According to an FDA warning, prolonged use of Actos may cause an increased risk of developing bladder cancer.

The seminar will provide an in-depth look at the FDA’s recent update to its health warning regarding Actos, a Type-2 diabetes drug. Through exploration of Actos’ history, as well as recent studies and regulatory action, the faculty will delve into information and strategies that will help plaintiff lawyers understand how to proceed with current litigation.

Arsenault and his firm have filed several lawsuits on behalf of Actos victims who have developed bladder cancer.

To view the agenda, faculty and to register, visit www.justice.org/actos.

A veteran of class action and complex litigation, Arsenault’s firm is actively involved in the pending lawsuits against the makers of the recalled painkillers, and continues to investigate additional claims.

Darvon, Darvocet and other forms of propoxyphene where pulled from the U.S. market by the FDA in November 2010 because of serious, potentially fatal heart-related problems and overdose risks, which were determined to outweighed the drugs’ benefit.

A review of past headlines illustrate the vast number of defective products that have caused a multitude of injuries and cost Americans dearly: Bridgestone and Firestone tires, prescription drugs Vioxx, Baycol and Halcion, dietary supplement ephedra, medical devices like Guidant defibrillators, Medtronic pacemaker leads,and  Dalkon Shield; silicon breast implants, asbestos, and tobacco products just to name a few. Litigation has resulted in recalls of numerous products including Ford Pinto and Explorer, Chrysler minivans, baby cribs and strollers and infant car seats, children’s Tylenol, flammable clothing, birth control medication and devices, tainted food products, and the most recent Toyota vehicles causing unintended acceleration just to name a few.

Aviation litigation has resulted in a drastic drop in the number of crashes and deaths involving aircraft. According to the Consumer Federation of America, there has been a dramatic change in the rate of accidental deaths and injuries since the enactment of products liability laws and stiffer regulation. As a result they estimate that approximately 6,000 deaths and millions of injuries have been prevented on an annual basis.

People are powerless to protect themselves against defective products and the harm they cause without these laws and regulation, as well as the courageous attorneys willing to take on the manufacturers. Beware of the political hue and cry for so-called “tort reform” by business interests and insurance companies trying to gut these important safeguards. Those who support such disingenuous political initiatives just may end up being the victim of a dangerous product without legal recourse to compensate them for the resulting injuries.

During golf games, a doctor agreed to start new patients on Zyprexa for each time a sales representative parred, or put the ball in a hole within a predetermined number of strokes. If the sales rep parred four holes, the doctor agreed to prescribe Zyprexa to four new patients.

The notes were made public in South Carolina’s lawsuit against Lilly over Zyprexa marketing practices. State officials contend Indianapolis-based Lilly marketed the drug for unapproved uses and seeks to recoup $200 million it contends it wrongfully spent on Zyprexa prescriptions for ailments other than the approved schizophrenia and bipolar disorders. The state also is seeking a $5,000 fine for each Zyprexa prescription dating back to 1997 that could result in billions of dollars in fines.

Lilly resolved a marketing investigation over Zyprexa in January with the U.S. Justice Department, promising to pay $1.42 billion, including about $362 million to more than 30 states. South Carolina opted not to join that settlement. The only trial of a state’s lawsuit ended with an out-of-court settlement in which Lilly agreed to pay Alaska $15 million.

Zyprexa has been linked to excessive weight gain and diabetes. The lawsuits claim Lilly, faced with the loss of patent protection for its antidepressant Prozac, pushed its sales force to market Zyprexa for numerous non-FDA approved ailments including depression, anger and agitation and failed to properly warn of Zyprexa’s side effects. Lilly already pled guilty to a federal criminal charge of off-label promotion of Zyprexa for use in elderly patients.

Eli Lilly’s Zyprexa scam is just the latest in a long line of examples of a huge drugmaker unjustly enriching itself in the billions of dollars at consumers’ expense.

The device in question is Menaflex, a C-shaped patch used to repair a damaged meniscus in the knee, manufactured by ReGen Biologics, Inc. which had been repeatedly and unanimously declined over many years because the device often failed, forcing patients to undergo unnecessary second operations.

