Bellwether Fosamax Case Tossed From MDL

New Jersey U.S. District Judge Joel A. Pisano on Tuesday dismissed a suit brought against Merck & Co. Inc., in multidistrict litigation accusing the company of negligence over femur fractures allegedly caused by its osteoporosis drug Fosamax, finding the failure to warn claims fail because the drug's label is clear and accurate.

Judge Pisano granted Merck’s summary judgment motion on grounds that Plaintiff Barbara Gaynor’s claims fail because she took the drug after Merck revised its labeling in 2010 to fully convey the potential for fractures, and she did not set forth sufficient evidence that Merck did not give her doctor adequate notice.

The ruling comes a year after a defense verdict in another Fosamax suit, brought by a user of the drug before the labeling change. Following that decision, in Glynn v. Merck, Pisano dismissed roughly 650 similar cases. An appeal of the Glynn ruling on preemption is pending before the U.S. Court of Appeals for the Third Circuit. For more information on those topics, see my previous blog posts.

Another 215 cases pending in the MDL were brought by users of the drug after the label change.

It is expected that Judge Pisano will issue a show cause order as to why those cases should not be dismissed in light of the Gaynor ruling.

Gaynor, of Hicksville, New York, took Fosamax from 1996 until she fractured her right femur in September 2011. She claimed her long-term use of the drug made the relabeling immaterial, saying, “Merck has submitted no evidence that Mrs. Gaynor’s use of Fosamax in 2011 was a substantial factor in causing her femur fracture.”

Judge Pisano reasoned that that argument confused the proper analysis of a failure-to-warn claim by expecting that Merck first prove that no issue of fact concerning proximate cause existed.

Pisano called Gaynor’s contention that Merck should be liable for failing to warn of Fosamax’s dangers in the late 1990s and the early 2000s “baffling,” because he had ruled in Glynn that such claims are preempted. Merck maintained that it had sought FDA approval of a stronger warning but it was rejected.

Pisano wrote that Gaynor “re-characterized” her suit’s claim that Merck’s warnings about the side effects of Fosamax were inadequate when she later contended that the court should not decide that claim because it was not a proximate cause of her injury. He reasoned that she “cannot have it both ways.”

Merck has been named in 4,430 suits claiming Fosamax caused femur fractures. Of those, 2,785 are in state court in New Jersey, pending before Superior Court Judge Carol Higbee. Another 525 femur cases were filed in state court in California, and 1,120 went to the MDL.

There are approximately 1,150 suits pending over claims that Fosamax causes osteonecrosis of the jawbone. Many of those claims have settled.

MDL Judge Rules Some Fosamax Cases Preempted

The judge overseeing the Fosamax MDL has ruled that claims brought by plaintiffs whose injury is an atypical femur fracture injuries that occurred before the Fosamax label was changed to warn of such risks are federally preempted. His reasoning was the FDA denied Merck & Co.’s previous attempts to enhance the warning label.

Judge Joel Pisano of the U.S. District Court for the District of New Jersey held that the court’s preemption ruling in the bellwether case Glynn v. Merck & Co. applies to all pre-label change cases in this MDL. The court found no reason not to apply its preemption ruling to other similarly situated plaintiffs because: (1) the case in question had been selected as a bellwether; (2) preemption had been thoroughly briefed; and (3) plaintiffs had been repeatedly instructed to come forward with all their preemption related evidence.

It is not apparent if the plaintiffs will appeal the Judge’s ruling.

Merck Proposes Settlement Over Fosamax Osteonecrosis Claims

Merck has proposed a $27.7 million to settle with Plaintiffs who sued the company over allegations that its osteoporosis drug Fosamax caused osteonecrosis of the jaw. The condition is a disease that causes bones in the jaw to deteriorate or die.

The proposed settlement was announced earlier this month at a court hearing in New York to resolve 1,140 lawsuits pending in federal and state courts. Of course, any settlement would need to be approved by a judge. The case is In Re Fosamax Products Liability Litigation, U.S. District Court, Southern District of New York, No. 06-md-01789.

According to sources, the settlement would require a 100% participation rate and evidence that the claimants satisfy eligibility requirements. A high participation rate is common in global settlements for mass tort litigation, but this rate is above and beyond the normal participation threshold for such settlements.

At the December 9th hearing, it was announced that plaintiffs' law firms had until January 13, 2014 to inform the Defendants of their intent to participate in the settlement process. Plaintiffs have until March 31, 2014 to opt-out of the settlement. Merck would then have until May 15, 2014 to decide whether or not it will go forward with the deal.

