Product Liability Attorneys Blog

The U.S. Food and Drug Administration has determined that a previously-recalled device used for surgical knee replacement is likely to cause serious health problems.

Our product liability lawyers understand that the manufacturer, Stryker Corp., had initially issued a voluntary recall in January, but now the FDA has reclassified it is a Class I recall.

A Class I recall is the most severe designation that can be given, purporting that use of the product is accompanied by a high risk potential for serious injury or death. Class I recalls are fairly uncommon in the U.S., reserved only for the most serious situations.

The ShapeMatch Cutting Guides were tools used by surgeons that were supposed to help surgeons with the positioning of the components of the knee replacement, as well as to guide the marking of the bone prior to cutting.

Back in November, the company sent a message to all surgeons registered with the company to cease their orders. A voluntary recall came three months later, with the firm explaining at that time that a number of the devices could have been improperly manufactured.

The firm admits that problems with the devices had been reported soon after the ShapeMatch Cutting Guides hit the market. Among problems identified was that patients who had been implanted with the device complained of failure, meaning they had to undergo a potentially risky revision surgery to have the situation corrected or the device replaced.

Stryker had initially advised only routine care for patient follow-ups. Now, patients whose surgeons used this product should contact their surgeon, especially if they have been experiencing pain, numbness or other adverse effects.

The recall won't affect other Stryker products, such as the Triathlon Knee System or the Triathlon standard instrumentation.

Still, we would advise anyone who has undergone a procedure with a Stryker product to keep a watchful eye on the overall condition. News of this development with ShapeMatch was somewhat unsurprising, given Stryker's history. In March, the FDA received a series of additional injury and death reports regarding the firm's surgical waste management system, called Neptune. The two different components of the system essentially act as a vacuum to suction fluid from patients in the midst of a procedure. However, these devices ended up being recalled last year, after the FDA received word that one patient died and another was injured after the suction was improperly applied.

Stryker is also the manufacturer of the Rejuvenate hip replacement device. As you may recall, this product has been found responsible for increased rates of metallosis in patients. This is a condition involving the build-up of metal debris in the body's soft tissue. The Rejuvenate product has also been linked to a high rate of early failure, meaning many patients have had to undergo additional corrective surgery to have the faulty device replaced.

Patients with questions about the ShapeMatch Class 1 recall may also call Stryker directly at 1-888-STRYKER from 8 a.m. to 8 p.m. EDT Monday through Friday. For those who have suffered ill effects, we would also advise contacting an experienced product liability law firm.

Continue reading "FDA: Recalled Knee Replacement Devices Cause Serious Health Problems" »

Toyota, the top-selling vehicle manufacturer in the United States, issued yet another recall late last month - somewhat unsurprising given the fact that the company recalled more vehicles than any other last year, according to a recent report by the National Highway Traffic Safety Association (NHTSA).

Defective vehicle attorneys recognize that while recalls are sometimes issued in an abundance of caution, they often only occur after someone has already been seriously hurt or killed as a result of some defective aspect of a car or truck. Even when a manufacturer issues a recall, it does not make the firm immune from civil action if an injury or death occurs as a result of that defect after the fact.

Vehicle makers must have a solid commitment to safety, especially considering that motor vehicle accidents are one of the leading causes of death in this country. In 2009, some 2.3 million adult passengers and drivers were treated in emergency rooms, according to the Centers for Disease Control.

And yet, the NHTSA reports that last year, manufacturers issued more than 650 safety recalls that affected nearly 18 million vehicles. Of those, about half were at the prodding of the NHTSA. These included everything from the vehicles themselves to tires and child safety seats.

Toyota was by far the top offender in terms of affected vehicles. The company issued 12 recalls throughout 2012 that involved more than 5.3 million vehicles. Honda, by comparison, issued 16 recalls that affected 3.6 million vehicles. General Motors issued 17 recalls that affected about 1.5 million vehicles, and Ford issued 24 recalls that affected about 1.4 million vehicles. Chrysler Group rounded out the top five, with 13 recalls affecting more than 1.3 million vehicles.

Toyota's most recent recall involves more than 1 million U.S. vehicles - namely, Corolla, Corolla Matrix and Lexus IS sedans. The Corollas, produced between 2001 and 2004, reportedly have a design flaw that causes the air bags to suddenly inflate improperly. The Lexus IS sedans, meanwhile, have a loose nut that could render the front windshield wipers ineffective in heavy snow (when one would expect to truly need them).

Toyota has said that at least two crashes in the U.S. have been attributed to the air bag issue, and its believed there have been at least 46 "reports of problems." The actual number is likely much higher as many people may not have known about the manufacturer's flaw and didn't report it, assuming the incident was a result of operator error.

This recall comes just one month after the firm agreed to a $1 billion U.S. settlement after owners said their cars' value dropped significantly amid sudden acceleration issues, which had prompted another recall. Nearly 90 people were killed as a result of this problem, according to the NHTSA.

