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  • 05/08/2012 - 3:16am

    Abbott Laboratories has pleaded guilty and agreed to pay $1.5 billion over allegations that it promoted the anti-seizure drug Depakote for uses that were not approved by the Food and Drug Administration.

    The case includes a criminal fine and forfeiture of $700 million and civil settlements with the federal government and states totaling $800 million. Deputy Attorney General James Cole said Monday the settlement reflects the determination by government "to hold accountable those who commit fraud."

    At a news conference at the Justice Department, U.S. Attorney Timothy Heaphy said the top levels of Abbott systematically marketed the drug for purposes other than what federal regulators had allowed.

    Colorado Attorney General John Suthers announced that Colorado will receive $1.7 million of the settlement.

    The illegal conduct was not from "some rogue sales representatives," said Heaphy, the U.S. attorney for the western district of Virginia. He said the company engaged in the strategy from 1998 to at least 2006.

    Virginia Attorney General Ken Cuccinelli announced the state portion of the settlement between the company and 45 states and the District of Columbia.

    Depakote is an anti-seizure and mood-stabilizing drug prescribed for bipolar disorder.

    However, the company admitted that it marketed the drug for unapproved uses, including treatment of schizophrenia, agitated dementia and autism.

    The company admitted that it trained a specialized sales force to promote Depakote in treating dementia because the drug was not subject to federal regulations designed to prevent the use of unnecessary medications in nursing homes.

  • 05/07/2012 - 9:15am

    A Skokie-based cleaning service that misclassified employees as independent contractors, depriving them of minimum wage and overtime they had earned must pay $501,893.44 in back wages and liquidated damages for 75 workers a federal judge ordered this week.

    The lawsuit filed by the U.S. Department of Labor against Skokie Maid and Cleaning Services, Ltd., which resulted from investigations conducted by the department’s Wage and Hour Division, alleged violations of the Fair Labor Standards Act’s minimum wage, overtime and record-keeping provisions, a release from the Department of Labor said.

    “It is unacceptable for any employer not to pay workers their rightfully earned wages or to classify workers as independent contractors to circumvent wage laws,” Keith Chaikin, acting regional administrator for the Wage and Hour Division in the Midwest, said. “The Labor Department is committed to seeing that these workers are compensated in accordance with the law.”

    The default judgement was issued by U.S. District Court Judge James F. Holderman.

    The suit alleged that the company, which operates as Skokie Maid, misclassified 75 current and former cleaning employees as independent contractors and willfully failed to pay them for all hours worked. The employees also were not compensated with overtime pay for hours worked in excess of 40 per week, as required. Finally, the defendant failed to keep proper payroll records, the release said.

    The judgement requires Skokie Maid to pay $250,946.72 in back minimum wage and overtime compensation plus an equal amount in liquidated damages for the period of Nov. 16, 2008 to July 31, 2011. The Wage and Hour Division also assessed civil penalties of $70,125.

  • 05/03/2012 - 9:11am

    In August 2011, when Diana Wang began her seventh unpaid internship, this time at Harper’s Bazaar, the legendary high-end fashion magazine, she figured that her previous six internships – at a modeling agency, a PR firm, a jewelry designer, a magazine, an art gallery and a state governor’s office – had prepared her for the demands of New York’s fashion world.

    “I was so determined to make this one really worth my while,” says the 28-year-old Wang, who moved from Columbus, Ohio, to New York, where she was living with her boyfriend (also working as an unpaid intern at one point) and living off of her savings. “I knew I couldn’t do anymore internships after this.”

    As it turned out, Wang’s internship was just like many of the thousands of others: unrewarding in terms of both pay and marketable experience — not to mention the lack of a job offer. In fact, the only difference between her internship and most others was what happened about a month after it ended. Wang sued.

    On Feb. 1, the law firm Outten & Golden filed a class-action lawsuit against the Hearst Corporation, which owns Harper’s Bazaar, on behalf of Wang and any other unpaid and underpaid intern who worked at the company over the past six years. The lawsuit alleges that, among other things, Hearst violated federal and state labor laws by having Wang work as many as 55 hours a week without compensation.

    “It was disgusting,” says Wang, referring to her unpaid daily responsibilities like shipping hats between New York and London for $350 each way, not being able to eat lunch until 4 p.m., routinely shuttling heavy bags around Manhattan and working to 10 p.m. with no break for dinner – all while supervising eight other interns. “Thinking of the spring interns who would come in with high hopes just like my fellow interns and I had — I decided that someone had to put a stop to this practice, which was going to go on forever and get worse before it got better.”

    Hearst declined to respond to the specific accusations made by Wang because of pending litigation, but the company did release a statement: “The internship programs at each of our magazines are designed to enhance the educational experience of students who are receiving academic credit for their participation, and are otherwise fully in compliance with applicable laws. We intend to vigorously defend this matter.” (Time Inc.’s policy is to pay interns. Limited exceptions may be made where appropriate, such as when a student is receiving academic credit and meets other requirements as well.)

    In the workplace, there seem to be two long-established but contradictory rules: Everyone gets paid to work – unless there’s mindless drivel to do, of course, and then you get college kids to do it for free.

    For decades, that seemed just fine. But that was before a couple of interns sued Fox Searchlight in September after they were tasked with the responsibilities of production assistants, bookkeepers, secretaries and janitors without wages. This wasn’t mindless coffee-fetching, they argued. These were entry-level positions that were being filled by unpaid hands. Thanks to the struggling economy, companies were now relying on interns to do entry-level work without having to pay them wages or benefits.

    That lawsuit prompted other unpaid interns to sue, including Wang and an intern who took legal action against PBS’s “The Charlie Rose Show” in March.

    As college students make the annual rite of passage from college classroom to summer internship, those unpaid positions may have finally peaked. Says Ross Perlin, author of Intern Nation: “I think we may be at the very early stages of a significant backlash against an internship phenomenon that has gone off the rails.”

    Internship or Internment?

    The very first interns weren’t carrying luggage around New York City. Instead, they were anesthetizing, bloodletting and vaccinating. Between the mid-1800s and World War II, interns were only found in hospitals. Medicine was considered a unique field that could only be learned through observing and hands-on practice. Those internships are now the medical field’s modern-day residencies.

    Around the 1930s, education and business leaders started advocating for a more seamless transition from school to the workplace in areas other than medicine. Internships began spreading into other fields, first in public administration and later publishing, marketing and banking.

    As more internships sprouted across the country, Congress passed a number of laws regulating them, including the Fair Labor Standards Act of 1947, which specifically lays out a 6-point test, still in use today, for hiring unpaid interns. Under the Department of Labor’s test, an intern must be paid unless:

    1. The internship is similar to training that would be given in an educational environment
    2. The internship is for the benefit of the intern
    3. The intern does not displace regular employees
    4. The employer derives no immediate advantage from the intern
    5. The intern is not entitled to a job at the end of the internship
    6. The intern understands that he or she is not entitled to wages.

    The real intern boom didn’t occur until the 1970s and 1980s. That’s when two big shifts occurred, says Perlin. The first was a move from the traditional norm of holding on to one job and working there your entire life to multiple forms of “contingent labor.” It’s what sociologist Andrew Ross has called the “casualization” of the U.S. labor force. Employers soon realized the benefits of part-time employees, independent contractors and temporary workers. By hiring contingent workers, employers could pay less in benefits, prevent workers’ attempts to unionize and initiate layoffs much more easily. That was coupled with the proliferation of Human Resource departments, which are now often solely responsible for hiring and bringing in new employees, many of whom often begin as interns through a company’s internship program.