The FDA’s clinical trials showed the Menaflex medical device did not perform any better than standard surgical procedures. But after repeated extreme pressure from four New Jersey congressman and the former FDA commissioner, the agency overruled its scientists and approved the device for sale in the waning days of the Bush administration in December 2008. It’s not surprising that the four legislators received thousands of dollars in campaign contributions from ReGen executives.

The good news? This is the first time the FDA has publicly questioned its own approval process and admitted that a regulatory decision was influenced by politics. Perhaps this is the first of many good decisions by departments under the Obama administration that will benefit patients instead of the medical device and pharmaceutical manufacturers. The safety of the American public is, after all, the mission of the FDA.

Criticism and complaints have been mounting from former users of Yaz. As a result, Bayer is currently facing at least 74 lawsuits filed in connection with injuries caused by Yaz and Yasmin. The plaintiffs in the filed cases claim the pills put women at higher risk for strokes, blood clots and other health problems than other birth control pills on the market. Until the scientific data is more definitive, women may be taking unnecessary risks by using these drugs. Its up to them to weigh the potential risks to their health.

As injury attorneys who have represented thousands of clients injured by defective medical devices and pharmaceuticals, we know the importance of our court system in holding negligent manufacturers responsible. Our regulatory system alone cannot do the work of protecting consumers. The tort system is an important complement to any federal oversight. We call on Congress to pass, and President Obama to sign, the Medical Device Safety Act and to restore the rights of injured patients.

Vytorin, a combination of two drugs called Zetia and Zocor, was a top-selling drug intended to reduce cholesterol. Millions of Americans were prescribed the drug in an effort to reduce cholesterol by reducing arterial plaque. Significant revenue was generated for Merck and Schering-Plough through these prescriptions.

There was one problem though. Merck’s own clinical trial to study the effectiveness of the drug, called ENHANCE, allegedly showed that Vytorin was ineffective in reducing arterial plaque. Merck did not release the results of the study and, instead, continued to make money selling Vytorin.

Consumers would have little hope of successfully or economically bringing individual suits to recoup money paid for a worthless drug. Class actions, however, allow similarly situated consumers to pool all of their claims together in an effort to secure justice from companies who have cheated them. We are proud to have represented tens of thousands of consumers from throughout the country in consumer protection class action lawsuits. Consumer class actions oftentimes represent the best and only way for consumers to obtain justice.

Popularity of the Yaz line means big profits for Bayer. The deceptive advertising is another eggregious example of corporate disregard for the safety of the consumers buying the product in the name of profits. Let the consuming public beware!

Zicam is considered a homeopathic medication and not subject to actual recall or pre-market approval under Bush-era rules. New bills currently in Congress would give the FDA that authority. The Bush administration generally relied on “voluntary” action by drug manufacturers after protracted negotiations.

The new FDA warning letter used language typically describing a recall alert. It stated that Zicam Cold Remedy may pose serious risk to consumers in addition to being misbranded. What’s ironic about the whole thing is this: the products have no proven benefit. Consumers beware!

Sen. Charles Grassley continues to delve into the murky world of medical clinical trials. Now, a prominent Harvard researcher who is a leading advocate of early diagnosis of bipolar disorder in young children and treatment with anti-psychotic drugs is under fire for a lucrative relationship he had with Johnson & Johnson, the maker of Risperdal ( risperidone). Dr. Joseph Biederman told J & J that his planned study would result in conclusions that would benefit the company. Dr. Biederman’s study concluded that treatment with risperidone improved the symptoms of hyperactivity and attention deficit in bipolar children. That study helped generate a significant increase in use of the drug in children. Of course, that increase resulted in significant financial benefits to the drug manufacturer.

Several state attorney generals are now suing the drug manufacturers for defrauding their state Medicaid programs by improperly marketing their drugs for use in treatment of children to increase sales using their association with Dr. Biederman. Dr. Biederman only reported $200,000 of the actual $1.6 million in consulting fees he earned from the drug manufacturers to his employer, Harvard University. Harvard and the National Institutes of Health are investigating whether he violated federal and university research rules.

