Merck faces thousands of lawsuits for its osteoporosis drug, Fosamax (alendronate sodium). In addition to several state lawsuits, the drugmaker faces three groups of consolidated Fosamax litigations. The main injuries claimed in these lawsuits are osteonecrosis of the jaw (ONJ) and atypical femur fractures.
Lawsuits claim Fosamax is a defective drug and that Merck failed to warn doctors and patients about the risk of bone injury side effects.
There are two multidistrict litigations (MDL) and a multicounty litigation (MCL). The Judicial Panel on Multidistrict Litigation (JPML) formed an MDL for specific Fosamax injuries. Multidistrict litigation consolidates cases with the same damages against the same defendants to make litigation more efficient. The first of these was MDL No. 1789 in the Southern District of New York for ONJ, formed in 2006. The second was MDL No. 2243 in the Trenton Division of the District Court of New Jersey for femur fractures, formed in 2011.
Both MDLs have been through complex litigation issues. The history of the MDLs includes jury verdicts, dismissals and appeals. There was also one settlement for about 1,200 ONJ claims. Currently, the largest group of active femur fracture cases — a little over 3,000 — resides in the New Jersey MCL.
Lawsuits for Osteonecrosis of the Jaw (ONJ)
MDL No. 1789 focuses on Fosamax and jaw injuries — specifically osteonecrosis of the jaw. These were the first cases filed against Merck. ONJ is a rare, severe bone disease that affects the jaw and typically happens after dental work, such as tooth extractions. Exposed bone crumbles and dies because of lack of blood, causing jaw problems. Senior U.S. District Judge John F. Keenan is presiding over these cases.
Studies link bisphosphonate drugs like Fosamax to ONJ. Doctors refer to ONJ caused by Fosamax as bisphosphonate-related osteonecrosis of the jaw (BRONJ). Researchers theorize that Fosamax can cause ONJ because bisphosphonates make it difficult for bones to heal. Several plaintiffs in the MDL required multiple surgeries to restructure their jaws.
Plaintiffs’ claims in MDL No. 1789 include:
- Fosamax is defective because it may cause ONJ
- Merck did not adequately warn plaintiffs and their doctors that the drug could cause ONJ
- Merck fraudulently concealed the risks of Fosamax with respect to ONJ
- Merck is guilty of negligence
In 2014, Merck included the majority of these cases in a $27.7 million settlement. While there are still a handful of cases remaining in the MDL as of April 17, 2017, this MDL may soon be closed.
When did Merck Know Fosamax Could Cause ONJ?
Plaintiffs say Merck knew as early as 1995 that Fosamax could cause ONJ, according to legal documents filed in Linda Secrest v. Merck. Yet, the company failed to investigate further or warn the public.
Did You Know
Merck received notice from over 100 patients who had developed ‘dental pain’ and/or ‘dental infection’ during clinical trials in 1995.
Merck received additional notice from reports from “over a hundred patients who had developed ‘dental pain’ and/or ‘dental infection’ during clinical trials in 1995.” The company also received several reports of “adverse oral outcomes” linked to Fosamax in the late-90s, but Merck did not investigate further.
In October 2003, Merck received its first adverse event report expressly stating a Fosamax patient developed ONJ.
According to Merck, its Adverse Event Review Team (AERT) recommended it add a warning to the label in January 2005 after reviewing this and other reports. Plaintiffs dispute this fact and say the AERT recommended a warning label for ONJ as early as January 2004.
After the FDA sent a letter to Merck, the company placed a warning for ONJ on Fosamax in August 2005.
Lawsuits for Atypical Femur Fractures
MDL No. 2243 focuses on atypical femur fractures allegedly linked to Fosamax. Plaintiffs sued Merck after they took Fosamax and suffered femur fractures. According to legal documents, Fosamax contributes to fractures by increasing the mineral density of bone. This makes bones thicker but not necessarily stronger because the drug inhibits formation of new, healthy bone.
This process “does not necessarily correspond with reduction of fracture risk,” plaintiffs say. In fact, it actually makes bone “highly mineralized, homogenous, brittle, and more susceptible to fracture.” Fosamax may also linger in the body for several years after patients stop taking it, inhibiting new bone growth by as much as 50 percent.
In general, these lawsuits claim Merck is liable for “concealment of risks associated with Fosamax,” “gross exaggeration of the purported fracture reduction benefits conferred by the drugs,” and “overpromotion of the drugs for non-approved, or ‘off-label,’ indications.”
Plaintiffs’ claims in MDL No. 2243 include:
- Fosamax is defective because it may cause femur fractures
- Merck did not adequately warn plaintiffs and their doctors that the drug could cause Femur fractures
- Negligence in marketing and selling Fosamax
- Breach of warranty
- Fraudulent and negligent misrepresentation
U.S. District Judge Joel A. Pisano, now retired, presided over these cases. In 2014, he sided with Merck and dismissed cases with injuries that occurred prior to September 14, 2010. In order to get the dismissal, Merck argued that the FDA would have rejected its label change for femur fractures. According to Pisano, plaintiffs failed to show why their injury claims should not be dismissed on these grounds.