Other recalls last year include some 60,000 Honda Civics for faulty driveshafts, 800,000 Honda minivans and sport utility vehicles for faulty ignitions, 41,000 cars and crossovers for fuel leaks and 90,000 Ford vehicles that were at risk for catching fire.

Continue reading "NHTSA: Defective Vehicles Affect Millions Annually" »

After hundreds of deaths and tens of thousands of injuries over the course of more than a decade, the federal government is finally launching a formal investigation into the safety of bed rails used by nursing homes and home health care agencies across the country.
Product liability attorneys are carefully watching this issue, which over the years has involved a reticence on the part of federal authorities to issue recalls or even mandate warning labels, partially over how the product is classified but more due to resistance from the industry.

These are railings that are affixed to either side of the bed with the intent of preventing a disabled or elderly adult from falling out of bed. However, the product design has led to people getting their heads or necks caught either between the rails or in between the space between the rail and the mattress.

The New York Times recently chronicled the case that finally led to government action. In 2006, an 81-year-old grandmother was found dead in her bed at an assisted living home in Washington State. She had apparently been strangled after getting her neck caught in between the rails.

Her daughter, grief-stricken and angered, penned letters to both the U.S. Food and Drug Administration and the Consumer Product Safety Commission (CPSC). As it turned out, they had been aware of numerous and ongoing problems with the rails, but little action had been taken against the manufacturers.

The daughter began to conduct her own research into the number of deaths and injuries caused by the rails, and reached out once again to the CPSC. In turn, the commission has agreed to launch a formal study.

The daughter wishes it had been done sooner.

The agency has thus far determined that between 2003 and 2012, about 150 adults died after getting caught in the bed rails. During that same time frame, more than 36,000 were severely injured and taken to the hospital. Those are probably low estimates, however, as not every death and injury attributable to the bed rails was likely reported as such. Since 1995, when the commission first became aware of the issue, there have been more than 550 deaths.

Researchers familiar with the issue have said these deaths are 100 percent preventable.

The FDA first looked at the issue in 1995, after receiving a detailed report from a bioethics professor from Minnesota. However, the agency declined to take any action because, for starters, it couldn't decide whether the device should be classified as a medical device or a consumer product. The bigger issue, however, was fierce resistance from the industry and recent legislation passed to reduce regulatory action on businesses. It was estimated that a move to force the manufacturers to develop better designs, and for nursing homes to replace the older models, would have cost hundreds of millions of dollars.
So instead, manufacturers agreed to enact voluntary guidelines.

But clearly, that hasn't been enough, as elderly people continue to be harmed by these devices.

In 2006, the FDA gave advice to hospitals and nursing homes on how to use the rails and further recommended certain size limits, which would reduce the gaps that lead to so many injuries and deaths.

It's unclear at this point whether the new study will result in tougher guidelines, or more appropriately, a recall or sanctions of some form. But if you or your loved one has been injured as a result of bed rails, you may be entitled to compensation. As such, you should contact a law firm with extensive experience in handling product liability cases.

Continue reading "Inquiry Launched Into Elderly Bed Rail Deaths" »

The tobacco industry has once again lost an appeal to the U.S. Supreme Court following a major win for plaintiffs, who allege the products are dangerous and responsible for lung disease deaths.

The Supreme Court declined to hear an appeal by R.J. Reynolds Tobacco Co. and Vector Group Ltd.'s Liggett.

Plaintiff product liability attorneys understand this is a huge blow for the industry, as it is continuing to seek limitations on a 2006 Florida Supreme Court decision, holding that a jury's factual findings against the industry in a class action case would serve as a starting point for individual lawsuits.

Makers of cigarettes say that trial judges in Florida are applying the case law too broadly, thereby depriving the companies of the right to present a fair defense.

The Florida ruling decertified the class action lawsuit that had initially been filed by Dr. Howard Engle, a pediatrician who died after years of smoking. That decision meant that former class members had to file their own individual cases - but they were allowed to do so by outright stating that cigarettes caused their illnesses.

In other words, plaintiffs aren't required to show that cigarette makers knowingly sold defective and dangerous products. That fact is considered established by the earlier litigation. What the individual plaintiffs must prove is that they were addicted and that their subsequent illness and/or death was caused by cigarettes.

That was a big win for tobacco plaintiffs because it's not difficult to prove that someone who smoked for 30 years and who died of lung cancer was made ill by the cigarettes.

So far in Florida, some 65 tobacco cases have gone to trial, with awards amounting to more than $300 million. Another 8,000 cases are pending.

In R.J. Reynolds v. Clay, a jury found that Reynolds and Liggett were responsible for the death of a woman who died in 2003 of lung disease, after four decades of smoking. They awarded $20 million.

The Supreme Court's denial of an appeal means that the lower court's ruling will stand, which essentially paves the way for additional future tobacco litigation by more plaintiffs. That was exactly what the tobacco companies had hoped to avoid because there is much more at stake than just this one case.

