Author: AboutLawsuits

GlaxoSmithKline faces a wrongful death lawsuit over problems from Poligrip denture cream. The complaint was filed after a Miami man allegedly suffered paralysis and then subsequently died as a result of toxic levels of zinc that entered his body after using Poligrip to secure his dentures.

The Poligrip lawsuit was filed in Miami by the family of Rodney Urbanek, who died in 2008 at age 64. The denture adhesive cream contains high levels of zinc, and GlaxoSmithKline failed to warn consumers about the risk of serious health problems when too much zinc accumulates in the body, according to the complaint.

A number of similar denture cream lawsuits have been filed against GlaxoSmithKline over its Poligrip cream, and against Proctor and Gamble over its Fixodent denture adhesive. Dozens of cases filed in federal courts throughout the United States have been centralized in a multidistrict litigation (MDL) for coordinated pretrial litigation in the U.S. District Court for the Southern District of Florida.

While all of the Fixodent suits and Super Poligrip suits involve similar allegations that the manufacturers failed to warn that high amounts of zinc are contained in the denture adhesive creams, Urbanek’s lawsuit is believed to be the first wrongful death lawsuit brought to bear on one of the companies due to zinc poisoning from denture cream.

Increased levels of zinc in the body can deplete copper levels, causing a condition known as hypocupremia, which is known to increase the risk of significant neurological problems that can leave users with permanent and debilitating physical injuries. Although the recommended daily allowance of zinc is 11 mg for men and 8 mg for women, with 40 mg being the maximum amount of zinc that can be safely tolerated, some denture creams have been found to expose users to levels as high as 330 mg per day.

In October, GlaxoSmithKline added a new Super Poligrip zinc warning to the denture cream, notifying consumers that the product contains zinc and that excessive use of the cream could result in serious health effects. Prior packaging did not even acknowledge that the denture cream contained zinc, let alone discuss denture cream zinc side effects.

Toyota has halted both sales and production on eight different models of vehicles, including the popular Toyota Corolla and Toyota Camry lines, due to continuing problems with gas pedals that stick, causing vehicles to accelerate out of control.

The stoppage was issued in the wake of two massive Toyota and Lexus recalls due to the gas pedal problems. According to a report in the New York Times, Toyota has halted the sales and production until a fix for the defect is finalized. Vehicles impacted include the Avalon, Camry and Corolla sedans, the Matrix wagon, the Tundra pick-up truck, the RAV4 crossover and the Highlander and Sequoia sports utility vehicles (SUVs).

Earlier this month, a Toyota recall was issued for 2.3 million of those same vehicles. That recall came after a similar recall of Toyota and Lexus floor mats was issued for 4.2 million vehicles, after the company said that the acceleration problems were caused by the gas pedal getting stuck under thick all-weather floor mats.

Toyota officials have said the production and sales suspension is meant to restore consumer confidence in the company, which has taken a hit as a result of the recalls. However, some automotive industry analysts say that the unusual move may indicate that the recalls are symptoms of a more serious, widespread problem with Toyota vehicles, and even if that is not true, it may cause consumers to believe there is an issue.

Problems with Toyota and Lexus vehicles accelerating out of control gained national attention following a fatal accident in California in August, where an off-duty state trooper and three family members were killed while driving a Lexus ES 350 on loan from a San Diego dealership. Minutes before the fatal Lexus crash, passengers called police and reported that the Lexus had accelerated to 120 m.p.h. Witnesses reported that the car’s tires were on fire, which was likely due to the driver slamming on the brakes before slamming into an SUV, falling off an embankment, rolling over multiple times and bursting into flames.

Federal regulators have received more than 100 incident reports from Toyota owners regarding their vehicles accelerating out of control.

Medical errors from the use of radiation therapy can lead to severe and sometimes fatal injuries, but states lack rules requiring doctors and hospitals to disclose when radiation mistakes occur, even though they are often preventable.

The New York Times released a special report on Sunday delving into previously undisclosed cases of radiation therapy gone wrong across New York. The paper found that in New York alone, there were 621 radiation mistakes reported between 2001 and 2008. However, state officials say that other studies and evidence suggest that the number of errors may be massively underreported due to a lack of enforcement of reporting requirements.

The report comes as the FDA is investigating cases of radiation problems with CT scan procedures, after the discovery that a number of patients across the country have suffered radiation overexposure from scans performed incorrectly. The FDA released interim guidance in December for health care professionals and radiologists as it continues its investigation. The guidance advised them to review procedures and CT scan settings, and to be thorough in checking the amount of dosage prescribed for each CT scan patient.

In many cases, patients received radiation doses to the wrong parts of the body, or were subjected to radiation several times higher than prescribed. Diversified Clinical Services, the country’s larges wound care company, treated 3,000 radiation injuries in 2009 alone.

A CT scan radiation exposure study published in December in the Archives of Internal Medicine, which studied 1,119 adults who received CT scans in San Francisco in 2008, found a high amount of variation between radiation doses, with some radiation exposure varying as much as 13-fold between scans. The study estimated that 1 in 270 women who received a CT heart scan would develop cancer, compared to 1 in 600 men.

