Drug Injury Watch

Boles v. Merck Fosamax Trial Jury Verdict Is $8 Million For Plaintiff In June 2010

This Was A Retrial Of The First Fosamax MDL Case, Which Ended When Judge Declared Mistrial Back In September 2009

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  Merck Fosamax Verdict Cut to $1.5 Million From $8 Million (10/5/10, Bloomberg)

A federal judge cut a jury award against Merck & Co. in a lawsuit over its Fosamax osteoporosis drug to $1.5 million from $8 million while upholding the verdict in the case.

U.S. District Judge John F. Keenan in Manhattan today denied Merck’s request for a defense verdict or a new trial. The case resulted in a verdict for Shirley Boles, a 72-year-old Fort Walton Beach, Florida, woman who claimed she developed osteonecrosis of the jaw, or so-called jaw death, from taking Fosamax....

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The case of Boles v. Merck & Co., one of the hundreds of Fosamax jaw injury lawsuits that are combined in the federal court MDL titled In Re Fosamax Products Liability Litigation (MDL 1789, U.S. District Court, Southern District of New York, Manhattan), concluded yesterday with an $8 million verdict in favor of the plaintiff, Shirley Boles -- but it remains to be seen whether that remarkable result will withstand the expected post-trial legal motions that will be filed by defendant Merck.

As some of you may recall, the first trial of this Boles case ended in a mistrial back in September 2009 after U.S. District Judge John Keenan, who is presiding over the Fosamax MDL in New York, determined that the jury had become hopelessly deadlocked in their deliberations.

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For some insight about why this first plaintiff verdict in the Fosamax MDL litigation may not stand "as is", we turn first to a June 25, 2010 Wall Street Journal article, "Merck Loses Fosamax Case":

Merck said Friday that it plans to challenge the jury's decision and believes the awarding of compensatory damages was unjustified and excessive.

"We disagree with the jury's verdict. We believe the jury verdict was a result of plaintiff's counsel's inflammatory and prejudicial remarks," said Paul Strain of Venable LLP, outside counsel for Merck.  "The plaintiff was at increased risk for dental and jaw problems even if she was not taking Fosamax."

Merck has argued in part that Ms. Boles, a long-time cigarette smoker, has a history of dental problems and health problems.

U.S. District Judge John Keenan, who is overseeing the federal [Fosamax] cases, set a briefing schedule and is expected to hear post-trial motions to overturn the Boles verdict in September. Merck is likely to appeal if it doesn't succeed with its post-trial motions.

Additional details about why this Boles Fosamax lawsuit verdict may be in jeopardy come from a Bloomberg news report, "Merck Loses $8 Million Verdict in Trial Over Fosamax":

"We believe the jury verdict was a result of plaintiff’s counsel’s inflammatory and prejudicial remarks,” Paul F. Strain, a lawyer for Merck, said in a statement.

Merck unsuccessfully moved for a mistrial, claiming another lawyer for Boles, Gary Douglas, improperly used his closing statement to encourage the seven-person jury to punish Merck with its verdict.

"I have never heard a more outrageous summation in my life than the one I heard yesterday,” Keenan, 80, told lawyers today outside the jury’s presence.

Strain said in a phone interview that the jury’s findings and the amount awarded aren’t consistent with the evidence introduced in the trial. Merck will ask Keenan to throw out the verdict and, if necessary, will appeal, he said.

More information about how Merck will be attempting to get this $8 million verdict either reduced or thrown out altogether can be found in this June 25, 2010 company press release: "Merck Challenges Verdict in Federal FOSAMAX(R) (alendronate sodium) Trial".

Be assured that we will be monitoring the post-trial motions concerning this Boles Fosamax verdict and that we will report significant developments here on our Drug Injury Watch blog, such as whether this Boles plaintiff's verdict is reduced, reversed, or upheld.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

What Is New In First Half Of 2010 Concerning Atypical Femur Fractures In Patients Using Bisphosphonates

Fosamax, Boniva, And Other Drugs In This Class Are Under Scrutiny Due To This Emerging Drug Safety Issue

(Posted by Tom Lamb at DrugInjuryWatch.com)

We have reported previously about atypical low-energy femoral, or femur, fractures associated with the long-term use of Fosamax and other bisphosphonates.  For example, in mid-December 2009 we posted this article, "Bisphosphonates Such As Fosamax And Femur Fractures: Some Recent 2009 Medical Journal Articles", here on our Drug Injury Watch blog.

In this new article we take a quick look at various developments regarding this emerging drug safety issue involving the bisphosphonate class of drugs.

We start with a June 24, 2010 Wall Street Journal article, "WellPoint's Data Led It To Limit Use Of Drug Boniva Article", from we learn that the largest U.S. managed care business in terms of membership, WellPoint Inc., has found through internal research that the osteoporosis drug Boniva, which is marketed by Roche Holding AG's Genentech and GlaxoSmithKline PLC, is linked to higher fracture rates than two other bisphosphonates, Actonel, marketed by Sanofi-Aventis SA and Warner Chilcott PLC, and Fosamax, marketed by Merck & Co.

