Author: AboutLawsuits

U.S. researchers say that they have conducted a study which further links the weight-loss supplement Hydroxycut to liver damage, acute liver failure and death. 

The study, published late last month in the American Journal of Gastroenterology, looked at 17 cases of liver damage where Hydroxycut may have been a factor and found that in many of them, the likelihood that the weight-loss supplement was the cause of the damage was almost a certainty. In addition, the study suggests that the number of people affected by Hydroxycut liver damage could be much larger than the number of cases that prompted a Hydroxycut recall last May.

Hydroxycut is a dietary supplement and weight-loss aid that was recalled on May 1, 2009, after the FDA identified a number of reports where users suffered serious and potentially life-theatening liver damage. The FDA also reported that use of Hydroxycut was linked to reports of seizures, heart problems and a rare muscle damaging condition known as rhabdomyolysis.

Iovate Health Sciences, the manufacturer, faces a number of Hydroxycut lawsuits over liver damage and other injuries in state and federal courts. The federal cases have been consolidated and centralized for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Southern District of California. All of the cases in the litigation over Hydroxycut involve allegations that Iovate Health Sciences failed to adequately research their weight-loss products or warn about potential side effects of Hydroxycut.

In the new study, researchers looked at cases that had not yet appeared in medical literature, and examined the patients’ risk factors for liver disease, and the timing of Hydroxycut usage in connection with liver damage. In eight cases, scientists said there was a greater than 95% chance that the weight-loss supplement caused the patients’ liver damage. In five of the 17 cases, researchers concluded that it was “highly likely” that Hydroxycut caused the patients’ liver damage, meaning there was a 75% to 95% chance. In another two cases, Hydroxycut was ruled probably to blame, with a chance of 50% to 74%.

Researchers were able to eliminate most other likely causes for the liver damage. Subjects were generally healthy, with an average age of 30, and they were able to eliminate autoimmune diseases and exposure to other toxins that may have caused liver problems. In their conclusions, the researchers warned consumers to be cautious about the use of such weight-loss supplements, which are not clinically tested and do not need to be approved by FDA.

Christ Hospital and the Health Alliance for Greater Cincinnati have agreed to settle a whistleblower lawsuit involving allegations of an illegal kickback scheme that defrauded Medicare for an undisclosed amount. 

U.S. prosecutors accused the hospital’s cardiac care center of filing 100,000 Medicare or Medicaid claims that violated federal law, and was looking at charging the hospital and the alliance $11,000 for each claim. Details of the agreement with the government and a former cardiologist are undisclosed, but according to a report by Cincinnati.com, the settlement of the whistleblower lawsuit is said to likely approach or exceed $100 million.

According to federal investigators, the hospital was allotting time to cardiologists in its heart center based on the amount of coronary bypass procedures and the amount of catheter lab revenue that the doctors generated for the hospital. The charges were initially brought in a suit filed by Harry Fry, a former cardiologist at the hospital, in 2003. The U.S. Department of Justice joined the lawsuit in 2008, saying that it had found 100,000 claims filed between 1999 and 2004 that constituted Medicare and Medicaid fraud.

The hospital, which is no longer part of the Health Alliance, has denied the charges, saying that assigning time was not used to encourage doctors to refer patients to the hospital. Hospital officials say they are settling to avoid what could be a multibillion fine by the government, and are not admitting guilt with the settlement.

Whistleblowers who report a false claim against the government may be entitled to 15% to 25% of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

Lawsuits over side effects of Yasmin and Yaz were filed by nearly 40 women this month in Indiana, alleging that Bayer Healthcare Corp’s popular birth control pills caused them to suffer injuries like gallbladder problems and blood clot-related injuries.

The Yaz and Yasmin suits, which were filed in the U.S. District Court for the Southern District of Indiana in Indianapolis, will join a growing number of similar cases filed by women throughout the United States. Already more than 300 women have filed a Yaz side effect lawsuit or Yasmin side effect lawsuit against Bayer, and it is expected that thousands of cases will ultimately be filed.

One of the new complaints was filed on February 2 on behalf of 31 women who had to have their gallbladders removed after taking Yaz or Yasmin, and a second complaint was filed on February 3 on behalf of 8 more women who suffered various injuries allegedly caused by the birth control pills, such as a pulmonary embolism, deep vein thrombosis, stroke, heart arrhthymia leading to ablation surgery, petit mal seizure, micro-vascular stroke in the eye and hemolytic-uremic syndrome kidney failure. Although both of the complaints were filed in Indiana, the plaintiffs included women from 20 states, including Indiana, Ohio, Tennessee, California, New York, Georgia, Missouri, Utah, Michigan, Idaho, Oklahoma, North Carolina, South Carolina, Texas, Arizona, Arkansas, Pennsylvania, Kentucky, West Virginia and Virginia.

