Author: AboutLawsuits

Some flavors of Herr’s potato chips and Pringles crisps have now joined a growing list of food products that have been hit by a vegetable protein recall issued over salmonella contamination, which the FDA now says could have been avoided.

On March 8, Proctor and Gamble, which manufactures Pringles potato crisps, and Herr Foods Inc. recalled some of their snacks due to the risk of salmonella poisoning. In both the Herr’s and Pringles recall cases, the potato chips were flavored with hydrolyzed vegetable protein (HVP), supplied by Basic Food Flavors.

The latest products hit by the Basic Food Flavors recall include:

• Pringles Restaurant Cravers Cheesburger flavored potato crisps, with “Best by” dates of 02/2011 and 04/2011.
• Pringles Family Faves Taco Night flavored potato crisps, with “Best by” dates of 03/2011, 04/2011 and 05/2011
• Herr’s Cracked Pepper and Sea Salt Flavored Kettle Style Potato Chips, in 8.5 oz. bags with code dates of Feb 27, 2010 through MAY 15, 2010.
• Herr’s Cracked Pepper and Sea Salt Flavored Kettle Style Potato Chips in 1.875 oz bags with code dates of Feb 27, 2010 through June 12, 2010.

Proctor and Gamble says in a press release sent out this week that it issued the Pringles crisps recall after one supplier alerted the company to the use of the recalled HVP in the two brands. The recalled Pringles were only sold in the United States. The Herr’s potato chip recall was announced on Monday by FDA. No illnesses have been reported in either recall.

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. Over the last three weeks the FDA has announced recalls for a variety of products that used Basic Food Flavors HVP, including T. Marzetti vegetable dips, and Castella Chicken Soup, among numerous others. All of the recalls stated that they were being pulled due to fears of salmonella food poisoning from HVP.

FDA has released a letter it sent to Basic Food Flavors (pdf) which indicates that investigators have determined that the company knew its products were contaminated with salmonella, but continued to distribute tainted HVP to unwitting customers for about three weeks.

The FDA letter states that Basic Food Flavors received a private laboratory analysis indicating the presence of salmonella in its facility on January 21, 2010, but continued to manufacture and ship out HVP paste until February 15 using the same processing conditions.

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.

Salmonella Tennessee is a rare strain of salmonella, known primarily for being the strain that caused the February 2007 peanut butter recall.

U.S. District Judge Inge Prytz Johnson, who is presiding over the consolidated federal Chantix lawsuits, has established a discovery plan for the exchange of information during pretrial litigation, which seems to indicate the the first Chantix trial is unlikely to reach a jury until at least 2012.

All lawsuits filed in federal court against Pfizer over alleged side effects of Chantix, their popular smoking cessation treatment, have been centralized for pretrial litigation before Judge Johnson in the U.S. District Court for the Northern District of Alabama as part of a multidistrict litigation (MDL). The cases involve similar allegations that Pfizer failed to adequately research their medication or warn about the risk of suicide from Chantix or other psychological side effects.

When the Chantix litigation was consolidated in October 2009, there were 34 lawsuits pending in different federal district courts throughout the United States. Since then, several dozen more cases have been transferred into the MDL. In addition, Chantix lawyers are continuing to investigate hundreds of other potential cases that are expected to be filed in the coming months.

According to a Pretrial Order issued February 24, Plaintiffs and Defendants with Chantix cases in the MDL will produce documents, exchange information about their cases and conduct depositions between now and the end of 2011.

“This Joint Coordinated Plan of Discovery is intended to conserve judicial resources, eliminate duplicative services by all counsel and co-counsel, eliminate duplicative discovery, serve the convenience of the parties and the witnesses, and promote the judge and efficient conduct of this litigation,” wrote Judge Johnson in the Order.

The discovery plan calls for plaintiffs to provide Fact Sheets about their case within 60 days of the order, and individuals who file a lawsuit over Chantix in the future must complete the Plaintiffs’ Fact Sheet within 60 days of their case being docketed in the MDL. Defendants will produce documents relevant to the cases between now and August 2010, with the first depositions of Pfizer employees allowed to begin in September 2010. Depositions of individual plaintiffs, family members, physicians, sales representatives and other third party witnesses will begin in December 2010.

Expert witnesses must be designated by April 2011 and May 2011, for the Plaintiffs and Defendants respectively, with expert depositions set to begin in July 2011 and conclude by October 3, 2011. Motions practice on general causation and liability will then occur through the end of 2011, with case specific expert discovery not permitted to begin until after the Court decides the issues that are generally applicable to cases in the litigation.

“The Parties shall meet and confer at a later date, once discovery that is the subject of this Plan is substantially complete, to discuss a schedule for further case specific discovery,” ordered Judge Johnson. “Until that time, absent court order, no discovery other than that permitted by this Plan may be conducted.”

