Lawyers USA Your Business Partner

In the first bellwether state trial over the osteoporosis drug Fosamax, Merck won a defense verdict last week.

An Atlantic City, N.J. jury rejected a 67-year-old woman’s claim that she developed osteonecrosis of the jaw, or “jaw death,” after taking the drug.

Merck faces about 1,500 suits over Fosamax, including federal multidistrict litigation and hundreds of claims in New Jersey state court.

While both sides fought out the three-week trial largely over whether Merck adequately warned about the risk of bisphosphonates in Fosamax causing jaw decay, the jury never got past the first question put to it: whether the plaintiff had the debilitating jaw disease, also known as ONJ.

The jury ended its deliberations after answering “no” to that question, 9-1.

Paul Sizemore of the Sizemore Law Firm in El Segundo, Calif., who represented the plaintiff, said he was “baffled” by the verdict because two of the plaintiff’s treating physicians testified in person that she had the disease.

Winning defense lawyer Christy D. Jones of Butler Snow in Ridgeland, Miss. equated the verdict with a win on liability.

She said she was not surprised by the jury’s findings because “we know ONJ existed long before the advent of [Fosamax]. It occurs in the general population and is attributable to trauma, infection, radiation and many other explanations.”

But Meghan McCormick, who practices with Sizemore and also represented the plaintiff, said the redeeming aspect of the loss was that it didn’t mean that the jury rejected their argument that Fosamax causes ONJ because it never reached that question.

Eight continuous weeks

Plaintiff Alison Rosenberg took Fosamax first in 1999, then again from 2001 until 2006, when she claims she began suffering from ONJ.

ONJ is defined by eight continuous weeks of exposed jaw bone, a condition in which a person’s gums have worn away in the affected area.

The doctor who prescribed Fosamax to Rosenberg said had she been warned properly of the risks, she would have taken the plaintiff off the drug. An oral surgeon who treated Rosenberg for four months and did several CT scans testified that he diagnosed her with ONJ and sent her to an oral medicine specialist at the University of Pennsylvania, who also testified that she had ONJ.

“The jury essentially said, ‘We think you’re both wrong.’ That floored me a little bit,” said Sizemore.

But the defense pointed out gaps in the plaintiff’s medical records where doctors didn’t mention any exposed bone.

“The oral surgeon said [at trial that] he thought there was continuous exposed bone based upon reading the records, but at his deposition he acknowledged that on two occasions he failed to note the presence of exposed bone,” said Jones.

The defense also argued that there were other explanations for the plaintiff’s jaw problems, pointing to a tooth extraction in December 2005 and steroid injections in her back, knee and jaw.

But McCormick argued that those factors “may increase the risk [of ONJ] with Fosamax, but on their own are never driven to cause ONJ.”

All along, both sides thought that the most contentious piece of evidence was a 2006 patient product information sheet that said Fosamax may cause jaw problems.

“This was the best piece of evidence for us,” said McCormick, who added that the FDA asked for a label change in January 2005, but Merck didn’t change its label until July 2005. “During that time, [Merck] was dragging [its] feet while our client went to the doctor in March 2005 and could have been taken off the medication.”

“This was the first case that actually involved a time-frame that included the July 2005 label change in which Merck first advised doctors of the potential risk,” said Jones, who has tried two other Fosamax cases.

The plaintiff’s attorneys are weighing an appeal based on the court’s denying admission of a newer 2010 Fosamax label that mentions ONJ specifically for the first time.

A grain of rice

Sizemore said that in the end it may have been too difficult to overcome the perception that the plaintiff suffered a relatively minor injury.

“The jury is looking at a healthy, attractive 67-year-old lady. It’s hard to envision that she was in an excruciating amount of pain five years ago,” he said.

Had his client undergone a jaw resection, when parts of the jaw are cut out, or had a scar, the jury might have been more sympathetic toward her, Sizemore said.

The defense also did an effective job describing the size of the plaintiff’s dead jaw bone, which measured 1 x 2 x 2 millimeters, comparing it to a grain of rice split in half.

“Basically it was the size of the head of a pin,” said Jones.

The next Fosamax trial, in the case of Secrest v. Merck, is scheduled for March 14 in federal multidistrict litigation in New York.

Earlier this month, the judge overseeing those trials, John F. Keenan, asked lawyers to add two new cases to go to trial, including a case where a plaintiff began taking Fosamax before the July 2005 label change but developed ONJ after the change, and another case in which the plaintiff began using Fosamax after July 2005.

Plaintiff’s attorneys: J. Paul Sizemore, Jim Robertson and Meghan McCormick of Sizemore Law Firm in  El Segundo, Calif.; Marc D. Grossman of Sanders, Sanders, Block, Woycik, Viener & Grossman in New York.

Defense attorneys: Christy D. Jones of Butler, Snow, O’Mara, Stevens & Cannada in Ridgeland, Miss., Eileen Muskett of Cooper Levenson April Niedelman & Wagenheim in Atlantic City, N.J.

The case: Rosenberg v. Merck & Co.; New Jersey Superior Court, Atlantic City; Feb. 14, 2011; Judge Carol Higbee.

Questions or comments can be directed to the writer at: sylvia.hsieh@lawyersusaonline.com

Close this Window Bookmark and Share This Page

Save to Browser Favorites / Bookmarks

Print RSS Feed Ask backflip blinklist BlogBookmark Bloglines BlogMarks Blogsvine BuddyMarks BUMPzee! CiteULike co.mments

Connotea del.icio.us Digg diigo DotNetKicks DropJack dzone Facebook Fark Faves Feed Me Links Friendsite folkd.com

Furl Google Hugg Jeqq Kaboodle kirtsy linkaGoGo linkedin LinksMarker Ma.gnolia Mister Wong Mixx MySpace

MyWeb Netvouz Newsvine oneview OnlyWire PlugIM Propeller Reddit Rojo Segnalo Shoutwire Simpy Slashdot

Sphere Sphinn Spurl Squidoo StumbleUpon Technorati ThisNext Tumblr Twitter Webride Windows Live Yahoo!

Email This to a Friend

Copy HTML: 

 If you like this then please subscribe to the RSS Feed.

More »