Author: AboutLawsuits

A vegetable protein recall issued late last month by Basic Food Flavors, Inc. is resulting in a cascade of products being pulled from shelves due to the potential for salmonella food poisoning.

Over the last two weeks, the FDA has announced recalls for T. Marzetti vegetable dips, Castella Chicken Soup, Homemade Gourmet Tortilla Soup Mix, and various products by Tim’s Cascade Snacks and Earth Island’s “Follow Your Heart” products due to the potential for salmonella infection. All of the recalled products contained hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors, Inc., which warned customers that it’s protein was found to have salmonella contamination late last month.

Salmonella is a type of bacteria that attacks the gastrointestinal tract, causing mild to severe food poisoning. For most healthy adults, symptoms of food poisoning from salmonella typically resolve after a few days or weeks. However, young children, the elderly, and individuals with compromised immune systems have an increased risk of suffering severe food poisoning after ingesting the bacteria. If not properly treated, some cases of salmonella food poisoning can lead to hospitalization, dehydration or death.

HVP is similar to monosodium glutamate (MSG), except that it is a liquid instead of a salt. It is used as a flavor enhancer in many foods. Basic Food Flavors, Inc. has not issued a specific release giving the details of the recall, instead publishing a complex list of product codes affected by the HVP recall on its website with no explanation.

While there have reportedly been no illnesses connected with the recall, it has caused a number of companies that used the ingredient to pull their products from store shelves. Recalls that have resulted from the HVP salmonella contamination include:

• Johnny’s Fine Foods French Dip Powered Au Jus
• Tim’s Cascade Snacks Hawaiian Kettle Style Potato Chips – Sweet Maui Onion and Hawaiian Sweet Maui Onion Rings
• Castella Imports Inc., Castella Chicken Soup Base
• T. Marzetti Southwest Ranch and Spinach Veggie Dips, sold under the T. Marzetti, Oak Lake Farms and Great Value labels
• Homemade Gourmet Tortilla Soup Mix
• Earth Island “Follow Your Heart” products.

For more details, specific lot numbers and product names, see the FDA HVP recall press releases for each product line.

Customers who bought these products may return them to the place of purchase for a full refund.

The U.S. Judicial Panel on Multidistrict Litigation has scheduled a hearing for later this month to hear arguments about whether all federal Toyota gas pedal lawsuits should be consolidated and centralized in one district for coordinated handling as part of an MDL, or Multidistrict Litigation. 

The hearing is scheduled for March 25 in San Diego, and will give plaintiffs and defendants in the claims a chance to submit oral arguments for or against the centralization. If an MDL is formed, the cases will all be assigned to one judge for pretrial litigation to avoid duplicate discovery, inconsistent rulings from different judges and to serve the convenience of the court, the parties and witnesses.

A growing number of product liability lawsuits against Toyota have been filed in recent months after the Japanese automaker recalled millions of vehicles due to problems with uncontrolled acceleration. The Toyota gas pedal problems have been associated with dozens of accidents and a number of serious and fatal personal injury claims.

The request that the Toyota litigation be centralized came from plaintiffs Heather A. Lane and Daniel Weimer, Jr. However the plaintiffs disagree on where the cases should be handled. Lane wants the cases consolidated in the Central District of California, which currently has the most cases under consideration by the panel. Weimer is seeking to have the cases consolidated in the Eastern District of Louisiana.

Toyota has recalled nearly 9 million vehicles since September 2009, with 8.5 million recalled due to complaints that they can accelerate out of control. The acceleration recalls were done in waves, starting with 4.2 million recalled for problems involving the floormats, and then later recalls indicated that there was a mechanical or electrical problem with the gas pedals.

The Toyota gas pedal recall has resulted in a number of individual personal injury and negligence lawsuits, class action lawsuits, and several wrongful death lawsuits filed by family members of people allegedly killed when their Toyota or Lexus vehicles accelerated out of control.

The judicial panel is currently considering a request to consolidate 11 lawsuits from federal courts in California, Florida, Louisiana, and West Virginia. However, the ruling would also impact all future lawsuits filed over the Toyota gas pedal problems.

Last month Toyota became the target of probes by both federal prosecutors and the Securities and Exchange Commission (SEC). Both federal investigators and the SEC are looking into how the company reacted to complaints about Toyota accelerator problems, and are questioning whether the company attempted to cover up or downplay the seriousness and number of incidents being reported.

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

A California jury has ruled in favor of drug maker Allergan, Inc. in the first Botox lawsuit to go to trial, involving the death of a 7 year-old girl with cerebral palsy who received Botox injections to alleviate muscle problems associated with her disability.