Concerned about underreporting and mistakes in radiation therapy, New York health officials sent out a warning in 2004 calling for hospitals to be more careful, and for radiation specialists to continually monitor their equipment. Many of the radiation problems resulted from software glitches and incorrect radiation settings. In many cases, the equipment indicated there was a problem or that settings were incorrect, but such warnings went unseen by technicians who never bothered to look at their monitors.

The state of New York and some other states refuse to release information on where and how medical mistakes are made, making it impossible for private citizens to determine which facilities have the best radiation therapy track records. Reporting requirements for medical errors or disciplinary procedures are also often disregarded and unenforced.

A May 2009 report by Public Citizen on physician oversight discovered that in the 17 years the National Practitioner Data Bank (NPDB) has been established, only half of all hospitals have reported any disciplinary action against doctors who may have been negligent, committed medical malpractice or otherwise received a disciplinary action on behalf of the hospital that employed them.

The recent FDA investigation was sparked by the discovery that more than 200 patients at Cedars-Sinai Medical Center in Los Angeles were subjected to overexposure to radiation. Since then, the FDA has uncovered at least 50 more radiation CT errors.

In another case this summer, the U.S. Nuclear Regulatory Commission (NRC) discovered that at least 98 veterans were given incorrect doses of radiation during brachytherapy treatments for prostate cancer at the Veterans Affairs Medical Center in Philadelphia. What some have described as a “rogue” cancer unit at the hospital botched virtually every brachytherapy procedure it performed, placing radioactive metal seeds in the wrong locations, and sometimes in the wrong organs entirely. The unit continued to perform operations even after a machine used to measure whether patients were receiving the correct amount of radiation broke down.

The doctor who headed that unit, Dr. Gary Kao, has been removed from his position. The hospital and Dr. Kao face a number of lawsuits from veterans who sometimes suffered severe injuries due to the medical mistakes.

A former high-ranking AstraZeneca employee has admitted that the pharmaceutical company knew about the potential weight-gain side effects of Seroquel, but pressured medical staff to sign off on claims that the antipsychotic drug was weight neutral.

John Blenkinsopp, the company’s former U.K. medical advisor, told the BBC in an interview that AstraZeneca’s marketing wing pressured him to sign off on a claim that Seroquel was weight neutral, threatening his career when he refused.

The allegations come as AstraZeneca faces thousands of Seroquel lawsuits claiming that users developed diabetes and other injuries as a result of the drug makers failure to warn about the weight gain risks. The first Seroquel trial is currently expected to begin next month in New Jersey state court.

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Approved by the FDA in 1997 for the treatment of schizophrenia, it is also commonly used off-label for treatment of anxiety, obsessive dementia, compulsive disorders and autism. Seroquel has been used by more than 19 million people worldwide.

Blenkinsopp, who left the company in 2000, claims that he never signed off on Seroquel’s weight neutral claims; a decision that AstraZeneca marketing staff allegedly told Blenkinsopp would limit his career. As a result, while Seroquel consistently was advertised as being weight neutral in the U.S., only one ad in the U.K. made that claim.

“They came at me with a number of potential claims, all of which were trying to intimate that Seroquel was not associated with weight gain. None of which I would approve,” Blenkinsopp told the BBC. “The data pointed in the opposite direction.”

Blenkinsopp said he showed other AstraZeneca officials their own data, which showed that Seroquel caused weight gain, but even after seeing evidence to the contrary, they continued to push for him to agree that the drug was weight neutral.

According to internal AstraZeneca documents uncovered during the Seroquel litigation, a 2001 letter from a marketing official revealed that the drug maker had a global strategy aimed at suppressing the Seroquel weight gain side effects, casting the drug as weight-neutral years after clinical evidence demonstrated significant risks of weight gain among users, which could lead to diabetes and other serious health problems.

The FDA has notified healthcare professions about a recall involving about 2 million Exel/Exelint Huber needles, Exel/Exeling Huber Infusion Sets and Excel/Exelint “Securetouch” Safety Huber Infusion Sets. The Huber infusion set needles have the potential to push pieces of silicone into a patient’s body, potentially causing serious injury.

The Class 1 recall affects was announced on January 26 for infusion needles manufactured by Nipro Medical Corporation for Exelint International Corporation. Inspectors discovered that the needles can “core” part of the silicon membrane that the needles are pushed through when used with port implants, potentially introducing the substance into the patient’s bloodstream. A Class 1 recall means that the defect has the potential to cause severe injury or death.

The FDA has received no adverse event reports concerning the defective needles, but warns that it may be difficult for health care professionals to connect adverse patient events with the defective needles. However, the FDA has received reports of ports leaking, which is a sign of coring.

The defect was discovered by inspectors performing a review of a Nipro production facility in Japan. The needles are used to inject various medications into ports implanted in a patient’s skin. These ports have silicon membranes to prevent leakage of medication or blood that the needle is pushed through.

Huber needles are supposed to be designed to pierce the membrane without removing any of the silicon material. FDA inspectors found that Nipro-manufactured Huber needles cored out a small piece of silicone from the membrane in 60 to 72 percent of tests.

The recalled needles were manufactured between January 2007 and August 2009, with lot numbers that begin with “07,” “08,” and “09.” A full list of affected product codes and catalog numbers is available in the FDA’s recall notice.

