] decision to continue [Plaintiff] on Fosamax from 2004 to 2006." ( Id. )

Plaintiff responds that Merck has misread Dunn's testimony, pointing to another two statements Dr. Dunn made: first, that if she had " been aware in 2005 or 2006 that Fosamax can induce death of the jaw bone," she may have changed her prescribing practices; second, that a " Dear Doctor" letter would have made her aware that patients like Scheinberg were at risk for ONJ. Specifically, Dr. Dunn testified that if she had received a " Dear Doctor" letter, she would have prescribed Fosamax less frequently, particularly to patients with suboptimal oral health or who may need a tooth extraction. (Dunn Depo. 193-94.)

Moreover, Plaintiff maintains that the 2005 label was inadequate as a matter of law, as there is sufficient evidence that Merck failed to warn both the medical community as a whole and Scheinberg's prescribing physician about the risk of ONJ. Plaintiff further states that Merck did not take the additional steps necessary— such as distributing a " Dear Doctor" letter— to convey the risks associated with Fosamax to the medical community. To support these allegations, Plaintiff points to testimony from Dr. Parisian and Dr. Dunn, both of whom underscored the importance of a " Dear Doctor" letter.

Under New York law, a failure 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. Failure to warn claims are analyzed the same way under strict liability and negligence theories of recovery. See Anderson v. Hedstrom Corp., 76 F.Supp.2d 422, 439 (S.D.N.Y.1999) (" Where liability is predicated on failure to warn, New York views negligence and strict liability claims as equivalent." ); see also Denny v. Ford Motor Co., 87 N.Y.2d 248, 258, 639 N.Y.S.2d 250, 662 N.E.2d 730 (1995) (" Failure to warn claim ... couched in terms of strict liability, is indistinguishable from a negligence claim." ).

New York's " heeding presumption" dictates that the Court must presume that a user would have heeded warnings if they had been provided, and that the injury would not have occurred. See Anderson, 76 F.Supp.2d at 441. This presumption may only be rebutted by specific facts showing that the warning would have been futile. See id.

Given Dr. Parisian's testimony that the 2005 label change was inadequate, the only issue on summary judgment is whether Plaintiff has established proximate cause. To establish proximate causation in a failure to warn claim resulting from a pharmaceutical product, a plaintiff must show that an appropriate warning would have affected the course of treatment of the plaintiff's physician. In re Fosamax Prods. Liab. Litig., No. 06-MD-1789, 2010 WL 1257299, at *5 (S.D.N.Y. March 26, 2010).

Although Merck would have the Court consider only Dr. Dunn's testimony that supports its position, the fact remains that she has provided conflicting testimony on whether additional information about Fosamax would have impacted her decision

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making. Dr. Dunn told attorneys that if she had " been aware in 2005 or 2006 that Fosamax can induce death of the jaw bone," she would have changed her prescribing practices, yet also testified that the label " apprised" her of the risk of ONJ. There is obviously a question of fact as to whether different warnings could have changed Dr. Dunn's prescribing practice. It is for the jury to decide which of her statements to credit. See Liriano v. Hobart Corp., 92 N.Y.2d 232, 243, 677 N.Y.S.2d 764, 700 N.E.2d 303 (1998) (noting that failure to warn is typically a fact-intensive inquiry for the jury to decide).

C. Breach of Warranty (Express and Implied)

In moving for summary judgment on the breach of express warranty claim, Merck argues that it never made any affirmative statements of fact in connection with Fosamax. Moreover, Merck notes, the Plaintiff herself admitted that she did not see any advertisements for Fosamax.

Plaintiff responds that simply because Plaintiff did not see any advertisements for Merck does not mean that Merck did not make any express warranties. In a declaration dated December 7, 2012, Scheinberg asserts that she " recalls reading" the Fosamax patient handout from 2000. Scheinberg further states that she relied upon the misrepresentation that Fosamax would prevent fractures, and that if she knew this were false, she would not have continued taking Fosamax. (Scheinberg Decl. Dec. 7, 2012.) This testimony, according to Plaintiff, establishes that she received an express warranty from Merck.

To state a claim for breach of express warranty, the plaintiff must show that there was an " affirmation of fact or promise by the seller, the natural tendency of which [was] to induce the buyer to purchase, and that the warranty was relied upon." Schimmenti v. Ply Gem Indus., Inc., 156 A.D.2d 658, 549 N.Y.S.2d 152 (2d Dep't 1989) (quoting Friedman v. Medtronic, Inc., 42 A.D.2d 185, 345 N.Y.S.2d 637 (2d Dep't 1973)).