    Even before the financial collapse around 2007 and 2008, internships – both paid and unpaid – were increasing. The National Association of Colleges and Employers reported that 50% of college grads in 2008 had held an internship, compared with 17% in 1992. But the Great Recession accelerated that boom. Today, an estimated one-third to one-half of the 1.5 million internships in the U.S. are unpaid.

    “More and more people after they graduate are feeling they have no choice but to take on unpaid internships,” says Perlin. “It’s something that you have to do three, four, five times potentially to break into an industry or to get any kind of paying work. It may even be something you do in your 30s or 40s.”

    The Intern as Entry-Level Employee

    No need to tell Eric Glatt that. Twenty years ago he began teaching English as a foreign language, then went back to school to get an MBA, which landed him a job with an insurance broker in Midtown Manhattan. But he always wanted to work in movies, so he started taking film classes at night and began working on a couple documentary projects – one paid, one unpaid. After a brief stint with insurance giant AIG and a run-in with the financial crisis, he thought he’d give the film thing one more shot.

    At 40, Glatt was hired by Fox Searchlight as an unpaid intern on the set of the Oscar-nominated movie Black Swan. Because of his business background, Glatt was sent to the accounting department, where he carried around petty cash, filed receipts and made sure checks were signed. Initially, his job wasn’t labeled “intern.” It was “accounting clerk.”

    During his internship, Glatt says he started doing some research about whether his internship was legal – and that got him thinking.

    “I weighed my options for quite some time,” Glatt says. “I remember reading an article saying that unpaid internships were a lawsuit waiting to happen. I realized after a while, I’m that lawsuit.”

    Fox Searchlight declined to comment on the specifics of Glatt’s allegations but issued a statement through a company representative: “It is clear that these are meritless claims aimed solely at getting press coverage for the litigants and their attorneys. Fox Searchlight internships comply with all federal and state laws and regulations, by paying required wages or complementing the individual’s academic studies in for-credit programs, while also providing them valuable ‘real world’ business experience. We look forward to aggressively fighting these groundless, opportunistic accusations.”

    Fox and others seem to argue that they can get around not paying interns by offering college credit, but Glatt says he wasn’t enrolled in school at the time, and to the best of his knowledge, neither were any of the other dozen or so unpaid interns.

    “They were counting on the fact that nobody would sue,” says Glatt, “particularly kids who are out of school. This culture of expecting to be able to get free labor if you slap the title intern on it has become so pervasive that people don’t question whether it’s ethically wrong or legally acceptable.”

    The Influence of Occupy

    Something else was happening when Glatt was considering legal action: Occupy Wall Street. The downward mobility of young people was part of the overall language of Occupy, and unpaid internships fit perfectly into that narrative.

    “Unpaid internships have been talked about for the first time as a political issue in this country,” Perlin says. “There’s more awareness of the law, and these lawsuits are helping that.”

    While intern lawsuits aren’t unprecedented – there was a prominent lawsuit against an Atlanta public relations firm in the 1990s – there have been next to none, likely because former interns are worried that they’ll be ostracized in an industry in which they’re trying to work. Besides, even a successful settlement isn’t going to get them much money.

    “There’s still a big fear factor for interns about stepping forward and putting themselves on the line, risking potentially being blacklisted within an industry or within a firm,” Perlin says. “It’s a big thing to come out for not that much money. The back wages at stake are maybe several thousand dollars.”

    Alex Footman, another former Fox Searchlight intern who filed the lawsuit along with Glatt, says he worries about how others in the film industry will treat him now.

    “I realize that I have made a decision that could prevent me from being hired in the future,” Footman says.

    After Wang heard about Glatt and Footman’s lawsuit, she was encouraged to take legal action against Hearst. Then in March, another intern sued, this time a 25-year-old film student named Lucy Bickerton, who interned at “The Charlie Rose Show.”

    “It’s so ingrained, especially in the film industry, that you pay your dues,” Bickerton says.“You keep your mouth shut and are thankful for anything that comes your way.”

    Bickerton says so many college students entering the workforce think internships will automatically lead to jobs. But nobody questions whether those interns should actually be getting wages.

    “Nobody ever told me, ‘Don’t you think your time is worth getting paid for?” Bickerton says.

    Yvette Vega, executive producer for “The Charlie Rose Show” also offered a statement refuting the accusations: “We are confident that our practices are in accordance with applicable law and provide a valuable education experience for interns.”

    Before the trio of lawsuits, the Department of Labor announced that it was cracking down on unpaid internships by ramping up efforts to educate future interns about their rights and informing employers about federal law. But the best way for the department to take action is through complaints directly from interns — and that rarely happens.

    But some employers have already started changing their internship policies, including magazine publisher Conde Nast, while others are beginning to rotate interns through different departments, which appears to offer them a more educational experience and makes it harder to assign menial but essential tasks. While it’s difficult to predict, the threat of legal action may mean fewer unpaid internships offered this summer than in recent memory.

    For Wang, she says her internship at Harper’s Bazaar convinced her that rather than educating and training them, businesses will use interns any way they can simply to improve their bottom line.

    “I always wanted to intern in New York in the fashion industry. But I had blown through all my savings to work for this major magazine so they could meet their budget,” says Wang. “That’s why I did what I did. I didn’t know another way to raise a flag about what was happening.”

    A couple weeks ago, Wang was laid off from a new job at a web start-up. She’s moving back to Columbus.

  • 05/01/2012 - 9:15am

    The Mason City Human Rights Commission has decided in favor of a former Mason City woman who sued FedEx of Mason City for gender discrimination and retaliation.

    Lori Johnson is entitled to back wages totaling $45,000-$48,000, $60,000 in punitive damages and about $100,000 for all legal fees, according to her attorney, Mark Sherinian of West Des Moines.

    FedEx has the right to appeal the ruling to district court. Attempts to contact FedEx personnel for comment were unsuccessful.

    Court documents state Johnson was a FedEx employee who transferred to the Mason City office as a part-time courier in February 2003. The next year, she was upgraded to swing driver and held that position until October 2007 when she resigned.

    Her suit claims FedEx discriminated against her on the basis of her gender and retaliated against her when she filed actions against her supervisors.

    After numerous instances in which she claims she was treated unfairly, Johnson was terminated in January 2006 and filed a complaint with the Mason City Human Rights Commission, charging discrimination and retaliation. The commission issued a ruling in favor of Johnson in March of that year.

    She was reinstated but problems with management continued, including being passed over for jobs given to men, according to court documents.

    Also, in 2006, Johnson was diagnosed with multiple sclerosis. She repeatedly asked for a set route rather than a swing route because it would be less stressful and decrease her MS symptoms, according to her doctor.

    Her suit claims the company offered her a set route only after it learned she had put her house up for sale and was planning to move to Montana.

    Her case went before an administrative law judge who ruled in favor of FedEx on all counts in May 2011. Johnson appealed the decision to the Mason City Human Rights Commission.

    This month, the commission unanimously rejected the administrative law judge’s decision and said Johnson was entitled to lost wages, compensation for emotional distress and for legal fees.

  • 04/27/2012 - 9:02am

    A former city construction manager filed a whistleblower lawsuit Thursday accusing Pontiac of unlawful bidding practices, "insidious corruption, cronyism, and blatant disregard" for proper disposal of asbestos from demolition sites.

    Edward Wenz of White Lake Township said he was hired in Pontiac in 2011 under a three-year contract to supervise demolition of abandoned and foreclosed properties.