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

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

British regulators say that some of AstraZeneca’s claims about the potential weight gain side effects of Seroquel constituted a breach of ethics under that country’s pharmaceutical codes of conduct. 

On Monday, the Prescription Medicines Code of Practice Authority concluded that AstraZenca acted in a deceptive manner in at least one Seroquel ad published in the U.K. more than five years ago, which claimed that the drug did not cause as much weight gain as other antipsychotics. The authority says that the statement did not match the known evidence about the risk of weight gain and other Seroquel problems that AstraZeneca had on hand at the time the ad was published.

The UK panel highlighted an advertisement in the British Journal of Psychiatry in 2004, which claimed in large print that Seroquel had a favorable weight profile. The panel concluded that the advertisement was misleading, because the studies AstraZeneca used to support the claim were faulty, which the drug maker should have known. The ad was determined to have violated the requirement that all claims be accurate, fair and able to be substantiated.

The ethics violation ruling comes as the company faces about 26,000 Seroquel lawsuits in the United States, all of which claim that AstraZeneca failed to adequately warn users about the risks of weight gain from Seroquel, which can lead to diabetes and other serious injuries.

The first Seroquel trial is currently underway in New Jersey state court.

What AstraZeneca knew about the weight gain effects of Seroquel is expected to take center stage in this case, as well as other lawsuits pending in state and federal courts throughout the U.S. Internal documents produced during the Seroquel litigation suggest that the drug maker was aware of the potential weight-gain Seroquel side effects and continued to promote the drug as weight-neutral for years after clinical evidence demonstrated significant problems that could lead to diabetes and other injuries.

The drug maker has racked up $656 million in legal defense costs fighting the failure-to-warn lawsuits over Seroquel. In addition, Seroquel lawyers continue to file new cases for individuals who have developed diabetes, pancreatitis and a rare movement disorder known as tardive dyskinesia, so the cost of the litigation is expected to continue to increase.

Federal prosecutors have opened a criminal investigation into Wyeth’s promotions and marketing activities involving the organ transplant drug Rapamune.

Pfizer, which purchased Wyeth last year, announced in a regulatory filing on February 26 that it was under investigation by the U.S. Attorney’s office for the Western District of Oklahoma. Pfizer officials did not provide any further details on the potential allegations, and federal prosecutors declined to comment on ongoing investigations.

Rapamune (sirolimus) is an immunosuppressant that prevents the body from rejecting organs after transplant surgery. The drug generated $376 million in sales in 2008.

It is most often used in kidney transplants for hemolytic-uremic syndrome, which can reoccur in a transplanted kidney. However, the drug is also commonly prescribed off-label for liver transplants as well. It is illegal for drug companies to promote medications for off-label uses, even though doctors can prescribe approved medications for any purpose they feel is appropriate.

The new charges come after Pfizer agreed last year to pay $2.3 billion to settle charges that it illegally marketed the painkiller Bextra and other drugs. That settlement included the largest criminal fine in U.S. history, $1.195 billion. The fine was specifically for off-label promotion charges.

That Pfizer settlement followed a four-year investigation into the company brought about after whistleblower lawsuits were filed alleging that Pfizer was defrauding the government. The agreement was reached in September, including a corporate integrity statement in which Pfizer promised federal prosecutors that the company would toe the line on off-label promotion restrictions.

In June 2009, the FDA issued a warning to transplant doctors that Rapamune side effects could increase the risk of death in liver transplant patients after a study found that the chance of liver rejection was “significantly higher” for stable liver transplant patients who switched from a calcineurin inhibitor (CNI)-based immunosuppressive treatment to Rapamune.

The FDA already requires that Rapamune carry a “Black Box” warning advising against its use immediately after a liver transplant.

The FDA has approved a name change for the heartburn drug Kapidex, after receiving reports of pharmacists confusing it with other drugs.

Approved by the FDA in January 2009, Kapidex (dexlansoprazole) is a proton pump inhibitor approved for treatment of heartburn and acid reduction. It is manufactured by Takeda Pharmaceuticals North America, Inc.

The FDA name change approval was issued on March 4, indicating that Kapidex will become known as Dexilant in late April. The medication will also receive a new National Drug Code number, but no other changes will be made to the drug.

The Kapidex name will be changed to avoid medication errors where it may be confused with AstraZeneca’s Casodex, which is used to treat prostate cancer by reducing male hormones, or Actavis’s Kadian, a morphine-based pain killer.

Although there have been no reports of injuries or deaths associated with mixing up the medications, incorrect use of Kadian (morphine sulfate extended release) in particular could lead to a morphine overdose if it were confused for heart burn pills. Morphine is an opioid which can lead to a fatal overdose if too much medication is taken. A morphine overdose can cause respiratory depression and low blood pressure.

The confusion over medication names was identified as part of the FDA’s Safe Use Initiative, which started in November. The initiative is designed to reduce the number of preventable medication errors.

