Drug Injury Watch

Vioxx And Fosamax Lawsuits: Additional Legal Defense Money

Merck & Co. Continues To Be Pay Defense Lawyers, Not Plaintiffs, Taking Each Case To Trial

(Posted by Tom Lamb at DrugInjuryWatch.com)

Merck & Co., Inc.'s President and CEO Richard Clark reported to financial analysts during a January 30, 2007 Earnings Conference Call that the drug company has increased its legal reserves for the ongoing Vioxx litigation and new Fosamax lawsuits.

In short, from a January 30, 2007 Associated Press article about Merck & Co. published by the Asbury Park Press, here is the latest news about the Vioxx and Fosamax products liability legal cases from Merck & Co.'s 2006 Fourth Quarter Earnings Conference Call:

On the litigation front, Merck reported that as of Dec. 31 it faced approximately 27,400 lawsuits, some involving multiple plaintiffs, alleging harm from Vioxx....

Merck also said it faces about 265 potential Vioxx class-action lawsuits alleging personal injury or economic loss, and has entered about 14,180 agreements with other potential claimants suspending the time limit for them to sue.

The company said it added $75 million to its Vioxx legal defense fund in the quarter, after adding $598 million in the third quarter and $295 million in 2005.

It set aside another $48 million to start a legal defense reserve for lawsuits alleging that Fosamax destroys bone in the jaw; the company faces more than 100 such lawsuits.

The transcript of Merck & Co.'s 2006 Fourth Quarter Earnings Conference Call featuring Richard Clark provides more detail about Merck's additional payments to defense lawyers representing the company in the massive Vioxx litigation and the growing number of Fosamax lawsuits.  From Mr. Clark we learned the following:

After reviewing the actual cost incurred, and estimates of future cost, it was appropriate to charge -- to record a charge of $75 million to increase the reserve solely for legal defense cost related to the Vioxx litigation to $858 million as of December 31st. This reserve is based on certain assumptions and it represents the Company's best estimate of the legal cost that will be incurred through 2008. Incremental to that, as of December 31st, the Company established reserves of approximately $48 million solely for its future legal defense cost for the Fosamax litigation. The reserve is our best estimate of cost through 2008....  We are actively defending the Company in this litigation and we will continue to provide updates on the litigation as appropriate.

During this same 2006 Fourth Quarter Earnings Conference Call, Judy Lewent, Merck & Co., Inc.'s CFO and Executive Vice President, revealed more about how their Vioxx legal defense money has been spent and would be spent going forward:

During 2006, the Company spent $500 million in the aggregate, including $175 million in the fourth quarter, in legal defense costs worldwide related to Vioxx litigation. This spend [sic] is reflected in the current legal defense reserve balance. As [Richard Clark] mentioned, the Company determined that it was appropriate to record a charge of $75 million to increase the reserve solely for its future legal defense costs related to the Vioxx litigation to $858 million at December 31, 2006. Some of the significant factors considered in the establishment and ongoing review of the reserve for the Vioxx legal defense costs were as follows -- the actual cost incurred by the Company up to that time, the development of the Company's legal defense strategy and structure in light of the scope of the Vioxx litigation, the number of cases being brought against the Company, the cost and outcomes of completed trials, and the most current information regarding anticipated timing, progression and related costs of pretrial activities and trials in the Vioxx product liability lawsuits. Events such as scheduled trials that are expected to occur throughout 2007 and into 2008, and the inherent inability to predict the ultimate outcomes of such trials, limit the Company's ability to reasonably estimate its legal costs beyond the end of 2008. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves. The Company has not established any reserves for any potential liability relating to the Vioxx lawsuits and the Vioxx investigations. We continue to believe that every case contains a unique set of facts and the appropriate strategy is to defend these matters on a case-by-case basis.

As we were reminded in the January 30 AP article above, Merck took a $598 million charge in the third quarter of 2006 for its Vioxx defense costs, at which time the drug company said that those additional legal reserves (total to date, then: $858 million) should be sufficient to pays its Vioxx lawyers through the end of 2008.  Only three months later, however, in January 2007 -- and after paying $175 million just the past three months to the numerous law firms around the country defending Merck in the Vioxx cases -- Mr. Clark says the drug company thinks that in order to take Merck to the end of 2008 as regards the ongoing Vioxx litigation it (only) has to add another $75 million, now.  Like many others, no doubt, I am anxious to hear what Mr. Clark says about the drug company's Vioxx lawsuits costs on Merck's 2007 First Quarter Earnings Conference Call.