    His attorney, Robert Fetter, alleges Wenz was fired in February 2012 after he reported concerns to the U.S. Department of Housing and Urban Development, which provides federal funds for demolitions, and the Michigan Department of Environmental Quality.

    The suit said Wenz reported to HUD "unlawful bidding practices for construction contracts for friends and political supporters of officials." The city, Emergency Manager Louis Schimmel, Richard Marsh and Wade Trim Associates are listed as defendants.

    Marsh was Wenz's supervisor and is employed by Wade Trim, hired to oversee the city building department and the federal programs division.

    "He (Wenz) was a temporary employee we had and were no longer in need of his services, (so) he was let go," said Schimmel.

    Marsh, who is the federal programs administrator for Pontiac, declined to comment Thursday.

    According to the lawsuit, Wenz allegedly overheard a contractor — previously banned by the city's law department from receiving work because of shoddy practices — yelling at a building department worker about not getting promised "help" in securing city jobs.

    The next day, Wenz said Marsh reprimanded him. He was fired Feb. 3, the day he sent HUD a copy of a signed agreement with the contractor.

  • 04/27/2012 - 9:02am

    Three Camden police officers are suing the city on claims they weren’t fairly paid for overtime hours.

    Meanwhile, police officers for the Delaware River Port Authority are suing the agency over stalled contract negotiations.

    While the Camden City lawsuit filed last week in U.S. District Court in Camden contains few details and lists no amount owed to the officers, attorney Andrew Glenn said he expects dozens of other officers will join in the suit. The legal action is aimed at an alleged practice that he said some officers have described as continuing for as long as 20 years.

    “Basically, they are not paying them for hours worked,” Glenn said. “It’s a systematic problem that seems deliberate. It does not look accidental.”

    City officials, who paid out more than $1.4 million in overtime to officers in fiscal year 2011 according to a recent audit, declined to comment on the allegations on Wednesday.

    In the five-page lawsuit, officers Edgar Feliciano, Robert Chew and Xemaril Cruiz claim the city “knowingly and willfully” failed to pay them the required time and a half for overtime hours.

    Glenn said it’s unclear how much the three, along with other officers, may be owed as the city is in possession of all the payroll and time records.

    According to payroll records obtained by the Courier-Post, Chew was paid $209 in overtime in 2010, Feliciano was paid $838 and Cruz received $187. Records show one Camden police sergeant was paid nearly $10,000 in overtime during the same year.

    While Glenn said veteran officers have told him the practice of shorting officers on overtime pay dates back to 20 years or more, the lawsuit is limited to addressing grievances in the past three years.

    Still, Glenn estimates that hundreds of officers could have missed out on overtime payments in the three-year period.

    “It sounds like it’s daily and they are just cheating these people out of money,” said Glenn, whose South Orange law firm practices solely on overtime issues. “I had a lot of people telling me the same story.”

    John Williamson, president of Camden’s rank-and-file union, said the lawsuit was filed in conjunction with the union.

    “There are a lot of components to it,” Williamson said of the claims against the city.

    Williamson said one of the issues concerns the union’s belief that officers should receive compensation for days when they are required to be on call and therefore limited in their activities.

    In the DRPA lawsuit, officers for the authority have requested a federal judge to order binding arbitration to settle a stalled contract dispute.

    The lawsuit, filed last week in federal court, accuses the DRPA of failing to negotiate the officers’ contracts in good faith. The port authority officers, who patrol the agencies four bridges and PATCO rail line, have been operating on a contract that expired at the end of 2009.

    According to the lawsuit, a May 2010 offer made by the DRPA included no wage increases for 2010 or 2011 and a 2 percent wage increase in 2012. The union rejected that deal and countered last year with a four-year contract that gave a 2 percent wage increase for each year.

    A final offer by the DRPA earlier this year offered no wage increases.

  • 04/27/2012 - 9:02am

    A lawsuit filed on behalf of former Westmont fire chief Frank Trout seeks an unspecified amount of money from the Village of Westmont for what Trout claims are unpaid wages dating back to 2004.

    The lawsuit, which names Mayor Bill Rahn, Village Manager Ron Searl and the seven members of the village board as defendants, claims that Trout has not been paid for hours he worked as a duty officer for the Westmont Fire Department.

    Duty officer is a second assignment that calls for a fire department employee or officer to always be on duty to supervise personnel. The lawsuit claims Trout was not compensated, as other department employees were, for an unspecified amount of hours he worked as duty Officer.

    The lawsuit, filed in DuPage County Circuit Court on April 12, also seeks 2 percent interest for each month of Duty Officer work for which Trout was not compensated. The suit estimates that amount will exceed $50,000, in addition to attorney fees.

    Trout retired from the Westmont Fire Department after 42 years of service in January, nearly a month after he was arrested on a drunken driving charge after hitting a parked car in unincorporated Westmont. In February, he was acquitted of the DUI charge.

    The lawsuit also claims the Village of Westmont violated the Illinois Human Rights Act while investigating his DUI charge.

    It states the “defendants failed to investigate the reliability or accuracy” of third-party statements and “failed to afford (Trout) an opportunity to refute said statements or provide an accurate rendition of the circumstances surrounding his arrest.”

    Village officials declined to respond to the specific claims in the suit, but Westmont Village Manager Ron Searl they believe the lawsuit has no merit.

    “We’re going to vigorously defend it,” Searl said.

    Richard Blass, Trout’s attorney, said he could not specify the number of hours Trout worked for which he has not been compensated. Blass said the lawsuit includes a request of documents from the village, including timesheets, that would indicate the exact number of hours.

    Trout kept his own record of his hours worked as a duty officer, according to the lawsuit.

    Blass said Trout did not file any complaints with the village during the time he was not being compensated for hours worked as a duty officer.

    “(Trout) is a lay person; he’s not an attorney. I wouldn’t expect him to know to do that,” he said. “He did keep his own log (of hours worked). We plan on comparing that with what the village gives us.”

    The lawsuit alleges Trout’s compensation for hours worked as a duty officer stopped sometime in 2004, shortly after Searl was hired as village manager.

    The lawsuit claims that after Searl was hired, Trout was informed by the village’s finance director that village officials “believed Chief Trout was making too much money by receiving wages when performing duties as a duty officer.” So Trout stopped submitting payroll requests for his work as duty officer because he was “concerned that he might lose his job as was the fate of many other department heads at the time,” the suit states.

    Blass said now that the lawsuit has been filed, “the ball is in (the village’s) court.”

    To view a copy of the lawsuit, click the PDF file to the right of this article.

  • 04/27/2012 - 12:09am

    U.S. fashion designing house Betsey Johnson LLC filed for Chapter 11 bankruptcy protection late on Thursday, citing declining sales and profitability at its retail stores, court documents showed.

    "The economic recession had a devastating impact on higher-end fashion apparel brands, including Betsey Johnson Fashions," the company said in the filing.

    The case is: Betsey Johnson LLC, Case No.12-11732, U.S. Bankruptcy Court, Southern District of New York.

  • 04/24/2012 - 9:05am

    As reports indicate drug maker Bayer has started settling some of the estimated 10,000 lawsuits filed over alleged side effects from its oral contraceptives Yaz and Yasmin, the FDA stepped in this month to order more protection for potential users of the drugs.

    On April 10, 2012, the FDA announced it was requiring a label change for drugs such as Yaz which contain the chemical drospirenone, warning that the chemical may be associated with a higher risk for blood clots.

    According to an April 13, 2012 Bloomberg article, Yaz is still the fourth most popular oral contraceptive, earning Bayer over $1.5 billion in 2010 with prescriptions to millions of women.