The verdict was handed down Tuesday by an Orange County jury in a wrongful death Botox lawsuit brought by Dee Spears, the mother of Kristen Spears. The jury deliberated for under three days before returning a defense verdict. At trial, the drug maker argued that Spears’ November 2007 death was caused by complications of her cerebral palsy, not a result of a Botox overdose that weakened the muscles that controlled her ability to breath, as the mother alleged.

Botox is approved for both cosmetic use to reduce the appearance of wrinkles in the skin and to treat medical conditions such as strabismus (crossed eyes), hyperhidrosis (excess sweating), cervical dystonia (involuntary contractions of the neck muscles) and blepharospasms (involuntary blinking of the eye). However, it also commonly used off-label at high doses to treat stiff and jerky movements associated with cerebral palsy in children.

Minute quantities of Botulinum Toxin A are contained in Botox, which is the bacteria associated with the muscle paralyzing condition Botulism. A number of adverse event reports have been associated with side effects of Botox, where the medication spreads from the area of the injection to other parts of the body. These Botox problems have most commonly been seen among children with cerebral palsy, where the typical Botox dose is substantially larger.

In February 2008, the FDA issued a warning about the risks associated with use of Botox to treat cerebral palsy, after receiving a number of adverse event reports involving sudden death, breathing problems and other potentially life-threatening injuries. A “black box” Botox warning was added to the medication in August 2009, warning about the risk of botulism-like side effects, such as swallowing and breathing difficulties, that can occur if the injection spreads to other areas of the body.

More than a dozen people have filed lawsuits over Botox against Allergan, alleging that the company illegally promoted the medication for non-approved uses and failed to adequately warn about the risk of these severe and potentially life-threatening Botox injuries.

General Motors has issued a recall for 1.3 million Chevrolet Cobalts and Pontiac vehicles sold in the U.S., Canada and Mexico after the National Highway Traffic Safety Administration opened an investigation into more than 1,000 consumer complaints of the power steering suddenly ceasing to work on some vehicles. Among the reports of steering problems linked to vehicles were at least 14 car crashes.

The GM recall, issued on March 2, includes the 2005-2010 model year Chevrolet Cobalt, the 2007-2010 Pontiac G5, the 2005-2006 Pontiac Pursuit, and the 2005-2006 G4. The Pursuit is sold in Canada and the G4 is sold in Mexico. GM said it has been investigating the problem since 2009, and determined that in rare cases, the power steering motor on the vehicles can die and cause difficulty steering at speeds under 15 m.p.h.

GM officials say once the motors fail, the car can still be driven to dealers to have the motor replaced. When the defective power steering motors fail, drivers will see a “Power Steering” warning indicator and hear a chime alarm. However, officials say that the power steering can sometimes come back temporarily after the car is shut off and restarted.

The company said it will take some time for parts suppliers to provide new power steering motors to replace those affected by the recall. However, the company said that the vehicles can still be safely controlled when the problem arises.

“After our in-depth investigation, we found that this is a condition that takes time to develop,” said GM’s vice president of quality, Jamie Hresko in a GM press release. “It tends to occur in older models out of warranty.”

GM officials say that as the replacement power steering motors come in, they will target older vehicles first, since the problem does not appear to occur until the vehicles have 20,000 to 30,000 miles on them. The company will also have to repair thousands of cars still in dealer inventories across North America.

The company says that customers will be notified when plans for replacing the motors are finalized.

A seaman who alleges that he suffered permanent and debilitating injuries while working on a tug boat has filed a Jones Act lawsuit in Texas, seeking compensation from his employer. 

The lawsuit, filed by Joseph R. Dean in Jefferson County District Court on February 19, claims that Coral Marine Services is liable for injuries Dean suffered while working on a tugboat for the company. According to a report in The Southeast Texas Record, Dean says that he sustained disabling injuries while performing his job at sea onboard the Bailey Ann, a 50-foot tug.

Filed under the Merchant Marine Act, also known as the Jones Act, the complaint says that Coral Marine Services has refused to pay for Dean’s injuries, and seeks both compensatory and punitive damages of unspecified amounts.

The Jones Act, first passed in 1920, is geared at protecting U.S. shipping interests and the rights of sailors onboard ships flying under a U.S. flag. The act stipulates that goods transported from one U.S. port to another must be done on a ship built and flagged in the U.S., by a majority U.S. crew. In addition, the Jones Act codified the right of the seaman to sue their captain, fellow crewmembers or the ship’s owner for unseaworthiness or negligence that resulted in an injury while onboard the vessel. Generally, legal rights at sea are set by international maritime law, which does not make provisions for a sailor or seaman to sue those that operate the vessel for work-related injuries.

According to an annual report released by Bayer, the number of birth control lawsuits over Yaz, Yasmin and Ocella filed against the pharmaceutical company has risen to about 1,100 cases, and that number will likely continue rising rapidly as thousands of other women are considering claims for serious injuries that may have been caused by side effects of the birth control pills.