Plaintiff testified at deposition that she never read the 2005 patient handout, and did not see any advertisements. The colloquy went as follows:

Q. I assume you don't recall when you first heard about Fosamax. Right?
A. As a drug to take?
Q. At all, the first time you ever heard the word Fosamax.
A. I don't remember, but I remember having a conversation with someone and it was supposed to be the wonder drug on the market.
Q. The wonder drug on the market for what?
A. For helping your bones.
Q. And you don't remember if that conversation was with Dr. Hupart or with Dr. Kaplan?
A. No. I can't help you.
Q. Do you remember ever doing any research on your own into Fosamax?
A. When I was taking it? No.
Q. You indicated in your profile form that you never saw any advertisements, commercials, or other types of advertisements for Fosamax before you started taking it.
A. No, I've never— I never saw it while I was taking it either.

(Scheinberg Depo. 218-19.)

Plaintiff's recently executed declaration states that she read the patient insert when she began taking the medication. " In reading the patient insert, it informed me and I understood from reading it that Fosamax would prevent fractures in patients like me." (Scheinberg Decl. Dec. 7, 2012) She goes on to say that she relied on

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this information in taking Fosamax, and that she would not have taken it if she had known that it did not prevent fractures.

Under the law in this Circuit, a Court considering a motion for summary judgment may not rely on an affidavit that contradicts a party's deposition testimony. Mack v. United States, 814 F.2d 120, 124 (2d Cir.1987) (" It is well settled in this circuit that a party's affidavit which contradicts his own prior deposition testimony should be disregarded on a motion for summary judgment" ); Raskin v. The Wyatt Company, 125 F.3d 55, 63 (2d Cir.1997) (" [W]e follow the rule that a party may not create an issue of fact by submitting an affidavit in opposition to a summary judgment motion that, by omission or addition, contradicts the affiant's previous deposition testimony." ). In the present case, there is a conflict between the plaintiff's sworn testimony and her affidavit. The former indicates that plaintiff did not receive any express warranties from Merck, while the affidavit drafted for this motion avers the contrary. The Court treats plaintiff's deposition testimony as true for purposes of this motion. Accordingly, Plaintiff has failed to demonstrate that Merck made an affirmation of fact upon which she relied. Plaintiff's motion for summary judgment on the express warranty claim is therefore denied.

Merck next argues that it is entitled to summary judgment on the breach of implied warranty claims because the Plaintiff has failed to show that Fosamax was not minimally safe. Merck proffers that 270 reported cases of ONJ among millions of users of Fosamax is not a significant incidence rate. Merck argues that the Plaintiff has presented no authority for the proposition that such a low number of reports of ONJ should lead a court to conclude that the product is not minimally safe.

Plaintiff responds that there are issues of fact related to whether Fosamax is minimally safe, proffering that the incidence rate of ONJ among Fosamax users is not as infinitesimal as Merck suggests. Indeed, Plaintiff avers, peer-reviewed prevalence studies reveal a higher incidence rate: a study by the University of Southern California put the incidence rate at 4% while the National Institutes of Health found that 1 in 952 Fosamax users contracted ONJ. Moreover, Plaintiff cites various New York cases for the proposition that courts should not require a certain number of adverse events per capita before determining whether a product is minimally safe.

A manufacturer may be held liable under New York law for breach of implied warranty when its products are not " fit for the ordinary purposes for which such goods are used." N.Y. U.C.C. § 2-314(2)(c). Specifically, a Plaintiff may recover " upon a showing that [a] product was not minimally safe for its expected purpose," and the focus of a breach of implied warranty inquiry is whether the product meets " the expectations for the performance of the product when used in the customary, usual and reasonably foreseeable manners." Denny, 87 N.Y.2d at 258-59, 639 N.Y.S.2d 250, 662 N.E.2d 730.

Accordingly, summary judgment on the implied warranty claim hinges on whether Fosamax was " minimally safe." As an initial matter, the Court notes that it has previously found that " the risk for ONJ is small." The Court has further found that

The FDA approved Fosamax in 1995 for the treatment of osteoporosis and Paget's disease and in 1997 for the prevention of osteoporosis. Fosamax was the first of three nitrogen-containing bisphosphonates approved for oral administration to treat these conditions. Since

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their market introduction, oral bisphosphonates have been prescribed by doctors over 225 million times. The efficacy of these drugs in arresting bone loss and reducing the risk of fracture in osteoporotic persons is well-established.

In re Fosamax Prods. Liab. Litig., 645 F.Supp.2d 164, 171 (S.D.N.Y.2009). In opposing the instant motion for summary judgment, Plaintiff has failed to adduce sufficient evidence for the Court to find that Fosamax is not minimally safe, given that millions of prescriptions for Fosamax have been issued, and that Fosamax has been proven effective for fracture reduction. The incidence rate of ONJ among Fosamax users is so low that no reasonable juror could conclude that Fosamax was not minimally safe. See Daley v. McNeil Consumer Prods. Co., 164 F.Supp.2d 367, 374 (S.D.N.Y.2001) (granting summary judgment on Plaintiff's breach of implied warranty claim on the grounds that no more than a small " fraction of potential users" reported an adverse reaction). Therefore, Merck is entitled to summary judgment on the breach of implied warranty claim.