FDA officials said all drug names are evaluated before they go on the market, and FDA reviewers did not expect Kapidex to be confused with Casodex or Kadian.

According to the Institute of Medicine and FDA, there are 1.5 million preventable medication injuries in the U.S. each year, which add an additional $4 billion to the cost of health care. About 60,000 children are seen in emergency rooms nationwide each year due to accidental drug ingestion.

Drivers of some vehicles modified as part of the Toyota gas pedal fix, are telling federal regulators that the changes may not have resolved the uncontrolled acceleration issues with Toyota vehicles. 

According to the National Highway Transportation Authority (NHTSA), investigators are contacting Toyota drivers who are complaining that the fix, meant to solve problems with sudden acceleration in Toyota vehicles, is not working. Toyota Motors Corp. officials said last week they had been made aware of the reports by U.S. authorities.

Toyota has recalled more than 8 million vehicles since September 2009 due to problems with unexpected, sudden acceleration. The NHTSA says at least 52 people have been killed in crashes caused by Toyota gas pedal problems.

During the first wave of Toyota recalls in September, Toyota officials blamed the problem on thick floor mats that could jam under the pedal. However, the Japanese automaker later recalled millions more vehicles when it was discovered that, in some cases, the gas pedal itself was getting stuck without the floor mats. Consumers and some critics say they believe the problem is actually an electronics issue, but Toyota has dismissed such claims, saying that its own investigations have shown no sign that the acceleration problems are electronic in nature.

More than 60 people who received a gas pedal fix for their Toyota vehicle say that they are still experiencing unintended acceleration. However, most of the reports are unverified.

“If it appears that a remedy provided by Toyota is not addressing the problem it was intended to fix, NHTSA has the authority to order Toyota to provide a different solution,” the NHTSA said in a statement to news agencies.

The Toyota gas pedal problems have been associated with dozens of accidents and a number of serious and fatal personal injury claims. The incidents have touched off a wave of Toyota product liability lawsuits, including several wrongful death claims, and a number of Toyota class-action suits.

Later this month, the U.S. Judicial Panel on Multidistrict Litigation will decide whether to consolidate all federal lawsuits against Toyota into a multidistrict litigation (MDL), where the cases will be centralized in one federal court for pretrial litigation.

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

Financial analysts estimate that the pharmaceutical giant GlaxoSmithKline could face up to $6 billion in liability as a result of Avandia injury lawsuits filed over side effects of its diabetes drug, which has been linked to an increased risk of heart attacks, heart failure and other health problems.

UBS analyst Gbola Amusa issued the estimate in response to concerns caused by the release of a scathing U.S. Senate Committee report last week about problems with Avandia. Since then, the FDA has indicated that the agency is continuing to review the safety of Avandia, which many critics have argued should result in an Avandia recall.

Amusa indicates that since the drug currently only contributes about 1% to GlaxoSmithKline’s sales, the primary concern for the company stems from the liability it may face from the more than 13,000 Avandia suits that have been filed so far. The range of liability is currently estimated to fall between $1 billion and $6 billion, with the cost to the drug maker possibly hitting the top end of the range if Avandia is removed from the market.

Avandia (rosiglitazone) was 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 side effects. Some experts have estimated that Avandia has caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006.

The suits allege that GlaxoSmithKline failed to adequately warn users about the increased risk of serious and potentially life-threatening injuries, such as heart attack, stroke, congestive heart failure, liver failure, bone fractures, macular edema (vision loss) and death.

Federal Avandia litigation is consolidated for pretrial proceedings in an MDL, or multidistrict litigation, in the U.S. District Court for the Eastern District of Pennsylvania, where the first trials are expected to begin in June. Amusa said that UBS would better be able to predict the drug maker’s liability for the personal injury lawsuits over Avandia once the first “bellwether” trials have completed, which will help narrow the range of liability.

Nissan has announced that it is recalling about 540,000 trucks, minivans and sports utility vehicles (SUVs) due to a faulty brake pedal and inaccurate fuel gauges. 

The Nissan recall, issued last week, affects certain 2005-2010 Infiniti Qx56, Xterra, Pathfinder and Armada SUVs, Titan and Frontier pickup trucks and Quest minivans. The company reports that in some of the models, a manufacturing error can cause the brake pedal pin to disengage from the pedal. The company has received at least three reports of the pins becoming partially disengaged, resulting in a loss of braking ability. However, there have been no injuries reported in connection with the defective brakes.

Some of the vehicles are also being recalled because Nissan found that the fuel gauges were giving incorrect readings on vehicles with high mileage. The problem could lead to drivers being unaware that they are low on fuel, causing them to unexpectedly run out of gas.

