Pfizer could soon settle at least 90 percent of the personal injury lawsuits it faces over the painkillers Bextra and Celebrex.  The company announced today that it hopes to finalize a $894 million settlement by the end of the year.

Celebrex and Bextra are COX-2 inhibitors, a class of drugs that also includes Merck’s recalled Vioxx.  Such medications are linked to an increased risk of blood clots, heart attacks and strokes. In 2004, the Food and Drug Administration’s (FDA) 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.

Last November, Merck announced a $4.85 billion settlement with the thousands of people who had filed Vioxx injury lawsuits.  Under the terms of the settlement, Merck set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. Partial settlement payments started going out to some Vioxx plaintiffs last month.

Pfizer withdrew Bextra from the market in 2005, and  Celebrex is the only COX-2 inhibitor still on the market in the United States. Celebrex carries the FDA’s strictest “black-box” warning on its drug label, stating that it may cause an increased risk of serious cardiovascular events such as heart attacks and strokes.

Pfizer said it hopes to finalize the settlement by the end of the year.  A spokesperson for the company said that Pfizer would also like to include many of the remaining personal injury lawsuits the settlement.  The company will fight those not settled with court motions or at trial.

According to The New York Times, $760 million of the Bextra and Celebrex settlement would go to settle roughly 7,000  personal injury cases, $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs.

The death of a 5-month-old child in Brooklyn, NY has prompted Playkids USA to recall 2000 defective portable cribs.  The Brooklyn, NY child died in August, after becoming entrapped between the mattress and the drop side rail of the convertible crib.

According to the Consumer Product Safety Commission (CPSC), the sides of the portable crib are made of a mesh that expands, creating a gap between the mattress and the side through which an infant can slip. This poses suffocation and entrapment hazards for young children. (more…)

People who took Vioxx continued face an risk of heart attack and stroke for a year after they stopped taking the now-banned painkiller, according to a new study. It is also likely that long-term use of other NSAIDs pose similar risks, the authors of the study said.

This latest Vioxx study involved  followed people who had participated in the international APPROVe trial, which compared Vioxx to placebo over 3 years in an attempt to see whether the drug could cut the recurrence of cancerous colon polyps. The trial was stopped early in 2004 because of the increased risk for heart attacks and stroke. Nearly 2600 people participated in the APPROVe trial, and the authors of the Lancet study said they were able to contact about 84 percent of them. (more…)

As the  Coast Guard hearing into this summers’ Mississippi River oil spill resumed yesterday, one witness testified that a towboat involved in the spill was being operated as if someone onboard “had had a stroke.”  Chance Gould, pilot of the Tintomara,  testified that the towboat Mel Oliver ignored whistles, warning lights and demands over the radio to back up.

“The way it looked to me, it looked like someone had had a stroke on the boat,” Gould said.

According to Gould, the Mel Oliver cut across the river in front of his tanker for no apparent reason, causing the Tintomara to run over the oil-laden barge the vessel was towing.  The barge split in half, spilling much of its cargo into the river. It is estimated that about 280,000 gallons of oil actually spilled into the Mississippi.

Gould’s version concurred with radio transmissions released by the Coast Guard in August that showed the Mel Oliver received repeated warnings from both Coast Guard personnel and  the Tintomara to get out of the way in the minutes leading up to the crash. Unfortunately, no one on the Mel Oliver ever responded to the warnings.

Lawyers for American Commercial Lines LLC, the owner of the Mel Oliver and the barge it was towing, questioned Gould, and suggested that he was in the wrong by failing to allow the towboat to cross the river.  But Gould stood his ground, saying that it is a towboat’s responsibility to communicate its intentions when it plans to cross the river in front of a ship.

The Coast Guard hearing is expected to last several more days.  Among the witness likely to be called is John Bavaret, pilot of the Mel Oliver.   Bavaret did not have the proper license to pilot a tugboat. Terry Carver, master license pilot of the Mel Oliver, should have been in charge of the vessel but was nowhere to be found when the accident occurred.