Included among the claims are five Yasmin and Yaz class action lawsuits; three filed in the United States and two filed in Canada, according to Bayer’s 2009 annual report released late last month.

All of the lawsuits involve similar allegations that side effects of Yaz, Yasmin and Ocella increase the risk that women may suffer a stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder disease or other injury. The plaintiffs claim that Bayer failed to adequately research the birth control pills or warn about the increased risks when compared to other available forms of oral birth control.

Yaz and Yasmin are two similar birth control pills that are both manufactured by Bayer, containing a combination of ethinyl estradiol and drospirenone, a new type of progestin. Ocella, which is a generic version of Yasmin, is distributed by Barr Laboratories, Inc. However, Bayer indicated in the annual report that they are taking over Barr’s defense in certain Ocella lawsuits under the terms of their licensing agreement.

Drospirenone, or drsp, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. This can cause a condition known as hyperkalemia, which is linked to potentially life-threatening heart problems and other health issues. Yaz litigation claims allege that the oral contraceptives have been responsible for at least 50 deaths in the U.S. alone, with some estimating the number is closer to 60.

Many of the lawsuits also claim that Bayer over-promoted Yaz and Yasmin, alleging that the drug maker advertised additional benefits over other birth control pills without fully disclosing the potential increased risk of problems from Yasmin and Yaz. 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.

According to Bayer’s annual report, the drug maker expects that the number of lawsuits will continue to climb. Yaz and Yasmin lawyers are continuing to review potential cases for women who have suffered injuries, and some estimates suggest as many as 25,000 women could file a suit over the birth control pills.

Despite the lawsuits and purported health risks, Bayer raked in $1.7 billion from Yaz, Yasmin, and a low-strength version of Yasmin called Yasminelle in 2009. Sales overall for the company’s birth control pills was up 4.6 percent over 2008 numbers.

A federal judge is considering leveling a judgment against a foreign company which has refused to answer to a Chinese drywall lawsuit filed in the United States. The ruling could give plaintiffs the right to seize any assets of Taishan Gypsum Co. that touch U.S. soil.

In the first lawsuit to go before a judge involving claims that defective Chinese drywall filled homes with sulfuric odors, corroded electrical equipment and caused other property damage, there was something missing: the defendant. Taishan Gypsum Co., the manufacturer of some of the Chinese drywall blamed for damages in thousands of homes across the country, has never answered the lawsuit against it and did not send legal representation to the trial last week before U.S. District Judge Eldon Fallon in New Orleans.

Fallon is currently considering plaintiffs’ demands that a ruling be issued against Taishan that would allow them to go after any assets the company has on U.S. soil and, potentially, allow them to seize the company’s shipments as well. The case was brought by a group of Virginia homeowners, who are seeking $2.5 million in damages, and a ruling is expected in the near future. While any decision will be limited to this one group of plaintiffs, it could have an impact on hundreds of Chinese drywall lawsuits filed by other homeowners in various states.

According to the U.S. Consumer Product Safety Commission (CPSC), federal investigators have received nearly 3,000 complaints from across the United States from homeowners who say that toxic wallboard from China releases sulfuric odors, causes health problems, and corrodes wiring and appliances. Many of the problems with the Chinese drywall have been confirmed by laboratory testing.

Millions of sheets of toxic drywall were imported from China into the United States between 2004 and 2007, due to a domestic shortage caused by a housing boom and construction following a serious of hurricanes that struck the southeastern United States. The CPSC has confirmed more than 6 million sheets were imported into the country in 2006, and additional temporary support personnel are being brought in to verify more shipments.

A number of homeowners throughout the United States have filed contaminated Chinese drywall lawsuits against manufacturers and distributors. In June 2009, all of the federal drywall litigation was consolidated and centralized in an MDL, or Multidistrict Litigation. The cases were assigned to Judge Fallon, who has put the litigation on a “fast track.”

A new study into the side effects of BPA (Bisphenol A) indicate that there may be a link between the ubiquitous plastic bottle chemical and the development of asthma. 

The findings of a study by U.S. researchers from across the country were presented this weekend at the American Academy of Allergy, Asthma & Immunology’s annual meeting in New Orleans, Louisiana. Researchers found that mouse pups born to mice who had been exposed to at least 10 micrograms of BPA were more susceptible to developing allergic asthma. The study is likely to further increase concerns about the safety of BPA exposure, especially among young children and pregnant women.

BPA is used to make many plastic products hard and shatterproof. Originally developed as a form of synthetic estrogen, it is used in the manufacture of many consumer products, such as bottles, cans, cups, baby bottles and other food containers.

While BPA has been linked to asthma in mice in the past, the latest study is the first that studied specific dosages. The researchers exposed female mice to 0.1, 1, and 10 microgram per milliliter doses of BPA before, during and after pregnancy. Researchers indicated that mice are accepted as good scientific models for asthma and allergy effects on humans, which they say means that the results of the study should be cause for concern.