The lawsuits contain nearly identical allegations to those raised in other cases, claiming that Bayer failed to adequately research their medications or warn about the risk of Yaz and Yasmin side effects.

It is suspected that the problems with Yaz and Yasmin are linked to the use of a “fourth generation” progestin, known as drospirenone, which is unique to these birth control pills and a generic version of Yazmin marketed as Ocella. Drospirenone can cause an increase in potassium levels in the blod, which can lead to a condition known as hyperkalemia if potassium levels become too high. This may disrupt normal heart rhythms and slow the flow of blood through the heart to the point where it permits a blood clot to form.

The complaints also claim that Bayer over-promoted Yaz and Yasmin, alleging that the drug maker promoted additional benefits over other birth control pills without fully disclosing the potential increased risk of side effects. The FDA has previously penalized Bayer for deceptive advertising in connection with the birth control pills. Last year, the pharmaceutical company was required to spend $20 million to run a corrective advertising campaign after promoting unapproved and unsubstantiated health benefits of Yaz while downplaying side effects.

All federal Yaz and Yasmin cases are consolidated in an MDL, or multidistrict litigation, which is centralized in the Southern District of Illinois. It is expected that the two new complaints filed in Indiana will be transferred into the MDL, for coordinated pretrial proceedings together with the other federal cases. Similar mass tort consolidation has been formed for Yaz and Yasmin cases filed in Pennsylvania state court and a petition is also pending to consolidate cases filed in New Jersey state courts.

A ground beef recall first issued by a California meat company last month, has been expanded to include five times more meat after federal investigators determined that approximately 4.9 million pounds of beef and veal products were produced in unsanitary conditions that could have caused E. coli contamination.

The expansion of the Huntington Meat Packing Inc. veal, beef products and ground beef recall was announced on February 12 by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). The original recall was announced on January 18 for 864,000 pounds of beef products after FSIS inspectors determined that some of the meat was contaminated with the E. coli O157:H7 bacterial strain.

A criminal investigation has been opened by the Office of Inspector General, with the assistance of FSIS, into Huntington Meat Packing’s practices after it was found that the company did not follow its own health and safety plans and failed to keep reliable records about its activities. Although no cases of food poisoning have been reported in connection with the recall, the FSIS says that all of the company’s meat should be considered suspect.

E. coli O157:H7 is one of the more common causes of food poisoning in the United States. When left untreated, it can lead to dehydration and potentially life-threatening illness. While most healthy adults recover from food poisoning caused by E. coli within a few weeks, 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).

The original E. Coli O157:H7 recall included meat from both January and some from 2008 that the FSIS said may still be in storage. The expansion includes beef and veal products produced from January 22, 2009 through January 4, 2010. The recall includes ground beef, ground beef patties, burrito filling and veal patties. Beef products under both the Huntington and Imperial Beef Co. labels are affected by the recall. All of the recalled products have an establishment number of 17967 inside the USDA mark of inspection label.

Anyone with questions about the recall should contact the company at (888)894-8242.

The CDC reports that there are about 76 million cases of food-related illnesses reported every year, with more than 300,000 people hospitalized and 5,000 deaths. There were at least nine major recalls of beef products in 2009.

A recall has been issued for Trader Joe’s Chocolate Chip Chewy Coated Granola Bars due to the risk that they may be contaminated with bacteria that could cause salmonella poisoning.

The Trader Joe’s granola bar recall was announced by the FDA and Trader Joe’s Company on February 10. The bars were manufactured by Bloomfield Bakery, a subsidiary of Ralcorp Holdings. Although there have been no illnesses reported in connection to the salmonella contamination, consumers have been urged not to eat the granola bars and to return them to Trader Joe’s for a full refund.

The recall affects Trader Joe’s Chocolate Chip Chewy Coated Granola Bars with a UPC number of 82818, and with Use by Dates and Lot Codes of 16JUL10H2 and 17JUL10H1. The bars were sold in a 7.4 ounce box with the Use by/Lot Codes on top of the box and on each individual bar’s packaging.

Salmonella food 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.

Trader Joe’s has removed all of the remaining products from its shelves and destroyed them, and the Bloomfield Bakery has suspended operations while the FDA conducts an investigation. Customers with questions can contact Trader Joe’s at (626)599-3817.