This is actually the second time in eight months that the U.S. Supreme Court has declined to hear an appeal by R.J. Reynolds and other tobacco companies. The previous case actually involved the appeal of four different so-called "Engle-progeny" cases, which had a combined award of $53 million.

Still, tobacco companies have been successful in winning federal Engle-progeny cases - which is why they are fighting so hard to get the Supreme Court to hear their argument. Analysts have speculated that if the high court heard just one case, it would likely side with manufacturers, setting the stage for far fewer tobacco suits.

On the other hand, if the court continues to decline the industry's requests, the industry will continue to take these multi-million dollar hits. As such, there is talk that the industry may work to settle these cases for several billion dollars, in order to simply be done with them.

But for now, it appears they still have a lot of fight left in them. That's why having a highly-skilled attorney on your side in these cases is so critically important.

Continue reading "R.J. Reynolds v. Clay - $20M Tobacco Verdict Stands" »

A manufacturer of bed lining for babies - also known as "crib bumpers" is facing a class action lawsuit by parents who say the products are dangerous and, contrary to their purpose of preventing crib-related injuries, have actually caused infant deaths by suffocation.

Our product liability attorneys realize that crib bumpers have yet to be recalled, and in fact, are still sold at stores. This is despite the fact that many pediatric experts have called for a ban on the products.

The Journal of Pediatrics in 2007 published a study, based on reports from the Consumer Product Safety Commission between 1985 and 2005. What they found was that there were 27 accidental deaths involving children between the ages of 1 month and 2 years directly attributed to suffocation when the infants were either strangled by one of the ties or became wedged against the padding and suffocated. In 11 of those cases, the infants suffocated when their face was simply resting against the bumper pad. At the time, the study conclusively determined that the products were dangerous.

Still, they weren't banned.

Last year, federal authorities took CPSC to task over the fact that it had reportedly been aware of the dangers of these products for years, and yet failed to warn parents. In fact, the agency apparently failed to investigate 17 of 52 reports of infant deaths involving the product over the course of two decades.

Now comes this lawsuit.

The complaint contends that, according to the Centers for Disease Control, an estimated 665 babies have died since 2009 of accidental suffocation or strangulation while in bed. It does not say how many of those involved crib bumpers.

The mother named in the suit does not claim that her own infant suffered injury or death. Still, she claims that she purchased the product, which purports to be safe when installed correctly. She says this claim amounts to false advertising and deceives the public into believing the products are safe when in fact they put babies at risk of crib death.

She is targeting Carter's, which is one of the biggest companies marketing baby clothing and products in the country. It sells crib bumpers for around $70 individually, and nearly $200 when purchased as part of a matching bedroom set.

The complaint indicates that with this company alone, infant bedding sales soar above $50 million each year, and that includes some 200,000 crib bumpers.

The City of Chicago banned crib bumpers last year, and several states are considering similar action. Still, the federal government has yet to act.

The dangers of these products appear to mimic those we heard in previous years regarding the drop-side crib. These products, which were sold for many years, had been blamed in dozens of deaths before they were officially banned last year. The CPSC, in the first change to U.S. crib standards in three decades, additionally required that crib makers construct infant beds that were more durable.

Sadly, those measures won't help those families who are already grieving the loss of a beloved child whose life was needlessly and suddenly cut short due to a dangerous infant bedding product.

In this case, the plaintiff is seeking restitution, damages for consumer law violations, unfair competition and disgorgement of unjust profits. Additionally, the plaintiff is asking the company to issue corrective advertising.

Continue reading "Crib Bumper Manufacturer Faces Class Action Lawsuit" »

Dozens of batches of a generic form of the drug Lipitor have been recalled, after tiny bits of glass were discovered. The drug is manufactured by an Indian firm with a history of quality-control issues.

Our defective drug attorneys understand that the company, Ranbaxy Pharmaceuticals Inc., is that country's largest. It wasn't long ago that U.S. regulators banned imports of the company's medicine amid quality-control concerns. Over the last several years, the U.S. Food and Drug Administration has cited the company for numerous lapses in quality. And company officials reportedly lied to authorities about test results on more than 24 of its generic drugs.

Back in 2006, the company underwent an extensive investigation and was sanctioned by the FDA for failing to properly test the safety and shelf life of its products; it was also accused of blatantly lying about those results to federal investigators.

Two years later, the FDA banned Ranbaxy shipments of more than 30 different medicines, while the U.S. Department of Justice ordered the company to hand over internal documents that allegedly proved it was dishonest about the formulations and ingredients used in certain medicines.

But because Ranbaxy held the only license to legally produce the generic form of Lipitor just after the patent expired (and only one company can compete with the brand name for at least the first six months), the FDA agreed to lift the ban, so long as the medicines were made at the firm's New Jersey laboratory.

