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Katrina Victims Win Latest Court Battles

Thousands of victims of Hurricane Katrina finally have some good news to celebrate: A U.S. District Court judge ruled yesterday that the Federal Emergency Management Agency (FEMA) must resume making housing-relief payments to those displaced by the disaster. In handing down his decision, Judge Richard Leon delivered a sharp rebuke to FEMA and the Bush Administration, calling FEMA’s application process “Kafkaesque” and even unconstitutional. Earlier this week, a Louisiana judge ruled that flood victims may be eligible for further compensation from insurers than originally delegated.

In his ruling against FEMA, Judge Leon, who was appointed by President Bush, ordered the agency to immediately restore its short-term housing-relief benefits for evacuees, including the benefits they would have received over the past three months. It also requires FEMA to send out detailed, clearly worded letters of explanation with “more fulsome instructions” to those whose benefits are being denied. Previous FEMA notices were “unconstitutionally vague and uninformative,” according to Leon. In addition, FEMA must institute a fair and easy-to-understand appeals process for the victims.

Medtronic’s Bid to Dismiss Lawsuits Denied

Minneapolis-based Medtronic, manufacturers of a controversial implantable cardioverter defibrillator (ICD), had their motion for summary judgment denied in U.S. District Court, meaning that the company may still have to face personal-injury lawsuits regarding their allegedly faulty product. The company announced its intention to appeal the decision, which was made by Judge James Rosenbaum in Minneapolis District Court.

Medtronic is currently facing hundreds of lawsuits associated with battery malfunctions in their defibrillators, and the denial of their motion may clear the way for another round of legal action. In some cases, the batteries, which were designed to last for years, only lasted for a few days. Medtronic reported in February of 2005 that the devices were susceptible to “rapid battery depletion” due to a “shorting mechanism.” The problem relates to ICDs manufactured between April 2001 and December 2003.Thousands of patients have had to undergo a second surgical procedure in order to remove and replace the device.

Health Canada Issues New Warning Regarding Tamiflu

The popular antiviral drug Tamiflu is under fire again, this time from Health Canada. The Canadian government issued a new safety advisory today, warning consumers that Tamiflu may be linked to hallucinations and abnormal behavior, including self harm. In conjunction with the new warning, Health Canada is asking manufacturer Hoffmann-La Roche to update its prescription information to reflect these risks.

Health Canada was spurred to action by reports coming from overseas, primarily Japan, of teenagers and children who have suffered adverse psychiatric effects while taking Tamiflu. According to Health Canada, as of November 11 “there have been 84 reports of adverse events occurring in Canadian patients using Tamiflu, including 10 which reported a fatal outcome. A causal relationship has not been confirmed in these cases. There have been seven Canadian reports of psychiatric adverse events, suspected by those reporting the events, due to Tamiflu, most involving elderly patients. There have been no Canadian reports of abnormal behavior or deaths involving children.”

Health Canada Issues Health Advisory for Rituxan

In conjunction with drug maker Hoffmann-LaRoche, Health Canada has issued new safety information regarding Rituxan, which is used in the treatment of non-Hodgkin’s lymphoma (NHL) and rheumatoid arthritis. According to the company, post-market and clinical studies have revealed reports of serious side effects, including abdominal pain, bowel obstruction, and perforation, in Rituxan patients. Most of the reports, including all related fatalities, are from NHL patients who combined chemotherapy with their Rituxan regimen.

In a letter sent earlier this month to health-care professionals, Hoffmann-LaRoche and Health Canada noted that “the pharmacovigilance database for Rituxan indicates that 47 cases of bowel obstruction (9 deaths) and 37 cases of gastrointestinal perforation (4 deaths) have been reported in Rituxan patients, based on an approximately 730,000 cumulative patient exposure.”

FDA Announces New Warning for Methadone Patients

According to the U.S. Food and Drug Administration, patients treated with methadone are susceptible to life-threatening alterations in their breathing and heartbeat–and, in some cases, even death. The FDA issued its latest health advisory yesterday, warning patients of potential problems if their methadone intake isn’t strictly monitored.