Vehicle owners and stockholders are filing class action lawsuits in the wake of a series of massive Toyota recalls, suing the Japanese automaker for the lost value of both stocks and the vehicles themselves. The company also faces a number of Toyota injury lawsuits filed by individuals who have suffered a severe personal injury or death in an accident caused by problems with the accelerator or brakes.

New Toyota class action lawsuits were filed recently on behalf of all Toyota hybrid owners in the U.S. District Court in Los Angeles on Monday, and on behalf of California owners of recalled Prius and Lexus hybrids in Los Angeles County California Superior Court on Friday. Both Toyota class action suits were filed due to the latest Toyota recall of 2010 Prius and Lexus HS250h models over brake problems. In addition, a lawsuit was filed on Monday in the U.S. District Court in Los Angeles on behalf of all Toyota stockholders.

The Toyota stockholder lawsuit alleges that the company’s stocks dropped 20% because of the recalls, and charges Toyota executives with deceiving investors about the health of the brand when they knew that there were acceleration and brake problems. It names the company’s top executives, as well as the company itself, as defendants in the suit.

The two lawsuits filed on behalf of vehicle owners allege that the company long knew about problems with the Toyota hybrids’ brake systems but did not warn consumers. It charges Toyota with breach of warranty, product liability, negligence, and violating California fair business practice laws.

Earlier this week Toyota recalled more than 437,000 of the 2010 gasoline-electric hybrid vehicles because the brakes ceased to work for a moment due to a software glitch. About 150,000 of the recalled vehicles were in the hands of U.S. owners.

The Toyota hybrid recall followed several waves of recalls over sudden acceleration problems in a number of leading Toyota vehicle lines.

In September 2009, a Lexus and Toyota recall was issued for 3.8 million vehicles that contained certain all-weather floor mats, which Toyota indicated could get stuck under the gas pedals, causing unintended acceleration. In January, Toyota issued another recall for 2.3 million Toyota vehicles, including 600,000 that were not subject to the prior floor mat recall due to an actual mechanical problem that was causing some gas pedals to stick. Shortly after, the company stopped production and sales on eight of its most popular vehicles, including the Corolla, Camry, and Tundra. The company has also announced it is recalling nearly 2 million vehicles in Europe and almost 80,000 in China.

The Toyota accelerator pedal recalls have resulted in more than 60 lawsuits, including over a dozen wrongful death and personal injury claims.

Canadian researchers are reporting that the antidepressant Paxil may interfere with breast cancer drug treatments, increasing the risk of relapse and death in breast cancer survivors.

The new study, conducted by scientists and doctors at the Institute for Clinical Evaluative Sciences and the Sunnybrook Health Sciences Center in Toronto, was published in the latest issue of the British Medical Journal. Researchers found that selective serotonin reuptake inhibitors (SSRI), like Paxil, can interfere with tamoxifen, an estrogen-based breast cancer therapy drug.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor by GlaxoSmithKline PLC prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion last year. It is also available as a generic.

Researchers looked at 2430 women age 66 or older who had been treated with tamoxifen for breast cancer between 1993 and 2005, and who were also taking Paxil or another SSRI at some point during that time period. The study’s results indicate that the drug reduces or completely mitigates the effectiveness of tamoxifen, confirming scientists’ suspicions that Paxil inhibits tamoxifen’s bioactivation.

About 1.5 million women worldwide are expected to be diagnosed with breast cancer this year, researchers say. It is the most commonly diagnosed form of cancer for women. Experts estimate that about 25% of women dealing with breast cancer experience a depressive disorder. Many of those women are prescribed an antidepressant.

“Our findings have major implications for clinical practice, particularly in light of the frequency of combination therapy,” researchers said. “In our study, 30% of women who started tamoxifen treatment also received antidepressants, and paroxetine was the most commonly used SSRI.”

The study comes as Glaxo tries to deal with hundreds of lawsuits from plaintiffs claiming that Paxil causes suicidal tendencies and birth defects. The company has reportedly already spent more than half a billion dollars to settle Paxil lawsuits, and still faces hundreds more.

There are currently about 600 more Paxil birth defects lawsuits pending. Following a jury award in October for $2.5 million in one Paxil birth defect trial in Pennsylvania, Savvas Neophytou, a London-based Panmure Gordon analysts, told investors that Glaxo faced a potential liability of $1.5 billion in the cases.