The Nissan fuel gauge and brake recall affects 539,864 vehicles worldwide, with 418,865 of those vehicles in the U.S. The brake problems affect 2008-2010 Infiniti QX56 and Armada SUVs, the Titan pickup truck and the Quest minivan. All of the same vehicles except the Quest are affected by the fuel gauge problem. A recall is also being issued for 2005-2008 Pathfinder and Xterra SUVs, as well as the Frontier pickup, due to the fuel gauge problem.

The recall hits Nissan, the third largest Japanese auto maker, as Toyota, Japan’s largest car manufacturer, is still reeling from recalling about 9 million of its vehicles due to gas pedal and brake problems. The Toyota recalls included pulling 437,000 Toyota Prius and Lexus HS250h’s from the streets due to brake problems caused by the hybrid vehicles’ software.

Nissan has sent recall notices to registered vehicle owners. The company warns that the brake problem could result in a crash and injury. The company suggests that vehicles with the fuel gauge problem face no real danger, and recommended that drivers of those vehicles keep the gas tank at least half full at all times until they can take the cars in to be fixed.

The company estimates that dealers will be ready to start taking vehicles in to inspect and repair them by March 22.

As a result of the investigation into a food poisoning outbreak linked to peppered salami, which has sickened 245 people nationwide, a recall has been issued for red and black pepper from two different spice companies.

The pepper recalls, announced on Friday by the FDA, affect black pepper sold by the Mincing Overseas Spice Company and red and black pepper distributed by the Wholesome Spice Company.

The FDA and the U.S. Centers for Disease Control and Prevention (CDC) have been investigating an outbreak of Salmonella Montevideo food poisoning linked to salami and other pepper-coated meats sold by Daniele Internationale Inc., of Rhode Island. A salami recall was issued for a number of Daniele Internationale products in January.

Both the Mincing Overseas Spice Company of Brooklyn, NY, and the Wholesome Spice Company of Dayton, NJ, are wholesale spice suppliers who do not sell pepper directly to customers. Both sold pepper to Daniele Internationale, which federal investigators say has tested as positive for the same strain of salmonella bacteria that has sickened 245 people in 44 states.

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

The recall affects two lots of black pepper from Mincing Overseas Spice Company sold in 50, 25, and 20-pound cartons. The company’s name is in the side of the cartons and the lot numbers are 3258 and 3309. The recalled black pepper was shipped to Florida, Iowa, Illinois, Indiana, Massachusetts, Oklahoma, New Jersey, New York, Pennsylvania, Rhode Island, Texas and Wisconsin.

Wholesome Spice Company has recalled ground red pepper and whole black pepper sold specifically to Daniele International, and on February 25 recalled crushed red pepper sold from April 6, 2009 through January 20, 2010 in 25-pound boxes.

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

Customers who received the recalled black pepper should stop using the pepper immediately and contact the supplier and an FDA recall coordinator to determine whether a sub recall of their products is needed.

A Class 1 medical device recall has been issued for Transseptal Sheath Introducer Kits by Thomas Medical Products, a subsidiary of General Electric’s healthcare division, because the sheath tips can break off during heart procedures, potentially causing permanent injury or death. 

The sheath introducer recall was announced by FDA on March 5, after Thomas Medical Products notified healthcare professionals last month about potential problems after receiving at least five adverse event reports. The FDA recall notice says that the sheath introducer kits have tips that can separate and potentially cause damage to the heart or move through arteries into the brain or other vital organs and cause blockages, damage and death.

The Transseptal sheath introducers are used to pass heart catheters through the middle heart wall from one side of the heart to another.

The sheath introducer recall affects 119 lots of Transseptal Sheath Introducer Kits distributed worldwide between October 1, 2006 and December 27, 2009. The kits were sold under brand names including HeartSpan, CHANNEL FX, Torflex, and the Braided Guiding Introducer kit. For a full list of lot numbers affected by the recall, see the Thomas Medical Products press release.

Class 1 recalls are the most serious classification of medical device recall, and are issued when the FDA believes that a problem could reasonably result in serious injury or death.

The Transseptal Sheath Introducer Kit recall is the fourth sheath pulled by Thomas in recent months. The company issued a Safesheath introducer recall in February, a Viper Sheath introducer recall in November, and a Cordis Crossover Catheter Sheath recall in October. All of the recalls involved manufacturing defects that could lead to pieces of the sheaths breaking off inside the body.

Customers who have recalled sheaths may contact the company at 1(866)466-3003. 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.

GlaxoSmithKline will issue a Poligrip recall in Japan for all of their denture cream products that contain zinc, due to the risk of serious and debilitating physical injuries that can be caused by using the adhesive cream to keep ill-fitting dentures in place.

The recall of Poligrip EX, the Japanese version of the popular denture cream sold as Super Poligrip in the United States, comes after U.K.-based GlaxoSmithKline acknowledged that zinc poisoning from the denture cream can cause serious health problems.