Third Hormone Replacement Therapy Trial Against Wyeth Underway In Arkansas

Plaintiff Alleges Taking Prempro For Almost Ten Years Caused Her Breast Cancer

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the third hormone replacement therapy (HRT) case to get to trial, 71-year old Helene Rush alleges that her breast cancer diagnosed in 1999 is due to the fact that she took Prempro, Wyeth Pharmaceuticals Inc.'s estrogen-progestin hormone therapy medication, for nearly ten years.

According to a January 23, 2007 Associated Press (AP) article published by the Houston Chronicle, Wyeth countered that allegation in the trial's opening statement phase when the drug company's lawyer argued that Rush would have probably developed breast cancer even if she never took Prempro.

This January 23 article in the Houston Chronicle also puts the Rush Prempro trial into context as regards the overall hormone replacement therapy (HRT) litigation:

Helene Rush's case against Wyeth is the second suit in Arkansas federal court and the third nationwide that accuses the drug maker of negligence regarding its hormone replacement therapy. More than 5,000 similar suits have been filed across the country.

In the nation's first trial, a jury last year rejected claims made against Wyeth by another Arkansas woman, Linda Reeves of Benton. In Pennsylvania, a married couple won a $1.5 million jury award in a similar case, but a judge in October declared a mistrial.

In fact, there are two different Wyeth medications involved in these HRT lawsuits:

• Prempro, which is a combination of estrogen and progestin; and,
• Premarin, which is estrogen only.

As background, after researchers said in July 2002 that more breast cancer and heart problems occurred among women taking estrogen-progestin pills -- based on some results from the Women's Health Initiative study -- many women stopped taking the Prempro and Premarin.

U.S. District Judge Bill Wilson is presiding over the Rush Prempro trial in Arkansas; it is expected to last two to three weeks.

Blood Thinner Medication Warfarin Linked To Brain Bleeds In Elderly

Patients More Than 80 Years Old At An Increased Risk Of Intracerebral Hemorrhage

(Posted by Tom Lamb at DrugInjuryWatch.com)

The January 9, 2007 edition of the medical journal Neurology has a report concerning a new study which reveals that elderly patients using the blood-thinning medicine warfarin may be at greater risk for having a serious brain hemorrhage.  Warfarin is sold under various different brand names, with one of the more popular being Coumadin.

According to a January 9, 2007 Newsday article by staff writer Jamie Talan about this Neurology article regarding the new warfarin study:

Scientists at the University of Cincinnati College of Medicine found that use of the anticoagulant medicine increased in the 1990s, and the surge in prescriptions caused a rise in the number of drug-induced intracerebral hemorrhages, especially in people over age 80.

"We've had no idea how often this was happening," said Dr. Matthew Flaherty, lead author of the study that appears in the journal Neurology. Use of the blood thinner increased after many studies showed warfarin was effective at preventing ischemic strokes in people with atrial fibrillation, an abnormal heart rhythm.

As background, ischemic strokes are caused by a blood clot that forms in the brain or travels to the brain.  By contrast, intracerebral hemorrhages involve a blood vessel bursting in the brain; as such, it is commonly referred to as a brain bleed. An intracerebral brain hemorrhage is a relatively rare form of stroke, accounting for less than ten percent of total annual stroke events.

The practical effect of this news about the increased risk of brain bleeds in elderly patients using warfarin, or Coumadin, was covered in a January 8, 2007 article by HealthDay reporter Steven Reinberg:

One expert thinks that doctors need to evaluate a patient's risk of stroke versus their risk of bleeding before prescribing warfarin.

"This study demonstrates that we need to be careful when we use these therapies," said Dr. Michael B. Rothberg, an associate professor of medicine at Tufts University School of Medicine.

Not all patients with atrial fibrillation will benefit from warfarin, Rothberg added. "Not all patients with atrial fibrillation should be getting warfarin," he said. "Patients at the highest risk for stroke will benefit the most, and patients at the highest risk for bleeding will benefit the least," he said.