A defect that could cause airbags to explode and send lethal shrapnel into the passenger compartment, has lead to an expansion of a previous Honda airbag recall. With an additional 378,758 Honda vehicles, the recall now affects more than 826,000 cars and minivans.

The Honda recall expansion was announced this week for 2001 and 2002 model year Honda Accords, Civics, Accura TL sedans, Odyssey minivans and CR-V crossovers. The airbags could inflate with such force that parts of them may explode outward, sending pieces of metal or other debris into the vehicle.

At least one person has died as a result of the Honda airbag problems, and several others have been injured. Honda says that it is aware of at least 12 incidents associated with the defective airbags.

The recall started in November 2008, with the recall of only 4,000 model year 2001 Honda Civics and Honda Accords. In July 2009, Honda expanded the recall by 440,000 more vehicles, including 2001 and 2002 Accords, 2002 and 2003 Acura TL Sedans and 2001 Civics.

The problems with Honda airbag are linked to a defect that could cause the inflator to over-pressurize the airbag when deployed. The high pressure can cause the inflator to rupture, sending a burst of metal shrapnel into the passenger compartment. The defect is only known to occur in the driver’s side airbag.

“When Honda identifies concerns of this nature, nothing is more important to the company than fulfilling our obligation and responsibility to alert our customers,” Honda officials said in a press release. “To this end, as with the July 2009 recall expansion, in addition to contacting customers by mail, owners of these vehicles will be able to determine if their vehicle requires repair by going on-line or calling.”

Honda indicates that there had been no new incidents, but that the expansion is being done out of caution because it cannot verify that the propellant used in the recalled models met with manufacturing specifications.

Honda car owners can check to see if their vehicle is affected at http://www.ahm-ownerlink.com/SEO/HondaRecall.asp and http://owners.acura.com/recalls/.

About 800,000 Tiny Love wind chime toys have been recalled in the United States and Canada after a 2-year-old was injured by one of the chimes’ sharp metal rods.

The wind chime recall was announced on February 10 by the U.S. Consumer Product Safety Commission (CPSC) after the distributors, Tiny Love Inc. and the Maya Group Inc., received at least five reports of babies pulling the wind chimes apart and exposing the sharp metal rods. The injured child suffered a puncture wound to the cheek from one of the exposed rods.

The recall affects 600,000 wind chimes sold in the U.S. and 200,000 sold in Canada. The Tiny Love wind chime toys were sold separately, and with the Gymini Kick & Play Activity Gym and Tiny Smarts Gift Sets. The recalled wind chime models include the Baby Wind Chime, Baby Wind Chime – Ocean, Tiny Smarts – Baby Bunny, the Wind Chime – Duck (sold with the Gymini Kick and Play Activity Gym), Wind Chime – Louie, Wind Chime – Ella, and the Bunny Wind Chime sold with the Tiny Smarts Gift Set.

The wind chimes were sold at Toys ‘R’ Us, Wal-Mart, Target, Buy Buy Baby, and TJ Maxx stores nationwide from February 2002 through February 2010. The chimes sold separately for $8, while the Tiny Smarts Gift Sets sold for $22 and the Gymini Kick & Play Activity Gyms were sold for $70.

The CPSC recommends that consumers take the recalled wind chimes away from babies immediately and contact Tiny Love at www.tinylove.com for a free replacement.

A study by University of Washington (Seattle) researchers indicates that a certain type of birth defect may be linked to the weed killer atrazine.

The study is to be presented at the annual meeting of the Society of Maternal-Fetal Medicine in Chicago, and indicates that atrazine may cause some cases of a birth defect known as gastroschisis, an abdominal wall defect which causes some of an infant’s organs, usually intestines, to develop outside of the body. Syngenta Corporation, which manufactures the herbicide, vehemently reject the study’s findings, despite the fact that it is at least the third such study to link atrazine to birth defects in recent years.

Atrazine (ethylamine and isopropylamine) is a widely used herbicide, with more than 70 million pounds used in agriculture every year in the U.S. The weed killer has been banned by the European Union due to how easily it contaminates waterways and drinking water supplies. It has also been held in suspicion by critics due to its effects on species such as amphibians, and the growing body of evidence that it causes a variety of birth defects.

Researchers looked at 805 cases of children born with gastroschisis between 1987 and 2006, and 3,616 infants born without defects were used as a control group. They found that gastrochisis was more common among infants born to mothers who lived within 15.5 miles of a water body that was found to have high levels of atrazine contamination. They also found that the closer the mother lived to the contaminated water source, the more likely the risk of a birth defect, and that the defects were more prevalent among mothers who conceived in the spring, when atrazine use is at its highest.