    Several studies have indicated the blood clots associated with the drug may be linked to an increased risk of stroke, deep vein thrombosis and pulmonary embolism injuries to the lungs.

    In 2009, The British Medical Journal published research from Denmark and the Netherlands linking the chemical drospirenone in Yaz to an increased risk of blood clots, a contributing factor for stroke.

    In October, 2011, the FDA released a study of more than 800,000 women taking oral contraceptives which showed that those taking drugs like Yaz had a 74% increased risk of developing blood clots.

    A federal Multi-District Litigation court in Illinois set up to handle lawsuits filed over alleged Yaz side effects has reported more than 10,000 cases filed. The formal case is known as Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100).

    Bloomberg’s April 13, 2012 article also reported that the annual report released by Bayer on February 13, 2012 announced that the company has now settled at least 70 cases. No details or amounts of the settlements were given and the company has not admitted any fault.

    According to the FDA warning, those taking Yaz are encouraged to talk with their physician before making any changes to their prescription.

    Lawyers are still helping those who have suffered a side effect after taking Yaz learn about their legal rights. However, they caution that time may be limited. YazLawsuit.com contains more information on the lawyers currently settling Yaz lawsuits, FDA warnings and research related to the drug.

  • 04/22/2012 - 4:22pm

    For heart attack survivors, statins are miracle drugs. Statin medications, including Lipitor and Crestor, are so effective at lowering “bad” cholesterol and preventing secondary heart attacks and strokes that they have become the world’s most widely prescribed drugs.

    Their anti-inflammatory effects hold such promise that doctors such as David Agus – author of 2012 bestseller The End of Illness – are urging everyone over age 50 to be on statins. British researchers have gone so far as to recommend that statins be handed out free at fast food outlets to “neutralize” the fats in cheeseburgers and milkshakes.

    But in February of this year, the U.S. Food and Drug Administration issued new alerts warning that statins may cause memory problems and an increased risk of Type 2 diabetes. Regulators had previously noted the risk of severe muscle pain. Less conclusive studies have reported side effects including irritability, aggression, kidney damage and cataracts.

    In light of the risks, a growing number of independent researchers are questioning whether people with no history of heart disease should be taking cholesterol-lowering drugs.

    An estimated three to four million Canadians are on statins. As many as 70 to 80 per cent of statin prescriptions are given to people with risk factors but no obvious signs of heart disease, a practice known as primary prevention.

    Routine use of statins, despite the risks, prompted American cardiologist Eric Topol to declare in a recent New York Times editorial that North Americans are “overdosing” on cholesterol-lowering drugs.

    According to the research that led to the FDA alerts, more than one in 200 people taking statins will develop Type 2 diabetes, says Dr. Topol, a genomics professor at the Scripps Research Institute in La Jolla, Calif. In Canada, that works out to an estimated 15,000 to 20,000 new cases of Type 2 diabetes.

    Meanwhile, statins reduce cardiac events in just two out of 100 patients taking the drugs for primary prevention, Dr. Topol points out.

    “It’s only the tiny minority that actually derives benefit,” he says in an interview. “The [medical] community hasn’t acknowledged that.”

    Other researchers are even more skeptical of statins – a market worth more than $20-billion a year. The Vancouver-based Therapeutics Initiative, an independent drug review body, has analyzed 12 large randomized controlled trials to evaluate outcomes for patients taking statins to prevent heart disease.

    After eliminating studies with a high risk of bias, “there’s no evidence that the benefits of using statins for primary prevention outweigh the risks,”says the group’s director, Jim Wright.

    Dr. Wright’s voice of caution is echoed by Rita Redberg, a cardiologist at the University of California, San Francisco, who warns against giving statins to healthy people, even those with higher cholesterol, because of potential side effects.

    Barbara Roberts, director of the Women’s Cardiac Center at the Miriam Hospital in Rhode Island, has found that women report more side effects and reap fewer benefits from statins than men do. In her new book, The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs, she argues that many of the guidelines followed by doctors to prevent heart disease are based on “shoddy science.”

    Her case against statins couldn’t be more at odds with the prevailing views in the medical community.

    Todd Anderson, director of the Libin Cardiovascular Institute of Alberta, says he doesn’t agree that everyone should be on statins. But, he adds, “We’re not using them as much as we should.”

    While cholesterol levels aren’t the only factor in heart disease, he says, clinical trials have shown “a pretty good linear line for percentage reduction in LDL [“bad”] cholesterol and percentage reduction in [cardiac events].”

    Relative to other medications, statins are “pretty safe,” says Dr. Anderson. Statins increase blood sugar by a small percentage, which for some people may be enough to push them over the edge from having pre-diabetes to diabetes, Dr. Anderson explains.

    He adds that many drugs increase the risk of Type 2 diabetes, including blood pressure medications and beta blockers. “You have to put it in perspective.”

    Guidelines set by the Canadian Cardiovascular Society in 2009 recommend statin therapy based on the patient’s risk factors, including cholesterol levels, smoking, blood pressure and genetics. Dr. Anderson, who co-authored the document, notes the guidelines caution against unnecessary cholesterol-lowering therapy and emphasize the role of exercise and improved diet in reducing artery-clogging fats.

    Dr. Topol points out that patients may be able to reduce their “bad” cholesterol and increase levels of “good” (HDL) cholesterol with lifestyle changes alone. But, he says, some people get “phenomenal” results from regular exercise and a healthier diet, “while others, they do it all and have nothing to show for it.”

    If lifestyle changes fail, he advises patients to ask a doctor if they can start with a lower dose of a less potent drug (such as 20 milligrams of simvastatin, the generic form of Zocor).

    Patient awareness is crucial since there’s a good chance the recent FDA warning about statins will be ignored by the medical community, Dr. Topol predicts.

    He adds that people on statins tend not to follow a healthy lifestyle. “They figure, I’m covered here, so I can still be overweight and eat things that I shouldn’t eat and not exercise,” he says. “It’s been like a false sense of security.”

  • 04/20/2012 - 9:10am

    A group of Canadian women has filed a class action lawsuit against Johnson & Johnson alleging the company’s transvaginal mesh devices caused them to suffer serious, life-altering injuries. The transvaginal mesh lawsuit further alleges that Johnson & Johnson, along with its Ethicon, Inc. and Gynacare units, failed to adequately warn patients and physicians of the magnitude of the risk of serious side effects when using one of their transvaginal mesh products compared to alternative treatments.

    Carol Kouyoumjian, one of the Canadian women involved in the lawsuit, recently told CTV.ca that she received a Johnson & Johnson transvaginal mesh device six years ago in order to treat stress urinary incontinence. The surgery did not cure her condition, but has left her with chronic leg pain.

    “I woke up from surgery and the pain was absolutely unbelievable,” she said. “If the pain scale runs from 1-10, mine was a 12. My legs were literally vibrating.”

    Kouyoumjian eventually lost her job as a nurse because she is no longer able to remain on her feet for hours at a time, CTV.ca reported. Her doctors have given her no choice but to live with her pain.

    “I have been advised not to have it removed because over time, it becomes part of your body and that can cause many complications,” Kouyoumjian told CTV.com

    Transvaginal Mesh Complications

    Transvaginal mesh devices are used in the surgical treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The devices are inserted transvaginally, and act as a hammock to support sagging pelvic organs and muscles. This past July, the U.S. Food & Drug Administration (FDA) said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh products like Gynecare Prolift from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. Injuries attributed to the use of transvaginal mesh devices include

    • Inflammation and infection 
    • Pain from mesh shrinkage 
    • Extrusion of mesh through the vaginal wall 
    • Pain during intercourse and urination

    According to the FDA, even when women undergo surgery, sometimes multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.