Huber needles are manufactured for Exelint by 20 companies, and over 6 million Huber needles are sold in the U.S. each year. The FDA said some needles from other manufacturers showed signs of coring on occasions, but after testing, the FDA has determined that only the Nipro-produced needles showed a regular tendency to core membranes.

Any health care facilities, professionals or patients who have needles affected by this recall should immediately stop using then and return any unused needles to Exelint International Corporation.

A new study has found that the long-term use of powerful opioid painkillers, like Oxycontin and Vicodin, can nearly triple the risk of bone fractures in older adults.

The study, published earlier this month in the Journal of General Internal Medicine, found that the side effects of Oxycontin, Vicodin, morphine and other opioids can lead to frequent dizziness and sedation when used over long periods of time, making older adults more susceptible to falls and serious bone fractures. Researchers found that the higher the dosage, the higher the risk.

Researchers from a number of institutes from Washington and California performed a cohort study involving 2,300 adults age 60 or older who suffered from chronic pain that was unrelated to cancer. The study found that subjects not taking some form of opioid pain medication had an annual fracture rate between 3 and 4 percent. However, subjects who were prescribed a daily opioid dose of less than 50 milligrams per day had a 6 percent annual fracture rate. Those taking at least 50 milligrams, considered a moderate dose, or more saw that fracture rate jump to 10 percent.

Opioids have already been connected to a number of painkiller side effects, such as nausea, constipation, dizziness and sedation. They are also frequently associated with a high risk of drug addiction and drug overdose.

Oxycontin is a form of the narcotic oxycodone which is designed to release the painkilling medication into the bloodstream gradually over a 12-hour period. Approved by the FDA in 1996, drug abusers quickly discovered that the pill could be crushed and snorted or inhaled for an instant high. Often referred to on the street as “Hillbilly Heroin” or “Killers,” the drug has been linked to hundreds of drug overdoses and deaths.

The pill is the best-selling prescription pain medication in the U.S., with more than $2 billion in annual sales.

Last summer, an FDA advisory panel went as far as recommending that a Vicodin and Percocet ban be issued on use of the opioids due to the risk of overdose, particularly when used with acetaminophen. The FDA has not acted on the Percocet and Vicodin recall recommendations and is not bound to follow the advisory panels’ recommendations.

Vicodin and generics that use the same active ingredients are prescribed more than 100 million times a year in the United States. However, safety issues are a serious concern, as more than 400 people per year die, and 42,000 are hospitalized, from overdoses due to drugs that use acetaminophen.

A worker at BP’s Texas City oil refinery has been awarded $1.72 million by a Galveston jury in an industrial accident lawsuit.

The verdict was handed down on January 15th in the 10th Judicial District Court, in favor of Ernesto Tamez and his wife, Maria. Tamez filed his personal injury lawsuit against Maxim Crane Works for liability arising from an accident at the BP Plant where he worked on January 18, 2006.

Tamez was hit by an oil burner that was elevated by a crane operator who worked for Maxim. Tamez suffered a crush damage injury to his back, neck, shoulder and ribs, requiring extensive surgery.

The jury found Maxim Crane Works fully liable for the industrial accident after plaintiffs argued that the operator moved the oil burner without first receiving an “all clear” signal to indicate that no one was in harm’s way. The operator also allegedly moved the burner in a way that unbalanced the load. The damages award includes $300,000 for lost wages, $550,000 in medical expenses and $170,000 for Tamez’s wife.

BP’s Texas City Refinery is the third-largest oil refinery in the United States, and has been the subject of several major safety incidents. As recently as September, the U.S. Occupational Safety and Health Administration hit BP with an $87.4 million fine for not complying with a safety agreement made after a March 23, 2005 explosion and fire that killed 15 workers and injured more than 170 others.

In February 2009, BP Products North America agreed to pay $180 million to resolve a separate environmental lawsuit over benzene emissions at the oil refinery. That case involved violations of a 2001 consent decree and Clean Air regulations which were identified during inspections by the U.S. Environmental Protection Agency (EPA) following the March 2005 blast.

Under the terms of that settlement, BP agreed to spend $161 million to address their Clean Air Act violations by setting up better pollution controls, enhanced maintenance and monitoring devices and improving their internal management practices. Another $6 million was designated to fund a project to reduce air pollution in Texas City and $12 million was paid as a penalty.

A recall has been issued for several types of blood centrifuges, which have been found to occasionally explode, potentially spraying healthcare staff and lab technicians with shrapnel and potentially with tainted blood.

The centrifuge recall was announced on January 21 by FDA and Hettich Centrifuges of Beverly, Mass., after a report was received involving the rotors breaking apart in a Hettich centrifuge. The incident caused the spinning centrifuge to explode, sending projectiles out of the housing and causing damage to the surrounding area. Although no injuries were reported in this incident, the centrifuge problems pose a risk of serious injuries or infection if the defect results in other failures.

Hematocrit, or haematocrit, centrifuges measure the packed cell volume of blood, which helps determine the amount of red blood cells. The centrifuge’s rotor spins vials of blood at about 10,000 RPMs (rotations per minute), causing the blood to separate into layers.