D. Fraudulent Concealment and Fraudulent Misrepresentation

Merck next moves for summary judgment on Plaintiff's fraudulent misrepresentation and concealment claims. The Complaint alleges that Merck made two misrepresentations that concealed two valuable pieces of information. First, Plaintiff avers that Merck falsely represented that Fosamax was safe for osteoporosis and Paget's disease, which concealed Fosamax's substantial risks. Second, Plaintiff states that Merck falsely represented that Fosamax was safer than the alternatives on the market, concealing the fact that it was not safer than alternatives. According to Merck, there is no evidence that either of those statements is false.

To state a claim for fraudulent misrepresentation under New York law, a plaintiff must show: " (1) the defendant made a material false representation, (2) the defendant intended to defraud the plaintiffs thereby, (3) the plaintiffs reasonably relied upon the representation, and (4) the plaintiffs suffered damage as a result of their reliance." Swersky v. Dreyer & Traub, 219 A.D.2d 321, 643 N.Y.S.2d 33 (N.Y.1996). A claim for fraudulent concealment requires the same showing as that for fraudulent misrepresentation, with the additional requirement that the plaintiff must demonstrate that the defendant had a duty to disclose material information. See Banque Arabe et Internationale D'Investissement v. Maryland Nat. Bank, 57 F.3d 146, 153 (2d Cir.1995); Allied Irish Banks, P.L.C. v. Bank of America, N.A., No. 03 Civ. 3748, 2006 WL 278138, at *6 (S.D.N.Y. Feb. 2, 2006). For both forms of fraud, the element of damage includes a requirement that the plaintiff establish proximate causation. See, e.g., Hunt v. Enzo Biochem, Inc., 471 F.Supp.2d 390, 399-400 (S.D.N.Y.2006) (stating that a claim of common law fraud under New York law " requires a showing of proximate causation" ).

Plaintiff has failed to show that Merck's statement that Fosamax is " safe and effective for the treatment of osteoporosis and Paget's disease" is false. Specifically, there is no evidence that Fosamax is ineffective in treating those diseases. As the Court has found, " [b]y all estimates, the risk of developing ONJ while taking an oral bisphosphonate for osteoporosis is very small." In re Fosamax Prods. Liability Litig., 645 F.Supp.2d at 171.

Moreover, Dr. Dunn has testified that she was " apprised" of the possible risk of ONJ, invalidating Plaintiff's assertion that Merck concealed information of the risk of

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ONJ from prescribing physicians. Therefore, Merck is entitled to summary judgment on the fraudulent concealment and misrepresentation claims.

E. Punitive Damages

Merck argues that punitive damages are reserved only for the " singularly rare cases" in which the Defendant is proven to have acted intentionally or with wanton disregard. Merck reminds the Court that it has twice ruled that Merck's conduct before the 2005 label change was not wanton or intentional. Merck urges that the fact that it issued a label change in 2005 provides even more support for the assertion that it did not " consciously disregard" the safety of others.

Plaintiff insists that Merck acted willfully because New York law provides that fraud may be predicated on a defendant's " concealment, if the defendant had a duty to disclose." Plaintiff states that Merck continually and systematically " grossly overstated the efficacy of Fosamax" in an attempt to " shift the treatment threshold" and persuade doctors to prescribe Fosamax to more patients. Plaintiff also points to evidence that the FDA issued warnings to Fosamax about its " misleading" advertisements. Finally, Plaintiff states that Merck delayed changing the label and " cooked the books" in an attempt to downplay the incidence of ONJ.

There is no additional evidence in this case to cause the Court to permit this Plaintiff to assert a claim for punitive damages. In denying punitive damages on theories of intentional and grossly negligent conduct in Boles, the Court found " no evidence— let alone clear and convincing evidence— that Merck had ‘ actual knowledge’ of the ‘ high probability’ that Fosamax would cause Boles to develop ONJ." In re Fosamax Prods. Liab. Litig., 647 F.Supp.2d 265, 284 (S.D.N.Y.2009). Boles involved a claimed injury date of September 2003, and at that point in time the only evidence of any possibility that Fosamax caused ONJ included " a handful of reports of exostosis from the mid- to late-1990s." Id. Here, Plaintiff has not presented any additional evidence that would lead the Court to believe punitive damages are appropriate. Indeed, Merck had taken more steps with respect to informing the medical community of adverse events by the time of Scheinberg's injury.

Given the small number of ONJ cases relative to the total number of Fosamax users, there is no evidence in this case suggesting that Merck concealed information about the efficacy of Fosamax. There is no evidence to suggest that Merck had an awareness of a " high probability" that Fosamax caused ONJ, and Plaintiffs' assertions that Merck simply ignored the reports of ONJ are without merit. On the evidence presented by Plaintiff, no reasonable jury could conclude that Plaintiff would be entitled to punitive damages. Therefore, Merck's motion for summary judgment is granted with respect to Plaintiff's claims for punitive damages.

IV. Defendant's Daubert Motions


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