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. Sales have declined since Fosamax lost patent protection in 2008. Through September, Merck had reported $421 million in Fosamax sales in 2013, a sharp drop from years past.

Of the lawsuits over Fosamax, about 860 of the cases were before Judge Keenan in New York. Since the cases were consolidated in 2006, Keenan has presided over all of the federal cases. Judge Keenan had held a series of "bellwether" trials, allowing Merck and plaintiffs' lawyers to assess trends and outcomes in similar cases. This is also common in consolidated mass tort cases.

The last Fosamax trial before Judge Keenan was held in February 2013 and resulted in a $285,000 verdict for the plaintiff. Merck lost just one other of the five bellwether trials when a jury awarded Florida resident Shirley Boles $8 million. The judge later cut that sum to $1.5 million. Merck won two other trials in a New Jersey state court over jaw injury claims.

Merck still faces over 4,115 lawsuits over claims that Fosamax causes a completely different type of injury-femur fractures. Those injuries have been more publicized by the media Those lawsuits are consolidated separately in an MDL in front of Judge Brown in the U.S. District Court for New Jersey. What does this proposed settlement mean for those cases? That is unknown, but it may indicate that Merck wants to settle those claims and get all of these Fosamax lawsuits behind them.

Jury Rules In Merck's Favor in Fosamax Trial

A New Jersey jury ruled in favor of pharmaceutical company Merck & Co.in a Fosamax femur fracture trial in Trenton on April 29. The Plaintiff claimed its Fosamax osteoporosis treatment caused her femur to fracture spontaneously while she was gardening. The case was Glynn v. Merck & Co., 3:11-cv-05304, U.S. District Court for the District of New Jersey.

 

Merck, which is the second-largest pharmaceutical company in the US, is facing more than 3,300 lawsuits claiming that it ignored signs that extended use of bisphosphonates such as Fosamax caused femurs to deteriorate in some patients. Another 1,230 cases allege that Fosamax caused similar fractures in jaws.

 

Bernadette Glynn, 58, sued Merck over claims the company, based in Whitehouse Station, New Jersey, was aware Fosamax might cause brittle bones and increase fracture risks years before the drug was made available to the public. The case was seen as a bellwether for how other cases might be resolved.  

 

At the start of the three-week trial, Merck’s lawyer, Chilton Varner, said consultants’ early warnings about the drug were “theoretical” and that early studies showed people who took Fosamax instead of a placebo had fewer fractures.

 

Glynn claimed Fosamax weakened her femur over a seven-year period, causing the thigh bone to snap in April 2009, when she bent over in her garage to pick up a frog-shaped lawn ornament while gardening.

 

Glynn’s leg was repaired with surgery and the use of rods, according to her complaint. She and her husband, who sued in September 2011, appeared in court on April 9 with their children. She has never had osteoporosis and was prescribed the drug to address low bone-mass density, Pennock during the trial.

 

The jury ruled out Fosamax as a cause. Instead, the jury ruled that Glynn’s femur fracture was consistent with a traumatic injury

Fosamax, which was approved for sale in the US in 1995, generated sales of up to $3 billion a year until patent protection lapsed in 2008.

 

Fosamax, its generic equivalent and other similar bisphosphonate drugs are prescribed to treat osteoporosis. In 2010, a study published in the Journal of Bone and Mineral Research found that the drug, approved in 1995, could be linked to an increase in femur fractures.

 

Nationwide Fosamax lawsuits were categorized into two different federal pretrial case consolidations for efficiency purposes. Cases involving alleged femur fractures are handled in the U.S. District Court for the District of New Jersey (MDL-2243). Lawsuits related to Fosamax’s alleged jaw death side effects are being handled in the U.S. District Court for the Southern District of New York (MDL-1789).

 

Reclast and Boniva Drug Lawsuits Added To Fosamax MDL

The U.S. Judicial Panel on Multidistrict Litigation issued on order on February 3, that all federally filed lawsuits which claim femur fractures by individuals taking both Reclast and Fosamax, or Boniva and Fosamax, or all three drugs, will be consolidated with Fosamax only lawsuits, which were consolidated under Judge Garrett E. Brown in the U.S. District Court for the District of New Jersey as part of multidistrict litigation, or MDL.

The Judicial Panel decided that even though they are three separate medications manufactured by three separate entities, there are common questions of fact that justify case consolidation. Specifically, the JMPL order stated, “Although most of the presently centralized actions involve questions of fact arising from allegations that the use of Fosamax or its generic equivalent alone caused femur fractures or similar bone injuries, plaintiffs in at least five of the centralized actions allege that they suffered femur fractures as a result of their use of either Fosamax and Reclast or Fosamax and Boniva.” Fosamax, manufactured by Merck, is the most commonly used bisphosphonate in the United States for the treatment of osteoporosis.    