The recall, issued in both the U.S. and Canada, affects the 201424-01 Haematokrit 20 with 2050 haematocrit rotor, the 2004-01 Mikro 20 with 2076 haematocrit rotor, the 2070 Mikro 12-24 with 2050 haematocrit rotor, and the 2075 Haematokrit 24 with 2050 haematocrit rotor. The model number is located either on the front of the centrifuge or on the name tag at the rear. The rotors will also have the model number 2076 or 2050 stamped on them.

The exploding rotors can result in personal injury and damage to the surrounding area, the recall warns. However, the centrifuges are spinning vials of human blood as well, and an explosion could result in healthcare personnel being sprayed with human blood and potentially being exposed to blood borne diseases and infections, such as [http://www.aboutlawsuits.com/topics/hepatitis/] hepatitis and HIV.

Anyone who has a centrifuge affected by the recall should immediately stop using the plastic rotors and contact Hettich Instruments Management I for a free replacement metal rotor.

A product liability lawsuit has been filed against General Motors of Canada, Ltd. by the family of a Texas man who they say was killed when the structure of his Chevrolet 1500 pick-up truck failed during an accident.

The Chevrolet lawsuit was filed by the family of Randall Newman on January 5 in the Marshall Division of the Eastern District of Texas, according to a report in The Southeast Texas Record. The family claims that Newman’s truck failed to meet crashworthiness standards.

Newman suffered fatal injuries in an accident on July 17, 2008, when his 2002 Chevrolet 1500 truck was hit by another vehicle while crossing an intersection. Newman’s pick-up truck was struck on the drivers’ side door, driving parts of the truck and brush guard into the passenger’s compartment.

The wrongful death lawsuit alleges that the truck’s design and marketing was unreasonably dangerous and defective, and claim that if the truck had met accepted crashworthiness standards, then the passenger survival space would not have been destroyed. The pillar, roof rail and other safety systems in place all failed to keep occupants in the vehicle reasonably safe, according to the complaint.

The plaintiffs argue that affordable, available technology existed at the time of the truck’s design that would have made it able to better survive the impact, but GM did not utilize them.

The lawsuit charges GM of Canada with gross negligence, product liability, and seeks compensation for economic loss, mental anguish, loss of companionship, medical expenses, funeral and burial expenses, among other damages.

An Oregon jury has awarded $4.75 million following shoulder pain pump trial involving a plaintiff who alleged that the I-Flow On-Q Painbuster destroyed cartilage in his shoulder when it was used to deliver pain medication following arthroscopic surgery.

The verdict was returned on Friday in Multnomah County, Oregon in a case filed by Matthew Beale against I-Flow Corp., which was acquired last year by Kimberly-Clark Corp. The shoulder pump lawsuit is one of several hundred cases filed throughout the United States involving similar allegations against I-Flow and other pain pump manufacturers, such as Breg, Inc., Stryker Corp. and DePuy, Inc.

Intra-articular use of the infusion pumps to deliver a combination of pain medications directly into the shoulder joint during the days after arthroscopic shoulder surgery has been linked to a risk of shoulder chondrolysis, which involves the progressive destruction of cartilage in the shoulder. This could result in reduced range of motion, pain, clicking and popping in the shoulder joint, potentially resulting in the need for a shoulder replacement surgery.

Beale received a shoulder pain pump after tearing a bicep in 2004. His doctor inserted an I-Flow On-Q Pain Buster instead of prescribing oral pain medications. According to the complaint, Beale soon began to experience clicking noises and pain from his shoulder, and his doctors subsequently determined that the cartilage in his shoulder had eroded away in a short matter of time.

As a result of the shoulder damage, Beale has limited motion in his arm and experiences intense pain. He also claimed that he will have to undergo numerous shoulder replacement surgeries and will likely have to retire early as the pain intensifies over the years.

Following a three-week trial, the jury ordered I-Flow Corp to pay $4.75 million, including $1.3 million in compensation for Beale’s wife, Krista. I-Flow allegedly encouraged doctors to use the OnQ Pain Buster, even though it was not approved by the FDA for intra-articular use following arthroscopic surgery.

In November 2009, the FDA warned health care professionals that the use of pain pumps following surgery to continuously infuse medication in this manner has been linked to problems with chondrolysis of the shoulder. The FDA required the manufacturers of the local anesthetics and makers of the pumps to add new warnings about the risk of chondrolysis, particularly involving the shoulder.

Hundreds of shoulder pump lawsuits are currently pending in different state and federal courts throughout the country, with several other shoulder surgery pump trials scheduled throughout 2010.

In August 2008, The U.S. Judicial Panel on Multidistrict Litigation denied a request to consolidate and centralize all federal cases before one judge in an MDL, or multidistrict litigation. At that time, the MDL panel found that consolidating the cases was not appropriate because the shoulder pump litigation involved a number of different manufacturers of pain pumps and different medications used in the devices.

Attorneys representing plaintiffs in the cases have indicated that they intend to renew their request to consolidate the federal lawsuits at a hearing before the MDL panel scheduled for later this week.

The Beale shoulder pump trial was being closely followed by lawyers involved in the cases, as it was viewed as a good gauge on how juries will respond to similar evidence presented in other cases throughout the country.

A Maryland malpractice lawsuit has been filed against Dr. Mark Midei and St. Joseph Medical Center in Towson, Md. by a patient who is one of several hundred people who were recently notified that they may have received a heart stent that was not necessary.

