New FDA Analysis Cautions against the Long Term use of Fosamax in Light of its Limited Benefits and the Possibility of Complications.

On May 9, 2012, a new U.S. Food and Drug Administration (“FDA”) analysis cautioned against long term use of Fosamax due to its uncertain benefits and the possibility of bisphosphonate complications. The FDA analysis, published in The New England Journal of Medicine, was motivated by a growing debate over how long women should continue using the drugs, known as bisphosphonates, which are sold as generic versions of brands like Fosamax and Boniva. The FDA’s analysis reviewed the long term use of bisphosphonates and found that the drugs offered little, if any, benefit after three to five years of use. According to the FDA, “the long-term safety and efficacy of bisphosphonate therapy for osteoporosis are important concerns for the FDA. In response to post marketing reports of rare but serious adverse events associated with bisphosphonates, such as atypical femur fractures, osteonecrosis of the jaw, and esophageal cancer, the FDA performed a systematic review of long-term bisphosphonate efficacy.”

As reported by the New York Times, the concern is that after years of use, the drugs may in rare cases actually lead to weaker bones in certain women, contributing to “rare but serious adverse events,” including unusual femur fractures, esophageal cancer and osteonecrosis of the jaw, a painful and disfiguring crumbling of the jaw bone.

According to the New York Times, some women with moderate bone density and no other risk factors are unlikely to derive benefits from long term use of bisphosphonates. Yet, women continue to take these medications for years. Dr. Clifford J. Rosen, an endocrinologist and researcher at the Maine Medical Center Research Institute told the New York Times, “I think a lot of people are going to come off this drug.” In an accompanying article in The New England Journal of Medicine by Dr. Rosen and others, the researchers estimate that perhaps 60 percent to 70 percent of current users would be candidates for coming off the drugs after three to five years.
According to the study, women who have been diagnosed with osteopenia, a mild version of low bone density, are especially good candidates to stop taking bisphosphonates after three to five years, particularly in light of the recent safety concerns.

Attorneys at Pope, McGlamry are filing lawsuits against the drug manufacturers on behalf of individuals who have experienced bisphosphonate complications such as atypical femur fractures. If you or a loved one has suffered a femur or thigh-bone fracture after taking Fosamax, Actonel, or Boniva, contact our Georgia pharmaceutical litigation attorneys today. Schedule a free consultation.

MDL INITIAL ORGANIZATION CONFERENCE TO TAKE PLACE NEXT WEEK FOR WRIGHT MEDICAL’S CONSERVE HIP IMPLANT SYSTEM

On April 23, 2012, Judge William S. Duffey, Jr., will host a joint Initial Organization Conference in the Northern District of Georgia, in Atlanta, with respect to the latest metal-on-metal hip implant multidistrict litigation (MDL), In Re: Wright Medical Technology, Inc., Conserve Hip Implant System Products Liability Litigation. On February 27, 2012, the Judicial Panel on Multidistrict Litigation (JPML) ordered the transfer and consolidation of Wright Medical Technology’s Conserve Hip Implant System, a metal-on-metal hip replacement.

On the agenda for the Wright Medical Conserve Hip Implant System Initial Organization Conference, the parties and the Court will discuss dates for direct filing of lawsuits, amending pleadings, dates for filing motions, discovery, a proposed case management order, and other procedures. Also on the agenda for the Wright Medical Conserve Hip Implant System MDL Initial Organization Conference will be the selection of Lead and Liaison Counsel. Of the 30 plus cases pending in this most recently formed metal-on-metal MDL, the Wright Medical Conserve Hip Implant System Products Liability Litigation, Pope, McGlamry, Kilpatrick, Morrison, & Norwood, P.C., has been a unanimous selection to serve as lead and liaison counsel in the Wright Medical Conserve Hip Implant System Products Liability MDL in the Northern District of Georgia.

The Wright Medical Conserve Cup features a similar design to DePuy Orthopaedics’ ASR Cup, which was recalled in August 2010 after medical data suggested that a higher-than-expected number of people had their artificial hip fail within a few years resulting in revision surgery.
All of the Wright complaints allege that Wright Medical manufactured a defective metal-on-metal hip implant, known as the Conserve Plus, and failed to warn patients about the potential risk that the device may fail within a few years of surgery causing serious medical problems and the need of revision surgery. Plaintiffs say that the Conserve acetabular cup has a tendency to loosen and fail as metal particles are shed into the body from the metal parts of Wright Medical’s Conserve Hip Implant System rubbing against each other.

Since the FDA approved Wright Medical’s Conserve Cup metal-on-metal hip replacement system under their controversial 510(k) approval system, more than 200 adverse event reports have been submitted by patients or physicians, which likely only represent a fraction of the total number of problems with Wright Medical hip replacements. In May 2011, the FDA asked Wright Medical and other metal-on-metal hip makers such as DePuy, Stryker and Zimmer, to obtain more information about the level at which the metal particles released by hip replacements becomes dangerous, how much metal they actually release and to quantify the potential side effects of metallosis.