Lipitor is the world's top-selling drug. The generic version, called atorvastatin, is also a blockbuster with Ranbaxy being a top producer. On the company's U.S. website recently, the firm recalled 10, 20 and 40-milligrame doses of the pills. In all, there are more than 40 lots of the drug that have been deemed to be potentially hazardous. Each of those bottles contains about 90 pills, though there are a handful of lots in which the pill bottles contain 500. We don't know how many bottles specifically were in each of these lots, but when it comes to batches of medicine, most tend to contain several thousand pills each.

Company executives have refused to answer questions or provide any additional answers about the recall, other than a terse, written statement stating that the recall is only being done out of an abundance of caution.

Those who have a prescription of the drug should immediately stop taking it and contact their pharmacy to determine whether their pills were made by this particular drug maker, and whether their pills were among the lots affected by the recall.

This case is the latest in a string of safety and health concerns regarding prescription drugs. A Massachusetts company, the New England Compounding Center, has come under fire for contamination concerns after steroid injections distributed nationwide caused numerous fungal meningitis deaths and illnesses. NECC's sister company, Ameridose, has also fallen under intense scrutiny for cleanliness concerns and is one of the largest suppliers of pre-filled syringes to hospitals and clinics nationwide.

Continue reading "Generic Cholesterol Drug Recalled for Presence of Glass Particles" »

A company has been ordered to pay a $650,000 penalty for failing to immediately notify government officials of a defective water toy that posed a drowning risk to children.

Product liability attorneys know that even in cases where a recall is forthcoming, manufacturers are not exempt from responsibility.

Thankfully in this case, there were no drownings or other serious injuries reported - but there were several close calls, and this company had a history of marketing a defective product, according to federal regulators.

As far back as 2001, the Consumer Product Safety Commission reports there were at least a dozen reports of a defective strap in the seat of a "baby boat" that tore and subsequently resulted in children falling into the water. In a third of those cases, children were completely submerged under water before their caregiver was able to reach them.

Numerous consumer complaints were filed, prompting the company, Aqua-Leisure, to pull about 90,000 units of the product off store shelves.

However, the company continued to manufacture and sell different versions of inflatable infant boats. Between the summer of 2003 and the summer of 2006, the company was reportedly made aware of at least 17 instances where these products, too, either split, tore, ripped or otherwise failed. In four of those instances, the children unexpectedly fell and were submerged in the water. By mid-fall of 2008, the company was reportedly aware of nearly 25 cases involving problems with these products.

Instead of acting, according to the CPSC, the company did not let the government know until the spring of 2009.

And it wasn't until the summer of 2009 that the company issued a formal recall of all its 4 million inflatable infant toys sold in the U.S. within a seven-year window, between 2002 and 2009. By that point, there were more than 30 cases of these products tearing and children falling into the water.

Were it not for the fact that these children were closely supervised, the outcome could have been tragic.

Federal law mandates that any retailer, distributor or manufacturer has just 24 hours to inform government officials after substantiating a claim of a defective product that could pose a "substantial product hazard." Companies are also required to do this if they learn that their product fails to comply with any regulations or standards set forth by the CPSC.

In bringing the allegations that this company failed in its responsibility, a settlement was reached that ultimately allowed the company to pay a hefty fine, while avoiding an admission of wrongdoing.

Unfortunately, many new parents with a child on the way excitedly shop for products and equipment that they assume is safe for their baby. The deputy director for the Consumers Union was recently quoted by a local television reporter as saying that the biggest problem is that many have a false sense of security when it comes to purchases. You assume that if it's for sale, it's safe. Unfortunately, what typically happens is a product hits the market, and it's only after numerous safety problems surface that the product is pulled.

For example, drop-side cribs, which were hugely popular for decades, were recalled after strangulation and head injuries were reported. More than 30 babies died as a result prior to the recall. New construction of those cribs was finally banned in the United States last year.

Soft bedding and crib bumpers, too, have been deemed a problem - but only after millions have been sold. According to the CPSC, 12 babies died as a result of suffocation from sleep positioners before they were recalled.

Baby sling carriers, as well, have reportedly posed major risks. More than a dozen children died as a result of the fabric blocking their nose and mouth.

And highchairs, strollers and car seats routinely make the government recall list. Before making a purchase for your child, check with CPSC.gov to make sure you are not increasing the risk of injury in your home.

Continue reading "Dangerous Baby Products Result in Injuries, Deaths " »

Anyone who thinks that dangerous products are a rarity need only look at the history of Johnson & Johnson, which makes everything from surgical supplies to shampoo.

Our product liability attorneys know that in the last 2.5 years, the company has had no fewer than 25 recalls - and those are only the products it voluntarily identified as being faulty.

What is important for you to understand is recalls do not excuse a company from liability if their product causes harm. Too often, consumers -- and particularly medical patients -- think the Food & Drug Administration ensures these products are safe. That's simply not the case. In most cases, the government watchdog relies upon studies and clinical trials performed by a manufacturer looking to make billions by bringing the next big product to market.