The lawsuit against Dr. Midei and St. Joseph was filed last week in Baltimore County Circuit Court by Thomas Chaffee and his wife, Sharon. According to the complaint, Dr. Midei implanted to two stents in Thomas Chanffee’s heart, but only one of the stents was actually necessary.

It was reported last week that letters were sent to 369 former patients of Dr. Midei who received a stent implant at St. Joseph Medical Center. The hospital informed the patients that a subsequent review of their cardiac catheterization with stent placement resulted in different findings than they were initially told.

Dr. Mark Midei is the only doctor implicated so far in the investigation, and many former St. Joseph stent patients have discovered that Dr. Midei told them that they had substantial artery blockages, when they really had minimal blockages that did not require stent placement.

Cardiac catheterization procedures with stent placement, which cost about $10,000.00, are designed to keep open significantly blocked arteries. Typically it is only considered necessary for a stent to be implanted when an artery is at least 70% blocked, with anything under 50% considered “insignficant” and treatable without a stent. According to a report in the Baltimore Sun, some patients were exposed to the risks associated with stent placement by Dr. Midei when they had blockages as low as 10%.

Dr. Mark Midei headed up the cardiac catheterization unit at St. Joseph Medical Center in Baltimore County until he was stripped of his position and privileges at the hospital last summer amid a federal investigation involving cardiac stent procedures performed at the Towson, Maryland hospital.

Chaffee’s lawsuit alleges that St. Joseph hospital knew that their doctor was fraudulently or negligently telling patients that they needed the stent procedures that were not medical necessary and failed to take any actions to stop it.

The complaint is believed to be the first of what could be many Dr. Midei stent lawsuits involving St. Joseph Medical Center that are being investigated by lawyers in Maryland.

Approximately 1.24 million pounds of pepper-coated salami/salame and other Italian sausage products have been recalled because they may be contaminated with a strain of salmonella linked to cases of food poisoning in 38 states.

The pepper-crusted salami recall was announced on Friday by The U.S. Department of Agriculture (USDA) Food Safety and Inspection Service for several varieties of ready-to-eat cured meats distributed by Daniele International, Inc. Samples of the pepper salami have tested positive for Salmonella bacteria, and similar products were eaten by many customers who have reportedly suffered food poisoning symptoms caused by the Salmonella Montevideo strain of the bacteria.

A multi-state Salmonella Montevideo outbreak has sickened 184 people, including at least 35 cases that required hospitalization. Many of the illnesses reportedly involved individuals who purchased salami sold at Costco

Salmonella poisoning can cause symptoms such as abdominal cramps, nausea, vomiting, bloody diarrhea and fever. While symptoms tend to resolve within a few days or weeks for most healthy adults, the elderly, young children and those with weakened immune systems may be more susceptible to severe, and potentially life-threatening, infections.

The recall includes various packages of salami / salame coated with coarse black pepper, or salami packaged with other cured meats that are crusted with pepper. At this time, it is unknown whether it is the meat or the pepper that may be contaminated with salmonella.

The recalled salami was sold under various brand names such as Daniele, Black Bear, Dietz & Watson and Boars Head, including:

• Daniele Naturale Salame Coated with Coarse Black Pepper
• Daniele Pepper Salame
• Black Bear of the Black Forest Baby Genoa Pepper Salame
• Daniele Deli Selection, Genoa Salame, Smoked Salame, Peppered Salame, Rustic Salame
• Daniele Surtido Fino Italiano, Salmi Genoa Con Pimienta, Lomo Capocollo, Salami Calabrese
• Daniele Italian Brand Gourmet Pack, Hot Calabrese, Pepper Salame, Hot Capocollo
• Dietz & Watson Artisan Collection Party Platter Pack, Hot Calabrese, Pepper Salame, hot Capocollo
• Daniele Italian Brand Gourmet Pack, Hot Calabrese, Pepper Salame, Hot Capocollo
• Danielle Gourmet Combo Pack, Pepper Salame, Capocollo, Calabrese
• Daniel Italian Brand Gourmet Pack Emballage Assorti Gourmet Italien, Hot Calabrese, Pepper Salame, Calabrese Piquant, Salmi Au Poivre, Hot Capocollo, Capocollo Piquant
• Boars Head Brand All Natural Salame Coated with Coarse Black Pepper
• Dietz & Watson Artisan Collection, Baby Genoa Pepper Salame, Made with 100% Port Coated with Black Pepper and Pork Fat
• Daniele Deli Selection, Genoa Salame, Sweet Sopressata, Peppered Genoa, Milano Salame
• Daniele Gourmet Italian Deli Selection, Sweet Sopressata Salami, Peppered Genoa Salami, Hot Sopressata Salmi, Milano Salami, Salami Sopressata Doux, Salami Genoa Poivr, Salami Sopressata Piquant, Salami Milano
• Daniele Salme Bites Pepper Salame
• Daniele Gourmet Italian Deli Selection Assortment de Fines Charcuterie Italienne, Sweet Sopressata Salami, Milano Salami, Salami Sopressata Doux, Salami Milano
• Daniele Naturale Salame Coated with Coarse Black Pepper
• Daniele Deli Selection, Genoa Salame, Sweet Sopressata, Peppered Genoa Salame, Sweet Sopressata, Peppered Genoa, Milano Salame

