Pharmaceutical Drug Litigation Updates

Bone drugs linked to rare thigh fractures: Health Canada

Quoted from http://www.ctv.ca/CTVNews/Health/20111220/osteoporosis-thigh-bone-femur-fracture-111220/

Bone drugs linked to rare thigh fractures: Health Canada

The Canadian Press

Date: Tuesday Dec. 20, 2011 8:51 AM ET

TORONTO — Health Canada is alerting Canadians that a class of drugs used for osteoporosis is linked to a slightly higher risk of a rare but serious thigh bone fracture known as an atypical femur fracture.

The advice is the result of Health Canada's review of bisphosphonate drugs, which has led to new warnings and precautions for patients and doctors and will lead to new labels for the drugs.

The department says the risk is higher for those taking the drugs, but the benefits of using the medications to avoid other osteoporosis-related fractures outweighs that risk.

Atypical femur fractures are rare, accounting for less than one per cent of all hip and femur fractures.

They can occur with minimal or no impact to the thigh area, and can occur in both legs in the same person.

Health Canada says patients who are currently taking or who took bisphosphonate drugs previously and who notice new or unusual pain in the hip, groin or thigh should talk to their doctor as this may be a sign of an atypical femur fracture.

The U.S. Food and Drug Administration announced similar findings and warnings in a statement issued in October 2010.

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Fordham Professor To Lead Fosamax Settlement Talks

Quoted from http://www.law360.com/health/articles/288052/fordham-professor-to-lead-fosamax-settlement-talks

Fordham Professor To Lead Fosamax Settlement Talks

By Erin Fuchs

Law360, New York (November 28, 2011, 3:22 PM ET) -- A New York federal judge last week chose a Fordham University School of Law professor as a special master tasked with brokering a settlement of roughly 900 suits consolidated in a multidistrict litigation alleging Merck & Co. Inc.'s Fosamax causes jaw deterioration.

U.S. District Judge John Keenan on Nov. 22 appointed John D. Feerick, formerly dean of Fordham's law school, as special master, noting that the plaintiffs' steering committee and Merck had agreed to his appointment.

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Analysis: Corporate defendants rack up wins in test trials

Quoted from http://www.reuters.com/article/2011/10/31/us-trials-bellwethers-idUSTRE79U4WB20111031

Analysis: Corporate defendants rack up wins in "test" trials

By Moira Herbst

NEW YORK | Mon Oct 31, 2011 12:26pm EDT

NEW YORK (Reuters) - A string of courtroom victories by drugmakers in key product-liability trials could be a signal that these and other companies can beat back claims in upcoming cases against them.

AstraZeneca Plc (AZN.L), Merck & Co (MRK.N) and Pfizer Inc (PFE.N) are among the companies to win closely watched bellwether cases in recent years.

Bellwether cases are sample trials ordered by judges in situations where hundreds or thousands of plaintiffs have similar claims consolidated before a single state or federal court. Typically, a judge chooses a few individual lawsuits to proceed ahead of the rest. As their name suggests, the result of these battles can be predictive.

A win by the defendant might prompt settlements or spur plaintiffs to drop other cases.

Upcoming test trials include the first in federal court against Bayer AG (BAYGn.DE) for allegations that its Yaz/Yasmin birth-control pill caused heart attacks and other medical problems. An Illinois federal court set the trial for January.

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F.D.A. to Review Safety of Popular Bone Drugs

Quoted from http://www.nytimes.com/2011/09/06/health/06bone.html

F.D.A. to Review Safety of Popular Bone Drugs

By DUFF WILSON

Published: September 5, 2011

Two advisory panels of the Food and Drug Administration will consider on Friday whether to recommend requiring women who use popular bone drugs like Fosamax to take “drug holidays” because of rising concerns about rare side effects with long-term use, according to people involved in the review.

Advisory panels to the F.D.A. are looking at the long-term effects of drugs like Fosamax.

The panels and F.D.A. staff members are also expected to conduct a comprehensive safety review of the medical evidence to date, after 16 years of growing use of the drugs, to determine whether they have proved to be safe and effective in use longer than three to five years. The recommendation could affect many of the estimated four million women in the United States who take the drugs, called biphosphonates. Biphosphonates inhibit a bone renewal process called resorption, adding bone mass, but possibly causing brittleness as well.

Fosamax was first approved in 1995 to treat postmenopausal osteoporosis and Paget’s disease of the bone, conditions that weaken bones. It has also been marketed, controversially, for a pre-osteoporosis condition called osteopenia. The Fosamax patent expired in 2008 and generics have flooded the market.