Johnson & Johnson -- one of the world's largest consumer product's companies -- has issued recall after recall in recent years. Reuters recently pulled together a list of products the company has recalled since the summer of 2009. The defective-product risks range from slight to severe.

The DePuy Orthopaedics hip recall is expected to cost Johnson & Johnson billions as thousands of patients have the defective hip removed and a replacement hip implanted. The product, of which about 93,000 were sold, was failing, and many patients were required to undergo a second hip implant surgery.

In January of this year, The FDA accused J&J of failing to report problems with the company's insulin pump, which resulted in perilously high blood pressure and respiratory failure in a number of patients.

The company's over-the-counter division has also suffered through numerous recalls:

Certain brands of infants' and children's Tylenol, which was yanked from the shelves in September of 2009 for a possible bacterial contamination.

Two months later, Tylenol Arthritis pain caplets were recalled after there were numerous reports of a mildew-like odor from the medication that resulted in nausea, vomiting, diarrhea and stomach pain. The following month, that recall was expanded to include larger bottles as well.

Then in January, similar reports of that mildew-like smell (which was ultimately linked to a chemical in the wood pallets used to ship the medicine) led to another recall that included 53 million over-the-counter medications, including Tylenol, Motrin, Rolaids, St. Joseph's Aspirin, and Benadryl. These products were sold not only in the U.S., but also in the UAE and Fiji.

There were also recalls in 2010 for infants', children's and adult pain relievers and allergy medication over concerns about manufacturing deficiencies that affected the purity and potency of the medications. Then another round of Tylenol recalls when there weren't enough warnings about the amount of alcohol used in the flavoring.

In December of that year, about 500,000 bottles of contact lens solution were recalled for complaints of stinging pain. That same month, all Rolaids antacids were recalled due to small bits of metal and wood found in the tablets.

In February 2011, syringes containing antipsychotic medication were pulled because of cracks in the syringes. The next month, insulin pumps were pulled for potential leaks, and there was another recall of 700,000 bottles of Tylenol - for the same must/mold problem. Same problem again in April with Topamax, a drug used to treat epilepsy.

In September, several batches of an anemia drug sold in more than a dozen countries were recalled due to inconsistent potency.

And in August, the company reached a $181 million consumer fraud settlement with 36 states and the District of Columbia over its marketing of antipsychotic drug Risperdal. The company was reportedly promoting the drug for unapproved uses.

Continue reading "J&J & The Risk of Recalled Medical Products" »

A $7.2 million judgment was awarded to a man stricken with "popcorn lung," a potentially fatal disease of the respiratory system, also known as bornchiolitis obliterans.

Essentially, this man consumed one to two bags of microwave popcorn per day, and was reportedly exposed to a chemical called diacetyl, which is used to create the butter flavor. It can also cause serious respiratory issues.

Our product liability lawyers know, historically, the majority of these cases have been brought by employees of popcorn manufacturers. This is believed to be one of the first awards of its kind involving a consumer and could signal more legal heat is ahead for the popcorn industry.

The man had sued both the manufacturer and the seller of the popcorn.

Back in 2000, eight workers at a Missouri popcorn manufacturing plant were diagnosed with bronchiolitis obliterans, an otherwise rare lung disease. The state Department of Health was called in to research what was happening. Inspectors traced it back to the diacetyl, and recommended all workers at popcorn manufacturers wear respirators.

Although it remains a legal product not banned by the Food and Drug Administration, many companies in 2007 began replacing the diacetyl with other flavoring elements. Those companies include Orville Redenbacher, Pop Secret, Act II and Jolly Time. However, the ingredient that many companies began using, called 2,3-pentandione (referred to as "PD"), may not be any safer. Unfortunately, a number of studies, including one in The American Journal of Pathology, have indicated that these chemicals may be just as dangerous as diacetyl.

Scientist exploring the effects of PD on rats found that those exposed to the chemical showed damage to airway linings in the nose and lungs - similar to what you would see with extensive diacetyl exposure.

Bronchiolitis obliterans is often misdiagnosed as emphysema, bronchitis or asthma. It can appear either gradually or suddenly, and is characterized by a dry cough, shortness of breath and wheezing. It essentially reduced a persons' breathing capacity from a normal 80 percent range down to a range of 15 to 20 percent.

Workers in other industries have also reported being exposed to chemicals that caused the disease. Those industries include: Nylon, textile sprays and battery manufacturing.

Popcorn plant employees had for years been victorious in court with these claims, with more than 600 filed in all. About $50 million was awarded in jury trial verdicts. Many more of those cases were settled out of court.

Manufacturers had previously said consumers should be safe, so long as they follow packaging directions to open the bags away from the face. Apparently, though, this is not eliminating the risk.

A similar case has already been filed against Con-Agra, and we expect more in the near future. Both companies in the most recent case say they plan appeal the verdict.

Continue reading "Popcorn Eater Wins $7M for Rare Lung Disease" »

Potential Salmonella poisoning has spurred a recall of fruit that was sold in major chain stores in almost every state across the country, as well as Washington D.C. and Canada.