According to the latest data from the Centers for Disease Control and Prevention (CDC), cases of Salmonella Montevideo food poisoning have been identified in Alaska (2), Arizona (5), California (30), Colorado (2), Connecticut (4), Delaware (2), Florida (2), Georgia (3), Iowa (1), Illinois (11), Indiana (3), Kansas (3), Louisiana (1), Massachusetts (12), Maryland (1), Maine (1), Michigan (1), Minnesota (4), North Carolina (9), North Dakota (1), Nebraska (1), New Hampshire (1), New Jersey (7), New York (15), Ohio (9), Oklahoma (1), Oregon (8), Pennsylvania (3), Rhode Island (2), South Carolina (1), South Dakota (3), Tennessee (3), Texas (7), Utah (7), Virginia (1), Washington (14), West Virginia (1), Wyoming (2).

An E. coli poisoning lawsuit has been filed on behalf of a 14-year-old boy who was hospitalized after eating tainted beef that was part of a recent nationwide meat recall that has caused at least 21 cases of food poisoning in 16 different states.

The complaint was filed last week in 3rd District Court in Utah, on behalf of a boy identified only as “CD.” According to a report in The Salt Lake Tribune, the boy was hospitalized for two days with gastrointestinal bleeding after eating contaminated meat linked to an E. coli outbreak that surfaced late last year in Utah, California, Colorado, Florida, Hawaii, Iowa, Indiana, Kansas, Michigan, Minnesota, Nevada, Ohio, Oklahoma, South Dakota, Tennessee and Washington.

As a result of this food poisoning outbreak, about 248,000 pounds of meat distributed by Oklahoma-based National Steak and Poultry were recalled on Christmas-eve. The recall included a number of different blade tenderized beef products, including sirloin tips and skirt steaks.

The meat was reportedly contaminated with a strain of bacteria known as E. coli O157:H7, which is one of the more common causes of food poisoning in the United States. When left untreated, the illness can lead to hospitalization, dehydration and potentially life-threatening illness. While most healthy adults recover within a few week from food poisoning caused by E. coli, young children and the elderly could be at risk for more severe illness. If the toxin enters the blood stream, E. coli could also lead to kidney failure known as Hemolytic-Urenia Syndrome (HUS).

USDA and CDC officials say that the tenderization process, which involves the meat being poked by hundreds of thin needles, may increase the risk of E. coli on the surface being pushed into the interior of the meat, where heat from cooking is less likely to kill it if it is not heated all the way through. About 50 million pounds of meat was tenderized this way per month in 2008, according to the USDA.

The E. coli beef lawsuit is believed to be the first case filed as a result of the food poisoning outbreak linked to meat distributed by National Steak and Poultry.

The FDA and Nipro Medical Corporation have announced a nationwide recall of all GlucoPro Insulin Syringes due to a risk that the needle may break off of the syringe during injection.

The insulin syringe recall was issued on Thursday for all products with expiration dates before November 1, 2011. If the needles detach from syringe, they could potentially remain in the skin after injection, push back into the syringe or become stuck in the insulin vial. There have been no reported injuries in connection to the defective insulin syringes.

The recall affects all lot numbers and product codes for the GlucoPro Insulin Syringes, which were distributed throughout the United States and Puerto Rico. Consumers have been urged to stop using the defective insulin syringes and to return them to the place where they were purchased for reimbursement. However, the recall does not include syringes made specifically for use with the Amigo Insulin pump.

Last October, a similar recall of Accusure insulin syringes was issued for the same risk, that the needle could detach from the syringe. That Accusure recall involved more than 250 million insulin syringes.

Any individuals who have experienced an adverse reaction using defective GlucoPro Insulin Syringes or another type of syringe should contact the FDA’s Medwatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

A lawsuit has been filed in federal court claiming that Ocella birth control, a generic version of Bayer’s Yasmin and Yaz, caused an Iowa woman to suffer a stroke and other side effects.

The Ocella lawsuit was filed by Andrienne Cechura and her husband Kenneth, on December 28, 2009 in the U.S. District Court for the Northern District of Iowa. The complaint was filed against Bayer Healthcare, and several of their subsidiaries, including Berlex Laboratories, which originally developed Yasmin birth control in 2001.

According to the complaint, Andrienne Cechura was prescribed Ocella, a generic version of Bayer’s birth control pill, which was sold by a generic drug maker under a licensing agreement with Bayer. The lawsuit alleges that side effects of Ocella caused Cechura to suffer a serious and life-threatening stroke after taking the birth control pill between April 2009 and July 2009.

Ocella, Yaz and Yasmin all contain a combination of ethinyl estradiol and drospirenone, a new type of progestin that is unique to these birth control pills. Drospirenone, or drsp, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels and potentially serious health problems.

In June 2008, Bayer and Teva Pharmaceutical’s Barr subsidiary reached an agreement where Barr purchased a generic version of Yasmin from Bayer and sold it under the Ocella brand.

Earlier this month, Cechura’s lawsuit over Ocella was transferred to the U.S. District Court for the Southern District of Illinois, where it will be consolidated with more than 225 other Yaz suits and Yasmin suits filed against Bayer. The cases all involve women who allege that the drug maker failed to adequately research their medication or warn about the risk of suffering a blood clot or other serious injury, such as a stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder disease or sudden death.