Syngenta Corp. released a statement dismissing the link between atrazine and birth defects, claiming that the study results are not credible. “A large number of rigorous scientific animal studies have consistently shown that atrazine does not cause birth defects and does not cause reproductive effects,” the company said in a statement.

However, critics point out that the new study is the latest in a series of studies by different groups that have found links between atrazine use and the rate of birth defects. Even the U.S. Department of Health and Human Services’ Agency for Toxic Substances and Disease Registry indicates that atrazine at high levels causes birth defects in animals.

A 2007 study by Indiana researchers published in the Journal of Pediatric Surgeryfound that gastrochisis and other defects occurred at a higher rate in Indiana in locations where atrazine was heavily used. Another study published in 2009 in Acta Paediatricafound that the risk of nine different types of birth defect nationwide could be linked to atrazine.

About 360,000 Discovery Kids Animated Marine and Safari Lamps have been recalled due to a defect which can cause them to burst into flames.

The Discovery Kids Lamp recall was announced on February 9 by the U.S. Consumer Product Safety Commission after the manufacturer, Innovage LLC, received nine reports of problems. At least seven of the lamps have reportedly caught fire, causing three incidents of minor property damage and injuring one child due to smoke inhalation.

The fires are starting due to a defect in a printed circuit board inside the lamp that causes an electrical short, according to the CPSC’s Discovery Kids lamp recall announcement.

The recall affects the Discovery Kids Animated Marine Lamp with a model number of 1627121 and the Discovery Kids Animated Safari Lamps with model numbers 1627124 and 1628626. The lamps have “Discovery Kids” printed on the front top left corner, are silver in color, and depict rotating marine or safari scenes.

The lamps have an 11-digit batch number on the bottom of the lamp that begins with the number 2. The model number is located on the bottom of the packaging.

The lamps were sold at department stores, drug stores, by mass merchandisers, through direct sales and online from July 2009 through January 2010 for about $10. The lamps were made in China.

The CPSC recommends that anyone using the recalled Discovery Kids lamps should stop immediately and contact Innovage at www.lamprecall.org for a full refund.

Toyota has officially issued a Lexus and Prius recall due to brake problems that will affect about 437,000 gasoline-electric hybrid vehicles.

The global Toyota Prius and Lexus HS250h recall was announced earlier this week, after days of speculation over what Toyota Motor Corp. would do to address the brake problems they have known about for months. About 150,000 Prius and Lexus vehicles in the U.S. will be affected by the recall, as the Japanese automaker is still reeling from the recall of more than 8 million vehicles over sudden acceleration problems.

Toyota officials say that the Lexus and Prius brake problem is caused by the vehicle switching between traditional braking systems and an electronic system that helps recharge the hybrid car’s battery. Drivers feel a moment where the brakes do not appear to be working as the system switches over. The problem can be fixed by a software adjustment, the company claims.

More than 100 complaints about the 2010 Prius’s brake system have been filed with the National Highway Traffic Safety Administration (NHTSA), even though the vehicle was only released last summer. Toyota said it began receiving complaints about the brakes in the later months of 2009. The company informed dealerships last month and says it has developed a software fix for the problem.

The Prius has become the flagship of the Toyota car line, and the company has trumpeted its intention to eventually release gasoline-electric hybrid versions of all of its vehicles, which would potentially use similar hybrid brake software.

There have been no accidents or injuries reported due to the defective brake systems, and the bulk of the recalled vehicles were sold in Japan, which had been untouched by the recent string of Toyota recalls.

In September 2009, a Lexus and Toyota recall was issued for 3.8 million vehicles that contained certain all-weather floor mats, which Toyota indicated could get stuck under the gas pedals, causing unintended acceleration.  In January, Toyota issued another recall for 2.3 million Toyota vehicles, including 600,000 that were not subject to the prior floor mat recall due to an actual mechanical problem that was causing some gas pedals to stick. Shortly after, the company stopped production and sales on eight of its most popular vehicles, including the Corolla, Camry, and Tundra. The company has also announced it is recalling nearly 2 million vehicles in Europe and almost 80,000 in China.

The Toyota accelerator pedal recalls have resulted in more than 60 lawsuits, including over a dozen wrongful death or injury claims.

Photo Courtesy of: http://www.flickr.com/photos/danielctw/ / CC BY 2.0

The deaths of three infants have led to a drop-side crib recall for half a million cribs sold under the ChildESIGNS and Generation 2 Worldwide labels.