Product liability lawyers understand that at least 105 people in 16 states have been infected with the strain since July 1 as a result of consuming these mangoes. Of those, 25 were hospitalized.

We continue to see cases of food poisoning, sometimes with fatal results. Many remember the massive peanut recall in 2009, which resulted in more than 1,000 products being pulled from shelves. At least 8 people died and more than 500 suffered serious illness. Smuckers and Skippy have both recalled peanut butter because of the risk of salmonella poisoning.

Those who were sickened in this case ranged in age from 1 year-old to 86 years-old, with 54 percent being female. We're likely to hear about more cases, as the illness takes time to manifest itself and then even longer for a person or hospital to report it.

Salmonella can be deadly to young children, the elderly and those with weakened immune systems. In some cases, an infection from Salmonella can get into the bloodstream and cause arterial infections, endocarditis or arthritis.

It's also important to note that a recall doesn't release a company from liability if someone were to become seriously ill or worse.

The concern in this case is specifically regarding fresh cut mangoes that were distributed by stores like Walmart, Starbucks and Winn-Dixie, among others. The fruit were originally produced by Splendid Products, which distributed them to Daniella Brand which then sold them to Ready Pack Foods, Inc. From there, the mangoes were sold across the country in the form of a dozen different products, including:

• Super FruitMedley
• Mango
• Super Fruit Blend
• Fruit Tray Bien
• Fruit & Chocolate Platter
• Sliced Mango
• MangoFandango
• Gourmet FruitBowl
• Sweet Sunshine Platter
• Seasons Choice
• Seasonal HarvestFruit Blend
• Chicken & Mango Salsa Salad

Use-by dates range from Aug. 22 through Sept. 8, 2012.

The voluntary recall extends to all customers who may have purchased these products. Consumers should record the UPC code number and immediately throw away the contents of the packages.

Retailers are asked to check store shelves for the items and remove them from there as well, but that doesn't guarantee their might not be a few that slip by. It's not clear from the FDA's announcement how the mangoes might expose consumers to Salmonella, but it's critical that consumers heed this warning.

While many people who contract Salmonella make a complete recovery, some things you need to know about an infection:

• The most common symptoms include fever, diarrhea and abdominal cramps some 12 to 72 hours after consuming the infected product;
• The main reason for hospitalization of Salmonella sufferers is severe fluid loss due to diarrhea;
• An Salmonella infection can spread from the intestines to the blood, and when this happens, a person can die if they are not properly and swiftly treated with antibiotics;
• Young children and older folks are the most susceptible to serious illness;
• Every year, some 42,000 people are sickened by Salmonella - though those are only the cases that are reported;
• About 400 people in the U.S. die each year due to Salmonella infections.

What's more, Salmonella infections are preventable with proper food preparation and handling. Manufacturers and suppliers of these products need to be held responsible when someone becomes severely ill due to a company's negligence.

Continue reading "Salmonella Risk Prompts Mango Recall" »

The manufacturer of the popular "Bumbo baby seat" has recalled its product for a second time after widespread risks of falls that have been known to cause serious head injuries to infants.

With 4 million units purchased in the U.S., many parents had become enamored by the seat, with its bright colors and unique shape, which purported to allow young infants to sit upright before they otherwise would be able to do so unassisted.

While many are rushing to defend the seat, product liability attorneys would note that a number of these incidents - which included infant skull fractures - reportedly occurred when the product was being used exactly as intended.

Manufacturers of a defective product may be held responsible in a number of different scenarios, including when there was a:

Design defect;
Manufacturing defect;
Failure to warn of those defects.

The reported issue with the Bumbo seat - and it's been a recurring one - is that infants have been falling out of the seats. They wiggle out or arch their backs, causing the seat to flip over. Victims have suffered moderate to severe injuries as a result.

Back in 2007, the South African manufacturer issued a voluntary recall, which affected about 1 million of the seats. The recall followed numerous reports of infants becoming seriously injured when the product was used on a raised surface.

The company remedied the issue by printing a warning label directly onto the product, indicating the danger of using it unsupervised or on an elevated surface, such as a table or counter top.

However, since that recall, another 3 million of the seats have been sold - and many more children have been injured.

The Consumer Product Safety Commission reported that it is aware of at least 50 incidents since that initial recall involving babies who fell out of the seat when it was being used on a raised surface. In about 20 of those cases, the infants suffered some sort of skull fracture.

But many parents heeded warnings not to use the product on a higher surface - and their children were still injured. There were reportedly an additional 35 or so reports of infants who either fell or wiggled their way out of the seat while it was being used on the floor. In those instances, there were at least two reports of skull fractures. Other injuries included bruises, bumps and other moderate injuries.

Thankfully, there have thusfar not been any reports of deaths attributed to the product.

The product sells for anywhere from $30 to $50 at major retailers, such as Babies R Us, USA Babies, Target, Walmart and others, dating back to 2003.