The Wright Conserve Hip Implant System is a metal-on-metal design, which consists of cast cobalt chromium molybdenum that provides the receptacle for the cobalt chromium molybdenum femoral head. The metal femoral head rotates within the metal monoblock Conserve Cup, which does not have a liner, resulting in the release of metal particles that can cause metal toxicity in the blood, soft tissue and bone. This can result in metallosis, tissue necrosis, pseudotumors and other problems, according to the complaints.

If you or a loved one had a Wright Conserve Hip System implanted and have suffered complications, or experienced a hip replacement failure requiring revision surgery, you may be entitled to recover significant damages from the defective product manufacturer, Wright Medical.

Actos Whistleblower Suit Unsealed

In late February 2012, U.S. District Court Judge F. Dennis Saylor unsealed a qui tam whistleblower lawsuit, alleging that a doctor contracting with Takeda Pharmaceuticals, the manufacturer of Actos, was met with resistance from her superiors at Takeda when she attempted to report Actos bladder cancer findings. Dr. Helen Ge claimed that Takeda hired her under contract in September of 2008 and charged her with the task of reviewing various drugs in the Takeda portfolio for adverse reactions, including Actos.

In her whistleblower complaint, which was filed under seal in June of 2010, Dr. Ge asserts that at a time when an excess of 100 cases of Actos bladder cancer had been reported to the company, the U.S. Food & Drug Administration (“FDA”) only received 72 of those reports. Dr. Ge’s complaint also alleges that Takeda failed to report all cases of Actos heart failure to the FDA and instructed its medical reviewers not to report hundreds of non-hospitalized or non-fatal congestive heart failure cases as serious adverse events. Dr. Ge claims that her contract with Takeda was abruptly terminated when she approached the firm with accusations that the pharmaceutical company was underreporting adverse reactions to Actos. Dr. Ge’s complaint was recently summarized in Lawyers Weekly USA (March 19, 2012).

Last year, the FDA issued a safety bulletin on the findings that taking Actos for more than 12 months is associated with an increased risk for bladder cancer. Actos is a Type 2 diabetes medication that became a popular treatment for Type 2 diabetes patients when GlaxoSmithKline’s Avandia was found to be linked to a greater risk of heart attacks and other adverse cardiac events. Takeda may have been motivated to fraudulently report and under report serious adverse events so that Actos would not suffer the same fate as Avandia. According to Dr. Ge’s lawsuit, Takeda’s alleged conduct was driven by an economic desire to falsely enhance Actos’ safety profile and to increase sales.
Dr. Ge’s lawsuit is filed in the U.S. District Court for the District of Massachusetts, and is filed under the False Claims Act. It seeks to recover funds paid to Takeda by Medicaid, Medicare, and other federally funded healthcare programs.

In addition to the whistleblower lawsuit, men and women all over the United States are filing claims against Takeda for Actos related injuries such as bladder cancer. If you or a loved one has been diagnosed with bladder cancer after taking Actos, you should contact one of Pope McGlamry’s Actos side effects lawyers (Atlanta: 877-285-7656 / Columbus: 877-265-7656) today to discuss your claim.

The American Academy of Orthopaedic Surgeons Discusses Problems with Metal-on-Metal Hip Replacements at Annual Conference

The Annual Meeting of the American Academy of Orthopaedic Surgeons was held in San Francisco, California on February 7-11, 2012.  A significant portion of the conference was spent discussing Metal-on-Metal hip replacements, their problems, and the “Current Status and Recommendations for Patient Management.”  Several of the nation’s premier orthopaedic surgeons can be seen discussing metal-on-metal hips at the link below.

Of interest, all members of the panel agreed that there is no indication for the use of Metal-on-Metal total hip implants.  Meaning that from the perspective of some of the most innovative and well know orthopaedic surgeons in the US and Great Britain, there is no reason to ever implant in a patient a Metal-on-Metal total hip implant.  What is shocking is that even Dr. Thomas Schmalzreid, the designer of the recalled DePuy ASR Total Hip System, agreed that there is no clinical use for the Metal-on-Metal total hip implant.

This opinion was echoed by the recommendation made in the Lancet, the preeminent British medical Journal.  In March of this year, the Lancet reported that Metal-on-Metal stemmed total hip implant systems should not be used and that those that have received Metal-on-Metal total hip replacements should be carefully monitored.

Numerous companies, including Wright Medical Technology, Zimmer, Biomet and Johnson & Johnson’s DePuy Orthopedics Division are facing lawsuits from patients who claim they suffered severe pain, swelling, tissue damage, metal poisoning and other complications after receiving a metal-on-metal hip replacement system.  Pope McGlamry has been pursuing claims for clients implanted with metal-on-metal implants, including the Johnson & Johnson/DePuy Orthopaedics ASR Implant and Wright Medical’s Conserve Hip Implant System.

If you or a loved one have a hip implant and have suffered complications, or experienced a hip replacement failure requiring revision surgery, you may be entitled to recover significant damages from the defective product manufacturer. The lawyers at Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C., are actively handling claims for you injury and loss.