The plaintiffs appealed their case to the Third Circuit Court of Appeals, and in March 2017, the appeals court reversed Pisano’s order. The panel found a reasonable jury could conclude the FDA only objected to use of the words “stress fracture” in the label because it was misleading. If Merck submitted a new label following FDA’s suggestions, it could have been approved.
“A reasonable juror could conclude that some of these physicians would not have prescribed Fosamax if atypical femur fractures had been listed in the adverse reactions section,” Judge Julio Fuentes wrote in the panel’s opinion.
The MDL cases will continue and could advance to more trials.
There are about 300 femur fracture lawsuits also pending in California state court. A trial was scheduled for April 25, 2016, but was stayed at the plaintiff’s request. Plaintiffs have yet to schedule a new trial date.
When did Merck Know Fosamax Could Cause Fractures?
Legal documents in Bernadette Glynn’s trial in 2013 claim Merck knew about the risk of Fosamax femur fractures as far back as 1990. Merck consultants told the company that the drug could interfere with the bone’s natural healing process and create micro fractures, Glynn’s attorney said at trial. These micro fractures could lead to spontaneous fractures of the femur.
Did You Know
Legal documents in Bernadette Glynn’s trial in 2013 claim Merck knew about the risk of Fosamax femur fractures as far back as 1990.
Lawsuits in this MDL claim Merck didn’t warn patients that Fosamax could cause femur fractures. The date Merck actually warned of femur fractures is important in this litigation. The process to add a warning did not start until 2008 at the request of the FDA, according to plaintiffs.
In June 2008, the FDA contacted Merck and other manufacturers of bisphosphonate drugs and requested studies they conducted on atypical fractures caused by bisphosphonate use, according to Merck’s statements in court documents. In May 2009, Merck proposed a label change to the FDA for “low energy femoral shaft and subtrochanteric fractures.”
According to Merck, “FDA approved a label change for the Adverse Reactions/Post-Marketing Experience section of the label, but it did not approve a label change to the Precautions section.”
In October 2010, after receiving additional studies, the FDA issued a Safety Communication requiring “bisphosphonate manufacturers to add information on [atypical femur fractures] to the Precautions section of the drug labels and require a new Limitations of Use statement in the Indications and Usage section of the label because ‘these atypical fractures may be related to long-term . . . bisphosphonate use.'”
Jury Awards and Settlements
There have been few settlements or jury verdicts in Fosamax cases. So far, Merck offered $27.7 million in 2013 to settle about 1,200 ONJ cases. This remains the largest settlement in Fosamax litigation and does not include femur fracture cases. There have yet to be any settlements or jury awards for plaintiffs who claim Fosamax caused femur fractures.
Merck offered $27.7 million in 2013 to settle about 1,200 ONJ cases. This remains the largest settlement in Fosamax litigation.
In 2010, a New York jury awarded $8 million to Shirley Boles of Walton Beach, Florida. Boles took Fosamax from 1997 to 2006 and claimed the drug caused her to develop ONJ. The first trial ended in a mistrial because of a deadlocked jury, but U.S. District Judge John F. Keenan scheduled it for a retrial. During the retrial, Boles claimed negligence and strict liability for defective design.
The judge later reduced the verdict to $1.5 million. Keenan also sanctioned Boles’ attorney, Gary Douglas, $2,500 for his conduct, which included calling Merck’s conduct “reprehensible” and “disgusting.”
Rhoda E. Scheinberg
Another New York jury awarded Rhoda E. Scheinberg $285,000 and concluded Merck failed to warn her or her doctor about the risk of ONJ. But it did not find that Merck defectively designed Fosamax. The award was for pain and suffering. The court previously dismissed Scheinberg’s punitive damages claim.
Scheinberg took Fosamax from 2000 to 2006. After a tooth extraction in 2006, she developed ONJ. In the trial, Merck claimed Scheinberg’s ONJ developed because she had periodontal disease and diabetes and used other prescription drugs.
Multicounty Litigation in New Jersey
The third and largest group of Fosamax femur fracture cases is pending in the New Jersey MCL in Middlesex County before Judge Jessica Mayer, according to Merck’s financial report for 2016. There are about 2,860 lawsuits in the MCL.
Groups of these cases are currently undergoing discovery. So far, there are no scheduled trials. Merck stated it intends to defend against the allegations in these cases.
Michelle Y. Llamas is a senior content writer and researcher for Drugwatch. She is also the host of the Drugwatch Podcast where she talks to patients, experts and advocates about drugs, medical devices and health. She uses her technical writing experience to provide easy-to-understand information on how drugs and devices work. But she also tells people what happens when products that are supposed to improve their lives can hurt them.
- By Jeffrey M. Vinocur (Own work) [GFDL (http://www.gnu.org/copyleft/fdl.html), CC-BY-SA-3.0 (http://creativecommons.org/licenses/by-sa/3.0/) or CC BY 2.5 (http://creativecommons.org/licenses/by/2.5)], via Wikimedia Commons. Retrieved From: https://upload.wikimedia.org/wikipedia/commons/8/87/US_Eastern_Pennsylvania_District_Court.jpg
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