Last month, the company discontinued Super Poligrip with zinc in the United States, but has not issued a recall here. GlaxoSmithKline indicated that the U.S. products will be replaced with zinc-free versions.

The zinc contained in denture cream products can enter the body, especially when too much is used to keep dentures in place. 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.

Glaxo has only been selling Poligrip EX in Japan since 2007. It has sold about 1.9 million units there since marketing began.

A large number of denture cream lawsuits have been filed against GlaxoSmithKline over its Poligrip cream and against Proctor and Gamble over its Fixodent denture adhesive. About 70 cases filed in federal courts throughout the United States have been centralized in a denture cream multidistrict litigation (MDL) for coordinated pretrial litigation in the U.S. District Court for the Southern District of Florida.

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 wrongful death lawsuit against Toyota has been filed on behalf of a California state trooper and three of his family members who were killed when a Lexus ES350 experienced uncontrolled acceleration, and careened off the road. The fatal accident sparked much of the media attention on Toyota gas pedal problems that have resulted in the recall of millions of vehicles in recent months. 

The case was filed over an August 2009 accident that killed off-duty California Highway Patrol Officer Mark Saylor, his wife Cleofe, their 13 year-old daughter Mahala and Cleofe’s brother, Chris Lastrella.

At the time of the crash, Saylor was driving a loaner vehicle from a dealership while his car was being repaired. The Lexus accelerated out of control, reaching speeds as high as 120 m.p.h. before slamming into another vehicle and careening off an embankment.

While the car was accelerating out-of-control, Lastrella called 9-1-1- from inside the vehicle to get help. In addition, witnesses reported that the car’s wheels burst into flames as Mark Saylor stood on the brakes in an attempt to stop the vehicle.

Following the crash, investigators determined that the floor mats were the incorrect size for the car and got jammed under the accelerator. They also found that the brakes were ineffective in slowing the car.

The Lexus wrongful death lawsuit was filed in San Diego Superior Court on Tuesday by Saylor’s family. It names Toyota Motor Corp. and other Toyota entities in the U.S., as well as El Cajon Luxury Cars, Inc. as defendants.

Approximately one month after the accident, on September 29, Toyota announced a floor mat recall impacting 3.8 million Toyota and Lexus vehicles that contained a certain type of floor mat on the driver’s side that could cause the accelerator to stick.

The Japanese automaker later recalled millions more vehicles when it was discovered that, in some cases, the gas pedal itself was getting stuck without the floor mats. The Toyota gas pedal problems have been associated with dozens of accidents and a number of serious and fatal personal injury claims. The incidents have touched off a wave of Toyota product liability lawsuits, several other wrongful death claims, and a number of Toyota class-action lawsuits.

Later this month, the U.S. Judicial Panel on Multidistrict Litigation will decide whether to consolidate all federal lawsuits against Toyota into a MDL under one federal court for pretrial litigation. Unless the Saylor lawsuit is transferred to federal court, it would likely remain a separate California state lawsuit.

Chris Lastrella’s mother, Fe Lastrella, testified before the U.S. House Oversight and Government Reform Committee last week during a hearing over the Toyota recalls. The company’s actions have been highly criticized, as documents and other evidence suggest that the company knew of the sudden acceleration problem long before the deaths and the recall.

During the hearing, Akio Toyoda, the company’s president and grandson of the company’s founder, personally apologized to Saylor’s family.

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.

Health care professionals are warning of increasing signs of problems with metal-on-metal hip implants, which could affect up to 3 percent of all recipients.

The warnings, highlighted in a story by the New York Times, come from surgeons and hip specialists who say that metal particles shed into the body as the hip implants wear down can cause complications. A number of studies have brought attention to the problem as the popularity of the metal hip implant parts has spread in recent years.

The “metal on metal” hip implants account for about one-third of the 250,000 hip replacements performed each year in the U.S. They became popular due to the belief that the metal structure, usually chromium or cobalt, would be more durable than other types of hip implants. However, after a series of studies over the last couple years, surgeons are warning that one to three percent of all metal on metal hip implant recipients may experience hip failure, and possibly need to have the devices replaced, due to metallic debris.

The metal particles are shed into the body as the devices wear down, particularly in the ball-and-socket joints. The metal particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.

Last year, U.K. researchers studied 660 patients who had received metal hip implants from DePuy Orthopaedics and found that 3.4 percent suffered from adverse reactions to metal debris.

Canadian researchers also reported last year that patients who received the Zimmer Durom hip replacement system had different levels of metallic ions in their bloodstream than people who did not have the implant. Researchers found that Zimmer Durom Cup recipients had much higher levels of chromium and cobalt in their blood than those who underwent other procedures.