Fosamax, Reclast, and Boniva all belong in class of drugs known as bisphosphonates, and are designed to prevent bone loss that can occur during menopause as osteoporosis. On occasion, Fosamax was prescribed for a condition known as osteopenia, a term used to describe possible early onset of osteoporosis (see my blog from August 2011 regarding “osteopenia”). However, the FDA imposed new warnings regarding bisphosphonates and the link between long-term use and an increased risk of atypical femur fractures. The warning says that consumers should seek medical attention as soon as they experience groin or thigh pain while taking the drugs, which can sometimes signal a forthcoming thigh bone fracture, which often occurs with little to no trauma. Some patients say that their bone fractures occurred while doing limited physical activity, such as walking down the stairs or even the sidewalk.

Reclast is manufactured by Novartis as a once-a-year injectable medication. Boniva is manufactured by Roche as a once-a-month oral medication, and Fosamax is a weekly, daily, or monthly oral tablet or solution manufactured by Merck.

Pittman, Dutton & Hellums is currently investigating claims for those people who have taken bisphosphonates, including Fosamax, and have been injured. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or booths@pittmandutton.com.

Merck Wins Another Bellwether Fosamax Trial

Merck, manufacturer of the drug Fosamax, has declared itself the victor in the fifth bellwether trial concerning the product and a condition known as osteonecrosis of the jaw (“ONJ”). The Whitehouse, N.J., drug maker is facing hundreds of cases in state and federal courts, generally alleging that use of Fosamax can cause a jaw-destroying condition known as ONJ and that Merck failed to properly warn of this risk.

On October 3, Merck issued a press release announcing that “a federal court jury in New York found in its favor in the Secrest v. Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her FOSAMAX use.” Secrest v. Merck (case no. 1:06-cv-06292)—a so-called bellwether lawsuit—is the fifth lawsuit involving claims that Fosamax caused a plaintiff to suffer ONJ to go to trial. Merck, the developer and manufacturer of the brand-name drug, is currently defending thousands of Fosamax cases, including cases alleging that the drug caused users to suffer femur fractures, as well as ONJ cases. The cases involving femur fractures were recently transferred to a separate MDL.

Merck won three of the first four bellwether trials in the ONJ MDL. The first case to be tried to a verdict, Maley v. Merck, resulted in a defense verdict for Merck in May 2010; the second case to be tried to a verdict, Boles v. Merck, initially resulted in a mistrial in September 2009 after the jury was unable to reach a unanimous verdict and a retrial of that case in June 2010 resulted in a plaintiff verdict-which was later reduced by Judge Keenan and which Merck intends to appeal after the damages portion of the case is retried; the third case to be tried to a verdict, Graves v. Merck, resulted in a defense verdict for Merck in November 2010; and the fourth case to go to trial, Rosenberg v. Merck, which was tried in the Superior Court for Atlantic County, New Jersey, resulted in a defense verdict for Merck in February 2011.

The outcome is significant because bellwether trials are used to assist attorneys to evaluate similar cases for determining settlement talks and strategies. As of June 30, 2011, there were about 1,650 lawsuits, including approximately 2,050 plaintiff groups, that have been filed in federal and state courts.

Evaluating a Potential Fosamax Case: Part II

How should you evaluate a potential Fosamax case?

One important tool is determining whether the patient was diagnosed with osteopenia or osteoporosis at the time they were first prescribed Fosamax.

Osteopenia is a condition where bone mineral density is lower than normal. It is considered by many doctors to be a precursor to osteoporosis. However, not every person diagnosed with osteopenia will develop osteoporosis. More specifically, osteopenia is defined as a bone mineral density T-score between -1.0 and -2.5. This score is based on a deviation from the bone mineral density of a healthy 30 year old white woman. Any test result over a -2.5 will result in a diagnosis of osteoporosis.

In reality, osteopenia is an arbitrary diagnosis. It is an invented term to characterize women who may be at risk of osteoporosis and have lost some bone density. There is no real medical basis for developing this term or choosing that number. Many women are told they have osteopenia when they may never develop osteoporosis. The definition or term is controversial among the medical community. The patient’s diagnosis may not always be determined by a test result from a bone scan but from the doctor’s notes/diagnosis. However, if we find the test result fits in that -1.0 to -2.5 reading and the doctor prescribed Fosamax, it is almost a certainty that the doctor diagnosed the patient with osteopenia.