The recall was announced on Tuesday by the U.S. Consumer Product Safety Commission (CPSC), which warns that the hardware on the cribs can break, causing the drop side to detach and potentially entrapping and suffocating infants. So far, three deaths have been attributed to the defective cribs, including an eight-month old in Newark, Ohio in July 2007, an eight-month old from Richmond, Indiana, in October 2003, and a six-month-old from Staunton, Virginia in September 2002. All three children became entrapped by the drop side and suffocated.

The CPSC has received 20 other incident reports involving the Generation 2 Worldwide and ChildESIGNS cribs, two of which resulted in the non-fatal entrapment of other infants when the drop-side detached.

The CPSC has warned that it has limited information on the cribs, because they were all produced by Generation 2 Worldwide, which appears to have gone out of business. They were sold under both the Generation 2 Worldwide and ChildESIGNS labels.

The drop-side crib recall includes all Generation 2 Worldwide and ChildESIGNS drop-side cribs, regardless of model number. “Generation 2 Worldwide” is on a label on the headboards, and some models will have “ChildESIGNS” on a label on the teething railing.

The CPSC does not have accurate production year information, but estimates that about 500,000 of the cribs were sold at retailers nationwide, such as Wal-Mart, Kmart, and Buy Buy Baby for between $60 and $160.

A number of major retailers and manufacturers have stopped selling drop side cribs due to repeated problems with drop side cribs. One company, Simplicity, has had more than 2 million drop side cribs recalled, and the CPSC reports that at least 11 drop-side crib deaths have been linked to Simplicity cribs. The company was driven out of business by the repeated product recalls.

One of the biggest concerns surrounding drop-side cribs is that they are not sufficiently durable. In addition, many parents reuse the cribs for multiple children or pass them down to other family members. When the cribs are disassembled and then reassembled, the risks associated with defective designs could increase greatly, resulting in potentially life-threatening hazards. In addition, many of the cribs are inexpensive and built without durable parts.

The CPSC recommends that anyone using the recalled cribs stop immediately and find an alternate sleeping arrangement for their infants. Consumers should contact the place of purchase for a refund, exchange or other remedies, which may vary.

About 12,200 automated external defibrillators (AEDs) manufactured by Cardiac Science Corporation are being recalled because they may fail to deliver life-saving shocks when needed.

The defibrillator recall was announced on February 3 by FDA after Cardiac Science determined that the AEDs were defectively manufactured. The recalled units may not function correctly during a resuscitation attempt, which could lead to serious injury or death, the company said. The recall is a Class 1 recall, the most serious medical device recall category.

There have been no failure incidents reported in connection to the defective AEDs. The defect was found by internal quality control at Cardiac Science Corporation.

The AED recall affects Cardiac Science’s Powerheart 9300A, 9300E, 9390A and 9390E, as well as the CardioVive 92532, the CardioLife 9200G and 9231. The recall is a separate issue from a medical device correction alert issued by the company on November 13 dealing with some of its defibrillators.

The affected AEDs were manufactured between October 19, 2009 and January 15, 2010. Any customers who purchased an AEDs during that time can check Cardiac Science’s website to determine whether their unit is affected by the recall. The company is also informing customers by letter.

Replacement defibrillators will be available after February 15 and will be replaced at no charge.

The company recommends that any recalled defibrillators be immediately taken out of service.

A new study suggests that hormone replacement therapy (HRT) can increase the risk of women developing asthma after menopause. While HRT has long been suspected of increasing the risk of asthma, researchers found that the greatest increase in risk came from the use of estrogen-only HRT therapy.

The study, conducted by French and Mexican researchers, was published in the latest issue of the medical journal Thorax on February 8. The study represents over a decade of research on more than 57,000 women. While both estrogen-only and combination HRTs were found to increase asthma risk, researchers said the only significant increase was that associated with estrogen-only pills.

Hormone replacement therapy involves the use of hormones and progestins to artificially boost hormone levels in women undergoing menopause due to surgery or in postmenopausal women, to provide relief from symptoms such as hot flashes, irregular menstruation or weight gain.

Researchers studied 57,664 French women to look at the use of HRT and asthma symptom onset every two years between 1990 and 2002. The researchers found that HRT use in general increased the risk of asthma by 21%. However, the use of estrogen-only HRT pills more than doubled that risk, increasing the likelihood of postmenopausal women developing asthma by 54%. Estrogen-pill users who had never smoked or had some other allergy before being diagnosed with asthma faced the highest risks; 80% and 86% higher than other women, respectively.