    In the U.S., most of the transvaginal mesh devices currently on the market were cleared through the agency’s 510(k) fast-track approval process, which grants access to the market without much pre-market safety testing, based on the idea that the products were similar in design to a previously-approved device. However, the FDA is considering rescinding 510(k) approvals for transvaginal mesh devices used in POP repair, and has asked the makers of such devices to conduct safety studies of the products.

    Johnson & Johnson Transvaginal Mesh Lawsuits

    Johnson & Johnson now faces more than 550 U.S. lawsuits filed by women who allege they sustained serious injuries following surgery with the Gynecare Prolift vaginal mesh product to treat POP and SUI. Earlier it this year, it was learned that the Gynecare Prolift device was sold on the U.S. market for two years before Johnson & Johnson filed an application for its approval.

    Lawsuits involving transvaginal mesh products made by Johnson & Johnson’s Ethicon and Gynecare units have been consolidated in a multidistrict litigation in the U.S. District Court for the Western District of West Virginia. Three other transvaginal mesh litigations involving products made by American Medical Systems, C.R. Bard and Boston Scientific are also pending in the same jurisdiction.

  • 04/20/2012 - 9:10am

    New York officials today accused Sprint Nextel Corp. of under-collecting and under-paying over $100 million in state and local sales taxes on flat-rate access charges for wireless calling plans.

    New York Attorney General Eric Schneiderman announced on Thursday a lawsuit against Sprint Nextel requiring the company to pay three times its underpayment plus penalties if found liable to New York state and local governments, including school districts.

    "Everyone else had no trouble figuring out what the tax law was, except for Sprint," Schneiderman said during a conference call.

    Schneiderman said Sprint's major wireless competitors, including Verizon, AT&T, T-Mobile, and MetroPCS, have followed the law regarding the taxes. Last week, Verizon was included in a list of largest corporate tax-dodgers by liberal-leaning group, Citizens for Tax Justice.

    The Attorney General called Thursday's action a "first-of-its-kind lawsuit."

    The lawsuit is the first tax enforcement action filed under the New York False Claims Act in which those found liable under the False Claims Act must pay triple damages, penalties and attorneys' fees. Under the law, whistleblowers may receive up to 25 percent of any money recovered by the government as a result of information they provide.

    "This complaint is without merit and Sprint categorically denies the complaint's allegations," said John Taylor, Sprint Nextel spokesman. "We have collected and paid over to New York every penny of sales taxes on mobile wireless services that we believe our customers owe under New York state law. With this lawsuit, the Attorney General's office is claiming New York consumers, who already pay some of the highest wireless taxes in the country, should pay even more. We intend to stand up for New York consumers' rights and fight this suit."

    Twenty-nine states and the federal government have passed False Claims Acts, but New York's Act "expressly covers tax fraud as a result of a landmark law," the Attorney General's office said.

    "This case represents a new era in tax fraud prosecutions," Schneiderman said. "We're sending a message to corporations that failure to pay your fair share of taxes will not be tolerated."

    In 2011, Schneiderman created the "Taxpayer Protection Bureau," as one of his first acts in office. The bureau is charged to work with whistleblowers and enforce the False Claims Act in tax and other government fraud cases.

    Schneiderman's investigation of Sprint began with a whistleblower lawsuit, called a "qui tam" action, filed in New York State Supreme Court in Manhattan in March 2011, just after the Taxpayer Protection Bureau was created.

    Working with the New York State Department of Taxation & Finance, the bureau conducted an investigation.

    Schneiderman's office said that by filing Thursday's complaint, the Attorney General has taken over the action from the whistleblower on behalf of New York's taxpayers.

  • 04/19/2012 - 9:00am

    The recession has certainly changed a lot of people's work schedules and work demands - so much so, more than 7,000 lawsuits were filed last year over unpaid overtime.

    With that in mind, here are some of the rules for overtime, when you earn it and when you don't.

    First, you have to know if you are an exempt or non-exempt employee.

    Exempt employees can not earn overtime. They are employees designated as executive, administrative, or professional, outside sales employee, computer systems analysts, computer programmers, software engineers, and other similarly skilled computer employees.

    Non-exempt employees do earn overtime, only if they make less than $455 per week.

    And keep in mind, the U.S. government does not limit the number of hours an employee 16 and older can work.

    The rate of overtime is quite familiar to most of us - one and one-half times an employee's regular rate of paid after 40 hours of work in a workweek.

    You are not automatically paid overtime in the case that you work weekends, nights or holidays. According to the U.S. Department of Labor, that is up to the employer.

    The "workweek" can be any seven consecutive days. It's not dependent on the calendar. But your employer can not average your hours over two weeks.

    Each work week stands alone.

    Your overtime check must be remitted to you on the day you're normally paid for the normal hours you worked.

    And if your employer pays you a lump sum for overtime independent of the hours you actually worked, it does not cancel the employer's responsibility to pay you for each and every hour of overtime you paid.

    It's important to note that there are exceptions to these rules. State and local government workers such as firefighters, law enforcement have different rules.

  • 04/18/2012 - 9:01am

    Everyone from pharmaceutical reps to home health care aides to waiters and waitresses in fancy restaurants are sick of working off the clock, and they’re looking to finally punch in.

    This week, the Supreme Court is reviewing a case involving pharmaceutical representatives who claim they’re owed overtime pay even though their employer, GlaxoSmithKline, contends they’re sales people and not entitled to it.

    Last month, a case involving celebrity chef Mario Batali’s restaurants and unpaid overtime and tips for employees was settled for $5.2 million. And earlier this year, Swiss drugmaker Norvartis AG agreed to settle a class action overtime suit for $99 million brought by its sales representatives.

    Overtime cases brought by the U.S. Department of Labor jumped to 11,990 in 2011 and netted $140 million in overtime wages, up from 8,788 cases and about $107 million in wages in the previous year, the agency reported Tuesday. And such lawsuits filed in federal courts rose 15 percent in 2011, compared 2010, according to Richard Alfred, an employment attorney with Seyfarth Shaw, adding that wage and hour suits overall have jumped 325 percent since early 2000.

    Show-me-the-overtime-money fever seems to be raging across the country.

    “There’s been more pressure on workers to work more hours,” said Letty Mederos, vice president of work and family programs for the National Partnership for Women & Families. At the same time, she added, there’s been a deterioration of overtime protections and more employers are putting workers in job categories that are overtime exempt, sometimes thwarting the law.

    Mederos believes workers are just looking to get what they’re owed in an economy that has seen productivity rise but pay stagnate. “Employees have been getting the short end of the stick,” she stressed.

    Not everyone agrees the push back is mainly driven by worker ire.

    Confusion regarding overtime laws -- covered under Fair Labor Standards Act, or FLSA, enacted in 1938 -- is a big contributor, maintained Alfred, who mainly represents employers. “The laws are difficult to apply in the modern workplace,” he said.

    To such claims, Nancy J. Leppink, deputy administrator of the labor department’s wage and hour division, countered: “The primary principle of the Fair Labor Standard Act is that workers must be paid for the hours that they work. As technology and work environments have evolved, the Department of Labor has worked to ensure this tenet stands strong and that workers receive the pay they have earned.”

    Not getting what you’re owned today may be a function of tough economic times, said Karen Tramontano, an expert in employment law and the chief executive officer at business consultancy Blue Star Strategies. “Companies have been trying to figure out how to cut costs and maximize productivity and one of the ways they cut costs was figuring out how to get around the Fair Labor Standards Act,” she explained.

