Articles Posted in Drug Company Fraud

In the pharmaceutical industry, there have been some very bad days for manufacturers, but today was really a bitter pill for Abbott Labs. The company was slapped with the second largest criminal fine for a single drug. Why? Because a Virginia judge found that the company promoted a drug called Depakote for uses that were not approved by the Food and Drug Administration (FDA).

As California defective drug lawyers, we have been involved in many cases involving dangerous drugs, off label uses and other issues that relate to the regulation of medications. In fact, we have been at the forefront of many of the most important medical and drug litigations in the country over the past decades.

In this case, the use that was never allowed by the FDA approvals for Depakote was a use for dementia patients and those with schizophrenia. But because these uses were not approved, their promotion for these off-label uses is not permitted.

The company will pay a large settlement with specific states and the federal government for providing information that amounted to false claims to healthcare programs provided by the government.

Other clean-up programs that the company has agreed to in this matter, include a probationary period that will last five years in which the chief executive officer of the company and the company’s board of directors must certify compliance with relevant laws. Other agreements relate to corporate integrity that is intended to put it on a path that will avoid fraudulent practices in the future.
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The U.S. Department of Justice provides a wealth of information on the important rights provided under the Americans with Disabilities Act (ADA). The ADA was enacted to provide protection to those with disabilities against discrimination, but also to ensure equal opportunities for those with disabilities in employment, government services, public accommodations, commercial facilities and transportation. The law mandates the establishment of TDD/telephone relay services.

There are many aspects of the ADA that have been further developed as the law in this area has expanded and developed. For example, the area of design and accessibility are major parts of the ADA. The federal government has issued standards with regard to the accessible design. These establish guidelines for accessible design for state and local government facilities as well as public accommodations and commercial facilities.

The extensive questions and answers provided on the U.S. Equal Employment Opportunity Commission, U.S. Department of Justice, Civil Rights Division website are really helpful for a basic understanding of the parameters of this law. There is a great deal of information about employment discrimination protections under the ADA, in such areas as appropriate accommodations for those protected under the ADA, attendance and leave policies, the interface between the ADA and state workers’ compensation laws and many other important areas of the law.

The California Injury Attorney Blog has kept our readers posted on the heart-related dangers associated with the diabetes drug, Avandia. Last week, after months of anticipation, the FDA advisory panel convened to provide its conclusions on the RECORD study, funded by the drug’s manufacturer GlaxoSmithKline. The panel’s recommendations move on to the FDA.

The public has needed clarity on this for some time now, but they did not get it from the advisory panel’s recommendation to the FDA. Although the Advisory Panel did not pull the drug from the market, the debate was heated and the vote interesting as 17 members voted to keep the drug on the market but want new restrictions, three said nothing needs to be added to the warnings, and 12 sought a recall of the drug from the market.

Avandia’s competing drug Actos does not appear to have the same level of cardiovascular risk associated with it. At least that is what the scientific community is saying at the moment.

The California Injury Attorney Blog has posted previously on boxed warnings issued by the United States Food and Drug Administration (FDA) for such drugs as Avandia. It is very important to learn about any warnings related to medications you are taking. These warnings are very important for both the public and healthcare professionals. This time we share important information about the drug Plavix.

Earlier this year, the FDA added a boxed warning to Plavix, which is used as an anti-blood clotting medication. Plavix has been the second-best selling drug in the world.

The drug is intended to reduce various risks, including heart attack, stroke and death in patients with heart disease. The drug is supposed to make platelets less likely to form blood clots.

Reuters is reporting that an email from an FDA reviewer and known whistleblower appears to confirm findings that the diabetes drug Avandia carries a risk of serious cardiovascular problems. The findings have not yet been published, but as the California Injury Attorney Blog noted recently, the FDA is about to host its public meeting scheduled in July to report on the safety risks associated with Avandia.

The latest study apparently shows increased risks in the following percentages: risk of stroke 27%; risk of heart attack 25%; and, risk of death 17%. The research was based on data from about 230,000 patients, mainly over 65 years of age.

These findings, as well as the FDA’s review of another major study, will be presented at the July advisory panel meeting. Avandia sales have dropped since a 2007 Cleveland Clinic study. It is widely thought the drug may be taken off the market after the July meeting.

The story of Fen-Phen is long and arduous. The drug Fen-Phen caused serious injury and death and although it has been off the market for over ten years now, many patients were not diagnosed with the serious medical conditions that it caused until after they had stopped taking the diet pill.

The lawyers of Hersh & Hersh, who bring you the California Injury Lawyer Blog, were the first firm to take action against the drug manufacturer who made Fen-Phen. The firm was the first to file and settle a lawsuit making the connection between Fen-Phen diet pills and the progressive and potentially fatal disease, primary pulmonary hypertension (PPH).

The impact of the drug was of historic proportions, but not in a good way. Many people were harmed as these pills caused such serious injury in some cases the only way to survive was lung transplantation. The symptoms for many Fen-Phen users did not appear immediately. And when they did, they were serious or fatal.

Sadly, this is not the end for the impact that diet drugs and supplements can have on the unsuspecting public. The long term adverse health effects of taking some of these quick-fix drugs and supplements can be very dangerous indeed.

Diet drugs, supplements and other substances are sold to the public by the millions. We want our readers to be aware that there can be not only adverse medical consequences for taking diet drugs and herbal substances, but it is possible for these substances to interfere with other prescription medications a person is taking at the same time.