According to an August 2009 birth control study published in the British Medical Journal, pills containing drospirenone, such as Yaz, Yasmin and Ocella, carry a 6.3 times increased risk of a first deep vein thrombosis or pulmonary embolism. When compared to women taking some other types of oral birth control, the increased risk was nearly four timers more among users of Yaz, Yasmin and Ocella type birth control.

Lawyers involved in the Chantix litigation, which was recently consolidated in federal court for pretrial proceedings, are scheduled to meet with the Court for the first time on Monday, to discuss management of the cases and the leadership structure of the multidistrict litigation (MDL).

Dozens of Chantix lawsuits filed in federal district courts throughout the United States have been centralized in the U.S. District Court for the Northern District of Alabama before District Judge Inge P. Johnson. All of the cases involve allegations that Pfizer failed to fully research their stop-smoking drug or adequately warn about the potential risk of Chantix side effects, which could increase the risk of suicide, suicidal attempts, abnormal behavior and other problems.

In October 2009, the U.S. Judicial Panel on Multidistrict Litigation ordered that 34 Chantix cases be consolidated for pretrial proceedings before Judge Johnson. Since that time, another 41 lawsuits over Chantix have been transferred into the MDL as tag-along cases, and many Chantix lawyers expect that hundreds of additional cases will be filed in the coming months.

The agenda for the conference, laid out by a court order issued in November, called for the parties to discuss whether it may be possible to reach an early Chantix settlement. Counsel for Plaintiffs and Defendants were also asked to submit brief written reports prior to the meeting, which explain their preliminary understanding of the facts involved in the Chantix litigation and what they expect the critical factual and legal issues to be.

At the meeting, or shortly after, it is expected that Judge Johnson will appoint Chantix attorneys to serve in leadership roles, including lead counsel, liason counsel and members of the plaintiffs’ steering committee, who will perform services that benefit all plaintiffs who have filed a Chantix lawsuit.

In consolidated MDL proceedings, lead counsel typically act as a spokesperson for all plaintiffs at the pretrial proceedings and in response to inquiries from the court, as well as submit and argue motions before the court, examine witnesses at hearings and negotiate stipulations and potential settlements with the defendants, which would apply to all cases. The liaison counsel receive and distribute orders from the Court and documents from opposing counsel, as well as assist in the coordination of activities between both parties. Members of the steering committee are appointed to conduct discovery and other services during pretrial litigation.

Chantix (varenicline) was approved by the FDA in 2006 as a prescription medication to help people quit smoking. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, the drug has been linked to increased risks of suicide and suicide attempts, aggressive behavioral changes and other psychiatric side effects, which have resulted in fatal or catastrophic injuries for many users.

The FDA has received hundreds of adverse event reports involving Chantix problems, leading to a “black box” warning being added to the medication in June 2009 to warn consumers and the medical community about the potential psychological side effects. Pfizer has also been required to conduct clinical trials providing more data on how often neuropsychiatric symptoms with Chantix occur and what conditions cause them.

An ongoing review of the side effects of Meridia, a prescription weight-loss drug that has been linked to an increased risk of heart attack and strokes in patients with a history of cardiovascular disease, has led the FDA to warn against its use for people suffering from heart problems.

The FDA announced new contraindications for the Knoll Pharmaceutical Co. drug on Thursday, saying that Meridia should never be given to patients with a history of cardiovascular disease, including:

• Heart attack
• Angina
• Heart arrhythmias
• Congestive heart failure
• Peripheral arterial disease
• Uncontrolled hypertension

The new contraindications were based on the “serious nature” of findings in an ongoing review of Meridia heart attack and stroke risks. According to the FDA, the manufacturer has already agreed to change the label.

FDA officials recommend that healthcare professionals carefully monitor the blood pressure and heart rate of patients given the drug, and that the use of Meridia be discontinued immediately if there are signs of a substantial increase of either. In addition, the agency said that Meridia should be discontinued if a patient does not lose at least 5% of their baseline body weight within the first three to six months of being on the medication. If an individual has not experienced substantial weight loss by that point, te FDA determined that continued Meridia treatment was unlikely to be effective and exposed the user to unnecessary Meridia health risks.

Meridia (sibutramine) was approved by the FDA in 1997 as a prescription-only weight loss supplement for obese patients with other risk factors such as diabetes, high cholesterol and controlled blood pressure.

In November 2009, the FDA announced that they were reviewing potential heart problems from Meridia after data suggested that side effects of the drug may cause users to suffer a higher number of cardiovascular events, such as heart attacks, strokes, resuscitated cardiac arrest or death.

The review was announced after FDA began examining data from a 10,000-patient study conducted in Europe known as the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event (SCOUT). The latest recommendations came after further review of that data.

The same data led the consumer activist group Public Citizen to petition FDA to issue a Meridia recall in early December. The petition is the group’s second attempt to get Meridia recalled. A 2002 petition to FDA to have Meridia pulled from shelves was denied because FDA said it was still waiting for the results of the SCOUT study.

The FDA said it anticipates finishing its review on Meridia and issuing a final report in March.