Why should we care? Because we should all be able to trust that approved drugs we are prescribed are actually safe and effective. When a well-paid medical researcher promises results before the actual studies are conducted, those conclusions, as well as the safety and effectiveness of the drug ,are suspect .

The legislation would give the FDA the authority to regulate cigarettes and other tobacco products.  Say what?  An agency that is already underfunded and understaffed is getting more responsibility?

In theory, regulating the tobacco industry sounds like a good idea.  The agency would be able to regulate the contents of tobacco products, make their ingredients public, prohibit flavoring, require much larger warning labels and strictly control or prohibit marketing campaigns, especially those geared toward children.

However, I’m not so sure the FDA is ready to take on new responsibilities.  The underfunded structure and oversight ability of the current FDA needs drastic change. There have been too many defective drugs and medical devices, tainted food and dangerous toys allowed to enter the marketplace.

After all of the tainted pistachio, peanut butter, lettuce and pepper scares, some in Congress think a separate food agency is necessary. If the FDA is given additional oversight over tobacco, their workload will only increase.  Congress needs to adequately fund and staff the FDA before dolling out new responsibilities.

Although she only reported $600 in income from Glaxo, Wagner was actually paid more than $160,000 for work on a major study of Paxil. That study has been widely criticized for over-promoting positive findings while down-playing increased suicidal thoughts and behavior in adolescents.

The National Institutes of Health requires researchers who receive federal grants to keep financial disclosures on file with their universities. Not only did Wagner, who was the director of child and adolescent psychiatry at UT in Galveston, not report her actual income from Glaxo , she also filled out several research proposals during the time she said she had no financial interest in the drug companies involved.

Sen. Grassley has led the investigation into doctor-drug company connections and exposed for national debate the undue influence big drug companies have over medical research. He has filed a bill to force drug companies to report gifts, travel and speaking payments to doctors. We should urge our senators to support this legislation. Medical research should be independent and trustworthy, not paid for by the very company who will financially benefit from it.

NuvaRing is a flexible vaginal ring placed near the cervix containing etonogestrel, a synthetic progestin to prevent pregnancy. NuvaRing continuously releases doses of etonogestrel and ethinyl estradiol over a three week period which prevents the ovaries from producing mature eggs. Etonogestrel has been associated with a higher risk of venus thrombosis and clotting than other progestins which work just as well. Blood clots, pulmonary embolisms (clots of the pulmonary artery), deep vein thrombosis (blood clot in a deep vein) and ischemic strokes have been associated with NuvaRing.

Over the years women have used approved birth control products such as Norplant implants and Ortho Evra patches which later were removed from the market or had stronger warnings added to their label. Currently there are over 50 lawsuits filed against Organon USA, Inc., the manufacturer of NuvaRing, alleging they not only knew of the risks and potential side effects, but concealed those risks from the FDA during the approval process and from the public in marketing their product.

Women are always looking for a less-stringent contraceptive to prevent unwanted pregnancies. Manufacturers have introduced innovative changes to meet those demands. Unfortunately, a number of these newer birth control products have been rushed to market without sufficient testing and concern for the health of the women who use them. The FDA is undergoing a radical overhaul under the new administration. Hopefully, a revamped FDA will have the resources and manpower to thoroughly test these new contraceptive products before they are approved and sold to an unsuspecting public.

The company has agreed to recall 14 of its products; however, Hydroxycut Cleanse and Hoodia will remain on the market. One of the most popular diet supplements on the market, Hydroxcut sold 9 million packages last year.

At the current time, the FDA is still trying to figure out what ingredient or combination of ingredients is causing the health problems. Victims are complaining of conditions ranging from jaundice and fatigue to cardiovascular problems and liver failure severe enough to require a transplant. In one case, the 19-year-old victim died from damage to his liver. Although serious reactions are rare, the FDA doesn’t want anyone taking chances. They are warning customers to stop using the supplement immediately.