Rothberg noted that although warfarin is standard treatment for atrial fibrillation, not everyone with atrial fibrillation is at the same risk of stroke. "I don't think that most doctors prescribing warfarin are assessing their patient's risk of stroke and risk of bleeding, but they should be," he said.

In closing, we want to make an important point:  As with all prescription medications, patients should talk to their doctors before making any decisions not to take warfarin, or Coumadin.

Judge Higbee Cuts Two Cases From January 2007 New Jersey Vioxx Trial

One Injury (Humeston) And One Death (Hermans) Case Involving Heart Attacks After Vioxx Use Will Go Before Jury

(Posted by Tom Lamb at DrugInjuryWatch.com)

In a January 13, 2007 Bloomberg article by David Voreacos we learned that Judge Carol Higbee has cut the Carver and Kieley cases from the consolidated Vioxx trial that is starting later this month. 

Merck & Co. persuaded a New Jersey judge to reduce from four to two the number of cases a jury will hear at the next trial over claims the company's Vioxx painkiller caused heart attacks.

State Superior Court Judge Carol Higbee trimmed the number yesterday in Atlantic City, where opening arguments at the trial are set for Jan. 22....

Jurors now will hear an initial phase on whether Merck failed to warn of Vioxx risks followed by a phase focusing on the heart attacks of both Humeston and Hermans.

Mr. Hermans died in 2002 from a heart attack after taking Vioxx for seven months.

Mr. Humeston survived a 2001 heart attack after taking Vioxx.  His personal injury case was the subject of the first New Jersey Vioxx trial; the first Humeston case ended in November 2005 with a defense verdict.  Judge Higbee later ordered that Mr. Humeston should get a new, second trial.  During his first trial Mr. Humeston reportedly said he took the painkiller Vioxx for only two months and not a regular, daily basis.

Judge Higbee's Plan For The Four Case January 2007 New Jersey Vioxx Trial

Plaintiff Humeston Gets Second Chance After Fall 2005 Merck Defense Verdict

(Posted by Tom Lamb at DrugInjuryWatch.com)

The proceedings in a four-plaintiff consolidated Vioxx trial will start on January 16, 2007 in Atlantic City, New Jersey, with Judge Carol Higbee presiding.  On that day potential jurors will complete questionnaires, with jury selection scheduled to start on January 18.

These four Vioxx cases -- Humeston, Kieley, Carver, and Hermans -- involve plaintiffs each of whom had heart attacks, allegedly caused by their use of Vioxx.

According to a a court document entitled "Vioxx Trial Information January 2007", the consolidated Vioxx trial will follow this plan:

Initial portion of the trial will be the four cases consolidated on issues of what Merck knew about the risk of Vioxx; what warnings they gave the physicians; whether the warnings were adequate.  There will be jury questions at the end of this phase of the trial[.]  If verdict on these questions is in favor of Merck, the case is over.  If in favor of Plaintiffs, then cases will go on with the same jury with separate, individual trials on issue of whether Vioxx caused each plaintiff's heart attack and damages.  All trials will be with the same jurors.

Interestingly, one of the cases involves plaintiff Michael Humeston, whose first trial resulted in a defense verdict for Merck in the fall of 2005.   

However, after it was learned in May 2006 that Merck had made a data error in a critical Vioxx study, with the new findings seemingly adverse to the drug company, Judge Carol Higbee vacated the Humeston defense verdict and ordered that there be a second trial for Mr. Humeston.

Permax And Dostinex Significantly Increase Heart-Valve Damage Risk

January 2007: NEJM Reports That Studies Show Increased Risk Of Four To Seven Times At Normal Doses

(Posted by Tom Lamb at DrugInjuryWatch.com)

The January 4, 2007 issue of The New England Journal of Medicine (NEJM) contains articles about two case studies that provide some of the strongest evidence that treatment with the Parkinson's disease drugs Permax (pergolide) and Dostinex (cabergoline) can cause cardiac-valve dysfunction.  Patients who take Permax or Dostinex, according to the NEJM articles, are four to seven times more likely to suffer damage to their heart valves than patients who did not take either of these medications.

While news of heart-valve damage associated with Permax and Dostinex is not new -- first getting some attention in 2002 -- the degree of increased risk of this serious side effect is resulting in calls for the use of these drugs to be discontinued for the treatment of Parkinson's disease.