Some researchers involved with the project suggested that the results could be linked to an airway inflammation caused by female hormones. They also said that the results should be weighed with both the other risks and benefits of HRT.

In 2002 the National Institutes of Health released the results of studies that found women receiving HRT were at higher risk of breast cancer, strokes and heart attacks. The studies, part of the Women’s Health Initiative, sparked a large number of the hormone replacement therapy breast cancer lawsuits currently pending throughout the country.

There are currently about 9,000 lawsuits against Prempro, one of the leading HRTs in the U.S.. The drug was originally distributed by Wyeth, which was acquired by Pfizer last year. All of the lawsuits claim that inadequate warnings were provided about the risk of invasive breast cancer from the HRT drugs and that the drug makers intentionally hid the cancer risk from women.

A new study by U.S. researchers has linked the industrial cleaner trichlorethylene (TCE) to an increased risk of Parkinson’s Disease.

The study, which will be presented at the American Academy of Neurology’s (AAN) 62nd Annual Meeting in Toronto in April, found that workers who were exposed to TCE were five times more likely to have Parkinson’s Disease. Researchers with the Parkinson’s Institute of Sunnyvale, California, say that the industrial cleaner and solvent destroys the ability of certain parts of the brain to create dopamine; a neural transmitter that relays crucial chemical information throughout the brain.

Researchers looked at 99 sets of twins from a list of World War II veterans and looked for cases where one twin had Parkinson’s Disease and the other did not. Upon researching the job histories of those twins, the histories were looked at in a blind analysis by industrial hygienists and preventative medicine specialists. The researchers determined that workers who were most likely exposed to TCE were 5.5 times more likely to have Parkinson’s Disease than those who were not exposed.

TCE was once used as a metal cleaner, dry cleaning solvent, and even as an anesthetic, but is no longer widely used in any area but metal cleaning due to other toxicity issues. Animal testing revealed that it specifically killed dopamine-creating cells in the substantia nigra, which is the same part of the brain that affect’s Parkinson’s Disease.

Parkinson’s Disease is caused by the death of dopamine-producing cells and causes severe tremors, limb rigidity and other symptoms. It is eventually fatal and about 100,000 Americans are diagnosed with the condition each year.

“This is the first time a population-bsed study has confirmed case reports that exposure to TCE may increase a person’s risk of developing Parkinson’s Disease,” said Dr. Samuel Goldman, the study’s author, in an AAN press release. “TCE is a popular industrial solvent that is still widely used to clean grease off metal parts.”

A Class 1 medical device recall has been issued for Safesheath CSG Sheath Introducer Systems by Thomas Medical Products, Inc. due to reports that the tip of the sheath can break off and enter patients’ blood vessels.

The Safesheath introducer recall was posted this week by FDA after the manufacturer sent letters to health care professionals and customers in December. It is the latest in a series of recalls of sheaths and catheter products made by Thomas Medical Products due to manufacturing problems. The recall is classified as a Class I, the most serious, because the Safesheath defect has the risk of causing serious injury or death.

Thomas Medical Products is a subsidiary of General Electric’s healthcare division.

The Safesheath CSG sheath introducer systems, distributed by Pressure Products, Inc., are tube-like devices that are placed into blood vessels. The Safesheath has an infusion side port that allows doctors to place defibrillator wires and catheters easily into blood vessels once the sheath is in place. The recall has been issued because the tips of the sheaths can break off and potentially move through the blood vessel to the brain or heart, which can cause serious injury or death.

Thomas Medical Products has received 38 reports of tips coming separated, but did not indicate whether any of the cases resulted in serious injury or death.

The recall affects certain lots of Safesheath CSG Sheath Introducer systems distributed from December 1, 2005 through December 14, 2009. A complete listing of affected lots and catalog numbers is available in a press release put out by GE on January 29.

The Safesheath recall is the third sheath pulled by Thomas in the recent months. The company issued a recall for the ViperSheath Sheath Introducer in November, and a Cordis Crossover Catheter Sheath recall was issued in October. In both cases the sheaths were found to stretch and fracture, potentially causing injury or death to patients. In both cases, there were reports of patients who required surgery to remove pieces of the sheaths after they broke inside their bodies.

Thomas Medical Products and Pressure Products are notifying customers of the recall and arranging for the return of unused products. Anyone who ha suffered an adverse event due to defective Thomas Medical Product sheaths can contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

A medical device company is recalling 7.8 million catheters and intravenous (IV) fluid delivery system components after receiving reports of at least one possible death related to the products. 

