Epilepsy Drugs Must Carry Warning About Suicide Risk
October 28, 2010
Epilepsy drugs must carry a new warning about the risk of suicidal thoughts or actions, as urged by a U.S. Food and Drug Administration advisory panel in July.
The FDA announced changes to the drugs’ prescribing information in a statement today on its Web site. In keeping with the recommendations of its outside advisers, the agency rejected a proposal to require that the drugs carry the agency’s strictest caution, outlined in a black box.
Earlier this year, regulators reviewed 199 studies of 11 epilepsy drugs, led by the top-selling Topamax, from Johnson & Johnson, and GlaxoSmithKline Plc’s Lamictal, and found 80 percent more suicidal thoughts and behavior in patients taking the treatments. Pfizer Inc. led opposition to the new warning, saying that its Lyrica and Neurontin pills were safe and it was unfair to combine data for medicines that work differently.
“Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” said Russell Katz, head of the FDA’s neurology products division, in the agency’s statement today.
In all, 4.3 of every 1,000 patients taking one of the drugs had a suicide-related event, compared with 2.4 of every 1,000 patients on a dummy pill. That translates to about one more suicide or suicidal thought for every 530 patients treated. Risks varied and were only statistically significant for Topamax and Lamictal.
Article: Bloomberg
Airborne pays $7 mln in settlement with 32 states
Airborne Health Inc has agreed to pay $7 million to settle investigations by 32 state attorneys general and the District of Columbia over the past marketing and labeling of its products.
Airborne did not admit any wrongdoing in the settlement. It previously settled two matters involving similar claims.
The privately held company makes popular dietary supplements with vitamins, minerals and herbs that it says help support the immune system.
“We’re putting the dietary supplement industry on notice — snake oil sales pitches will no longer be given free reign,” Connecticut Attorney General Richard Blumenthal said in a statement. “Our strong coalition of states will continue to investigate and pursue companies that make false claims about dietary supplements and other products.”
The agreement will not impact Airborne’s products “because it deals with language that had already been dropped from our advertising and labeling,” Airborne Founder and Chief Executive Victoria Knight-McDowell said in a statement.
“Even though we believe the legal claims against Airborne were unjustified, we wanted to close the book on these legal and regulatory issues.”
According to Blumenthal, Airborne agreed to certain prohibitions against making claims over the benefits of its products. The company also may not demand where a retailer puts its products in stores, he said.
Article: Reuters
Top New York State court rejects cigarette claim
New York State’s top court on Tuesday rejected a product liability claim against tobacco companies by smokers who said they should have used lower levels of tar and nicotine.
The New York State Court of Appeals, in a 6-1 decision, upheld a lower court ruling that found lawyers for smoker Norma Rose failed to prove that “light” cigarettes had the same impact as regular cigarettes.
“A strong argument can be made that, when the pleasure they give smokers is balanced against the harm they do, regular cigarettes are worse than useless,” according to the decision. “But it is still lawful for people to buy and smoke regular cigarettes, and for the cigarette companies to sell them.
“To hold, as plaintiffs ask, that every sale of regular cigarettes exposes the manufacturer to tort liability would amount to a judicial ban on the product.
“If regular cigarettes are to be banned, that should be done by legislative bodies, not courts,” the decision said.
A jury had awarded $3.42 million in compensatory damages to Rose and her husband Leonard. The amount was divided equally between Brown & Williamson Tobacco Corp, now a unit of R.J. Reynolds Inc and Philip Morris USA. Punitive damages of $17.1 million were also assessed against Philip Morris, now part of Philip Morris International Inc..
Article: Reuters
LAX Hilton workers file suit
Employees of the Hilton Los Angeles Airport filed a lawsuit Tuesday alleging that the hotel’s workload did not allow for breaks and that workers were not paid for all of their hours, in violation of labor laws.
The lawsuit seeks class-action status for roughly 1,500 current and former LAX Hilton employees.
Hilton spokesman Ruben Gonzalez declined to comment, saying the hotel had not yet received the lawsuit.
Adela Barrientos, a housekeeper at the hotel for 10 years, said she was required to clean, straighten up and restock 16 rooms in an eight-hour shift. She said she gave up rest breaks other than a 30-minute lunch so that she could finish her work. Even without breaks, she said, it’s tough to get it all done.