Exposure to BPA is suspected of causing hormonal changes by impacting the human endocrine system. It has also been linked to cancer, heart disease, diabetes, and obesity. Some research has suggested that BPA can cause developmental abnormalities and other problems over time in infants and young children.

In January, the FDA recommended that parents take “reasonable steps” to reduce infant exposure to BPA. The FDA is conducting a health risk review of BPA, despite having deemed the material safe previously. The BPA re-evaluation was started in June after the agency received substantial criticism from outside groups, politicians and its own scientists.

Many retailers, such as Wal-Mart and Toys “R” Us, have already voluntarily decided to stop selling baby bottles that contain the BPA chemical, and many of the largest manufacturers of baby bottles, such as Avent, Evenflo, Disney First Years, Platex, Gerber and Dr. Brown, have voluntarily agreed to stop making baby bottles with BPA as well.

There are also growing calls for a ban on the use of BPA by states, municipalities and by federal lawmakers. U.S. Senator Charles Schumer has introduced legislation intended to ban BPA in infant products, and there are bills calling for BPA bans currently under consideration in several states. Last week, the state of Maryland banned BPA in cups and bottles used by children ages 4 and younger. The state of Minnesota and the city of Chicago have already passed BPA bans.

An Illinois jury awarded $17.87 million last month to a Bloomington woman who says she contracted mesothelioma cancer from asbestos exposure in a local factory nearly 50 years ago. The mesothelioma lawsuit verdict included a rare award of punitive damages as a result of the defendants’ failure to warn employees and customers about the known hazards of absestos.

The case was filed by Jayne Menssen, claiming that Penumo Abex LLC and Honeywell International Inc., as well as companies they evolved from, knew about the dangers of asbestos exposure, but failed to issue warnings or take precautions to protect employees. Menssen worked as a secretary from 1967 to 1969 at Union Asbestos and Rubber Co., which later became known as Unacro Industries Inc.

Mesothelioma is a rare form of cancer found in the lining of the chest and lung. The only known cause of mesothelioma is asbestos exposure, and it is often not diagnosed for 20 to 40 years after exposure. As a result of the long latency period, the cancer is very advanced when it is diagnosed and life expectancy with the disease is limited.

Asbestos was widely used in a variety of manufacturing and construction applications throughout the last century, with use peaking in 1973. Most uses of asbestos were banned in the United States in the mid-1980s. Despite the ban, the U.S. Centers for Disease Control and Prevention says that the number of mesothelioma deaths continues to rise each year due to the latency period, with the number expected to peak in 2010.

After a four week trial and a day of deliberations, a McLean County jury returned an award in Menssen’s case on February 8, according to a report in The Pantagraph. The verdict included $3.5 million in compensatory damages against both the defendants, but the jury also leveled punitive damages of $4.37 million against Pneumo Abex and $10 million against Honeywell.

A jury assesses punitive damages against a defendant when it can be determined that the defendant acted in bad faith, either by specifically misleading or deceiving a plaintiff, intentionally doing harm, or by clearly knowing that their actions could lead to harm but performing those actions anyway. Punitive damages awards are rare in any lawsuit, but particularly rare in asbestos litigation, since in many cases the defendant’s actions occurred decades before the issue came to trial.

Asbestos litigation is the longest running mass tort in U.S. history, with the first asbestos exposure case filed in 1929. Over 600,000 people have filed lawsuits against 6,000 defendants after being diagnosed with mesothelioma, asbestosis or other asbestos-related diseases.

The County of Santa Clara in California has filed a lawsuit over Avandia against GlaxoSmithKline on behalf of both diabetes patients and health care providers, claiming that the drug maker falsely advertised the diabetes drug and concealed the increased risk of heart attacks and other side effects.

The case, filed in the U.S. District Court in San Jose, is believed to be the first government lawsuit against the company over the diabetes drugs. According to a report in the San Jose Mercury News, County officials said they had been planning the Avandia class action lawsuit for some time, but decided it was time to file after a U.S. Senate Finance Committee report last month revealed that some drug safety officials inside the FDA have called for an Avandia recall. The Avandia lawsuit cites estimates that the drug has caused between 60,000 to 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006.

The county itself said that it has been especially affected by Avandia problems because of a county-run hospital that spent $2 million on Avandia between 1999 and 2007 for patients, and also floated the bill for numerous patients who suffered heart attacks and other side effects of Avandia. County officials did not have an estimate of the number of patients in the county who took the drug or allegedly died due to Avandia.

Avandia (rosiglitazone) is a thiazolidinedione agent, a class of drugs approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years over concerns about the risk of Avandia heart problems.