A January 4, 2007 Wall Street Journal (WSJ) article by John Hechinger provides this insight on the reaction from the medical experts:

Bryan L. Roth, a University of North Carolina psychiatrist, said the fresh research marked the largest and most definitive findings of the heart risks of these drugs. Dr. Roth, who is also director of the National Institute of Mental Health's drug-screening program, said the findings should lead doctors to discontinue using the drugs and to tell patients to get echocardiograms to make sure they don't have damage.

"The incidence is kind of mind-blowing," said Dr. Roth, who wrote an article in the journal accompanying the studies. "It's so prevalent in people taking these medications, you kind of wonder why it was missed."

A January 3, 2007 Reuters article discussed how higher doses of Permax and Dostinex caused an even higher rate of heart-valve damage in patients:

The British study showed patients taking pergolide [brand name: Permax] were 7.1 times more likely to develop heart valve damage than those who took other treatments. Patients taking the highest doses of the drug had a 37 times greater risk.

The study showed patients taking cabergoline [brand name: Dostinex] were 4.9 times more likely to develop heart valve damage. At higher doses patients were 50.3 times more likely to suffer damage.

The January 4 WSJ article also gives some position statements from the drug companies responsible for these two ergot-derived dopamine antagonists, Permax (pergolide) and Dostinex (cabergoline).

As background, in 1989, Eli Lilly & Co. brought pergolide to market under the name Permax.  Valeant Pharmaceuticals International now markets the drug in the U.S.

Jeffrey D. Misakian, a Valeant spokesman, called Permax "a safe and effective treatment for patients with Parkinson's disease." He said the company "no longer promotes the drug" but makes "it available for those who prescribe it." He said the company recently worked with the FDA to modify its label to advise physicians that the product "should be used with caution."....

Pfizer markets cabergoline in the U.S. under the brand name Dostinex not for Parkinson's but for a hormone condition, the excessive production of prolactin. The company markets it for Parkinson's in Europe under a variety of brand names. Michael Berelowitz, a Pfizer senior vice president, said its safety monitoring noted a problem a year ago, leading to labeling changes that mention heart-valve risk. But, he said, "It still has a place in the treatment of patients."

The type of heart-valve damage that can be caused by Permax and Dostinex is the same kind of heart damage that led to the withdrawal of the diet drug combination "fen-phen."  Further, this damage to the heart valve can lead to heart failure and sudden death.

Levaquin Associated With Blood Sugar Problems And Liver Disorders

January 2007 Article Sets Forth Reports Made To Health Canada In Past Ten Years

(Posted by Tom Lamb at DrugInjuryWatch.com)

The January 2, 2007 edition of the Canadian Adverse Reaction Newsletter (Volume 17, Issue 1) includes an article concerning reports of blood sugar problems and liver disorders associated with Levaquin (levofloxacin) made to Health Canada during the past ten years

According to this article, entitled "Levofloxacin: dysglycemia and liver disorders":

• "[Levaquin] is a broad-spectrum fluoroquinolone antibiotic that is indicated for the treatment of certain respiratory tract, skin and urinary tract bacterial infections in adults."
• "From Jan. 1, 1997, to June 30, 2006, Health Canada received 22 domestic reports of dysglycemia suspected of being associated with levofloxacin. Described dysglycemic adverse reactions (ARs) included 1 report of diabetes mellitus, 2 reports of hyperglycemia alone, 16 of hypoglycemia alone and 3 of hyperglycemia and hypoglycemia combined."
• "With regards to liver disorders, from Jan. 1, 1997, to June 30, 2006, Health Canada received 44 domestic reports of liver and biliary disorders suspected of being associated with levofloxacin. Of these 44 cases, there were 5 cases of hepatic failure, 9 of hepatitis and 1 of hepatorenal syndrome. Five of these 15 cases of liver disorders were fatal. The remaining 29 reports included ARs of increased liver enzyme levels, cholestatic hepatitis and jaundice."

This January 2007 article concludes by stating that Health Canada will continue to monitor adverse drug reactions that may be associated with Levaquin, and urges doctors as well as other health care providers to report any new cases of blood sugar problems or liver disorders possibly involving the use of Levaquin.