Zimmer already faces a number of lawsuits over other problems with the Zimmer Durom Cup hip implant. A temporary Zimmer Durom Cup recall was previously issued in 2008, due to a high number of hip replacement failures associated with the product. Sales were suspended during the Durom Cup recall and the product was reintroduced with new warning labels and instructions for surgeons on techniques needed to avoid the risk of complications. The Canadian study, underwritten by Zimmer, called for revised Zimmer Durom Cup to be recalled as well.

A number of plaintiffs have filed Zimmer Durom Cup lawsuits alleging they had experienced cup failures, leaving them in constant pain and requiring additional medical treatments and surgery.

All of the major orthopedic medical device companies manufacture their own version of “metal on metal” hip implants, and several have said that the metallic debris problem does not pose a significant risk. However, an increasing number of orthopaedic surgeons and experts disagree. In a recent editorial in the Journal of Arthroplasty, the medical journal warned doctors to avoid the use of the metal hip implants, and said they should only be used “with great caution.”

A panel of outside advisers to the FDA are scheduled to meet today to review what steps the regulatory agency might take to reduce the risk of potentially serious problems for diabetics caused by insulin pumps. The FDA has noted a disturbing number of problems with insulin pumps, which are growing in popularity.

Insulin pumps are small medical devices worn by Type 1 diabetics that provide an alternative to daily injections of insulin by syringe or an insulin pen.

According to information released this week in advance of an advisory panel meeting in Gaithersburg, Md., the FDA indicates that it has received nearly 17,000 adverse event reports involving insulin pumps since October 2006, with 310 involving the death of the person using the device. In addition, there have been a number of insulin pump recalls in recent years among different manufacturers, with 18 recalls for insulin pump products issued between October 2004 and May 2009.

Last summer, a recall was issued for Medtronic Paradigm insulin pump Quick Sets was issued after the company determined that about 60,000 infusion sets used with the pumps were defective and could give too much insulin to users due to an air pressure problem. A number of Medtronic insulin pump lawsuits have been filed over diabetic-related injuries resulting from the defective infusion sets. The FDA issued a warning letter to the company over its manufacturing processes, noting that it had quality assurance problems and that the on-site medical professional hired to determine if there was a medical problem with the devices had only a high school diploma.

In an infusion set background report (pdf) issued to the FDA’s General Hospital and Personal Use Devices Panel, reviewers noted that the problem was not limited to Medtronic.

“Device problems critical to insulin pumps exist across manufacturers,” the report notes. Reviewers also said that the device manufacturers have failed to identify problems in the bulk of the adverse event reports they have received from insulin pump users, and in a large number of reports, it appears the manufacturers did not even try. Insulin pump manufacturers also have failed to investigate cause of deaths associated with their devices.

FDA reviewers found that the most common cause of death and injury from the use of either defective insulin pumps or from using them incorrectly was hypoglycemia; lower than normal blood glucose. However, the FDA also has identified a growing number of insulin pump-related automobile accidents.

Between 2006 and 2009, there were at least 29 adverse event reports of motor vehicle accidents associated with insulin pumps. In some cases, drivers wearing insulin pumps and suffering from low glucose levels lost consciousness or died while driving and crashed into other vehicles, drove off the road, into lakes, and even slammed into buildings at high speed.

FDA officials say that a string food recalls due to a vegetable protein contaminated with salmonella highlight the need for congress to give the agency more power to prevent food poisoning outbreaks. 

In an FDA news release about the ongoing recall of products using hydrolyzed vegetable protein (HVP) from Basic Food Flavors, Inc., agency officials say that they could have prevented the HVP recall if they had more enforcement and prevention authority. The vegetable protein recall, which has resulted in a wide variety of food recalls in the last two weeks, came after one Basic Food Flavors, Inc. customer reported to FDA that they had received HVP contaminated with Salmonella Tennessee.

“This situation clearly underscores the need for new food safety legislation to equip FDA with the tools we need to prevent contamination,” Dr. Jeff Farrar, associate commissioner for food protection in FDA’s Office for Foods, said in the press release. FDA officials repeatedly pressed home the link between the recalls and the need for more FDA authority in a phone conference with reporters this week as well, according to the Wall Street Journal.

Food safety legislation has been introduced in Congress, but the Senate version of the bill has stalled. FDA officials and supporters of the legislation say that the bill would give the agency the power to force companies to recall products, keep better records and increase the number of food manufacturing inspections the FDA can perform.

Over the last two weeks the FDA has announced recalls for a variety of products that used Basic Food Flavors HVP, including 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. All of the recalls stated that they were being pulled due to fears of salmonella food poisoning from HVP.

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.

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.

Salmonella Tennessee is a rare strain of salmonella, known primarily for being the strain that caused the February 2007 peanut butter recall.

A full list of products affected by this recall is available here.

A Philadelphia jury has awarded a firefighter $100,000 in a hearing loss lawsuit filed over the design of sirens used by the city’s emergency response vehicles. The case is one of several hundred similar lawsuits involving hearing damage for firefighters caused by Q-Sirens, made by Federal Signal Corp..

