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On July 1, 2009, more than two dozen passengers from Royal Caribbean’s Freedom of the Seas were taken to the hospital after the amphibious tour bus in which they were traveling crashed in St. Thomas.

Royal Caribbean said in a statement that the passengers were on a “Pirate Duck Adventure” tour organized by the line at the time of the accident. The tour bus, which has a boat-like hull for traveling in water and wheels to move on land, veered off the road at a low rate of speed, the statement says.

Royal Caribbean says forty-nine (49) passengers were on the tour bus at the time of accident, and twenty-nine (29) were taken to the hospital. Of those, nine sustained non-life threatening injuries, and a spokeswoman tells USA TODAY all but one were able to return to the ship before it set sail later in the day.

Royal Caribbean spokeswoman Cynthia Martinez says the Freedom’s captain held the ship’s departure last night so the injured passengers could make it back on board.

“Our thoughts are with our guests that were involved in this unfortunate accident,” Royal Caribbean CEO Adam Goldstein says in the statement. “The safety and well-being of our guests is our highest priority, and we will continue to do our very best to assist them.”

The passengers were traveling on The Duckaneer, a popular tour option for cruisers visiting St. Thomas that is hard to miss when it motors down the roads of St. Thomas’ port, Charlotte Amalie.

The Freedom of the Seas is on a seven-night cruise of the Eastern Caribbean out of Port Canaveral, Florida that also includes stops in CocoCay, Bahamas; and Philipsburg, St. Maarten.

On July 1, 2009, the FDA announced that the agency will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency’s strongest safety warning over side effects including depression and suicidal thoughts. The new requirement is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs.

The FDA is also requiring an additional study on Chantix and Zyban to determine the extent of the side effects. Pfizer Inc., the manufacturer of Chantix, had already updated its labeling following the beginning of an FDA investigation into the potential side effects in 2007 after receiving several reports of psychiatric problems in patients.

Despite the new, stricter warnings, the FDA said consumers and doctors still have to weigh the benefit versus the risks when taking the drug.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

“Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Last fall, the FDA also began looking into scores of patient reports about blackouts and injuries while taking Chantix.

The Federal Aviation Administration later banned use of Chantix by pilots and air traffic controllers. The drug’s label also warns that patients may be too impaired to drive or operate heavy machinery.

Chantix was approved in 2006, and reached sales of $846 million in 2008.

“The labeling update underscores the important role of health care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely,” said Dr. Briggs W. Morrison, senior vice president of the primary care development group at Pfizer.

Pfizer said it made the revised label warnings in agreement with the FDA and is immediately making the information available to health care providers and patients.

On June 30, 2009, Government experts announced that prescription drugs such as Vicodin and Percocet, which combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.

A FDA panel voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market. The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA. Panelists cited FDA data indicating 60% of acetaminophen-related deaths are related to prescription products.

Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.

“We’re here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact,” said Dr. Judith Kramer of Duke University Medical Center.

But many panelists opposed a sweeping withdraw of products that are so widely used to control severe, chronic pain.

“To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake,” said Dr. Robert Kerns of Yale University.

In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.

The FDA is not required to follow the advice of its panels, though it usually does.

Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to FDA data. Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.

The FDA convened the two-day meeting to ask experts to discuss and vote on a slew of proposals to reduce overdoses with acetaminophen. The drug has been on the market for about 50 years and many patients find it easier on the stomach than ibuprofen and aspirin, which can cause ulcers.

Earlier in the day, panelists took aim at safety problems with Tylenol and dozens of other over-the-counter painkillers. In a series of votes, the panel endorsed lowering the maximum dose of those products.

FDA’s experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.

The group was not asked to recommend an alternative maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Johnson & Johnson’s Extra Strength Tylenol is 1,000 milligrams, or two tablets.

In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.

However, panelists rejected a proposal to pull certain cold and cough medicines off the market because of their role in overdosing.

The drugs in question, such as Procter & Gamble’s NyQuil or Novartis’ Theraflu, combine acetaminophen with other ingredients that treat cough and runny nose.

The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.

But panelists cited FDA data that said the medications play a minor role in acetaminophen overdoses, with only 10% of acetaminophen-related deaths involving a cold and cough product.

“I don’t think we should be advocating a solution to a problem that really is not there,” said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.

The panel voted 24-13 to keep the products on the market.