Eli Lilly and Co. said on Thursday it has agreed to pay up to $500 million to settle 18,000 Zyprexa lawsuits alleging it had failed to adequately warn patients that Zyprexa may increase the risk of diabetes.

“While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians,” said Sidney Taurel, chairman of the board and chief executive officer of Eli Lilly and Company. “We wanted to reduce significant uncertainties involved in litigating such complex cases. Our decision to resolve the claims does not change the fact that Zyprexa has and will continue to improve the lives of millions of patients around the world who are suffering from schizophrenia and bipolar disorder. These settlement agreements will enable Lilly to focus first and foremost on addressing unmet medical needs through research, educational programs and partnerships with doctors and patients.”

In June 2005, Lilly agreed to pay about $700 million to settle 8,000 Zyprexa lawsuits in the United States.

The majority of the of the Zyprexa lawsuits claim that before September 2003, the package insert warning about the potential link between Zyprexa and hyperglycemia and diabetes was not adequately displayed.

In September 2003, the Food and Drug Administration required label changes for Zyprexa and all atypical antipsychotics, adding more information warning about a possible link with diabetes.

In 2004, a panel of the American Diabetes Association found that Zyprexa caused diabetes more than other widely used antipsychotic drugs, in part becuase it has a tendency to cause more higher weight gain. However, the FDA has never made a similar finding.

Which events in 2006 had the greatest impact on your legal rights? Below are our nominations for the top 10 stories of 2006:

• The Battle for Net Neutrality - CNET
• ATT Collaborates with Illegal Domestic Spying Program - EFF
• U.S. Subpoena Power Used for Censorship - New York Times
• U.S. Panel Rejects Plan for Paper Ballots - New York Times
• FDA Declares Diary and Meat from Cloned Animals Safe for Humans to Eat - Wired News
• U.S. judge rules NSA wiretaps are illegal | The San Diego Union-Tribune
• Bush Re-Ups U.S. Patriot Act - BBC New
• Immigration Reform - USATODAY.com
• American Travelers to Get Secret ‘Risk Assessment’ Scores - EFF

Now it is your turn to vote them up or down as you feel. You are welcomed to add your own to the dynamic list, which is on the Legal News Watch Squidoo. We used the new Plexo feature to do this.

Legal News Watch is back and just in time for 2007.

We are finally using WordPress to bring you the Stories That Impact Your Rights. We are happy to report that all the old content, including your comments, were successfully migrated to the new system. You can expect to see a fresh batch of news very soon.

We would like to wish everyone a very

Happy New Years.

Pargluva, a proposed diabetes drug from Bristol-Myers Squibb and Merck & Company, appears to increase the risk of death, heart attack or stroke, according to a study published in a leading medical journal last week.

The study was conducted by the two Cleveland Clinic cardiologists who warned in 2001 about the cardiovascular risks associated with Vioxx, which was pulled from the market last year. They used the data, from the company-funded clinical trials, that was submitted to the Food and Drug Administration.

Their analysis found 1.47 percent of the diabetic patients who took Pargluva during clinical trials died, suffered a heart attack or stroke-more than double the rate among those taking a placebo or an already approved rival drug sold as Actos.

James Brophy of McGill University in Montreal wrote an accompanying editorial for the study that was also published in The Journal of the American Medical Association, where he questions the “methodological decisions in the sponsor’s FDA application” that may foster an illusion of safety for Pargluva. He also included a list of 8 methods observed in the application that in his opinion may have contributed to an overestimate of the safety profile.

(via The Journal of the American Medical Association)

Jason Tomczak, an iPod Nano owner, has filed a lawsuit against Apple Computers, Inc. alleging the company launched the digital music player despite knowing that it was defective.

The lawsuit, filed in the U.S. District Court in San Jose, California, claims that the iPod Nano scratches “excessively during normal usage,” rendering the screen on it unreadable, and charges Apple with violating state consumer protection statues, breach of express and implied warranties that accompanied the iPod Nano.

Apple introduced the iPod Nano in September as a “revolutionary full-featured iPod yet thinner than a standard #2 pencil and less than half the size of competitive players.” However, the lawsuit claims the design of the iPod Nano is defective because it does not have sufficient resin to protect its face from extreme scratching and irreparable damage.

Consumers “would not have purchased iPod Nanos or paid as much for them had they known the truth about the product,” the lawsuit contends.

The suit is seeking class action status, restitution and disgorgement of profits, compensation for damages, punitive damages, attorneys’ fees and recovery of all costs associated with the suit.

(via Reuters)

Electronic Arts has agreed to pay $15.6 million to settle a class action lawsuit brought by computer graphic artists seeking overtime compensation, the company announced on Oct. 5, 2005. The class includes computer graphic artists, including “animators,” “modelers,” “Texture artists,” “lighters,” “background effects artists,” “special effects artists” and “environmental artists,” who worked at EA’s California studios at any time from July 29, 2000 to the present.

Under the terms of the settlement, the claims of the alleged class will be dismissed, and EA will make a total payment of $15.6 million to cover all claims by the class members, plaintiffs’ attorney fees, any incentive payments to the named plaintiffs and all administrative costs of the settlement.

Any portion of the settlement fund that is unclaimed by class members will go to the Jackie Robinson Foundation, a national nonprofit organization that awards college scholarships to minority students, with a preference toward students interested in studying interactive entertainment.