More than 600 firefighter hearing loss lawsuits in Pennsylvania state court are coordinated as a mass tort in the Philadelphia against Federal Signal. The product liability lawsuits allege that the Q-Sirens were negligently designed and unreasonably dangerous, because they emit an intense noise that can cause permanent hearing damage for firefighters over time.

After four days of deliberation, a Philadelphia Court of Common Pleas jury ruled in favor of firefighter Edward Smyl on Tuesday, in the first case to go to trial in the state. Smyl claimed to suffer hearing loss after working for the Philadelphia Fire Department between 1975 and 2007.

The jury found Federal Signal to be guilty of negligence and awarded $100,000 in damages, but disagreed with strict liability charges also filed by the plaintiff. According to a report in The Legal Intelligencer, the award will be capped at $75,000 under an agreement reached between the parties that kept the case in state court.

Federal Signal announced in a press release on Wednesday that it intends to appeal the verdict. The company says that the ruling against strict liability charges proves that the sirens were not defectively designed, and the award of damages on a negligence theory should be reversed.

In similar lawsuits over hearing loss among firefighters filed against Federal Signal throughout the United States, the company has been successful in defending many of the cases. A lawsuit filed by New York firefighters was dismissed, and the decision was upheld on appeal last summer. In addition, voluntary dismissals have been obtained for cases filed in Maryland, New Jersey and Missouri. However, the company reports that litigation is ongoing in Philadelphia and Chicago.

Bayer reports that it has reached settlement agreements with nearly half of the plaintiffs who have filed a Magnevist lawsuit, involving claims that the company’s gadolinium-based MRI contrasting agent caused users to develop a rare and potentially life-threatening condition, known as nephrogenic systemic fibrosis (NSF).

In its 2009 annual report, the company states that it has been served with approximately 310 nephrogenic systemic fibrosis lawsuits involving Magnevist, and settlements have been reached with approximately 140 of the plaintiffs. While Bayer indicates that it is not admitting liability in the cases, additional lawsuits are anticipated and the company will continue to consider the option of nephrogenic system fibrosis settlements on a case-by-case basis.

The cases involve allegations that Bayer was aware that side effects of gadolinium contrast agents like Magnevist could result in the debilitating condition for some users and failed to adequately warn users and the medical community about the risk of NSF.

Magnevist is one of five gadolinium based contrast agents manufactured by four different company. Other manufacturers have been named in the same or similar lawsuits over nephrogenic systemic fibrosis, with GE Healthcare’s Omniscan contrast agent associated with the most cases in the United States. Unlike Bayer, GE Healthcare has not indicated an intention to settle Omniscan cases.

Nephrogenic systemic fibrosis (NSF), which is sometimes referred to as nephrogenic fibrosing dermopathy (NFD), is only known to occur after exposure to a gadolinium-based contrast agent (GBCA) among individuals with impaired kidney function. The painful and disfiguring condition causes a hardening and thickening of the skin and other tissue throughout the body, severely restricting movement. There is no cure for the progressive disorder, and no consistently successful treatments are available.

The FDA ordered the manufacturers of all types of gadolinium MRI contrast agents to add a “black box” warning in 2007, indicating that individuals with severe kidney problems could develop NSF. In December, an FDA advisory panel of medical experts met to review the risk of NSF, and recommended that the warnings for Bayer’s Magnevist and GE’s Omniscan should be strengthened to indicate that they should not be used by patients with moderate to severe kidney problems. Although the FDA is not bound to follow the recommendations of their advisory panel, they usually do.

Although all types of gadolinium MRI contrast agents have been linked to NSF, reports suggest that the risk of NSF associated with Omniscan may be higher than other contrast agents. Many experts have argued that the warnings about the risk of NSF from Omniscan should be stronger than what is contained on the other contrast agents.

All federal gadolinium lawsuits have been consolidated in the U.S. District Court for the Northern District of Ohio as part of a multidistrict litigation (MDL), for pretrial litigation. The lawsuits target Bayer and GE, as well as Bracco Diagnostics’ MultiHance and ProHance, and Mallinckrodt’s OptiMARK.

The FDA has issued a Class 1 recall for several models of Baxter HomeChoice automated dialysis systems because of a defect that can cause the machines to overfill a patient’s abdominal cavity with fluid. Reports of at least one death and several serious injuries have been associated with the problems.

Baxter International Inc. and the FDA sent a letter to health care professionals on Wednesday notifying them of the Baxter HomeChoice dialysis machine recall. The FDA classified the action as a Class 1 medical device recall, meaning that the defective product has the likely potential of causing serious injury or death.

It has been confirmed that at least one death and several serious injuries have occurred among users of the dialysis machines that overfilled their abdominal cavities, causing a condition known as Increased Intraperitoneal Volume (IIPV).