“It’s practically impossible,” she said. “The job is exhausting. At the end of the day, you’re spent.”
Barrientos was one of four hotel employees who spoke at a news conference arranged by Unite Here, a hospitality industry union that has been working for years to organize employees at the hotels in the airport corridor.
The Hilton has fought the effort long and hard and has accused the union of manufacturing lawsuits and other actions to create public pressure.
Four other hotels have agreed not to oppose the union’s efforts and to recognize it in collective bargaining if a majority of employees sign up for representation. At least two of them have entered into employment contracts with newly unionized workers.
Randy Renick, a Pasadena attorney who is representing the Hilton employees, said he was suing the hotel and its owner, Fortuna Enterprises, seeking to require the Hilton to give employees breaks, pay back wages to employees who worked through their breaks and pay penalties for violating the law. The suit also alleges that employees were not properly paid for overtime when they worked extra-long days or weeks.
“It is unfortunate in today’s economic times that employees are forced to file suit to receive the wages for the hours that they worked,” Renick said.
He had previously filed similar actions against other hotels in the airport corridor that he said the companies had agreed to settle.
Article: LA Times
Insurance loophole claimed in fire deaths
An insurance company with a potential $25 million liability from a 2007 Houston office fire is claiming smoke that killed three people was “pollution” and surviving families shouldn’t be compensated for their losses since the deaths were not caused directly by the actual flames.
Great American Insurance Company is arguing in a Houston federal court that the section of the insurance policy that excludes payments for pollution — like discharges or seepage that require cleanup — would also exclude payouts for damages, including deaths, caused by smoke, or pollution, that results from a fire.
“This is shocking. It’s an extraordinary effort by an insurance company to avoid paying on a contract for insurance,” said Randy Sorrels, who represents several family members in wrongful death lawsuits from the fire in a six-story atrium building on the North Loop.
Great American has asked U.S. District Judge Lee Rosenthal to find that the deaths caused by the smoke, fumes and soot from the March 2007 fire set by a nurse working in the building will not be covered by the policy because there is a specific exclusion for pollution and it mentions smoke, fumes and soot.
‘We think it is wrong’
“This took me by surprise,” said Don Jackson, the Houston lawyer for building owners Boxer Property Management Corp. He said the insurance company that has the primary $1 million policy on the premises hasn’t made this argument and he disagrees with the effort by excess insurance carrier Great American.
“We think it is wrong. It’s inappropriate for the insurance company to try to run and hide now,” said Jackson.
In October, vocational nurse Misty Ann Weaver was sentenced to 25 years in prison after pleading guilty to three counts of felony murder and one count of first-degree arson for setting the fire to conceal that she had failed to complete paperwork on time.
Great American’s legal request, filed in late November and set for hearings in February, notes that there are four pending lawsuits against the property owners for wrongful death and injury, and contends that the insurance company should not have to pay on any of them.
Kevin Sewell, the Dallas lawyer who filed the request, did not return phone calls Tuesday afternoon. Great American spokeswoman Diane Weidner said company policy is to not comment on pending litigation.
Seth Chandler, a University of Houston Law Center professor who teaches insurance law, said while the insurance company’s maneuver wasn’t out of bounds, it will test the limits of the law.
“This is pushing the boundaries of the absolute pollution exclusion,” Chandler said. “We’re going to have a battle between the literal language of the policy and the way people speak of pollution.”
Article: Chron.com
Due Diligence With Social Networks
Gone are the days when due diligence, or a litigation background check, amounted to reviewing a resume and examining public records — or even Googling!
Today, a witness, juror, expert or potential business partner is more likely to have a social networking site than a criminal conviction. Many painstaking attorneys would be sure to check for court records, but they might miss out on the additional benefits of this new information arena.
The Pew Internet & American Life Project reports that 66 percent of Internet users under the age of 30 have a social networking profile. CareerBuilder.com found that 37 percent of employees they surveyed did too. By contrast, only 9.5 percent of potential hires have criminal convictions.
Social networking activity can be quite revealing — a kind of informal resume and kitchen table chat, not tailored to a specific event or situation, and very likely full of unguarded admissions.