The F.D.A. announced in July that it would convene a joint meeting of advisory committees on drug safety and reproductive health to reconsider osteoporosis drugs after evidence surfaced linking long-term use with unusual breaks of the femur or thigh bone, bone death in the jaw, and possibly esophageal cancer.

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US judge narrows benchmark Fosamax case vs. Merck

Quoted from http://www.reuters.com/article/2011/08/30/merck-fosamax-idUSN1E77T1IJ20110830

US judge narrows benchmark Fosamax case vs. Merck

By Jonathan Stempel

NEW YORK, Aug 30 (Reuters) - A federal judge on Tuesday threw out part of a bellwether lawsuit against Merck & Co (MRK.N) over claims that its osteoporosis drug Fosamax causes jaw damage.

The plaintiff, Linda Secrest, may pursue her claim that Fosamax suffered from a design defect and caused her jawbone tissue to die, a condition known as osteonecrosis of the jaw, or ONJ, U.S. District Judge John Keenan wrote.

But the judge said Secrest, a former United Airlines flight attendant living in Florida, cannot pursue punitive damages or her claim that Merck failed to warn of possible problems with Fosamax, saying no reasonable jury could rule in her favor.

The lawsuit is the fourth bellwether case over Fosamax, which generated billions of dollars in annual sales for Merck before the Whitehouse Station, New Jersey-based company lost U.S. patent protection in 2008, allowing generic sales.

Results of bellwether cases may foreshadow the potential outcomes of other, similar lawsuits.

 

Merck has said it faced roughly 1,650 Fosamax-related cases in various courts as of June 30, including 910 before Keenan.

It won two of the earlier bellwether trials, while a jury ordered it to pay $8 million to the plaintiff in the third case.

Keenan later reduced that payout to $1.5 million, prompting the plaintiff, Shirley Boles, to request a new trial on damages. Merck appealed a separate legal issue to the federal appeals court in New York.

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FDA Reviewing Osteoporosis Drugs for Esophageal Cancer Risk

Quoted from http://www.bloomberg.com/news/2011-07-21/fda-reviewing-bisphosphonates-for-esophageal-cancer-in-women.html

FDA Reviewing Osteoporosis Drugs for Esophageal Cancer Risk

By Anna Edney - Jul 21, 2011 5:18 PM ET

U.S. regulators are reviewing oral medicines to combat bone weakening from companies such as Merck & Co. and Roche Holding AG (ROG) for evidence they cause esophageal cancer and say patients should still take the drugs.

The Food and Drug Administration made the comments in an announcement today ahead of a meeting of agency advisers Sept. 9, where they will discuss the safety of the osteoporosis treatments. The agency is reviewing conflicting studies based on U.K. data that found no increased risk and a doubling in the risk of the throat cancer.

More than 40 million people either have osteoporosis in the U.S. or are at high risk because of too low bone mass, according to the National Institutes of Health. The disease is a structural deterioration of tissue that leads to fragile bones and an increased risk for fractures.

“The benefits of oral bisphosphonate drugs in reducing the risk of serious fractures in people with osteoporosis continue to outweigh their potential risks,” the FDA said.

Merck shares rose 59 cents, or 1.7 percent, to $36.18, at 4:15 p.m. in New York Stock Market trading. Roche shares rose 1.8 Swiss francs, or 1.3 percent, to 141.5 francs at the close of Zurich trading.

Differences in methodologies may account for discrepancies in findings, the agency said. The gastrointestinal side effects of bisphosphonates could increase a patient’s likelihood of undergoing an endoscopy that would lead to more cancer detection, the agency said.

Bisphosphonate drugs include Whitehouse Station, New Jersey-based Merck’s Fosamax and Basel, Switzerland-based Roche’s Boniva. The FDA urged those taking the treatment to follow directions carefully, and to take the drug first thing in the morning with a full glass of water.

Isle woman sues drugmaker after breaking thigh bone

Quoted from http://www.staradvertiser.com/business/businessnews/20110630__Isle_woman_sues_drugmaker_after_breaking_thigh_bone.html

Isle woman sues drugmaker after breaking thigh bone

 

By Kristen Consillio

POSTED: 01:30 a.m. HST, Jun 30, 2011

 

Lois Takamori, a 62-year-old retired Kailua school teacher, was talking with friends at a gym in 2009 when a slight step backward broke her thigh bone.

Takamori filed a federal lawsuit Wednesday against drugmaker Merck & Co., claiming the thigh bone fracture was a result of taking the prescription drug Fosa­max for eight years.

Fosamax is commonly prescribed to postmenopausal women to prevent bone loss from osteoporosis, a condition prevalent among Asian and Caucasian women.

