Lawsuits filed by World Trade Center rescue workers sickened by the toxic dust at Ground Zero will be able to proceed, following an appeals court ruling  limiting New York City’s immunity in such lawsuits.  The city had been trying to have the World Trade Center rescue workers’ suits dismissed, claiming that because it was responding to the terrorist attacks of  9/11, federal and state laws provided immunity from such lawsuits.

In the hours and days after 9/11 terrorist attacks, thousands of rescue workers descended on Ground Zero to help with recovery efforts. Sifting through dust and rubble, sometimes with their bare hands, many lacked the clothing and equipment that could have kept them safe from harm. Several studies have confirmed that Ground Zero first responders are suffering from ill health as a result of their exposure to toxic dust at the site. Released last May, the initial findings of a three-year study conducted by the Mt. Sinai Medical Center found that of the 9,000 WTC first responders examined, 70-percent had suffered some type of lung ailment after the attacks, and that 60-percent still faced respiratory problems. Another report released by the FDNY that same month reported that cases of the rare lung disease sarcoidosis had risen dramatically among firefighters and EMS workers who were first responders at Ground Zero. And the New York City Department of Health also found that one in eight first responders still suffer from Post Traumatic Stress Disorder. (more…)

Eli Lilly and Company and the state of Alaska have mutually agreed to settle that state’s lawsuit against Lilly over the use of Zyprexa.  Lilly will pay the state of Alaska $15 million and agreed to ensure that Alaska is “treated as favorably as any other state” that may settle with the company in the future over similar claims.  Lilly and Alaska Attorney General Talis J. Colberg announced the settlement in a press release.  Zyprexa, which is often prescribed in the U.S. and in more than 80 other countries, is a short- and long-term treatment of schizophrenia and specific bipolar disorders.  Lilly shares closed at $50.17 at the end of Tuesday’s trading.

Last month, two shareholders accused Lilly of recklessly disregarding risks posed by illegal drug marketing practices related to its anti-psychotic drug Zyprexa.  Connecticut’s Attorney General, Richard Blumenthal, is also suing Eli Lilly over the marketing of Zyprexa as are at least nine other states for similar reasons; federal prosecutors are also involved and reportedly in talks over a large settlement with the drug giant.  For its part, Connecticut is looking to recover over $190 million it spent on Zyprexa over many years on the grounds that Lilly illegally marketed the Zyprexa for unapproved uses and concealed risks associated with the drug.  “The illegal marketing campaign exploited children and senior citizens—causing severe weight gain, diabetes, and cardiovascular problems,” Blumenthal said in a statement. “This scheme involved payments to public officials, bogus educational events, and ghostwritten promotional articles summarizing suspect studies.” (more…)

The results of a study published in this week’s Archives of Internal Medicine reveal that oral sodium phosphate solution (OSPS) bowel preparation for colonoscopy should not be used in elderly patients even if creatinine levels are in the normal range.  It seems that the solution may cause acute kidney failure and long-term renal damage.  “Oral sodium phosphate solution preparations are preferred cleansing agents for colonoscopy because of ease of use and excellent preparation quality,” wrote Anand Khurana, MD, from Texas A&M University in Temple, and colleagues.  “Besides causing acute renal failure in some patients, the high phosphorus content can potentially cause chronic kidney damage to patients undergoing colonoscopy.”  OSPS is one of the most common bowel-cleansing preparations and the new research suggests the risks of OSPS and tablets are rare but real, particularly for the elderly.

The study looked at 286 patients with creatinine levels in the normal range who underwent colonoscopy or sigmoidoscopy with use of OSPS preparation.  Most patients were white with an average age of 68; 2/3 were women and none had a history of kidney disease.  All followed a standard dietary and phosphate solution preparation the day before the procedure.  The study ran from 1998 to 2005 and was followed up for one year to determine effects on renal function.  Patients were compared with a control group of 125 patients.  Although both groups had similar baseline characteristics, they had significantly different renal function at six months. In an accompanying editorial, Hemant K. Roy, MD, from Feinberg School of Medicine, Evanston-Northwestern Healthcare in Evanston, Illinois, and Laura K. Bianchi, MD, call these findings “alarming,” although they need confirmation.  Khurana and his team found that its use was associated with a six percent drop in kidney function six months later; that figure rose to eight percent one year later.  “This magnitude of loss of kidney function is significant,” said Khurana. (more…)

Merck & Co. has agreed to extend an important deadline for its Vioxx settlement. Now, people wishing to receive early partial payment of their settlement have an extra month to file paperwork backing up their Vioxx injury claim.  The deadline for those willing to wait for full payment remains July, but could go  as late as October.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The Vioxx recall led to thousands of lawsuits. (more…)

The U.S. Food and Drug Administration (FDA) is warning consumers to not purchase or use both the “Blue Steel” and “Hero” products.  Both of these products are being marketed as supplements for erectile dysfunction and sexual enhancement and are being labeled and marketed as dietary supplements throughout the United States.  Blue Steel and Hero are considered unapproved drugs—the FDA is calling these products illegal drugs—they have not been proven to be safe or effective and, as a matter-of-fact, the FDA is saying that these illegal drugs pose serious health risks.  Blue Steel and Hero products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level.

These products are promoted and sold over the Internet and are advertised as “all natural” and labeled as dietary supplements; however, Blue Steel and Hero products do not qualify as dietary supplements because they contain undeclared and unapproved substances which are similar in chemical structure to sildenafil, the active ingredient in Viagra.  Viagra is an FDA-approved prescription drug for erectile dysfunction.  “Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking.” (more…)

Lawmakers in Congress are getting closer to passing legislation that would overturn a Supreme Court decision that barred people injured by defective medical devices from suing in state courts if the device was approved by the Food & Drug Administration (FDA).  Two members of the House of Representatives say they are drafting a bill to overturn the decision that should be ready sometime next month.

In the case considered by the Supreme Court, Medtronic Inc, the maker of the faulty Sprint Fidelis Defibrillator Lead and other defective devices,  had argued  that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts.  That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims.  Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws. (more…)

It has turned out that an important lung cancer study was actually funded by a cigarette company.  In late 2006, Dr. Claudia Henschke of Weill Cornell Medical College released a study revealing that the majority (80 percent) of lung cancer deaths could be prevented through widespread use of CT scans.  The study was published in The New England Journal of Medicine and indicated—in small print at the end of the piece—that the work was financed, in part, by the Foundation for Lung Cancer:  Early Detection, Prevention & Treatment.  A tax record review revealed the foundation was almost entirely underwritten by $3.6 million in grants from the parent company of the Liggett Group—the Vector Group—maker of Liggett Select, Eve, Grand Prix, Quest, and Pyramid cigarette brands.  From 2000 to 2003, the foundation received four grants from Vector.

Dr. Jeffrey M. Drazen, editor-in-chief of the journal expressed surprise, “In the seven years that I’ve been here, we have never knowingly published anything supported by” a cigarette maker.  As a matter-of-fact, more and more universities do not accept grants from cigarette makers; a growing awareness of the influence companies can have over research outcomes has led most medical journals and associations to demand researchers accurately disclose financing sources. (more…)

Investors in auction rate securities have filed  lawsuits against Morgan Stanley and Merrill Lynch, alleging those brokerages deceptively marketed the investment vehicles and took actions that made auction rate securities all-but-impossible to sell.  Both lawsuits, filed in federal court in Manhattan, are seeking class action status.

Auction rate securities are long-term corporate bonds, municipal bonds and preferred stock on which the interest rates are reset periodically based on bids submitted through securities firms. Generally, rates are reset every  seven, 14, 28 or 35 days. Because they can be sold during weekly or monthly auctions, banks and brokerages often touted auction rate securities as short-term investments or cash equivalents.   (more…)

Heparin has been recalled in France, Italy and Denmark amid fears that the blood thinner may be contaminated with the same substance that US regulators found in heparin supplied by Baxter International.  Baxter heparin has been tied to over 700 adverse reactions and possibly 19 deaths in the US.

In the US, Baxter first recalled 9 lots of heparin in January, after the drug was linked to serious, and sometimes fatal reactions in some patients.  Those reported reactions to Baxter heparin included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening. In February, Baxter expanded the heparin recall to include all of its heparin products, and suspended sales of its drug.  Last week, B. Braun Medical initiated its own heparin recall as a precautionary measure, and American Health Packaging, a unit of AmerisourceBergen Corp, said it was voluntarily recalling 1,421 units of heparin injection vials as part of Baxter’ broader recall.   (more…)

Washington state lawmakers overwhelmingly passed a toy safety bill setting the toughest restrictions in the nation on the lead content of children’s products.  If passed, the bill would reduce the allowable level of lead in toys and other goods to 90 parts per million—possibly as low as 40 parts per million, the recommended limit of the American Academy of Pediatrics—far below the current federal standard of 600 parts per million. The new restrictions would take effect July 2009.  The bill also sets tough limits on cadmium, a metal used in paints and plastics and on plastic-softening chemicals called phthalates linked to childhood developmental problems.  The state accounts for about 2% of total US toy sales, which last year equaled $23.5 billion in revenues.

The move has some in the toy industry concerned and some small toy makers are planning to stop selling in the state if, as they expect, Democratic Governor Chris Gregoire signs the bill saying the cost of certifying their products as safe under the law would be prohibitive.  Representatives of Mattel Inc. and Hasbro Inc., met with Gregoire March 17 over Mattel’s concerns that half of the products made by its Fisher-Price unit would be barred from the state if the law is adopted.  Hasbro confirmed a meeting with the governor.  The Toy Industry Association (TIA) represents over 75 companies and said it wouldn’t make economical sense for toy makers to ship products to the state if the bill becomes law. (more…)