The company now warns that all consumers should immediately stop using the product until they can obtain and install a free repair kit. This kit includes installation instructions, a restraint belt with a warning label, instructions for safe use and a new warning sticker. The company maintains that even with this kit, the product should never be used on raised surfaces.

Despite the fact that injuries have been reported in a relatively few number of cases, compared to the number of the products that exist, we must also point out that not all injuries are reported to the commission, so there may be an unknown number of additional cases that have gone unreported.

Continue reading "Recall: Popular "Bumbo" Seat Has Caused Dozens of Child Injuries" »

There have been an inordinate amount of time and resources expended on the eradication of illegal narcotics, which of course, are dangerous and in some cases even deadly.

However, our product liability attorneys want you to know that you aren't immune from danger simply because you don't abuse cocaine or heroin. In fact, therapeutic medicines, which are often sold by your pharmacist or online, can be equally dangerous - if not more so - because many people have a false sense of security about them.

These are drugs that may be either watered down or downright counterfeit, and they're made either by criminal organizations or simply by manufacturers who are too lazy or cheap to follow through with appropriate medical guidelines.

We've often seen this as a major problem in the developing world, but the U.S. is fast seeing an increasing number of deaths relating to drugs that didn't do what they promised -- usually because they had little or none of the active ingredient advertised.

In Africa, for example, huge numbers of people were dying of the HIV virus, even though they were taking medication, because those medicines, rather than containing the necessary combination of chemicals to fight the disease, were made with talcum powder, chalk and other substances.

In fact, it's estimated that up to 10 percent of all vital drugs distributed in second or third-world markets would fail quality testing.

In the U.S., it's estimated to be far less of a problem, with less than 1 percent of all drugs being counterfeit. However, when you consider that there are approximately 4 billion prescriptions written each year -- we're talking about a potential 40,000 prescriptions that could be deadly.

For example, nearly 150 people died in the U.S. in 2007 and 2008 from use of a fake blood-thinning drug called heparin. Earlier this year, it was revealed that some 19 hospitals across the country had purchased a phony form of a cancer-fighting drug, Avastin. Thankfully, the issue was caught before anyone died, but the potential for harm was certainly there.

What is far more common is that reputable drug companies market products that turn out to be dangerous to consumers. Dangerous drugs and defective medical products are an ongoing risk to consumers because the health care system is motivated by profit, and watchdog organizations like the Food and Drug Administration lack the resources to conduct meaningful review, research or enforcement.

When it comes to counterfeit medications, finding those responsible can be a challenge. In the case of the fake Avastin, officials believe an underground Middle Eastern gang was responsible for its distribution. Officials raided the operation, but many core members are believed to have fled and reassembled in Iraq and Syria to continue operations.

What's troubling is that some of these manufacturers can often out-price the more responsible drugmakers, often putting the latter out of business. But the fact is that U.S. pharmacies and hospitals shoulder at least some of the responsibility for failing to ensure that these phony drugs aren't distributed to patients.

Continue reading "Dangerous Drugs: Phony Prescriptions Increasingly Common, Deadly" »

When news broke this month that Johnson & Johnson sold transvaginal mesh without the Food & Drug Administration's approval, it was the latest blow for the consumer-products conglomerate, which is also dealing with thousands of defective hip claims involving its DePuy hip implant.

In fact, Johnson & Johnson had received explicit instructions in August 2007 to stop marketing and selling transvaginal mesh under its Gynecare Prolift line. The government's federal watchdog requested information on 16 potential deficiencies in the product.

Defective medical product attorneys have begun to litigate thousands of cases involving faulty transvaginal mesh or defective hip replacements manufactured by Johnson & Johnson.

Transvaginal Mesh Litigation:
-Johnson & Johnson began selling the Gynecare Prolift product in 2005, without applying for a new application for the FDA, saying it was substantially similar to other products that had won FDA approval. Extended negotiation resulted in the FDA approving the product in 2008.

-From 2005 to 2010, nearly 4,000 cases of injury or death resulted from the use of transvaginal mesh (TVM) implants used to treat pelvic organ prolapse (POP). Surgical mesh has been around since the 1950s and was initially used to repair abdominal hernias. In the 1970s, it began to be used for POP repair and in the 1990s, surgeons began using it to treat stress urinary incontinence.

-Side effects and medical complications associated with transvaginal mesh can include infection, urinary problems, bowel perforation, organ damage and pelvic pain.

DePuy Hip Recall
-In 2010, Johnson & Johnson recalled its ASR XL hip-replacement system. The system became available in the United States in 2005 -- after J&J received special clearance from the FDA to market the devices without first performing clinical trials to determine the safety of the hip-replacement system.

-The company has since acknowledged high failure rates, saying 12 percent of patients needed "revision surgery." Defective product attorneys believe the actual proportion of patients needing additional surgery will be much higher over the life of the product. DePuy, a division of Johnson & Johnson, reported dislocations, infections, bone fractures, metal sensitivity and pain are all common side effects of the defective hip. Swelling, nerve damage, tissue damage, and muscle damage may also result.