It is important to be knowledgeable about what you are taking and in what combinations. There are many resources available for this information. For example, the Mayo Clinic website has an entire section devoted to the importance of knowing what you are taking and how it will interact with your other medications.

The story of Fen-Phen is tragic. Arm yourself with information before taking herbal or other supplements that claim to be helpful or good for you.
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Since 1999, GlaxoSmithKline has been selling the drug Avandia for Type 2 diabetes. The medication Avandia has a single ingredient – rosiglitazone — which has been linked to literally hundreds of heart attacks and heart failures. Other medications Avandamet and Avandaryl contain this ingredient. These medications still await their shelf life fate.

The risk of heart problems with this medication are well established and are the subject an FDA black boxed warning and FDA safety alerts issued in 2007 and 2010. In addition, in December 2008 the FDA issued Guidance for Industry recommending that manufacturers study heart safety in formulating diabetes treatments.

The 2007 black box warning clearly indicates that patients with symptomatic heart failure should not take the medication. It also states that the medication causes or exacerbates congestive heart failure in some patients. Finally, it notes that the data on the risk of myocardial ischemia are not conclusive and are under review.

The data still under review by the FDA includes a clinical study called “Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes” or RECORD, which was designed to evaluate the cardiovascular safety of rosiglitazone.

The FDA’s completed review of this study is expected in July 2010. Once the FDA completes its review of the data from the RECORD study, the agency will present the cardiovascular safety data on rosiglitazone at a joint meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At this time, the Advisory Committee will provide updates on “the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.”

In the earlier warnings, the FDA noted the following recommendations to patients taking Avandia and medications with rosiglitazone, including: don’t stop taking the medication without healthcare professional advice; talk with your healthcare professional about concerns regarding this medication; read the risks included in the medication guide, and report side effects to the FDA’s MedWatch.

Earlier this year, The New York Times published an extensive piece on Avandia and rosiglitazone. The article noted the opinions of several scientists who have urged the removal of Avandia from the market and as well as the ongoing “fierce debate” at FDA over whether to allow it to continue to be sold.

If you or a loved one has taken Avandia or a medication containing rosiglitazone and have had suffered heart attack or other cardiovascular problems, contact Hersh & Hersh for a free consultation on your legal rights.

Related Web Resources

Visit the Food and Drug Administration’s site for more information on how drugs are approved for use.
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The New York Times reports that AstraZeneca has agreed to settle a federal investigation of its marketing practices for the drug, Seroquel.

The settlement requires the company to pay $520 million and was announced on Tuesday by Attorney General Eric Holder. AstraZeneca denies the allegations, but agreed to the payment to avoid what would be protracted litigation with the government.

The drug was originally developed to treat schizophrenia. However, the pharmaceutical company allegedly paid doctors to market drugs for unapproved uses including uses by kids, the elderly, veterans and others. With federal investigations and whistleblower suits lingering, the company’s sales and marketing was front and center in this matter. This is the latest settlement in a line of federal investigations into the illegal marketing of antipsychotic drugs.

The claims center around the contention that the company misled doctors and their patients by failing to disclose studies that showed this drug increases diabetes risk. They also are alleged to have emphasized favorable research while also failing to disclose risks.

The uses for kids and others were not approved by the Food and Drug Administration and caused various side effects. Kids gained weight and other patients died as a result of the off-label uses.

The California Injury Attorney Blog has reported previously on the off-label marketing case against Pfizer and its settlement. Similar cases have been settled with Eli Lilly for Zyprexa and other pharmaceuticals.

Related Web Resources

Visit the Food and Drug Administration’s site for more information on how drugs are approved for use.
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In a very understated press release, Pfizer, Inc (no, it’s not a typo there is no period after Inc in the Pfizer name) has just announced its settlement with the Justice Department. The headline reads “Pfizer Concludes Previously Disclosed Settlement Agreement with the U.S. Department of Justice Regarding Past Promotional Practices.”

Contrast that with the AP headline “Pfizer to Pay Record $2.3 Billion Penalty Over Off-Label Promotions.”

This is big. And no matter how the facts are spun, this is big.

As part of this settlement, Pfizer will pay a $1.2 billion criminal penalty. The largest criminal fine in United States history.

What happened? The government found that the company engaged in the promotion of four prescription drugs to treat medical conditions that had not been approved by federal regulators.

This meant that the company was selling these drugs, including Bextra, for uses that had not been approved by the FDA. Off-label use of drugs is not an uncommon practice. But drug companies are not allowed to promote their drugs for medical conditions for which those drugs have not been approved — as occurred in this case.

Pfizer senior vice president and general counsel, Amy Shulman, stated that “corporate integrity is an absolute priority…”

But New York State Attorney General Andrew Cuomo had some choice words to describe the company’s actions in this case. “Pfizer ripped off New Yorkers and taxpayers across the country to pad its bottom line,” he said. “Pfizer’s corrupt practices went so far as sending physicians on exotic junkets as well as wining and dining health care professionals to persuade them to prescribe the company’s drugs for patients in taxpayer-funded programs.”

As part of this settlement, Pfizer will pay $1 billion to compensate government healthcare programs such as Medicare and Medicaid. Six whistleblowers who first brought these practices to light will also share in the recovery in this matter.
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