Settlement of the case, which is pending in the Superior Court of San Mateo County, California, must be approved by the Court before it can become effective.

Electronic Arts (EA), headquartered in Redwood City, California, is the world’s leading interactive entertainment software company. Founded in 1982, the company develops, publishes, and distributes interactive software worldwide for videogame systems, personal computers and the Internet.

(via Business Wire)

Paxil, an antidepressant drug, may increase the risk of birth defects for pregnant women taking it during the first trimester, the Food and Drug Administration warned last week.

The warning comes after Paxil manufacturer GlaxoSmithKline sent the FDA and doctors a letter about preliminary results from a study suggest an increase in the risk of congenital malformations associated with the use of Paxil (paroxetine) as compared to other antidepressants.

The types of congenital malformations, which were most commonly cardiovascular, were reflective of those seen in the general population. The most common cardiovascular malformations observed in the study were ventricular septal defects.

Septal defects are sometimes called a “hole” in the heart. It is estimated that nearly 1 percent of babies are born with this condition. In the vast majority (80-90%) of babies born with this condition, the hole is small. They will have no symptoms, and the hole will close spontaneously as the muscular wall continues to grow after birth.

Glaxo added that the preliminary results of this study and recent abstracts published by Alwan & Wogelius differ from previous epidemiologic studies, making it difficult to conclude whether a causal relationship exits.

Healthcare professionals are advised to carefully weigh the potential risks and benefits of using Paxil therapy in women during pregnancy and to discuss these finding as well as treatment alternatives with their patients.

(via U.S. Food and Drug Administration)

Strattera, an attention deficit hyperactivity disorder drug, may increase suicidal thinking in children and adolescents, the Food and Drug Administration warned on Thursday.

“Children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed (either increased or decreased),” the FDA said in a Public Health Advisory.

The warning follows a review and analysis of clinical trials conducted in children with ADHD that identified an increased risk of suicidal thinking for Strattera. There was one suicide attempt by a patient who received Strattera among nearly 2,200 patients in the trial. The analysis showed that 0.4% of children treated with Strattera reported suicidal thinking compared to no cases in children treated with the placebo.

Manufacturer Eli Lilly and Co. said last week it will add a “black box” warning to the Strattera label and is working with the FDA to finalize the product label content as well as information for healthcare professionals.

Strattera is the only non-stimulant drug approved for the treatment of ADHD. It has been on the market since 2002 and has been used in more than two million patients. Sales for Strattera topped $667million last year.

(via U.S. Food and Drug Administration)

A nationwide class action lawsuit was filed today against Pfizer Inc., alleging the world’s largest drug company devised a promotional scheme to boost sales of its anti-cholesterol drug Lipitor by misleading women and seniors about the link between the drug and heart disease.

The lawsuit, filed in the U.S. District Court in Boston, alleges that Pfizer engaged in a massive campaign to convince both doctors and patients that Lipitor is a beneficial treatment for nearly everyone with elevated cholesterol, even though no studies have shown it to be effective for women and those over 65 years of age who do not already have heart disease or diabetes.

“We intend to prove that Pfizer pocketed billions in sales to those who do not benefit from Lipitor,” Steve Berman, the lead attorney for the proposed class, said.

Lipitor, part of the class of drugs called statins, is the best-selling drug in the world, with sales in 2004 of more than $10 billion.

According to the complaint, women without heart disease taking Lipitor actually developed 10 percent more heart attacks than women treated with a placebo.

The proposed class action seeks to represent women who have taken Lipitor and who have no history of heart disease or diabetes; people aged 65 and over who have taken Lipitor and who have no history of heart disease or diabetes; and third-party payers such as insurance companies, union health and welfare funds, self-insured employers and others, who paid for Lipitor for patients in either of these two groups.

The lawsuit alleges that Pfizer violated state consumer protection laws against deceptive advertising and seeks reimbursement for women and seniors and third-party payers who bought Lipitor unnecessarily as a result of Pfizer’s deceptive marketing and promotional campaign.

“We intend to prove in this case that Pfizer’s false advertising created an enormous artificial demand for Lipitor, much of which would not exist if Pfizer had fully and fairly disclosed the truth about the drug,” Berman said.

(via PR Newswire)

Three California consumers filed a class action lawsuit last week against Palm, Inc., accusing the company of selling defective Treo 600 and Treo 650 smartphones.

The lawsuit, filed in the Superior Court of California for the County of Santa Clara, alleges that both devices suffer from numerous inherent defects that impair its functionality. These alleged problems include:

� Extremely poor sound quality manifesting itself in a buzzing sound that is heard by the recipients of telephone calls made from the Treo 600,

� Lost calls resulting from the Treo 600 spontaneously resetting itself in the middle of a phone conversation,

� Frequent freezing and crashing in the Treo 650 that requires the use of a hard reset during which all stored information is lost.

“We allege in our complaint that Palm has deliberately created a cycle of defective products whereby owners continue to receive defective phones until either they tire of the process or their warranty runs out,” Hector R. Martinez, attorney for the plaintiffs, said. “Each of the plaintiffs has attempted to have their phones replaced by Palm, instead of new phones they received what appear to be refurbished phones that had been returned to Palm by other customers — these replacement phones suffered from the same problems that were originally complained about.”

This case was jointly filed by the Law Office of Mallison and Martinez and the Rothken Law Firm.

(via Business Wire)