Toyota has announced another recall involving 2.3 million vehicles after discovering that the accelerator pedals can stick on several popular models, including the Camry, Corolla, Tundra and Avalon. The Toyota recall is separate from an on-going floor mat recall involving 4.2 million Toyota and Lexus vehicles, which was issued because of problems where accelerator pedals were getting caught under the floor mat.

According to a Toyota press release, this latest recall sprung out of investigations of cases where drivers said their gas pedals got stuck in the open position with no floor mats present. Approximately 600,000 vehicles included in this latest recall were not subject to the prior floor mat recall, with about 1.7 million Toyota vehicles subject to both recalls.

“Our investigation indicates that there is a possibility that certain accelerator pedal mechanisms may, in rare instances, mechanically stick in a partially depressed position or return slowly to the idle position,” said Irv Miller, vice president of Toyota Motor Sales U.S.A., Inc.

Toyota models affected by this latest recall include:

• 2009-2010 Toyota Rav4
• 2009-2010 Toyota Corolla
• 2009-2010 Toyota Matrix
• 2005-2010 Toyota Avalon
• 2007-2010 Toyota Camry
• 2007-2010 Toyota Tundra
• 2008-2010 Toyota Sequoia
• 2010 Toyota Highlander

The prior Toyota recall issued in September 2009 was blamed on thick all-weather floor mats that were causing the accelerator pedal to become physically jammed. In November, Toyota announced plans to address the problem by shortening the gas pedals on some models, and reconfiguring the floor surface beneath the pedals on others.

Problems with Toyota and Lexus vehicles accelerating out of control gained national attention following a fatal accident in California in August, where an off-duty state trooper and three family members were killed while driving a Lexus ES 350 on loan from a San Diego dealership. Minutes before the fatal Lexus crash, passengers called police and reported that the Lexus had accelerated to 120 m.p.h. Witnesses reported that the car’s tires were on fire, which was likely due to the driver slamming on the brakes before slamming into an SUV, falling off an embankment, rolling over multiple times and bursting into flames.

Federal regulators have received more than 100 incident reports from Toyota owners regarding the problem.

Toyota officials indicate that the latest recall was issued to address a different problem. Defective gas pedals in models affected by this week’s recall seem to start developing problems when the pedal mechanism becomes worn. The pedal may become hard to press down, slow to return to the closed position or may become stuck, causing the vehicle to accelerate out of control.

The company has said that it is still working on a solution for the problem. In the meantime, Toyota advises drivers of vehicles whose accelerator gets stuck to stop the vehicle using firm and steady application of the brakes. The company recommends against pumping the brakes, which could deplete the vacuum-assist feature. Once the vehicle is slowed, it should be driven to the nearest safe location, shut off, and a Toyota dealer should be contacted for assistance.

Spurting hot water from Conair Lysol steam cleaning mops resulted in the recall of about 162,000 mops by the manufacturer, Conair Corp., and the U.S. Consumer Product Safety Commission (CPSC) on Thursday.

There have been at least 14 consumer complaints where the steam cleaning mops erupted hot water mixed with Lysol, causing at least two burns that required medical attention.

According to the CPSC steam cleaning mop recall announcement, when Lysol is mixed with hot water in the steam cleaning mop, the water can forcefully squirt out and damage the housing unit. The spraying hot water and Lysol mix poses a burn hazard, and the ruptured housing unit is a laceration hazard as well.

The recall affects about 162,000 Lysol Steam Cleaning Mops manufactured by Conair Corp. The affected mops have a model number of SM10L or SM10R, which is printed on the bottom of the mop, underneath the microfiber cloth.

The mops, manufactured in China, were sold at department stores, hardware stores, home improvement stores and other retailers nationwide, as well as on the internet, from September 2006 through September 2009 for about $40.

Any consumers who have a recalled mop should stop using it immediately and contact Conair at www.conair.com/recallmop for a free replacement.

About 37,000 Thermador Built-in Ovens have been recalled after the manufacturer received reports that they can catch fire when used in self-cleaning mode.

The Thermador oven recall was announced on Thursday by the U.S. Consumer Product Safety Commission (CPSC) and BSH Home Appliances Corp., the manufacturer, after three reports were identified of incidents where the oven overheated in self-cleaning mode. In two of the incidents, nearby cabinets caught on fire, but there were no injuries reported.

According to the CPSC, the defective Thermador ovens have gaps in their insulation which can cause overheating when the oven is in self-cleaning mode. That overheating can cause cabinets alongside the built-in ovens to combust.

The recall affects Thermador built-in double ovens with model numbers C272B, C302B, SEC272, SEC302, SECD272 and SECD302, and serial numbers between FD8403 through FD8701. The model numbers and serial numbers are located on the underside of the oven’s control panel.

This oven recall is an expansion of a Thermador recall issued in June 2007 for the same problem. However, the previous recall was limited to single ovens and combination models which had a conventional oven and microwave. The original recall was issued after a Thermador oven fire caused a consumer to suffer extensive property damage. About 42,000 ovens were affected by the original recall.

The ovens were sold through appliance stores and specialty stores nationwide from June 2004 through July 2007 for between $3,000 and $4,400.

Any consumers who own the affected Thermador ovens should stop using the self-cleaning mode and contact the company at www.thermador.com for an inspection and free repair.