 Becton, Dickinson & Co. (BD) announced that it is recalling certain lots of its BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems because of a defect that could cause a patient to suffer an air embolism. Air embolisms, which occur when a bubble of air gets into the blood and travels through the heart, can result in serious injury or death. The devices also have the risk of blood leakage or the leakage of medication that should be delivered into the body, which can also lead to injuries and death.

While BD’s announcement made no mention of actual injuries or deaths reported, the Wall Street Journal reports that the recall was issued after the company received reports of a patient death last Thursday. The death, and another reported serious injury connected to the devices, have not been confirmed as being caused by the recalled IV components.

The components link needle-less IV catheters and medicine pumps to syringes, IV administration sets and other devices that introduce medication or draw blood from the patient’s body. The recall involves 2.8 million Q-Syte devices, and 2.9 million Nexiva units. The Nexiva units have two Q-syte devices packaged with them that could be affected by the recall.

The announcement is an expansion of a previous BD catheter recall, issued on October 28, 2009. The company says that the problem was caused by a manufacturer’s deviation that causes air to enter through the bottom disk of the septum of the devices. A list of catalog and lot numbers of devices affected by the recall expansion is available in BD’s press release. All of the lots affected products were distributed from November 2008 through November 2009.

The company says that it has notified customers worldwide by letter. Anyone experiencing adverse effects from the use of these devices should contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

The results of a new study indicate that side effects of Avandia may double the risk of heart attacks when compared to other diabetes drugs.

The new study, published in the American Diabetes Association medical journal, Diabetes Care, compared Avandia heart risks to those of Actos and other anti-diabetic drugs. Researchers from Harvard Medical School and Massachusetts General Hospital looked at hospital databases and compared the rate of myocardial infarctions in diabetic patients with the medications they were prescribed.

The study looked at more than 26,000 patients, and found that Avandia users suffered twice as many heart attacks as diabetes patients who were given Actos (pioglitazone) and metformin. Avandia users were 1.2 times as likely to have a heart attack as patients given sulfonylurea.

Avandia (rosiglitazone) is manufactured by GlaxoSmithKline PLC, and is a thiazolidinedione agent, a class of drugs approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels.

Concerns about the Avandia heart attack risk first gained widespread attention in May 2007, when a meta-analysis of 42 different clinical trials was published in the New England Journal of Medicine, suggesting that users of Avandia had a 43% increased risk of a heart attack. The FDA has since added a black box heart attack warning to Avandia, and some experts have estimated that the diabetes drug could be responsible for as many as 100,000 heart attacks since it was first introduced.

GlaxoSmithKline PLC currently faces thousands of Avandia lawsuits filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious heart side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania.

In 2008, Public Citizen filed a petition with the FDA calling on the agency to issue an Avandia recall, indicating that the number of serious and potentially life-threatening side effects outweigh any potential benefits provided by the diabetes drug. The FDA has not yet taken any action on the petition.

Federal investigators say that at least 213 people in 42 states have experienced food poisoning as part of a Salmonella Montevideo outbreak linked to pepper-coated salami.

The U.S. Centers for Disease Control and Prevention (CDC) announced the new numbers on February 4, indicating that the first reports track back to July 1, 2009. All of the 213 cases have been genetically connected to the same strain of Salmonella serotype Montevideo infections linked to recalled salami produced by Daniele International, Inc.

A pepper-crusted salami recall was issued on January 23 for approximately 1.24 million pounds of salami/salame and other Italian sausage products. The recalled salami was sold at Costco and other national retailers under the Daniele, Black Bear, Dietz & Watson and Boars Head labels. Last week, Daniele International expanded their salmonella recall by 17,235 pounds after Illinois inspectors found contamination in more unopened packages. The additional recalled items include Daniele Hot Sopressata Calabrese, Daniele Spressata Calabrese and Boar’s Head Brand Hot Sopressata Calabrese.

At least two Salmonella Montevideo lawsuits have already been filed against Daniele International over sicknesses caused by the tainted salami.

Rhode Island health inspectors, who examined the Daniele International processing facility, say they found an open package of black pepper which was contaminated with the same strain of salmonella. However, the FDA has been unable to confirm that the pepper is the source of the contamination and continues to investigate. The suppliers of the black pepper have voluntarily placed their product on hold while the investigation continues, according to an updated statement by the FDA.

Salmonella Montevideo 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.