Going back a couple of months, at the FDA's Drug Safety Oversight Board (DSB) Meeting held on April 15, 2010, one of the topics discussed was "Bisphosphonates and a potential risk of atypical femoral shaft fracture".  In particular, the DSB discussed:

• Overview of osteoporosis pathophysiology and treatment goals
• The National Osteoporosis Foundation 2008 established osteoporosis screening and treatment guidelines
• Bisphosphonate drug utilization trends in the U.S.
• Mechanism of action for bisphosphonates
• Efficacy and safety of bisphosphonates
• The American Society of Bone and Mineral Research’s draft definition of subtrochanteric femoral and hip fractures
• Data on the occurrence of subtrochanteric femoral fractures in patients using bisphosphonates from several large observational registry-based studies
• A recently published study (The FLEX trial) on the long term use of bisphosphonates
• The additional data needed to better ascertain whether bisphosphonates are associated with an increased risk of subtrochanteric femoral fractures
• Recommendations regarding future drug safety communications about bisphosphonates and a potential risk of atypical fractures

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About a month earlier, on March 10, 2010, there was this item "FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures", issued by the agency.

Moving into the medical realm, in early March 2010 the medical journal Clinical Endocrinology published this article, "Unusual Mid-shaft Fractures during Long-term Bisphosphonate Therapy" (from Medscape; free registration required).  From the Abstract for this article:

Conclusion  Long-term bisphosphonate therapy may increase the risk of unusual long bone mid-shaft fractures. This is probably due to prolonged suppression of bone turnover, which could lead to accumulation of microdamage and development of hypermineralized bone. At present, the scope of this complication in the larger context of patients receiving bisphosphonate therapy remains unknown, but appears to be small.

Lastly, at the 2010 Annual Meeting of the AAOS (American Academy of Orthopaedic Surgeons and American Association of Orthopaedic Surgeons), there were two so-called "Podium Presentations" of interest. 

First, there is "The Structural Effects of Long-Term Bisphosphonate Treatment Leading to Atypical Hip Fractures" (Podium No: 241), which included this statement:

Structural integrity worsened with long-term bisphosphonate treatment, suggesting an underlying structural mechanism contributing to atypical transverse subtrochanteric fractures.

And second, from "The Effects of Long-Term Bisphosphonate Use on Bone Quality"
(Podium No: 339), we get this finding:

Our data suggest that suppression of bone turnover with long-term bisphosphonates results in a loss of heterogeneity of the tissue properties that may contribute to the risk of atypical fractures.

Of course, we will continue to monitor the safety profile of Fosamax (alendronate), Boniva (ibandronate) and the other bisphosphonates.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

June 2010: FDA Launches Its Postmarketing Drug Safety Evaluations Web Site

New FDA Site Will Include A Summary Analysis Of Recently Reported Adverse Events And Related Medical Articles

(Posted by Tom Lamb at DrugInjuryWatch.com)

In mid-June 2010 the FDA announced that it will be making safety evaluations of postmarket adverse events publicly available on a new web site, Postmarketing Drug Safety Evaluations, and will update the information posted there on a quarterly basis.

From the agency's June 15, 2010 press release, "FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals":

Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on FDA’s website along with a brief discussion of the steps FDA is taking to address any identified safety issues.

Some side effects may not become apparent until after a medicine has been approved and becomes available to a larger, more diverse population than the patients who participated in clinical trials that supported approval. The new summaries provide a comprehensive look at safety data early in the product’s post-approval life cycle and are based on reports by manufacturers, providers, consumers and others to the FDA’s Adverse Event Reporting System (AERS).... periodic safety information submitted to FDA by manufacturers; information contained in the medical literature; and data from ongoing drug and biologic studies.

Included in the summaries may be information on potentially serious, previously unidentified risks, if any are found during the review, as well as known adverse events that occur more often than they did during clinical studies. The summaries will also include a brief discussion of any steps FDA may be taking to address these safety issues.

From a June 15, 2010 USA Today article, "New FDA website lets public find drug safety info", by reporter Rita Rubin:

On the Postmarketing Drug Safety Evaluations site, the FDA plans to share what it has learned about the safety of a new drug or biologic, such as a vaccine, 18 months after approval or after 10,000 patients have used it, whichever comes later.

The agency is making a "broad sweep" of adverse-event reports, medical studies and research, and drug utilization databases to look for safety problems, Robert Boucher, an official in the FDA's Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research, said at a news briefing.

For the initial posting, "Postmarketing Drug Safety Evaluation Summaries -- Postmarketing Drug Safety Evaluations completed through the fourth quarter of 2009", provides postmarket safety evaluations for 26 drugs that were approved by the FDA between September 2007 and January 2008.

We applaud the FDA for launching this new web site insofar that it makes available to the public possible emerging drug-safety issues earlier than the agency had in the past.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Blood Pressure Medication Benicar (Olmesartan) Might Be Unsafe For Some Patients

Two Clinical Studies Find Patients With Type 2 Diabetes Taking Benicar Had Higher Rate Of Death From A Cardiovascular Cause

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 11, 2010 the FDA announced that it had issued a safety alert about the blood pressure medication Benicar (olmesartan) which was titled "FDA Drug Safety Communication: Ongoing safety review of Benicar and cardiovascular events".  Benicar is also sold in combination with hydrocholorothiazide as Benicar HCT for the treatment of high blood pressure.  Benicar is in the class of drugs called angiotensin II receptor blockers (ARBs).