In May 2007, a meta-analysis of 42 different clinical trials published in the New England Journal of Medicine suggested that users face an increased risk of a heart attack from Avandia. The FDA has since added a black box heart attack warning to Avandia.

The Senate report released last month charged GlaxoSmithKline with covering up the heart side effects of Avandia for as long as they could, and determined that the company intimidated scientists who spoke out about the problems. In the report, they cited a 2007 report from FDA drug safety reviewers who said that the health risks of Avandia outweighed the benefits and said the drug should be withdrawn from the market.

GlaxoSmithKline issued a rebuttal of the report last week, saying it was unfair and mischaracterized scientific studies of the drug’s risks and the company’s actions.

Glaxo 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 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, where the first trials are expected to begin this summer. County officials said that it is possible that the class action lawsuit over Avandia they filed will be made part of the MDL.

The American Dental Association (ADA) indicates that it is continuing to monitor issues surrounding problems with zinc denture cream, which has been linked with serious and debilitating injuries for some users.

In a statement issued February 19, the ADA points out that a number of recent case reports in scientific literature have described patients with ill-fitting dentures who suffered neurological and hematological problems after using excessive amounts of denture cream with zinc to keep their dentures in place. The ADA notes that while more information is needed in studies to show a causal relationship, swallowing zinc in denture creams can lead to low blood copper levels and neurological damage from zinc poisoning.

Last month GlaxoSmithKline, which manufactures Super Poligrip denture adhesive, announced that it is discontinuing all of its zinc-based denture creams, including Super Poligrip Original, Ultra Fresh and Extra Care. The products will be replaced with zinc free creams in the near future, the company has said. However, Proctor & Gamble, which manufactures Fixodent with zinc, has not indicated any plans to reformulate their product.

The ADA warned denture wearers to see their dentists if their dentures do not fit well, as studies indicate that the problems are linked particularly to patients who have ill-fitting dentures and use excessive amounts of denture cream with zinc.

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.

Zinc is believed to help with the adhesive properties of the denture creams. However, until recently neither GlaxoSmithKline or Proctor and Gamble had alerted users that zinc was an ingredient in their products.

A growing number of Super Poligrip lawsuits and Fixodent lawsuits have been filed against the manufacturers for failing to adequately warn about the dangers of zinc in denture cream products. All federal denture cream lawsuits have been centralized in a multidistrict litigation (MDL) for coordinated pretrial litigation in the U.S. District Court for the Southern District of Florida.

According to a new report from Public Citizen, a consumer and public policy watchdog group, payments for medical malpractice lawsuits are at an all-time low and have fallen steadily throughout most of the last decade, contrary to popular belief.

Public Citizen released the medical malpractice report last week in advance of Obama’s health care summit, indicating that medical malpractice litigation has fallen steadily throughout most of the last decade and the entire cost of medical liability is only 0.6% to 1.3% of the cost of national health care.

Utilizing data from the National Practitioner Data Bank and other sources, the report contends that the real dollar impact of litigation is being blown out of proportion by health care reform opponents seeking political points and takes away from changes that would actually make medical care safer and better for patients.

In addition to the database, Public Citizen analyzed the results of about seven years of Texas tort reform laws, the strictest in the nation. Public Citizen’s findings suggest that the cost of health care in Texas skyrocket 50% faster than the national average after the reforms were enacted, and Texas still has the highest percentage of uninsured residents in the nation.

“Setting the clear moral implications aside, lawmakers who think medical malpractice litigation is a place to look for significant cost savings are simply mistaken. Medical malpractice litigation is already rare,” the report states. “Most of the compensation goes to seriously injured people who need lifelong medical care as a result of their injuries or to the families of patients who died due to negligence.”

The results of the data from the national database indicate that the number of medical malpractice payments on behalf of doctors in 2008 was the lowest it’s been since reliable records were made available in 1991. Payments for the first three quarters of 2009 were lower than those of 2008, suggesting that 2009’s numbers would be even lower. Fourth-quarter data was unavailable.

Public Citizen’s report, and previous reports released by the organization, urge lawmakers to address the quality of health care in the country, thus reducing the need for medical malpractice lawsuits and saving lives.

“The best course is clear,” the report concludes. “Policymakers from both parties should set their partisan instincts aside and reduce patients’ needs to seek redress instead of limiting their rights to it.”

Federal law enforcement officials have leveled criminal charges against Guidant LLC, a medical device manufacturer that Justice Department officials say knowingly sold defective defibrillator implants to consumers and then tried to cover up attempts to correct the defect.

Department of Justice (DOJ) investigators filed charges against Guidant on February 25 in federal court in St. Paul, Minnesota, after a four-year investigation into several models of the company’s implantable cardioverter defibrillators (ICDs). The charges allege that Guidant hid information from the FDA regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs which in some cases resulted in death.