    Another factor contributing to an uptick in suits, and general awareness of the issue, agreed both Mederos and Alfred, is increased enforcement of overtime laws on the part of the Labor Department.

    Indeed, the agency has added 300 new investigators since 2009, and Labor Secretary Hilda Solis has made no secret of her desire to fight wage and hour violations.

    In December, the Obama administration proposed revising the FLSA to include, for the first time, in-home care workers, who are not legally entitled to overtime pay, a right domestic worker advocacy groups have been fighting for. “My department is committed to fighting for good jobs for everyone, jobs that enable workers to earn a living wage, afford health insurance and save for retirement,” said Solis at the time the proposal was introduced.

    Another proposal that would strengthen overtime laws is the Rebuild America Act, introduced by Sen. Tom Harkin, D-Iowa, last month.

    The Act would raise the income level for those entitled to overtime no matter what their job classification. Right now, the cap is $455 a week, or about $24,000 a year. Harkin’s legislation would index the cap to inflation, putting it at about $54,000 a year, said Mederos.

    “The Act will also address the continuing erosion of overtime protection,” wrote Lawrence Mishel, an economist and president of the Economic Policy Institute, and Ross Eisenbrey, the Institute’s vice president, in a blog post last month, calling it “the best defense workers have against abusive schedules and worsening work-family conflicts.”

    High profile cases such as the one before the high court this week involving pharmaceutical reps at GlaxoSmithKline could also change the playing field.

    “If the Court rules that sales reps in this case are not exempt outside salespersons and the other exemptions are also rejected this could have a dramatic financial impact on pharma companies," said Lee Schreter, co-chair of the wage and hour practice at Littler Mendelson. “Not only could they be required to issue back pay to 90,000 sales reps, potentially costing billions, but the continuing costs to pay overtime would change the structure of the industry and ultimately the cost would likely be passed down to the consumer.”

    Blue Star’s Tramontano doesn’t buy that argument.

    “Employers always talk about how costs in the labor sector are going to be overwhelming for them and they always manage,” she pointed out.

    “There’s a reason we have a 40-hour work week as a matter of labor market policy in the United States; it’s good public policy,” she said, adding that “if you’re working beyond that and are entitled to compensation employers have to pay.”

    It's unclear how many U.S. workers are entitled to overtime today. Eisenbrey said about 105 million were eligible for overtime in 2004, based labor department estimates at the time.

    Here’s a link to a DOL page that provides specifics about your overtime rights.

  • 04/17/2012 - 12:18pm

    Air pollution from fracking includes the fumes breathed in by people nearby, as well as smog spread over a wide region and emissions of the greenhouse gas methane.

    On Tuesday, the Environmental Protection Agency is expected to announce the first national rules to reduce air pollution at hydraulically fractured - fracked - wells and some other oil and gas industry operations. The agency estimated that the plan it proposed in July would reduce smog-forming, cancer-causing and climate-altering pollutants from the natural gas industry by about one-fourth.

    The White House in recent weeks has been reviewing the EPA plan to consider possible changes, the normal procedure for regulations. Industry groups have lobbied for exemptions that would reduce the impact of the rule, saying the original requirements are too costly. Environmental and health advocates have been talking to White House officials as well, opposing the industry's proposed changes.

    The final version on Tuesday will show how President Barack Obama's administration navigates between the nation's needs for energy and health. Obama supports fracking because it yields vast amounts of natural gas, a fuel that burns cleaner than coal. He also has said that it should be done "without putting the health and safety of our citizens at risk."

    Pam Judy of Carmichaels, Pa.., says she fears that her family already is at risk from fumes from a large natural gas compressor station 780 feet from their home in the hills. When they built it, they were far from everything. Three years later, a natural gas compressor station was built on neighboring property.

    "We have fumes that are in our yard almost constantly," she said. "There are times when it smells like diesel or a kerosene smell. It's very difficult to pinpoint the exact smell. Then there are times we get a smell like chlorine. When we get that chlorine smell it literally will scorch your eyes and your throat."

    Air tests found 16 chemicals in her yard, including benzene, a chemical the EPA classifies as a carcinogen. She said test of her blood also showed exposure to benzene and other chemicals. Benzene can cause dizziness and headaches, symptoms she's had. Her adult children have had runny noses, headaches and sore throats that go away when they aren't at their parents' home.

    The family worries about long-term exposure and is wrestling with whether to stay. Their land was handed down in her family since her great-grandparents' day, Judy said. "It's really heart-wrenching for us to make the decision to move."

    Paul Parker, a retired vice president of an engineering company who worked with energy companies, has lived for 36 years in an area south of Pittsburgh where natural gas development has sprung up in the last few years. Parker said no to leases on his own property, but sees the development around him and says the area has been ruined.

    "When you go outside, it's like living in a chemical complex," he said. Pollution comes from vents on storage tanks near his property, he said, as well as nearby flaring to burn gas in early stages of well development and the diesel emissions of hundreds of trucks needed to haul water and equipment to well sites.

    Fracking involves pumping water, sand and chemicals deep underground to release gas. After the injection, the fracking fluids and gas flow back for a period of several days or more.

    The EPA's rule would require companies to use portable equipment to capture this gas that otherwise escapes to the atmosphere or gets burned off in flares, a process known as green completion. The equipment would reduce volatile organic compounds, which are part of what forms smog. The same equipment would capture methane, the primary constituent of natural gas, and make it available for sale.

    The industry estimates that more than 25,000 wells are fractured or refractured each year.

    The American Petroleum Institute, the lobby for the oil and gas industry, has asked the Obama administration to make the requirement apply only to wells where the gas stream is 10 percent or more of volatile organic compounds.

    That approach would exclude many wells.

    The EPA's existing rule for volatile organic compounds in the gas industry was issued in 1985 and applied only to leak detection at new and upgraded gas processing plants. That arrangement leaves much of the volatile organic-compound emissions from the oil and gas industry unregulated.

    API told the EPA earlier that the average well is 2.95 percent volatile organic compounds. API spokesman Carlton Carroll said on Friday that API had to correct that number because it was wrong. "We believe the average is closer to 10 percent," he said.

    API president and CEO Jack Gerard said in a letter three weeks ago to senior White House adviser Valerie Jarrett that emissions controls on low volatile organic-compound gas would not be cost-effective. He also asked for other changes, including at least two years for building the equipment needed for green completions.

    Environmental groups oppose those requests. They say that even small percentages of volatile organic compounds add up, because the volumes in fracking are so large. They also say that the industry over-estimated the costs of green completions, and they point out that in states such as Colorado and Wyoming, where the equipment is already required, the gas industry has continued to grow.

    Other parts of the EPA's plan would require equipment on compressors, storage tanks and new pneumatic controllers, the instruments that control pressure and other conditions.

    "This industry produces an astonishing amount of air pollutions," and the emissions have been largely ignored, said Joe Osborne, legal director of the Group Against Smog and Pollution.

    Some pollutants on a local level can mean greater risks for cancer and neurological and reproductive problems, Osborne said. Other pollutants combine to form smog, which spreads over a much wider area. Smog can make it hard to breathe, aggravate asthma and other lung diseases and permanently damage lungs

    In Pennsylvania, where GASP is based, parts of the state, along with much of the rest of the Eastern U.S., already don't meet health standards for smog. The good news is that smog levels have gone down in the past 20 years, Osborne said. But the development of shale gas "has the potential to halt that progress or potentially even reverse it."

  • 04/17/2012 - 8:54am

    More workers are fighting back against their employers.