After a two month break, a Coast Guard hearing into the July 23 Mississippi River oil spill is scheduled to resume today. While the Coast Guard has not issued a witness list for the hearing, a spokesperson for the towing company involved in the oil spill told the “New Orleans Times-Picayune” that it is likely the Louisiana River pilot who was steering the tanker Tintomara during the accident will be called to testify.  Various officials from DRD Towing, the company staffing the tugboat involved in the spill, American Commercial Lines, owner of both the tug and the barge involved in the crash, as well as barge industry experts, are also expected to appear, the newspaper said.

The Mississippi River oil spill occurred on when the tanker  Tintomara and a barge -carrying 419,000 gallons of oil – being towed by the tuboat Mel Oliver collided. The barge split in half, spilling much of its cargo into the river. It is estimated that about 280,000 gallons of oil actually spilled into the Mississippi.   (more…)

Health Canada is investigating five deaths in Canada among patients who received Botox injections.  Two of the deaths involved children with cerebral palsy who were being treated with Botox for drooling and muscle spasms.  The other deaths involved three women in their 60s, all of whom had underlying medical conditions such as Parkinson’s or cerebral palsy.

Health Canada said it is also looking into 8 reports of serious reactions following Botox treatment. The Botox reactions reported in Canada included throat swelling, respiratory arrest, difficulty swallowing and aspiration pneumonia, and infection that occurs when food or liquids are inhaled into the respiratory tract and lungs. (more…)

A judge has  sanctioned  defendants named in a class action lawsuit against SLS Residential, LLC. Southern District Judge Stephen Robinson assessed $35,000 in penalties after he determined that 80 former patients  had been told by SLS therapists that their private medical records would be made public if they did not opt out of the lawsuit.

SLS runs two residential treatment centers in the town of Southeast, NY  for adolescents and young adults.  In addition to a class action lawsuit, SLS is facing revocation of its state operating licenses for the two facilities. The class action lawsuit, filed by two former SLS Residential patients, alleges that they were subjected to physical and mental abuse.   The lawsuit claims that SLS staff illegally employed manual restraints and put patients in isolation rooms where they were physically and emotionally abused, subjected patients to nightly searches of their bodies and rooms, and denied patients the right to refuse treatment, leave the facility or phone family members.  The complaint also charges SLS with discrimination under the Americans With Disabilities Act, and  claims patients were targeted for mistreatment because they were mentally disabled. (more…)

A week after an FDA panel refused to recommend a ban on all over-the-counter (OTC) children’s cold medicines, makers of the drugs are warning that they should not be used in children under four. Manufacturers also plan on expanding an educational campaign aimed getting parents to be more careful in giving their kids cough and cold medicines.

According to the Consumer Healthcare Products Association, which announced the new advice on behalf of the industry, drug makers will also add a warning to their OTC children’s cold medicines that parents should not give children antihistamines to make them sleepy.  Antihistamines are among the ingredients used in OTC cold medicines. Many accidental overdoses occur when parents administer two or more drugs to their child – for example, one to treat fever and another for a cough and stuffy nose – without realizing that the medicines contain some identical ingredients. That often results in children receiving a dangerously high dose of an active ingredient, such as an antihistamine. (more…)

The maker of the psoriasis drug Raptiva  has warned that a patient taking it developed progressive multifocal leukoencephalopathy, or PML, a fatal brain infection.  Raptiva is the second Genentech medication to be linked to PML.  Last month, the company revised a warning on Rituxan to reflect the case of a rheumatoid arthritis patient who was treated with the medicine and died from the disease. Genentech said it will work with the Food & Drug Administration (FDA) to update the prescribing information for Raptiva and determine if further action is need

PML attacks the brain and central nervous system and is usually fatal.  It is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply. People with a weakened immune system or people taking drugs that suppress their immune system (immunosuppressants like Raptiva) are most likely to get the disease. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled. (more…)

At a hearing on children’s over-the-counter cold medicines, Food & Drug Administration (FDA) advisers refused to recommend that the drugs be banned, despite the high overdose rate associated with them.  Members of the panel said they were concerned that without access to these medicines, parents might be tempted to give adult versions to their kids.

“That is a concern for us,” said Dr. John Jenkins, who heads the FDA’s Office of New Drugs. “We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation.” (more…)