Guidant LLC is a subsidiary of Boston Scientific, which announced last November that it intends to pay $296 million in connection with the charges against Guidant. A DOJ press release announcing the charges indicates that Boston Scientific is likely to enter a guilty plea in connection with the charges.

ICDs are implants that monitor patients for abnormal heart rhythms and deliver electric shocks to keep the heart beating at the proper rhythm. The DOJ charges claim that Guidant was aware as early as 2002 that the Ventak Prizm 2 DR had the potential to suffer an electric arc, which could short-circuit the device, making it unable to provide life-saving heart rhythm corrections when the patient needed it.

The DOJ accuses the company of changing the design to fix the problem, and then lying to the FDA about the design changes to cover up the fact that there was a problem. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law, and even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.

The FDA determined that the warnings constituted Class 1 medical device recalls, the most serious category of recalls, which indicate that a product has the probability of causing serious injury or death.

“The government charges that Guidant committed serious crimes by undermining the FDA’s role to guard the American public against potentially dangerous medical devices,” said Assistant Attorney General Tony West in the DOJ statement. “Our message is clear: We will vigorously prosecute individuals and organizations who put profit over public health and safety by violating the law.”

The DOJ has put up a website for those who have been implanted with Guidant ICDs. The site contains case-related information, and notices of court events and hearings. The website is http://www.justice.gov/civil/ocl/Cases/Guidant/index.htm.

Breaking a five-case losing streak for Pfizer, Inc., a Philadelphia jury ruled late last week in favor of the drug company and its subsidiary, Wyeth, in a Prempro breast cancer lawsuit. While the jury did find that the company failed to adequately warn about the risk of breast cancer from Prempro, the plaintiff failed to establish for the jury that the hormone replacement therapy (HRT) was the cause of her breast cancer.

The ruling, which was returned in a case filed by the family of Cheryl Foust, came only days after a different Philadelphia jury awarded nearly $10 million in compensatory and punitive damages in another breast cancer lawsuit over Prempro.

This is the fourth victory for the drug makers out of 11 cases that have gone to trial so far. However, there are an estimated 9,000 cases still pending, and many of the losses have involved substantial punitive damage awards designed to punish the drug makers for hiding the risk of breast cancer associated with Prempro.

Prempro is a hormone replacement therapy (HRT) that contains a combination of the drugs Provera and Premarin. The drug was originally developed by Wyeth, which was acquired by Pfizer last year. HRTs use 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.

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 most of the hormone replacement therapy breast cancer lawsuits currently pending throughout the country. All of the cases involve similar allegations that the drug maker was aware of the risk and kept it from doctors, causing plaintiffs to develop breast cancer.

Foust died in 2005 at the age of 56 from breast cancer. She had taken Prempro for about four years before being diagnosed with the disease in 2003. Although the jury held that Wyeth failed to adequately warn Foust’s prescriber about the risk of Prempro side effects and that the failure to warn was a factor in the decision to prescribe the medication, the jurors determined that it was not proven that Foust’s breast cancer was caused by Prempro.

A Class 1 recall has been issued for the StatSpin Express 4 Centrifuge, which FDA officials say can malfunction and send parts of the rotor and potentially contaminated blood flying out of the device.

The FDA alerted health care officials to the StatSpin centrifuge recall last week after StatSpin, Inc., the manufacturer, sent a letter to its distributors warning them of the defective centrifuges.

According to the FDA recall notice, the rotor of the centrifuge can break and separate from the motor, damaging a safety switch meant to shut the centrifuge down in case of a problem. The rotor pieces can explode out of the centrifuge housing, which could threaten bystanders with small shrapnel and potentially tainted blood from shattered blood vials in the centrifuge.

The recall is a Class 1 medical device recall, which means that the FDA has concluded that the defective device has a reasonable possibility of causing serious injury or death.

The recall affects the StatSpin Express 4 Centrifuges, model #510, with serial numbers of 00100 through 001679. The centrifuges were distributed from November 2007 through January 2010 by StatSpin, Incl, doing business ass IRIS Sample Processing.

The company itself first issued the recall on January 27, and then sent a letter to its distributors in early February. The FDA sent out the letter to healthcare professionals alerting them to the recall last week. There have been no reported injuries or deaths related to the defective centrifuges, which are used to spin blood to separate the blood from plasma.

Anyone using the centrifuges should contact the company at 1(800)782-8774, Users can return the devices to have an upgrade kit installed or have an upgrade kit sent to them to be installed by a trained technician.

About 14,000 packages of OneTouch SureStep Test Strips, used to measure blood glucose levels in people with diabetes, have been recalled because they could provide incorrect information about blood glucose levels.

The glucose test strip recall was announced in late last week by the FDA and the manufacturer, Lifescan. The FDA warns that glucose blood levels above 400 mg/dL can cause the strips to give falsely low glucose results.