"I took onestep backward and felt excruciating pain," she said of the fracture. "It'sa devastating breakage because it doesn't heal. I have discomfort, can't walk without a cane, so it's very limiting."

Takamori, who began taking Fosamax in 2001 when she was diagnosed with osteoporosis, had multiple surgeries to try to fix the fracture.

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Bones: Experts rethink long-term use of drugs

Quoted from http://yourlife.usatoday.com/health/medical/story/2011/05/Bones-Experts-rethink-long-term-use-of-drugs/47126182/1

Bones: Experts rethink long-term use of drugs

Bone experts are rethinking the way they treat osteoporosis now that research has linked widely prescribed drugs to rare but serious leg fractures.

• 

  File photo by Brian Branch-Price, AP

  Bisphosphonates, such as Fosamax, are among top-selling drugs for osteoporosis.

By Janice Lloyd, USA TODAY

May 13, 2011

Bisphosphonates, a class of drugs that are highly beneficial in reducing bone fractures in people with osteoporosis, the experts say, should not be prescribed to patients who don't have the disease but are at risk of developing it, as often has been the practice in recent years.

And osteoporosis patients should talk to their doctors about taking a "holiday" from the drugs after two or three years on the medications, says Ken Lyles, director of geriatrics research at Duke University. The drugs can be taken intermittently after several years, he says.

"This is a change, absolutely," says Lyles, a member of the American Society of Bone and Mineral Research. "I look at it as a positive thing. We're learning more. We have good drugs, but we need to know how to use them correctly."...

 

Bisphosphonates (Fosamax, Reclast, Actonel, Boniva) are among the top-selling drugs in the country. Annual sales exceed $3.5 billion, according to IMS Health, a research firm that tracks prescriptions. The Food and Drug Administration in November warned about potential risks of atypical femur fractures when taking the drugs, and a Swedish study last week in The New England Journal of Medicine called for "intermittent use" because of a reduced risk of fracture after taking a break from the drugs.

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Study Finds Slight Risk of Rare Fractures From Bone Drugs

Quoted from http://health.usnews.com/health-news/family-health/bones-joints-and-muscles/articles/2011/05/04/study-finds-slight-risk-of-rare-fractures-from-bone-drugs

Study Finds Slight Risk of Rare Fractures From Bone Drugs

Benefits of bisphosphonates in preventing most fractures outweigh risk, experts say

 

Related Articles

• Study Suggests Osteoporosis Drug Might Treat Loss of Bone in Jaw
• Health Buzz: Osteoporosis Drugs May Increase Risk for Thigh Bone Fracture
• Bone Drugs Linked to Rare Fractures, FDA Warns
• Health Buzz: Popular Osteoporosis Drugs Linked to Cancer Risk

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, May 4 (HealthDay News) -- Bone-building drugs called bisphosphonates have been linked to rare fractures of the thigh bone, but Swedish researchers report that the risk is so small that most patients needn't worry.

Bisphosphonates include the widely used medications Fosamax, Boniva and Actonel, which are typically taken by people with osteoporosis to increase bone strength and prevent fractures.

"Osteoporotic fractures are quite common and bisphosphonates reduce this risk a lot, but the price you have to pay for that is a small risk in getting a so-called fatigue fracture," said lead researcher Dr. Per Aspenberg, a professor of orthopedics at Linkoping University.

"These findings must be seen in the context of the debate that has been going on for the past year," he added. "Our data argues very strongly for a causal relationship."

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Revisiting Bone Drugs and Femur Fractures

Quoted from http://www.nytimes.com/2011/03/08/health/08brody-bone.html

Revisiting Bone Drugs and Femur Fractures

By JANE E. BRODY

Published: March 6, 2011

Nearly six years ago in this column, I discussed what was then a little-known problem associated with long-term use of bisphosphonates, the valuable drugs that protect against fractures caused by bone loss. The drugs, among them Fosamax, Actonel and Boniva, can slow bone loss, increase bone density and cut fracture rates in half in women with established osteoporosis.

Enlarge This Image

The femur of Dr. Jennifer Schneider of Tucson, an internist who after seven years on Fosamax suffered a nontraumatic femur fracture that took two years to heal.

Reports had begun to emerge that some women taking bisphosphonates for many years suffered an unusual fracture of the femur, the long bone of the thigh. There was little or no trauma; in most cases the women were simply standing or walking when the femur snapped in half. In some, breaks occurred in both thighs, and many of the fractures were unusually slow to heal.

Experts think the fractures happened because of the way the drugs work: by slowing the rate of bone remodeling, the normal process by which injured bone heals. As a result, microfractures that occur through normal wear and tear are not repaired. Although bone density may be normal, the bone can become brittle and crack under minor stress.

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