    Workers filed 32 percent more lawsuits against their employers for unpaid overtime last year than in 2008, according to USA Today. The uptick in lawsuits may be a sign that the job market is starting to improve enough for workers to stand up to their employers, who squeezed more out of employees during the recession and recovery.

    As companies laid off workers and postponed hiring plans during the recession, they sought to get by with fewer employees by forcing them to work longer hours, according to USA Today. With roughly four unemployed Americans for every job opening, companies likely have enough sway to force their employees to work harder.

    But that is not entirely legal. All hourly workers are entitled to overtime pay for working longer than 40 hours per week, according to the Fair Labor Standards Act. Salaried workers that earn less than $455 per week also are entitled to overtime pay.

    Having employees work longer hours is one of the many ways that companies have been squeezing more out of their workers. S&P 500 companies made an average $420,000 in revenue per employee in 2011: 11 percent more than in 2007, according to the Wall Street Journal. Corporate profits have continued to hit record highs, according to the Commerce Department. And the average size of firms keeps falling, according to the Labor Department.

    Many employees have been working harder for effectively lower pay. Inflation-adjusted wages fell about 2 percent in 2011, and the percentage of workers reporting no wage change is at its highest level in 30 years, according to the Federal Reserve Bank of San Francisco.

    But workers may be starting to gain some leverage. More employees quit their jobs in February than in any month since November 2008, according to Labor Department data cited by the Wall Street Journal.

  • 04/17/2012 - 8:54am

    A group of Pepsi Bottling Group Inc. employees will receive $187,275 as part of a settlement in a collective action over unpaid overtime compensation.

    Pepsi will also pay administrative costs and attorneys’ fees that bring the total above $270,000, according to court documents.

    Avary Leigh was the class representative of a group of about 60 employees who worked at six Pepsi Bottling Group locations who said they had not been paid for overtime hours over the past three years.

    The case was filed in U.S. District Court in Greenbelt because Leigh worked as a sales representative in the Capitol Heights location.

    The complaint stated that, from Sept. 15, 2008 to Dec. 8, 2009, Leigh had a vacation-relief position. That meant he delivered Pepsi products to stores and would cover the other sales representatives’ routes while they were on vacation.

    The complaint stated Leigh “performed work ‘off-the-clock’ after his shift and after he clocked out from his shift at the behest and direction of his supervisor.”

    Leigh’s attorney, Alan Crone of Crone & McEvoy PLC in Memphis, said the workers he represented experienced similar treatment at Pepsi Bottling Group centers in Capitol Heights, New England, Minnesota, Michigan, upstate New York and Western Pennsylvania.

    “They were happy with the settlement,” Crone said.

    Pepsi Bottling Group’s attorney, Samantha Hardy at Sheppard Mullin Richter & Hampton LLP in San Diego, did not return calls for comment.

    The settlement includes $187,275 in payments to the plaintiffs, a $9,000 incentive fee to Leigh, $15,000 in claims administration fees, $3,651 in costs and $64,273 in attorneys’ fees.

    U.S. District Judge Deborah K. Chasanow approved the settlement order on Feb. 27.

  • 04/16/2012 - 9:12am

    Bayer AG, the maker of Yaz and Yasmin birth control pills, has agreed to settle roughly 500 lawsuits alleging the contraceptives caused serious blood clots, some of which led to heart attacks and strokes. According to Bloomberg News, the settlements will cost Bayer roughly $110 million, or $220,000 per case.

    Yaz, Yasmin Lawsuit Background

    Some 11,000 plaintiffs have filed suit against Bayer alleging that Yaz and Yasmin and similar birth control pills caused a number of serious side effects, including:

    • Blood clots 
    • Deep Vein Thrombosis 
    • Pulmonary Embolism 
    • Strokes 
    • Heart Attacks 
    • Gallbladder problem 
    • Death

    The majority of those cases are being overseen by Judge David Herndon in a multidistrict litigation currently underway in the U.S. District Court for the Southern District of Illinois. Late last year, the first bellwether trials, or test cases, scheduled to start in that litigation were postponed indefinitely. Judge Herndon, at the behest of Bayer, instead ordered the parties to begin settlement negotiations, and appointed a special master, George Washington law professor Stephen Saltzburg, to mediate.

    Bayer Yaz and Yasmin Lawsit Settlements

    Bloomberg is reporting that the 500 Yaz and Yasmin lawsuit settlements were confirmed by two anonymous sources close to the litigation, though they have yet to be announced publicly. “Bayer HealthCare confirms that some cases pending in the current YAZ/Yasmin litigation in the U.S. are being settled,” Rosemarie Yancosek, a U.S. spokeswoman for the drugmaker, said in a statement emailed to Bloomberg. However, there was no confirmation on the number of settlements or their amounts.

    This isn’t the first time settlements of Yaz and Yasmin lawsuits have been confirmed by Bayer. As we reported previously, Bayer revealed in its Annual Report issued in February that it had settled somewhere in the neighborhood of 70 Yaz and Yasmin lawsuits filed by women who allegedly suffered blood clots, deep vein thrombosis, pulmonary embolism, strokes and other serious complications due to their use of the medications. Bayer did not reveal the terms of the settlements, nor did it admit any fault.

    New Yaz, Yasmin FDA Blood Clot Warnings

    News of the Yaz and Yasmin settlements come just days after the U.S. Food & Drug Administration (FDA) announced that the labels for those contraceptives, as well as others that also contain the synthetic progestin, drospirenone, would be updated to provide more information regarding their blood clot risks. In a Drug Safety Communication issued Tuesday, the FDA said it had completed its review of studies that assessed the association between drospirenone birth control pills and blood clots, and had determined that these drugs might pose a higher clot risk than oral contraceptives made with other progestins. The new label information will state that some of the studies reviewed by the FDA reported as high as a three-fold increase in the risk of blood clots, whereas other studies found no additional risk of blood clots with drospirenone-containing products. The new label information will also include a summary of the previously released results of an FDA-funded study of the blood clot risk. That study, released last fall, found that drospirenone-containing birth control pills were associated with a 1.5-fold increase in the risk of blood clots, compared to those made with other progestins, the FDA said.

  • 04/16/2012 - 9:12am

    It was supposed to be a routine trip to the doctor for 83-year-old Bernice Martens. But in the parking lot of the medical center, a caretaker dropped Martens while trying to lift her from the car to her wheelchair. It happened a second time when the caretaker tried to lift her client back into the car.

    Less than two weeks later, Martens was dead.

    Her caretaker, it was discovered later, wasn't qualified to work directly with clients -- something her employer, Senior Helpers in Bloomington, didn't know because the company didn't do a background check until after firing her.

    An investigation by the Minnesota Department of Health into the incident last October found negligence on the part of both the employee and Senior Helpers, and identified three violations of state statute. The employee, who wasn't named, denied to investigators that she dropped Martens and said she thought she used transfer belts, but wasn't sure. The employee was fired two days after the incident.

    "We want to extend our sincerest apologies to the family," Senior Helpers owner Mike Johnson said in a statement. "This is an isolated incident and we have a well established reputation of excellence serving this community. We thoroughly trained our caregiver and unfortunately this person did not follow procedure."

    It's the only substantiated complaint against Senior Helpers filed with the Minnesota Department of Health since 2008. The company, which operates nationwide, hires caregivers to work with seniors like Martens who lived on their own.

    For Martens' family, the findings come too late. The mishandling of Martens by her caretaker contributed to her rapid decline in health and ultimately her death, the family's attorney Mark Niemeyer said.

    "She was in very good health," he said. After falling, "she declined in a matter of days."