Although there have been no reported injuries in connection the defective OneTouch SureStep glucose test strips, patients who receive inaccurately low results may give themselves too low of an insulin dose. A low insulin dose can cause poor blood glucose control and could cause the patient to be unaware of dangerously high blood glucose levels. High blood glucose levels can lead to serious injury, coma and death.

Symptoms of high blood glucose levels can include thirst, frequent urination, headaches, problems concentrating, weakness and fatigue.

The recall affects eight lots of OneTouch SureStep Test Strips sold directly to consumers and some SurestepPro Test Strips sold to healthcare facilities. The recalled lots include 100-count OneTouch SureStep Test Strips with lot numbers 2969251, 2969798, 2982369 and 2983467; and 50-count OneTouch SureStep and Medicare/Mail Order strips with lot numbers 2969795, 2982566, 2969481 and 2998193.

The lot numbers are located on the outer carton and the test strip vial. The strips were distributed nationwide between August 1, 2009 and January 28, 2010.

Users who have test strips from the recalled lots should contact LifeScan to request replacement products free of charge. Consumers who have access to glucose testing meters that use different test strips should use those meters while waiting for replacements to arrive. If no other meters are available, consumers should continue to use the recalled test strips, but should contact their healthcare professional if they get a reading of 400 mg/dL, because their blood glucose levels may actually be much higher.

The company says it has contacted healthcare facilities who used the test strips in various meters and have informed them of the problem.

According to a new analysis of serious, disabling and fatal adverse events reported to FDA during the third quarter of 2009, the controversial diabetes drug Avandia was associated with the most reports, followed by the antipsychotic drug Seroquel.

The analysis, which was released Thursday by the Institute for Safe Medicine Practices (PDF), found that a total of 29,865 adverse event reports were received by the FDA during the quarter. This was an 8.4% increase over the number of reports filed during the third quarter of 2008.

There were a more than 1,200 reports received during the quarter involving severe or fatal side effects of Avandia, most of which involved cardiovascular problems. Coming in second, Seroquel side effects generated 977 adverse event reports. The only other drugs that received more than 500 reports during the third quarter were Lioresal and Fentanyl, with 796 and 688 reports respectively.

Both GlaxoSmithKline and AstraZeneca claim that the high number of reports connected with their drugs were caused by thousands of Avandia lawsuits and Seroquel lawsuits being pursued by former users who allege that the pharmaceutical companies failed to adequately warn about health risks associated with the drugs.

Avandia (rosiglitazone) is a thiazolidinedione agent, a class of drugs approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years over concerns about the risk of Avandia heart problems.

This week, the Senate Finance Committee issued a blistering report, accusing GlaxoSmithKline of hiding information on Avandia heart attack risk and intimidating scientists and doctors. The FDA has announced it is continuing to conduct an Avandia safety review amid calls from many for the federal agency to issue an Avandia recall.

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.

AstraZeneca faces about 26,000 lawsuits that allege the drug causes weight gain and diabetes, which plaintiffs maintain that the company knew but did not reveal to doctors and patients. The first Seroquel trial began last week.

Even though it did not appear on the list, the Institute made special mention in its executive summary about reports of injuries associated with over-the-counter nasal sprays and gels sold under the Zicam label. A Zicam recall was issued last summer after the FDA warned that the zinc-based sprays and gels were causing anosmia, a loss of the sense of smell. Although the FDA had received only 130 complaints, an investigation of the manufacturer, Matrixx Initiatives, Inc., turned up more than hundreds of unreported anosmia complaints from customers that the company failed to turn over to FDA as required by federal regulations.

The institute says more action is needed from FDA to find out the true scope of the Zicam problem.

“Further study is required to determine how many people permanently lost their sense of smell as a result of these withdrawn products,” the report states. “We recommend that the FDA Commissioner’s office conduct an independent review of the Zicam products episode for its implications for regulatory law, enforcement policy, and the possibility that other dangerous compounds may still be in widespread use.”

Zicam was sold as a homeopathic product, and did not undergo FDA premarket safety reviews. However, the company must submit any future products to FDA for review before it can release them to consumers.

Matrixx Initiatives also faces a number of Zicam lawsuits by people who claim to have lost their sense of smell after using the nasal sprays and gels.

Oppenheimer & Co. has reached a settlement with New York Attorney General Andrew Cuomo to return $31 million in losses to investors who lost money on auction-rate securities.

The settlement of the Oppenheimer lawsuit, reached on Tuesday, will require Oppenheimer to buy back auction-rate securities from more than 1,246 investment accounts.

Cuomo sued the company on behalf of investors, saying that the company promoted the auction-rate securities market as a conservative, low-risk, short-term investment that was an easy-to-sell alternative to cash. However, the auction-rate securities market froze in February 2008, preventing investors from accessing their capital and resulting in large losses.