Dialysis is used to replace kidney function in patients suffering from kidney failure. Peritoneal dialysis machines, like the Baxter HomeChoice and Home Choice Pro devices, pumps a sterile glucose solution into the abdominal cavity around the intestines, which absorbs waste products from the blood through osmosis before being drained out of the body. Peritoneal dialysis is known for its ability to be used at home by patients without assistance.

IIPV can cause a number of problems and potentially fatal injuries, including abdominal wall or diaphragmatic hernias, heart failure, acute hypertension, pulmonary edema, hydrothorax, decreased pulmonary function, pericardial effusion, and peritonitis. Children and non-verbal patients are considered to be most at risk. Children’s abdominal cavities are smaller and can be injured faster by IIPV than an adult, and non-verbal patients and children may not be able to adequately communicate that there is a problem.

According to a Baxter press release, signs of IIPV can include:

• Difficulty breathing
• Vomitting
• Feeling full or bloated
• Abdominal pain or discomfort
• Swelling of the genitals, belly button or groin
• Leakage of fluid from the peritoneal dialysis catheter
• Unexpected increase in blood pressure
• Children crying during therapy without apparent reason

The recall affects all Baxter HomeChoice Automated Peritonela Dialysis Systems with the product codes 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D, and 5C4474DR. The recall also affects Baxter HomeChoice PRO Automated Peritoneal Dialysis Systems with the product codes 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300 and T5C8300R. Both systems have been distributed to patients since 1994.

The FDA warned that patients and caregivers should watch for any signs of IIPV. If any signs of IIPV are noticed, the device should be stopped immediately and a manual drain initiated. Then a doctor should be contacted immediately.

Baxter is not currently taking the devices back from patients, and says that it is looking at a number of potential fixes, including software updates and undated medical guides. Baxter advised patients to continue to use the devices. However, the FDA warned that “clinicians should weigh the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy.”

A product liability lawsuit has been filed over the death of a California woman who was ejected from her 2001 Subaru Forester during a rollover accident, alleging that multiple defects with the vehicle failed to protect her during the crash. 

The wrongful death lawsuit was filed this week by the family of Lisa Ann Thayer, who was killed in a Subaru accident on I-40 in San Bernadino County on October 27, 2006. The complaint names Subaru of American, Inc., Fuji Heavy Industries LTD of Japan and Autoliv North America as defendants.

According to a press release issued by lawyers for the family on Tuesday, Thayer was wearing the seat belt properly at the time she lost control of the vehicle, which rolled over multiple times. However, the seat belt broke during the crash and Thayer was hurled out of the vehicle’s passenger compartment and killed. Her minor daughter, Emma Thayer, also suffered injuries in the accident.

The complaint alleges that the occupant restraint system in the 2001 Forester was defective, and failed to provide the passenger protection required by federal standards. In addition, the lawsuit claims that the defendants have known since at least 1970 that the unsupported, tempered glass often used in their vehicles could be laminated and enforced to help prevent ejection from the vehicle, but the auto maker has not done so.

In addition, the lawsuit says that Subaru knowingly misrepresented vehicle testing data to federal authorities, such as the National Highway Traffic Safety Administration (NHTSA) to make it appear as though the windows were safe. It also says the company ignored recommendations from its own engineers to make the window systems on the Forester and similar vehicles safer.

The Subaru product liability lawsuit, filed in Superior Court of California in Orange County, seeks an unspecified amount of damages for wrongful death, pain and suffering, personal injuries, medical expenses and economic losses.

A Nebraska jury has awarded $1.75 million to the mother of a 15-year-old girl who was killed in a car driven by an unlicensed teen.  

The jury award brings the total compensation in the wrongful death lawsuit to $1.9 million when added to an award for medical and funeral expenses already handed down by District Judge Paul Merritt, Jr., earlier in the case. According to a report in the Lincoln Journal Star, the complaint was brought by Alisa Heath, whose daughter, Megan Churchill was killed in an automobile accident in March 2007 while riding in a car driven by 17-year-old Ricky Turco and owned by his ex-wife, Naomi Brock.

Heath alleged that Turco drove a Chrysler Concorde into a tree at 60 m.p.h. after attempting to jump a hill in residential neighborhood. He did not have a license at the time of the car crash, and is currently serving 10 to 14 years after being convicted of manslaughter in Churchill’s death.

The auto accident lawsuit included a claim against Brock for negligence in allowing Turco drive her car, as Turco had an extensive history of traffic violations before the accident. The jury awarded Heath $1,750,000 for Churchill’s loss. Judge Merritt had already awarded Heath $151,639 for medical and funeral expenses.

The ruling is the second successful lawsuit against Turco and Brock. The father of Joshua Rice, another teen hurt in the crash, was awarded $56,688 in a lawsuit against the couple.