Because of the loose definition of osteopenia, the treatment for the ‘condition’ is even more controversial than the diagnosis. Many women diagnosed with osteopenia are treated with biosphosphates, including Fosamax. It is reported that half of all postmenopausal women are being told they had this "disease"—with the implication that they should begin taking drugs to treat it. These patients probably should not be treated with biosphosphates to begin with and better treatment would consist of monitoring by their doctors.

There are several reasons why the distinction between the two is important in evaluating a potential case. We know that osteoporosis patients are much more at risk for bone fractures, whereas osteopenia patients have almost as much risk for bone fractures than a healthy white woman age 30. An osteoporosis patient is much more likely to have a history of fractures, making the causation connection difficult. Also, an osteoporosis patient is probably on more medication than an osteopenia patient, thus making the causation connection even more difficult.

Our firm is currently investigating claims for those people who have taken Fosamax and have been injured. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or booths@pittmandutton.com.

MEDICAL COMMUNITY SHIFTS ITS STANCE IN RESPONSE TO APPARENT RISKS LINKED TO FOSAMAX

As evidence mounts that atypical femur fractures are linked to long term use of bisphosphonates, such as Fosamax, doctors are beginning advise their patients to discontinue its use after two to three years. Indeed, doctors must not only re think the length of time their patients take Fosamax, but perhaps they should re think to whom they prescribe it to as well.

Drugs like Fosamax were developed to make bones stronger and combat the detrimental effects of osteoporosis. The drugs were so popular that doctors began prescribing them not only to women with osteoporosis, but to those who were osteopenic, in other words those who are at high risk of developing osteoporosis. However, instead of delaying or preventing onset of osteoporosis, long term use of bisphosponates has been seen to make some women’s bones more brittle.

While reports may indicate that the causal link between bisphosphonate use and a-typical femur fractures has not yet been established, interestingly, recent conversations have switched not to whether the causal link exists, but the need to reduce the amount of time patients take the drugs and whether the benefits outweigh the risks. After all, in addition to the apparent risk of a-typical femur fractures, drugs like Fosamax have already been linked to severe musculoskeletal pain and osteonecrosis of the jaw, a condition where bone in the jaw begins to die due to poor blood supply.

Do the benefits outweigh the risks? Or, is the cure worse than the disease? There is no doubt that bisphosphonates increase bone mineral density, at least at the outset. In the early stages, the increased bone density may aid in preventing the more common hip and spine fractures suffered by many women with osteoporosis. Thus it’s not surprising that doctors would rather decrease the amount of time a patient takes a course of bisphosphonates rather than eliminate its use all together.

On the other hand, if one chooses to take bisphosphonates, the possible risks aren’t any better than had you elected to not take the drugs. Much like hip fractures common to those with osteoporosis, femur fractures are very serious. In fact, the femur is the strongest bone in the body, hence the oddity that some bisphosphonate users suffer a femur fracture by merely taking a step forward. Like hip fractures, the mortality rate for femur fractures is substantial. Compared to a mortality rate of 15% to 20% for hip fractures, the mortality rate for femur fractures is reported around 20% to 35%. Coupled with the other side effects liked to bisphosphonate use, it may be in a patients best interest to await more long term studies of the drug’s effects.

Our firm is currently investigating claims for those people who have taken Fosamax and have been injured. I you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

Evaluating a Potential Fosamax Case

How should you evaluate a potential Fosamax case? 

The length of time a person took Fosomax is likely the most important factor in determining whether a person has a claim. The magic number is five years. This number comes from an FDA warning issued on October 13, 2010 to patients and health care providers about the possible risk of atypical thighbone (femoral) fracture in patients who take bisphosphonates. According to the FDA warning, the optimal use of bisphosphonates use for osteoporosis is unknown and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years. Furthermore, the FDA recommends that health care providers consider periodic reevaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.

Why five years? While there is no doubt that use of Fosomax increases bone density that however “does not necessarily equate with good bone quality.” The problem is that “turnover is a natural part of maintaining bone health.” The use of Fosomax however reduces osteoclast activity and bone resorption. As a result, bone formation is also reduced, thus over a long period of time microdamage, that naturally occurs in bones, that would otherwise be normally repaired by the body, begins to accumulate.  

