In re Fosamax Products Liab. Litig.
| Decision Date | 29 June 2011 |
| Docket Number | No. 06 Civ. 9455 (JFK),06 MD 1789 (JFK),06 Civ. 9455 (JFK) |
| Parties | In re: FOSAMAX PRODUCTS LIABILITY LITIGATION This document relates to:Boles v. Merck & Co., Inc., |
| Court | U.S. District Court — Southern District of New York |
For Plaintiff Shirley Boles:
LEVIN, PAPANTONIO, THOMAS, MITCHELL, RAFFERTY & PROCTOR, P.A.
By: Timothy O'Brien, Esq.
For Defendant Merck Sharp & Dohme Corp.:
HUGHES HUBBARD & REED LLP
By: Norman C. Kleinberg, Esq.
Theodore V. H. Mayer, Esq.,
William J. Beausoleil, Esq.
VENABLE LLP
By: Paul F. Strain, Esq.
David J. Heubeck, Esq.
Stephe E. Marshall, Esq.
Plaintiff Shirley Boles ("Boles" or "Plaintiff") seeks compensatory damages for injuries allegedly suffered as a result of her use of Fosamax, a drug manufactured by defendant Merck Sharp & Dohme Corp. ("Merck" or "Defendant"). This is one of over 900 cases consolidated for coordinated pretrial proceedings as part of the In re Fosamax Products Liability Litigation, No. 06 MD 1789, multidistrict litigation (the "Fosamax MDL"). It is also one of several Fosamax MDL cases selected for trial as bellwethers, and to date has been tried twice: the first trial ended in a hung jury, and the second trial resulted in an $8 million verdict in favor of Plaintiff. At the conclusion of the second trial, Merck renewed its motion for judgment as a matter of law and moved in the alternative for a new trial. In its Opinion and Order dated October 4, 2010, the Court denied both motions and ordered a remittitur of the verdict to $1.5 million. In re Fosamax Prods. Liab. Litig., 742 F. Supp. 2d 460, 486 (S.D.N.Y. 2010) ("October 4, 2010 Opinion and Order"). Subsequently, Plaintiff rejected the reduced verdict and requested a new trial on damages.
Before the Court is Merck's motion for certification of the Court's October 4, 2010 Opinion and Order for interlocutory appellate review pursuant to 28 U.S.C. § 1292(b). For the reasons stated below, the Court certifies that its October 4,2010 Opinion and Order involves a controlling question of law as to which there is substantial ground for difference of opinion and that an immediate appeal from its October 4, 2010 Opinion and Order may materially advance the ultimate termination of this litigation and the Fosamax MDL.
Alendronate sodium, a drug sold by Merck under the brand name "Fosamax," belongs to a class of drugs called bisphosphonates. Physicians use these drugs to treat abnormalities in the bone remodeling cycle that arise from metabolic and oncologic diseases. Fosamax is administered orally, and is generally prescribed at lower doses than intravenously administered bisphosphonates. The U.S. Food and Drug Administration ("FDA") approved Fosamax for the treatment of osteoporosis in 1995. In 1997, the FDA approved Fosamax for the prevention of osteoporosis. Since October 2003, published reports have described the development of osteonecrosis of the jaw ("ONJ"), a condition characterized clinically by an area of dead jaw bone that becomes exposed to the oral cavity, among some bisphosphonate users. Symptoms include pain, swelling, and purulent secretion. The vast majority of ONJ cases have been reported in patients taking intravenously administered bisphosphonates. Reported alternate causes of ONJ includeradiation therapy to the head and neck, osteomyelitis (inflammation or infection of bone marrow), osteopetrosis, herpes zoster virus infection, chemotherapy, and major trauma. See In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 169-71 (S.D.N.Y. 2009).
As stated above, the Fosamax MDL consists of over 900 cases alleging that Fosamax causes ONJ and related jaw injuries. On August 16, 2006 the Judicial Panel on Multidistrict Litigation consolidated before this Court all cases involving allegations that Fosamax use had caused ONJ. In re Fosamax Prods. Liab. Litig., 444 F. Supp. 2d 1347 (J.P.M.L. 2006). Two months later, on November 1, 2006, the Court ordered the parties to develop a schedule for discovery and pretrial motions in twenty-five cases to serve as a pool for the selection of three cases for bellwether trial. (Case Management Order No. 3, ECF No. 5).1
In addition to this case, two others were selected for trial: Flemings v. Merck & Co., Inc., 06 Civ. 7631 (JFK); and Greene v. Merck & Co. Inc., 06 Civ. 5088 (JFK). After the Court dismissed the Greene case on the plaintiff's Rule 41(a)(2) motion, see In re Fosamax Prods. Liab. Litig., No. 06 Civ. 5088 (JFK), 2008 WL 5159778 (S.D.N.Y. December 10, 2008), Merck selected Koor v. Merck & Co. Inc., 06 Civ. 4110 (JFK), toreplace Greene. In Flemings, the Court granted summary judgment in favor of Merck, In re Fosamax Prods. Liab. Litig., No. 06 Civ. 7631 (JFK), 2009 WL 4042769 (S.D.N.Y. Nov. 23, 2009), aff'd Flemings v. Merck & Co., Inc., 399 Fed. App'x 672 (2d Cir. 2010), and that case was replaced with Graves v. Merck & Co., Inc., No. 06 Civ. 5513 (JFK).