    The family will try to settle with the company out of court, but is prepared to sue, he said.

    Only weeks before her death, Martens, 83, had moved from Illinois to an Eden Prairie senior apartment to be closer to her son, Scott Martens, and his family. They hired Senior Helpers caretakers to get Martens to appointments.

    On Oct. 25, 2011, Martens' daughter-in-law went with her to an appointment. According to the state report, the Senior Helpers employee arrived to pick her up, but had to get help lifting Martens from her wheelchair to the car. When they got to the appointment, the caretaker attempted to move Martens from the car to the wheelchair and dropped her on the ground. Medical center staff had to help get Martens into a wheelchair. The daughter-in-law reported the incident to Senior Helpers, but after the appointment, the employee dropped Martens a second time trying to lift her into the car.

    The caretaker didn't use a transfer belt in any of the three cases, even though Martens' care plan called for it, the report said.

    That night, Martens complained of pain to a different caretaker, who noted a "very large" bruise from her waist to arm pit, 6 inches wide. It wasn't reported to a nurse, according to the state.

    Two days later, Martens told a staff member she was "in pain all the time" after the two falls. The following day, she was admitted to a hospital with a massive hematoma. She died there a week later, her death certificate citing "aspiration pneumonitis."

    A background study is required of staff before direct contact in facilities licensed by the Department of Human Services. But Senior Helpers didn't submit one for Martens' caretaker until the day after firing her.

    "Had [Senior Helpers] conducted the background study prior to the [employee] providing services as required by statute," the state report said, "[Senior Helpers] would have been notified that the [employee] could not provide direct contact with clients."

    The state faulted Senior Helpers for failing to follow Martens' care plan, conduct a background study or report the maltreatment to a nurse. It is now in compliance, said Stella French, director of the Office of Health Facility Complaints.

    Neglecting to complete background studies on employees is rare, she said, but incidents involving transferring a patient from one place to another are "very common, unfortunately."

  • 04/15/2012 - 8:35pm

    Is our approach to mental health compromised by the drugs industry’s financial ties with health professionals?

    THE GLOSSY health brochure and website look innocuous enough.

    “Solutions for Wellness”, it says, along with information on nutrition, wellness and maintaining a healthy lifestyle. It’s a programme being rolled out by health professionals in many mental health services across the country.

    There is no mention of drugs of any kind – until you notice the programme itself is sponsored by drug manufacturer Eli Lilly, the makers of some of the most commonly prescribed mental health drugs such as Prozac and Zyprexa.

    It’s something which makes Agnes Higgins – an associate professor in mental health at Trinity College Dublin’s school of nursing – feel uncomfortable.

    “This is information which has been created by a pharmaceutical company and carries their logo. We are supposed to be providing impartial advice and support to patients. Should we be uncritically accepting or distributing this information?”

    For many, it is part of a worrying trend in recent years in which drug companies are playing a more active role in sponsoring medical events, research and education, potentially compromising the independence of nurses and doctors.

    Patient groups and growing numbers of health professionals fear the boundaries between education and promotion are becoming increasingly blurred, while patients can be left in the dark over the true value of medication.

    Mental health medication is big business. The number of prescriptions on the medical card in Ireland have increased by more than 25 per cent between 2006 and 2010, costing the State in excess of €100 million. This figure does not include private prescriptions, which would push the overall value of the market higher still.

    The industry insists there are measures in place to ensure marketing material provides accurate and unbiased information on drugs. The Irish Pharmaceutical Healthcare Association points to codes of conduct to guarantee ethical behaviour.

    As far as information leaflets or advertisements are concerned, the association says these campaigns help the wider public.

    “Pharmaceutical companies are well within their rights to support awareness campaigns on health matters, provided they do not mention or endorse individual products,” an association spokesman said.

    “The IPHA is very active in keeping member companies apprised of their obligations in this regard”.

    Despite these safeguards, the industry has been at the centre of numerous scandals over recent years over the exaggerated benefits of drugs, or withholding information on potentially harmful side-effects.

    Drug regulators, such as the Irish Medicines Board (IMB), have faced criticism for being close to the industry. In a study, Dr Orla O’Donovan of UCC’s department of applied social studies, found that the agency restricted public access to information regarding conflicts of interest.

    The IMB, however, says members of advisory committees are required to disclose any potential conflict. It says that while these have not been publicly available, this will change.

    “It is anticipated that publication of a summary of board member declarations will be completed in the coming weeks. Similar information for IMB senior management will also be published shortly,” a spokeswoman said.

    But an even bigger area, say many, are the intersecting circles of education at third level with the drugs industry. In the US, the industry sponsors up to 70 per cent of drug research in academic institutions; similar figures are not available for Ireland, though the industry also plays a central role.

    Research commissioned by the Mental Health Commission notes that while this funding can be very useful, the full implications of it need to be considered.

    Its research strategy document cites the argument that drug companies have helped create and reinforced a “narrow, biological approach to the explanation and treatment of mental disorders” which has led to the neglect of alternative non-drug based approaches. The documents concluded the industry has a role to play, with appropriate safeguards.

    Dr Dermot Walsh, former inspector of mental hospitals, says the relationships between the industry and doctors have much improved in recent years, though there is still a way to go.

    He points to the Medical Council’s guidelines on ethical behaviour which state that “doctors should not allow their relationship with commercial firms influence their attitude towards the design or the results of trials”.

    Many of these issues were covered in a report by the Oireachtas Joint Committee on Health and Children a few years ago. It recommended a number of changes to make our drug regulation system stronger and more transparent. There has been little progress on fully implementing the findings.

    “Many people were encouraged by the report because it gave official recognition for the first time of how conflicts of interest can arise in medicine,” says Dr O’Donovan. “What we would like to do is to reignite that discussion and the implications for public health.”

    'I don't believe in the "chemical brain imbalance theory" - yet I felt I was being coerced into taking that drug'

    WHEN RICHARD Patterson developed a mental health problem, he went in search of support from a health professional.

    He hoped the information he received would be objective – but he couldn’t help feeling he was the marketing target of the pharmaceutical industry.

    The leaflet he was given on how to improve his lifestyle was accompanied by the logo of a major pharmaceutical company, which manufactures some of the most commonly prescribed medications for depression and schizophrenia.

    Patterson, a critic of the “medical model” of psychiatry who feels drugs are not the answer, felt dismayed.

    “I didn’t have any problem with the material regarding the importance to general wellbeing of diet, exercise and stress management,” he says.

    “But, because pharmaceutical companies can’t advertise openly, it just serves as a marketing vehicle.”

    It’s not the only piece of literature sponsored by the industry he has seen in his time as a patient.

    He gives the example of a leaflet on the anti-psychotic drug Zyprexa which made various health-related claims.

    “Your doctor has recently prescribed you Zyprexa,” says the leaflet, accompanied by pictures of smiling couples and people out walking. “Congratulations on taking this important step on the road to recovery.”

    The company involved, Eli Lilly, pleaded guilty to criminal conduct in the US involving its marketing of Zyprexa, and agreed to pay $1.4 billion in fines.

    The charges Lilly was accused of included persuading doctors to prescribe Zyprexa to two categories of patients – children and the elderly – for whom the drug was not approved and in whom its use was especially deemed risky.

    All of this has made Patterson question how truly objective many doctors are, and how the influence of drug companies can sometimes seem all-pervasive.

    “In my case, the consultant wanted me to take a drug made by the company,” he says. “But, like many people, I don’t believe in the ‘chemical brain imbalance theory’ that underpins medical model-based psychiatry. Yet, I felt I was being coerced into taking that drug.”

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