“FDA has received reports of death and life-threatening side effects in patients taking methadone,” says the advisory. “These deaths and life-threatening side effects have occurred in patients newly starting methadone for pain control and in patients who have switched to methadone after being treated for pain with other strong narcotic pain relievers. Methadone can cause slow or shallow breathing and dangerous changes in heartbeat that may not be felt by the patient.”

AstraZeneca Warned by FDA About Misleading Seroquel Marketing Material

The U.S. Food and Drug Administration has sent a warning letter to drug maker AstraZeneca, claiming that some of the company’s promotional material for Seroquel contains “false or misleading” information. According to the FDA, AstraZeneca failed to adequately detail the risks of hyperglycemia and diabetes and omitted important data about neuroleptic malignant syndrome and other relevant conditions. Seroquel, an atypical antipsychotic that is used in the treatment of bipolar disorder and schizophrenia, earned roughly $2.76 billion in worldwide sales in 2005.

The FDA sent its warning letter on November 16 to James Gaskill, AstraZeneca’s director of promotional regulatory affairs. The letter held the company in violation of the Federal Food, Drug, and Cosmetic Act because of a misleading promotional sales aid for Seroquel. The promotional material does not include significant data from the product’s required patient-information labeling. According to the FDA’s letter, “The promotional material raises significant public health and safety concerns through its minimization of the risks associated with Seroquel.”

Volvo Recalls 360,000 Autos

The National Highway Traffic Safety Administration (NHTSA) has ordered a recall of approximately 360,000 Volvo automobiles due to faulty software in the cars’ electronic throttle-control units. The software flaw affects the vehicle speed control and may cause the car to suddenly lose power by errantly setting the maximum speed at roughly 15 miles per hour.

Cars affected include Volvo’s C70 and V70 models built between 1999 and 2002, S60s built in 2001 and 2002, S80s made between 1999 and 2001, S70 and V70X models built in 1999 and 2000, and the 2001 XC70. According to Volvo, more than 160,000 of the recalled vehicles have already been fixed after the company contacted car owners in March. The NHTSA decided to make the recall mandatory earlier this month.

Another Contact-Lens Solution Recalled

On Tuesday, the U.S Food and Drug Administration announced a voluntary recall by Advanced Medical Optics Inc. (AMO) of nearly 3 million units of its 12-ounce Complete MoisturePLUS contact-lens solution and Complete MoisturePLUS Active Packs because of bacterial-contamination fears. The large majority of the potentially tainted units were shipped to Asia, but more than 180,000 units are being recalled in the United States.

According to the release posted by the FDA, “Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at its manufacturing plant in China, AMO is recalling 18 lots distributed in the U.S. that were manufactured on the same production lines during the same production period. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis.”

Drug-Research Firm SFBC International Faces Class-Action Suit

SFBC International, now known as PharmaNet Development Group, has been named as a defendant in a securities class-action suit filed yesterday in the United States District Court of New Jersey. Plaintiffs are accusing SFBC and its senior officers of multiple violations of the Securities Exchange Act of 1934. This is the second class-action suit to be filed against the drug-research company this year.

The firm who filed the most recent suit, Bernstein Litowitz Berger & Grossmann LLP, alleges that “SFBC and its senior officers and directors violated the federal securities laws by making false and misleading periodic filings with the Securities and Exchange Commission (SEC) and making other false and misleading statements to investors.”

Mattel Recalls Polly Pocket Dolls

The U.S. Consumer Product Safety Commission (CPSC) today announced that California-based Mattel Inc. is voluntary recalling 2.4 million units of its Polly Pocket magnetic play sets. The CPSC has received approximately 170 reports of small magnets coming loose from these toys, which were manufactured in China. In three cases, young children were hospitalized with severe injuries related to the problem.

According to the CPSC announcement, “Tiny magnets inside the dolls and accessories can fall out undetected by parents and caregivers. The magnets can be swallowed, aspirated by young children, or placed by a child in their nose or ears. When more than one magnet is swallowed, the magnets can attract each other and cause intestinal perforation, infection, or blockage, which can be fatal. Aspiration to the lungs requires immediate surgery. Magnets placed in the nose or ears can cause swelling and be difficult to remove.” All three of the aforementioned hospitalized children suffered intestinal perforations that required surgery.




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