So far, the bellwether trial process has resulted in two verdicts in favor of Merck and one, this case, in favor of a plaintiff. The first Boles trial ("Boles I") was held in August 2009 and resulted in a mistrial after the jury failed to reach a verdict. Koor--then captioned Maley v. Merck & Co. Inc.--was tried in April 2010, and the jury returned a verdict in favor of Merck. Next the Court held a retrial of Boles ("Boles II") in June 2010. Boles II resulted in an $8 million jury verdict, which the Court reduced to $1.5 million.
Finally, the Graves case was tried in November 2010 and resulted in a second jury verdict in favor of Merck. The Court has set firm trial dates for three additional bellwethers: September 7, 2011 for Secrest v. Merck & Co., Inc., 06 Civ. 6292 (JFK); November 7, 2011 for Raber v. Merck & Co., Inc., 06 Civ. 6295 (JFK); and May 7, 2012 for Jelemma v. Merck & Co., Inc., 09 Civ. 4282 (JFK). The selection of an additional case for a bellwether trial is pending.
The plaintiffs in Boles, Graves, and Secrest were all Florida residents and therefore those cases involved the application of Florida products liability law. Merck has represented to the Court that approximately one hundred of the cases in the Fosamax MDL similarly involve Florida residents.
Boles alleges that she began to develop symptoms of ONJ after using Fosamax for five years. After having a tooth extracted in August 2002, Boles experienced complications resembling an infection. Standard treatment methods were not effective, and by late 2005 Boles' condition deteriorated to the point that she had exposed necrotic jaw bone in the oral cavity. She continued to suffer from numerous jaw complications, including the development of draining fistulae under her chin. These jaw injuries restricted her ability to eat and she has suffered significant pain.
Boles filed her case against Merck in the U.S. District Court for the Northern District of Florida. The case was transferred to this Court by order of the J.P.M.L in October 2006, and, as indicated, selected for trial as a bellwether two years later. Prior to the Boles I trial, Plaintiff withdrew her claims for breach of express and implied warranty, and the Court granted summary judgment in favor of Merck with respect to Boles' punitive damages claim. See In re Fosamax Prods. Liab.Litig., 647 F. Supp. 2d 265, 283-285 (S.D.N.Y. 2009). At the close of evidence in the Boles I trial, the Court granted Merck's motion for judgment as a matter of law on Plaintiff's claims for fraudulent misrepresentation and concealment, (see Boles I Trial Tr. 2359-60, Sept. 1, 2009, ECF No. 178), and after declaring a mistrial, the Court granted Merck's renewed motion for judgment as a matter of law on Plaintiff's negligent and strict products liability failure to warn claims, see In re Fosamax Prods. Liab. Litig., No. 06 Civ. 9455, 2010 WL 1257299, at *3-5 (S.D.N.Y. March 26, 2010).
The Boles II trial involved only Plaintiff's claims against Merck for negligent and strict products liability defective design claims. Punitive damages were not available.
The Boles II trial began on June 7, 2010 and lasted roughly three weeks. At the end of the trial, the jury returned its $8 million verdict in favor of Boles. Shortly thereafter, Merck renewed its motion for judgment as a matter of law and moved in the alternative for a new trial. Merck's renewed motion for judgment as a matter of law raised two issues relevant to the instant motion to certify the Court's October 4, 2010 Opinion and Order for interlocutory appellate review: (1) whether the evidence introduced at trial was sufficient to support a finding that the risks of Fosamax outweighed its benefits; and (2) whether there was evidence sufficient to establish thatFosamax presented a foreseeable risk of ONJ prior to October 2003.
Merck argued that if the evidence of risks and benefits of Fosamax were balanced "objectively" (i.e., not from the "viewpoint of any specific user"), the trial evidence was insufficient for a reasonable jury to conclude that Fosamax was a defective product. Additionally, Merck argued that Boles did not introduce expert testimony that would support a finding that adverse event reports collected prior to October 2003 put Merck on notice that Fosamax could cause ONJ. Boles argued that Fosamax was defective because it provided no benefit for users who were not osteoporotic at the time they took Fosamax, and that no expert testimony was required to support the jury's finding that the alleged injury was foreseeable.
On October 4, 2010, the Court denied Merck's motions and ordered the remittitur, reducing the verdict to $1.5 million. Noting that a district court could grant a renewed motion for judgment as a matter of law only "where it finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for the non-movant," October 4,...
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