What is also significant is that merely ceasing to take Fosomax or its generics, does not remove a person from the adverse effects of Fosomax. To the contrary, biphosphates, such as Fosomax, are stored in a person bones for up to ten years. In effect, early studies indicated that alendronate accumulates in the bone and re-circulates when bone containing the alendronate is remodeled. In fact, this quality was originally touted as one of the possible benefits of alendronate because “many years of treatment may produce self-sustaining concentrations.” (Study funded by Merck). Interestingly, this very same article published in 1998 noted that while the effects of alendronate may continue after a person has stopped treatment, “if alendronate were to cause an adverse effect that has not yet been recognized, endogenous exposure to alendronate would also continue after stopping treatment.” Thus, Merck clearly knew as of 1998 that absent studies of the long term effects of alendronate, Merck would essentially be gambling by continuing to manufacture and distribute Fosomax.

Our firm is currently investigating claims for those people who have taken Fosamax and have been injured. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

NEW WARNING LABEL FOR FOSAMAX

As a result of ongoing investigations regarding Fosamax and use of bisphosphonates (BPs) to treat osteoporosis, the FDA has announced that the risk of atypical fractures of the thigh will be added to the Warnings and Precautions section of all labels of BP drugs.[1] Specifically, these atypical fractures are known as subtrochanteric and diaphyseal femur fractures. Recent studies strongly suggest there is a causal link between people who take BPs and the increased risk of these atypical fractures.[2] Furthermore, not only are people who take BPs put in greater risk of fracture, these particular types of fracture are especially more dangerous than more common femur fractures.[3] Additionally, the use of BPs results in longer and more complicated healing of the bone.[4]

What is a subtrochanteric and diaphyseal femur fracture?

Aytpical subtrochanteric femur fracture is a fracture occurring on the shaft of a femur immediately below the lesser trochanter. That is, right below the hip joint. These fractures are not common, rather they account for about only 7% to 10% of all “hip/femoral diaphyseal fractures.”[5]  Furthermore, given the unique nature of this fracture, special implants are required in order for the fracture to heal, and they are also more susceptible to malunion or nonunion. Additionally, those affected are liable to suffer long term effects. One study indicated that after 2 years, about 50% of persons who suffered a subtrochanteric fracture did not recuperate their pre-fracture walking abilities and faced difficulties performing routine activities.[6] A total of 71% could not live in the same conditions as they lived previously. [7]

A diaphyseal fracture on the other hand, is a fracture that occurs on the main or midsection of the femur. These of course are one of the more common fractures. What is significant however is that these fractures are more typically associated with high trauma incidents, whereas people taking BPs have incurred these fractures as a result of little to no trauma.[8]

In general there are also other features seen in people taking BPs that make these particular subtrochanteric and diaphyseal fractures atypical. First, the fractures are transverse, that is a straight break perpendicular to the shaft of the femur, or it is a straight angled break.  Second, the breaks are clean, in that the bones are not crushed or splintered as you would expect from high trauma breaks. Third, incomplete fractures tend to occur on the lateral side of the femur. Finally, more minor features include patients whose bones show evidence of an increase in the thickness of the femurs wall, delayed healing, and patients also report that weeks prior to the fracture they experienced symptoms such as dullness and aching in their groin or thigh. 

What’s the cause?

While it remains unclear whether BPs are the cause of the unusual femur fractures, the evidence has certainly convinced the FDA to prompt these new warning label requirements. What studies show is that BPs do increase bone density and strength, that is after all exactly what they prescribed to do. That increased strength and density however is achieve by reducing bone turnover. That means essentially instead of  the “out with the old, in with the new,” as is the case for normal bone “remodeling,” it is more like, “keeping the old, and piling on the new.” The problem however is that bones naturally incur cracks and micro damage, which is in turn naturally repaired by the body through the process of remodeling. Absent remodeling which is suppressed by the BPs, micro damage begins to accumulate. Over time, the end result is a thicker, much denser bone, albeit one that is less structurally sound, thus the increased risk in these atypical fractures.

In the short run, it may be that using BPs to combat osteoporosis is an effective treatment. However, for those patients unaware of the risks associated with BPs, like those who have been affected by Fosamax, evidence indicates that whether a person should undergo long term treatment requires a careful assessment of the risks versus its benefits. For this reason the FDA specifically recommends that health care professionals reevaluate a patients need to continue BP therapy, especially in those when have been treated with BPs over five years.

Our firm is currently investigating claims for those people who have taken Fosamax and have been injured. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.

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[1] US Food and Drug Admin. FDA Drug Safety Commc’n: Safety Update for Osteoporosis Drugs, Bisphosphonates, and Atypical Fractures (2010).

[2] Shane E, Burr D. Ebeling PR, et al. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Report of a Task Force of the American Society for Bone and Mineral Research. 25 J. Bone Miner. Res. 2267 (2010).

[3] Id. at 2272.

[4] Id. at 2271.

[5] Id. at 2272.

[6] Id.

[7] Id.

[8] Id. at 2268.