Merck Wins Summary Judgment in Second Federal Bellwether Case Involving FOSAMAX® (alendronate sodium)

Merck Wins Summary Judgment in Second Federal Bellwether Case Involving FOSAMAX® (alendronate sodium)
WHITEHOUSE STATION, N.J., November 23, 2009 - Merck said today that U.S. District Court Judge John F. Keenan granted summary judgment in Merck's favor in Flemings v. Merck. Flemings is the second of three cases involving FOSAMAX (alendronate sodium) designated by the federal MDL court as a bellwether trial case.

In granting summary judgment in Flemings and dismissing all of the plaintiff's claims, Judge Keenan ruled that the physician relied upon by Ms. Flemings (Dr. Rose) was unqualified to render an opinion and that Ms. Flemings failed to present sufficient evidence to support her contention that FOSAMAX caused her to sustain osteonecrosis of the jaw (ONJ).

"It is clear that Dr. Rose's opinion is derived from a 'subjective belief' rather than from scientific knowledge and methodologies," wrote Judge Keenan. "Dr. Rose is not qualified as an expert under Rule 702 and his opinion is inadmissible under Daubert. Plaintiff has offered no other evidence to establish that FOSAMAX caused her to develop ONJ, and therefore her failure to warn claim is insufficient as a matter of law."

"We are pleased that the Court agreed with us that Ms. Flemings did not present any reliable evidence supporting her claim that FOSAMAX caused her to suffer ONJ," said Paul Strain of Venable LLP, outside counsel for Merck. "Unfortunately, Ms. Flemings had medical problems that cause people to develop jaw problems regardless of whether they were taking FOSAMAX."

Merck is represented in the Flemings case by Venable LLP and Hughes Hubbard & Reed LLP.

Status of Litigation
As of September 30, 2009, approximately 953 cases, which include approximately 1334 plaintiff groups had been filed and were pending against Merck in either federal or state court.

The first MDL bellwether case -- Boles v. Merck - previously resulted in a mistrial after several days of jury deliberations because the eight person jury did not reach a unanimous verdict. Merck has filed a pending post-trial motion in Boles asking Judge Keenan to enter judgment in Merck's favor. Boles was plaintiffs' top choice for bellwether designation and Judge Keenan selected randomly Flemings.

The third MDL bellwether case, Maley v. Merck, which was chosen by Merck, is currently scheduled to begin on April 19, 2010.

About FOSAMAX
FOSAMAX is indicated for the treatment and prevention of osteoporosis in postmenopausal women. FOSAMAX should not be used in patients with certain disorders of the esophagus that delay emptying, who are unable to stand or sit upright for at least 30 minutes, who have low levels of calcium in their blood, or in patients who are allergic to FOSAMAX. Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. Patients who experience new or worsening heartburn, difficulty or pain when swallowing or chest pain should stop taking the drug and call their doctor right away. Patients who develop severe bone, joint and/or muscle pain at any time should contact their doctor.

About Merck
Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching programs that donate and deliver our products to the people who need them. Merck. Be Well. For more information, visit www.merck.com.

Forward Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2008 Annual Report on Form 10-K, Schering-Plough's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site: www.sec.gov.
 
FOSAMAX® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA 

Suggested Articles

After delivering a "positive surprise" in December, Biogen is painting a fuller picture of its lupus drug.

A new CRISPR technique neutralizes SARS-CoV-2 by scrambling the virus' genetic code. It could prove useful for fighting other viruses, like influenza.

The deal, which follows a bidding war with AcelRx, gives Melinta another approved antibiotic and potentially complementary R&D expertise.