For decades, large corporations have repeatedly misled, lied, or unduly influenced the FDA. In so doing, the FDA betrayed the trust bestowed upon them by the American public.
A federal appeals court on Wednesday revived claims by several hundred plaintiffs who accused Merck & Co of failing to adequately warn about the risks of thigh bone fractures associated with its osteoporosis drug Fosamax.
In a 3-0 decision, the 3rd U.S. Circuit Court of Appeals in Philadelphia said the plaintiffs may proceed to trial on their failure-to-warn claims, and a lower court judge erred in finding the claims pre-empted by federal law.
Merck said it is reviewing its options, and that a judge, not a jury, should decide the pre-emption question. It also said it remains “confident” in Fosamax’s safety and effectiveness.
David Frederick, a lawyer for the plaintiffs, did not immediately respond to requests for comment.
Fosamax, whose chemical name is alendronate sodium, has been prescribed to treat or prevent bone loss in post-menopausal women since 1995.
But the plaintiffs claimed to suffer atypical femur fractures from long-term use, and said Merck knew about the risk for more than a decade before adding it to the Fosamax warning label in January 2011.
The Kenilworth, New Jersey-based company changed the label four months after an outside task force hired by the U.S. Food and Drug Administration published a report associating Fosamax with the fractures.
In March 2014, U.S. District Judge Joel Pisano in Trenton, New Jersey, dismissed all claims by plaintiffs injured before Sept. 14, 2010, the date of the task force report, leaving only about 20 active cases.
Merck & Co Inc said on Monday that it was prepared to pay $27.7 million to settle lawsuits by hundreds of people who sued the company over allegations that its osteoporosis drug Fosamax caused bones in the jaw to deteriorate.
Lawyers for Merck and plaintiffs disclosed the proposed settlement at a court hearing in New York to resolve 1,140 lawsuits pending in federal and state courts. Any settlement would need to be approved by a judge.
Merck, which confirmed the agreement later on Monday, said the accord requires a 100 percent participation rate and evidence that the claimants satisfy eligibility requirements. The deal covers about 1,200 people, the company said.
“We hope to bring this to a successful conclusion,” Paul Strain, a lawyer for Merck, said at the hearing in U.S. District Court in Manhattan before Judge John Keenan, who has presided over federal litigation by plaintiffs claiming that they developed osteonecrosis of the jaw from taking Fosamax.
The condition is a disease that causes bones in the jaw to deteriorate or die.
The settlement would resolve a large portion of the 5,255 product liability cases facing Merck over Fosamax, a one-time blockbuster drug with $3 billion in sales in 2007.
Doctors prescribe Fosamax to prevent age-related bone damage.
The drug can cause minor side effects including abdominal pain, acid regurgitation and constipation. In rare cases, people who take the drug may suffer from serious side effects such as femur fractures, jaw problems and esophageal ulcers.
For many people, one of the worries that comes with getting older is the risk of developing osteoporosis. This debilitating disease makes bones so brittle they easily break.
When Fosamax (alendronate) was introduced in 1995, it was promoted as the solution to osteoporosis and other bone-damaging diseases. However, studies show that the drug causes serious side effects that may be more problematic than osteoporosis itself.
The drug’s manufacturer, Merck, says the most common side effects include gastrointestinal issues, such as nausea, diarrhea, constipation and cramping. The U.S. Food and Drug Administration documented several of the drug’s more serious side effects and subsequently distributed numerous warnings.
Though rare, severe health problems associated with Fosamax can be crippling. These include femur fractures, Dead Jaw Syndrome, esophagus problems and musculoskeletal pain.
Some of these side effects led people to file Fosamax lawsuits against Merck.
Kent Klaudt of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP announced that Reba Inez Patton and her husband Patrick Patton of Tennessee have filed a lawsuit in the Superior Court of New Jersey against Merck & Co., the manufacturer of Fosamax, and GlaxoSmithKline, LLC, the manufacturer of Boniva, alleging these prescription drugs, which fall within the category of drugs known as bisphosphonates, increase the risk of atypical bone fractures and caused Mrs. Patton severe and permanent injuries.
Mrs. Patton was prescribed both Fosamax and Boniva. Mrs. Patton used Fosamax from approximately 2001 to 2006, and Boniva from approximately 2006 to 2010. On December 10, 2010, Mrs. Patton suffered a low energy, atypical femoral fracture when she took a step to walk up a flight of stairs.
“I wish this never happened to me. When I walk, it is scary because I do not want to fall again,” stated Mrs. Patton.
Bisphosphonates such as Fosamax and Boniva are intended to slow bone loss associated with osteoporosis. However, as the lawsuit charges, long-term use of Fosamax and Boniva causes weak or brittle bones, resulting in a rare type of low energy or low trauma femur fracture.
“Merck and GlaxoSmithKline negligently marketed these bisphosphonate products, which lack long-term benefits and also pose significant dangers to patients, especially those who have been on the drugs for many years,” commented attorney Klaudt.
The complaint also charges that Merck and GlaxoSmithKline failed to provide physicians and patients with sufficient instructions and warnings regarding the risk of severely suppressed bone turnover, resulting in stress fractures. Klaudt stated, “Neither doctors nor patients were warned by the manufacturers of these horrible atypical femur fractures caused by long-term use of bisphosphonates.”
Mrs. Patton charges in the complaint that she will require ongoing medical care and treatment due to her severe and permanent injuries, including severely suppressed bone turnover and a severe fracture in her left femur, fear of developing other harmful conditions, additional fractures, and pain and mental anguish.
“The accident changed a good part of my life; it put a lot of extra burden on my family. I just do not want this to happen to anyone else,” Mrs. Patton added.