The $31 million settlement will not pay back all of the money lost by investors. The total value of the frozen auction-rate securities held by customers of the brokerage firm exceeds the company’s ability to pay it back. Accounts that are less than $1 million, including those held by individuals, charities and small businesses, will be eligible for $25,000 reimbursement payments.

Auction-rate securities are bonds that are bid on by investors and sold to those who will accept the lowest interest rate during auctions regularly held to determine the bonds’ rates. When banks withdrew their support for auction-rate securities, investors were unable to sell the bonds, freezing their assets.

Cuomo, the Securities Exchange Commission, and others have been pressuring brokerages to reimburse investors for the face value of losses they suffered as a result of investments in the ARS market.

The Oppenheimer settlement is the latest in a string of auction-rate securities victories Cuomo has reached with various firms, including Morgan Stanley, UBS, Merrill Lynch, and Goldman Sachs. He has settled with 13 different firms in all, and there are still pending lawsuits against a number of brokerages. Including this week’s settlement with Oppenheimer, firms have agreed to pay back nearly $100 million in losses to auction-rate securities investors.

Cuomo still has some major outstanding lawsuits, including a claim against Charles Schwab over $787.9 million lost by Schwab customers when the market froze. The Charles Schwab lawsuit, filed in August, brought to light recorded Schwab conversations of Schwab representatives promoting auction-rate securities as infallible cash equivalent investments. Cuomo has also said that the ignorance defense does not work for Schwab, as the company should have responsibly known the risks and should have trained its brokers accordingly.

The family of a girl who was diagnosed with cerebral palsy as a result of a birth injury has been awarded $23.3 million by a Minnesota jury after suing a hospital for waiting too long to perform a Cesarean section.

The Minnesota cerebral palsy lawsuit was filed against Rice Memorial Hospital and Affiliated Medical Community Center by Elise Rodgers, as a result of alleged negligence during the birth of her daughter, Kylie, in June 2007. According to a report by Minnesota Public Radio, Rodgers claimed that negligent medical care caused the girl to suffer severe brain damage because doctors failed to act quickly once the fetal monitor warned the child was being deprived of oxygen during labor.

The family argued that Kylie’s umbilical cord was compromised, and that doctors should have performed a Cesarean before she suffered permanent brain damage. Kylie, who now has cerebral palsy as a result of the negligent care, requires constant suctioning of her airway, sometimes as often as every three to five minutes, in order to survive, according to the lawsuit.

In a verdict handed down earlier this month by a Kandiyohi County jury, Rodgers was awarded $10 million for the child’s future medical expenses, $1.7 million for past medical expenses, $1.5 million for future lost earnings and $10 million for disability, emotional distress and pain.

Cerebral palsy can be caused by an injury to an infant’s brain before, during or shortly after birth. If the brain of a baby is deprived of oxygen, it can result in irreversible damage that leaves the child with developmental problems, loss of motor functions and other life-long injuries and disabilities associated with cerebral palsy. The condition is also commonly associated with seizures, sensory impairments and cognitive limitation.

Medical malpractice lawsuits for cerebral palsy are often filed when a medical mistake or series of mistakes occur during prenatal care or delivery that result in the child’s brain being deprived of oxygen for an extended amount of time.

A grand jury has indicted a Delaware pediatrician on charges that he sexually assaulted more than 100 children over the last decade, filming the attacks on his patients in the creation of child pornography.

Dr. Earl Bradley faces 471 counts of child rape and sexual exploitation in an indictment handed down on Monday, which claims he raped 103 children between 1998 and 2009 and videotaped the attacks. All of the children were under the age of 16 and Bradley’s pediatric patients. In some cases, the alleged victims were only months old, and some children were raped on multiple occasions as parents and guardians brought them back to Bradley for medical care. All but one of the child abuse victims were girls.

Bradley, 56, conducted the attacks at his Lewes, Delaware, practice, BayBees Pediatrics, according to Delaware Attorney General Beau Biden, son of U.S. Vice President Joe Biden. Prosecutors say that Bradley’s sexual attacks were so vicious that at least five female victims passed out during the assaults. Legal experts across the country say they cannot recall a case where one child sexual predator had so many victims. Police are still struggling to identify some of the children from hours of video seized from Bradley’s home and office.

Bradley, who was arrested in December and is being held in lieu of $2.9 million bail, has been investigated twice before, in 2005 and 2008, for alleged claims of excessive kissing and improper vaginal exams, but the investigations did not lead to an arrest, and there was no report submitted to the state’s medical board.

Police have seized 13 hours of video, computers, hard drives and patient files from his home and medical office. The state’s medical board has also revoked Bradley’s license to practice medicine in Delaware.