Even if preparation of an Internet profile isn’t your primary objective, regularly check these sites, particularly if you will be preparing a due diligence declaration. These days, judges know the value of a Google search and have begun to expect that as a standard practice in locating people.
Article: Law.com
F.D.A. Panel Votes to Ban Asthma Drugs
A panel of federal drug experts voted on Thursday that the drugs Serevent and Foradil should be banned from use in the treatment of asthma, but the experts said that Advair and Symbicort, which together are far more popular, should continue to be used.
The experts, gathered by the Food and Drug Administration, said that too many doctors used Serevent and Foradil inappropriately and that asthmatic patients were often fooled by their own symptoms and used them incorrectly. Serevent and Foradil widen lung airways but increase the risks of death unless paired with a steroid. The drugs’ labels already warn of this risk but half of patients taking the medicines do not get a steroid. Even when patients are prescribed a steroid, many fail to take it.
GlaxoSmithKline, the maker of Serevent, and Novartis and Schering-Plough, the marketers of Foradil, argued that doctors want the freedom to mix and match these drugs with steroids. But Dr. Jesse Joad, a panel member and pediatrician from the University of California Davis Medical Center, said she did not “want to give a drug that is making the disease you’re treating worse.”
Dr. John Jenkins, a top F.D.A. official, cautioned that patients should consult their doctor before stopping any asthma drug regimen. And Dr. Jenkins said the agency would consider requiring drugmakers to undertake large studies to assess the safety of Advair and Symbicort, particularly in children.
The drugs’ makers rejected the committee’s decision to ban Serevent’s and Foradil’s use in asthma, although each said that it would cooperate with the agency.
Last year, Serevent’s sales were $538 million and Foradil’s were $362 million. Through the first nine months of this year, Advair’s sales were $5.66 billion, and Symbicort’s were $209 million.
Article: NY Times
Whistle-blower shares settlement
A Winder man credited with blowing the whistle on a Department of Defense contractor will collect an amount equal to roughly one-fourth of the company’s $4 million settlement with the government, according to the man’s attorney.
Buster Roderigas will collect $720,000 of the settlement with L-3 Vertex Aerospace, the whistle-blower’s Atlanta attorney, Lee Wallace, said late Wednesday. Separately, L-3 must pay Roderigas $318,000 in legal fees.
Roderigas tipped off the government about alleged wrongdoing by L-3, a Madison, Wis.-based firm that has an ongoing contract with the U.S. Army to provide helicopter maintenance at Camp Taji, Iraq.
Article: AJC.com
Medical payout upheld
A Lake County family will receive about $9 million in a medical malpractice case involving the death of a 12-year-old boy.
In 1999, Andrew Muno of Wildwood died on an operating table in Condell Medical Center in Libertyville during surgery to repair a cut tendon in his arm.
The boy had trouble breathing after receiving an antibiotic to which he was allergic and died.
Article: Chicago Tribune
Celebrity Chef Is Sued Over Tips
Tom Colicchio, the celebrity restaurateur and judge on Bravo’s popular “Top Chef” television show, was sued in federal court on Thursday by a former waitress who accused the company of misappropriating employee tips, withholding some overtime pay and sometimes failing to pay minimum wage. Mr. Colicchio’s restaurants — including Craft, Craftbar and Craftsteak — were also named in the lawsuit, shown below.
In the lawsuit, the waitress, Nessa Rapone, who used to work at the bustling, moderately priced Craftbar restaurant at 900 Broadway between 19th and 20th Streets, asserted that the company improperly shared employee tips with supervisors, did not keep proper time records and illegally retaliated by firing her when she protested.
The lawyers for Ms. Rapone, a Brooklyn resident who worked at Craftbar from March to May 2007, hope that the lawsuit will be certified as a nationwide class action.
The lawsuit, filed in Federal District Court in Manhattan, accused management of violations of federal and state wage laws, including failing to pay workers time and a half for all hours worked over 40. It also asserts that management shared employee tips with other workers who are not qualified under federal and state law to share in the tip pool.
Ms. Rapone’s lawsuit accused the company of not compensating her for the cleaning and care of the uniform that she was required to wear while working at Craftbar.
Article: NY Times