From this June 2010 FDA announcement:

The U.S. Food and Drug Administration (FDA) is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar (olmesartan) had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. Benicar (olmesartan) is also sold in combination with hydrocholorothiazide as Benicar HCT for the treatment of high blood pressure.

FDA's review is ongoing and the Agency has not concluded that Benicar increases the risk of death. FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks.

The Agency plans to review the primary data from the two studies of concern, ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Benicar.

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We get some additional information and explanation from a June 11, 2010 article, "Cardiovascular Events Trigger FDA Review of ARB", by Peggy Peck of MedPage Today:

There were 15 cardiovascular deaths in the olmesartan arm of the 4,447-patient Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP) trial versus three in the placebo arm, and in the much smaller Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial (ORIENT) study (with 566 patients), there were 10 cardiac deaths among patients taking olmesartan versus three in the placebo group....

The FDA said it planned to review the primary data from the two trials and the total clinical trial data on olmesartan to evaluate the possible association between olmesartan and increased cardiovascular-related death....

Both clinical trials were designed to determine if treatment with olmesartan, which is an angiotensin II receptor blocker (ARB), could slow the progression of kidney disease.

The FDA noted that clinical trials of other ARBs as well as other trials of olmesartan have not revealed an excess risk of cardiovascular mortality.

Benicar and Benicar HCT are marketed by Daiichi Sankyo, Inc., which has a U.S. headquarters in Parsippany, N.J.

We will continue to monitor the safety profile of Benicar and report any significant developments here at the Drug Injury Watch blog.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

June 2010 Update On Several Possible Zocor (Simvastatin) Side Effects

From Myopathy And Rhabdomyolysis To Tendon Ruptures And Interstitial Lung Disease

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury

[06-08-2011] The U.S. Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage [i.e., rhabdomyolysis]....

Read more at the FDA's web page

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What is rhabdomyolysis?

Rhabdomyolysis is a rare but very serious condition. It occurs when muscles are damaged and muscle cell contents are released into the bloodstream. If not detected early and treated promptly, rhabdomyolysis may result in acute renal failure, kidney damage, or other organ damage which may be fatal.

What are the symptoms of rhabdomyolysis?

Patients who develop rhabdomyolysis can have several different symptoms, but most often complain about muscle aches involving their calves, back, or their entire body. In addition to this type of muscle pain, weakness, fever, nausea, vomiting, and passing of dark urine can occur.

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The June 2010 FDA Patient Safety News (PSN) includes a video report, "Muscle Injury from High Doses of Zocor", that informs us about a clinical trial which showed the risk of myopathy and rhabdomyolysis is much higher in patients taking 80 mg of Zocor (simvastatin) -- the highest approved dose -- than in those taking a 20 mg Zocor pill.

This FDA PSN video report is a follow-up to a mid-March 2010 FDA MedWatch Safety Alert regarding higher doses of Zocor being associated with an increased risk of serious side effects involving muscle injury.  Further, the earlier MedWatch Alert about Zocor pointed out that its active ingredient, simvastatin, is also found in Vytorin, with Zetia, and Simcor, with Niacin.

Moving on, a May 29, 2010 article, "Researchers assess effects of statins on tendon rupture", describes an on-going medical study about whether Zocor and other statin drugs may be causing tendon ruptures:

Francesca Dwamena, an associate professor in the College of Human Medicine's Department of Medicine [at Michigan State University], is leading the study, which will analyze more than 100,000 Blue Care Network enrollees. The study is funded by a grant from the Blue Cross Blue Shield of Michigan Foundation....

While lowering cholesterol, statins [like Zocor] also inhibit certain proteins that are required for remodeling of tendons, she said. Without remodeling, tendons become very prone to injury and potential rupture.

Dwamena and her team seek to confirm the findings from a pilot study that found increased tendon ruptures in women. Before that study, statin-induced tendon rupture was only described in case reports and post-marketing studies. With a large population-based outlook, the researchers also will assess the effects of dose, duration and type of statin on tendon rupture.

Lastly, going back a couple of years, in August 2008 the medical journal Chest published an article, "Statins and Interstitial Lung Disease: A Systematic Review of the Literature and of Food and Drug Administration Adverse Event Reports”, which discussed a possible relationship between statin drugs such as Zocor and interstitial lung disease.  From the Abstract for this 2008 Chest article:

Conclusions  Statin-induced interstitial lung disease is a possible newly recognized side effect of statin therapy. The mechanism of lung injury is not defined. The current review provides novel information from the FDA-AER that supports a possible, although unusual, pulmonary class effect of statins.

We will continue to watch for reports of myopathy and rhabdomyolysis as well as tendon ruptures and interstitial lung disease in patient using statins like Zocor or simvastatin. 

If you have developed any of these possible Zocor side effects, or know about such a situation, you can submit a Comment, below, or send me an email.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects