In what may be a devastating blow to drug maker Merck, a New Jersey appeals court overturned a lower court’s decision to dismiss a proposed class-action suit against the company. In a unanimous ruling, the three-judge panel declared that the lower court “prematurely terminated plaintiffs’ opportunity” for legal recourse and must reconsider the case.

The proposed class-action suit seeks to hold Merck financially responsible for coronary testing of former Vioxx patients–including those who haven’t yet shown signs of adverse reactions. That group may very well include hundreds of thousands of former Vioxx patients.
More Merck Suffers Potential Legal Setback in Vioxx Case

A new study published in today’s edition of the Annals of Internal Medicine calls into question the safety and efficacy of human growth hormone (HGH) when used as an anti-aging therapy on elderly patients. HGH is commonly used off-label as an anti-aging therapy–meaning it is not approved for that usage–but researchers at Stanford University are now saying that hormone therapy does not produce the desired anti-aging effects and may, in fact, lead to severe adverse events.

According to the editors of the journal, “The researchers reviewed all clinical trials of GH to determine if it is safe and effective in the healthy elderly. They found that GH had no important effects on body composition but led to frequent adverse effects, most notably soft tissue edema and arthralgias [joint pain and swelling]…. Available evidence suggests that risks far outweigh benefits when it is used as an anti-aging treatment in healthy older adults.”
More New Study: Human Growth Hormone Ineffective, Unsafe

California-based Cardica Inc. announced a voluntary recall of 55 of their C-Port devices, which are used by doctors performing coronary artery bypass graft surgery. The company learned of a manufacturing defect related to its supplier and notified the U.S. Food and Drug Administration.

The recall applies to Cardica’s C-Port XA Distal Anastomosis System. Cardica designs and manufactures the devices, which is intended to replace hand-sewn sutures with easy-to-use automated systems in the connection of blood vessels. The company is offering to replace any of the faulty products.

A new study published today has suggested a connection between statins (drugs used to lower cholesterol) and the development of Parkinson’s disease. Researchers at the University of North Carolina found that patients with low levels of LDL cholesterol are upward of three and a half times more likely to develop Parkinson’s disease than those with higher LDL levels. Their study was presented in Chemistry & Industry, the journal of the British Society of Chemical Industry (SCI).

The SCI contends that the new study “provides the strongest evidence to date” of a link between statins and Parkinson’s. Lead researcher Dr. Xuemei Huang announced her plans for a large 16,000-patient study in order to test the theory. (Doctors at Harvard University are also conducting a large-scale trial to examine the link.) Since statins have become perhaps the most popular medications in the world–Pfizer’s Lipitor alone accounts for more than $12 billion in annual sales–Huang fears a big surge in the number of Parkinson’s diagnoses during the next five years. By then, statins will have been in common usage for more than a decade.
More Cholesterol Drugs Linked to Parkinson’s

In a significant turn of events, the U.S. Supreme Court agreed to hear an appeal in a case that may determine whether tobacco companies can be sued and tried in state courts. In the class-action case Watson v. Philip Morris, plaintiffs are objecting to the shifting of venue from state to federal court, a decision made by the 8th U.S. Circuit Court of Appeals in St. Louis.

The original class-action suit, filed in Arkansas state court, accused Philip Morris of deceptive marketing tactics with regard to a couple of its “light” brands. However, the tobacco company, which is a division of Altria Group Inc., requested that the case be moved to federal court, claiming that the Federal Trade Commission (FTC) was the primary regulator of tobacco advertising.
More Supreme Court to Rule on Change of Venue in Tobacco Case

The U.S. Centers of Disease Control and Prevention (CDC) issued a warning today about the potential hazards of administering over-the-counter cough and cold medicine to infants. Citing the deaths of three infants associated with the drugs, the CDC urged all parents to consult with medical professionals before giving the medicine to their young children.

In the Morbidity and Mortality Weekly Report published today, the CDC notes, “Cough and cold medications that contain nasal decongestants, antihistamines, cough suppressants, and expectorants commonly are used alone or in combination in attempts to temporarily relieve symptoms of upper respiratory tract infection in children aged [less than] 2 years. However, during 2004-2005, an estimated 1,519 children [under the age of 2] years were treated in U.S. emergency departments for adverse events, including overdoses, associated with cough and cold medications.”
More CDC: Cold and Cough Medicine May Be Unsafe for Infants

In a ruling that may have ramifications on hundreds of other lawsuits, a federal judge in Mississippi declared that State Farm Fire & Casualty Co. is liable for damage to a couple’s Biloxi home following Hurricane Katrina. While the insurance company is responsible for paying $223,292 in damages to the home, the key part of the ruling was the award by a jury of $2.5 million in punitive damages.

The ruling by U.S. District Judge L.T. Senter Jr. may be troubling news for State Farm and other insurers who are claiming that they are not responsible for damage caused by flooding. In the case of Norman and Genevieve Broussard, State Farm had contended that they were not responsible for the damages because they were caused by water. However, the judge sided with the Broussards, who claimed that the damage was mostly due to excessive winds. Senter left the decision about punitive damages to a jury, and the jury decided to award punitive damages because State Farm had initially (and illegally) denied the Broussards’ insurance claim.
More State Farm Loses Benchmark Katrina Case

In a pointed challenge to President Bush, the Democratic-controlled U.S. House of Representatives voted today in support of direct government negotiations with pharmaceutical companies in order to obtain lower drug costs for seniors. The measure passed by a vote of 255-170, with 24 Republicans crossing the aisle to support the measure. However, earlier in the day, White House spokesman Tony Snow signaled the president’s intent to veto the bill should it make it to the Oval Office.

Democrats believe that the new measure makes a marked improvement over the controversial, Republican-supported Medicare bill of 2003, which expressly forbids the government from directly negotiating with drug makers. “This legislation repeals a misguided provision in current law that explicitly prohibits the secretary of Health and Human Services from entering into negotiations with drug companies to lower the cost of prescription drugs for the 43 million beneficiaries of Medicare,” House Majority Leader Steny Hoyer said.
More House Backs Medicare Drug-Negotiation Plan

Aiming for an “impressive expansion and modernization” of its drug safety system, the U.S. Food and Drug Administration (FDA) announced a proposal to dramatically increase “user fees” collected from the pharmaceutical industry. The proposal calls for an $87.4 million increase in generated fees, bringing the total to $392.8 million.

“The proposed recommendations would support significant improvements in FDA’s ability to monitor and respond to emerging drug safety issues, as well as continuing FDA’s commitment to scientific improvements and streamlining the drug approval process,” said HHS Secretary Michael Leavitt. “I commend FDA for the important progress they have made and look forward to working with Congress to ensure action on these proposals.”
More FDA Wants to Increase Fees from Big Pharma

A new study published in the Journal of Pain has found that even moderate amounts of caffeine after exercising may lead to a “large reduction in pain.” As little as two cups of brewed coffee may produce a 48 percent reduction in post-workout soreness.

Researchers at the University of Georgia’s Department of Kinesiology believe that the “finding may improve the quality of life of individuals who experience skeletal muscle pain” after engaging in what they call “eccentric exercise,” defined as “when skeletal muscles produce force while being lengthened.”
More Caffeine Eases Post-Exercise Pain