Worldwide, some 93,000 patients had the defective hip-replacement system implanted in their bodies. With the metal-on-metal system, both the ball and socket are made of metal, which the company promoted as stronger and more reliable. However, victims of defective hips have been forced to contend with metal shavings in tissue around the implants.

While many consumers want to believe medical devices are rigorously tested by the government to ensure safety and the highest quality-control standards, veteran medical malpractice attorneys understand that is simply not the case.

Safety advocates continue to call for reforms. Among the most egregious issues endangering patient safety are:

-The FDA too often permits device makers to bring products to market without proper testing by expediting the approval process for devices the manufacturer contends are "substantially similar" to existing products already approved.

-Device and drug markers are permitted to conduct clinical trials in Third World countries, far from the prying eyes or regulators.

-The government often conducts no independent study regarding a product's safety, instead relying upon the studies conducted by the device manufacturer.

Continue reading "Transvaginal Mesh, DePuy Hips, Result in Thousands of Defective Medical Device Lawsuits" »

The family of a little girl killed when her family's minivan burst into flames will be allowed to bring present evidence of previous similar fires in their product liability claim.

We know that in these cases, establishing a history or a pattern can be critical to the success of the case.

In Funkhouser v. Ford Motor Co. Inc., the Virginia Supreme Court recently ruled that the family may introduce evidence of other dangerous fires in the Ford's Windstar minivan model, a van that was later recalled. That decision reverses a previous ruling by a lower court.

Based on court filings on the case, here is what we know:

The Funkhouser family had twin 3-year-olds, a boy and a girl. In May 2006, the little girl was inside her parents' 2001 Ford Windstar minivan, which was parked in the family's driveway. The vehicle burst into flames. The little girl suffered third-degree burns over 80 percent of her body. She was transported to the hospital, where she later died. Her twin brother was also inside the vehicle, and though he was injured, he survived.

Upon investigation, it was discovered that the van's engine was not on, and in fact, the key wasn't even in the ignition.

The girl's father contends that Ford was negligent and had breached its contract with consumers by failing to warn consumers of a history of dangerous fires. He says the fire started in the vehicle's dashboard, and points to seven similar fires involving Windstars that were manufactured in the five-year period between 1998 and 2003.

Ford, however, has countered that one of the children started the fire while playing with the cigarette lighter.

And this is why that pattern of fires becomes so important. Absent the evidence of other similar fires in this model of vehicle, Ford might successfully argue that this was a single, tragic incident that resulted from innocent child's play and poor supervision. In other words, it was not something the company could have foreseen and therefore there was no duty to warn parents.

However, if the family can establish that not only were these fires caused by an inherent manufacturing design flaw, but that similar incidents happened to other consumers in varying circumstances, their case is further bolstered.

While there were seven fires that the Funkhouser's knew of involving Windstars, the court ruled they could only present evidence of four. Of course, more is better in this case, but four is better than none.

An expert witness for Funkhouser plans to testify that the fires started in the instrument panel of the vehicle, most likely in the vicinity of the cigarette lighter and the controls. The cause, that expert maintains, is the ignition of combustible materials by heat that was generated by an "abnormal and undesired" electrical malfunction. Further, the witness intends to testify that no action by the occupants (i.e., the children) was responsible for the fatal blaze.

While the lower court ruled the previous fires were inadmissible, the state's supreme court ruled that decision had been reached in error and reversed. The case is expected to move to the trial phase within the next six to nine months.

Continue reading "Product Liability Claims Often Rely on a Pattern of Negligence " »

Our product liability attorneys want to make sure all parents of young children are aware of a recent recall that impacts nearly 40,000 children.

It's a stroller recall, due to a design flaw that could causesevere injuries to children, including amputation.

The recall was issued in both the United States and Canada by the U.S. Consumer Product Safety Commission and Health Canada, and covers a brand of three and four-wheeled strollers made by Kolcraft Enterprises Inc., a company based in Chicago.

The exact name of the stroller is Contours Options.

According to the safety commission, both children's and parents' fingers have been caught in the handle of he stroller, particularly when the user is trying to lock or unlock the hinge that is meant to adjust the handlebar. This is more than a pinch we're talking about. Injuries reported have included deep cuts, lacerations - and even amputations.

So far, just five injuries have been reported to the commission, with three of those being children whose fingers were literally sliced off. Another two cases involved adults whose fingers were either deeply cut or smashed. Those are just the cases that were reported to date.

It's likely, however, that given the large number of strollers that were sold, we'll be seeing more of these cases in the future.

Most product recalls have a return rate of somewhere between 15 and 30 percent, which means people may be likely to use them, even though they've been recalled.

In fact, according to a report recently released by USA Today, while recalls for children's products were down about 25 percent last year, very rarely are those recalls heeded. What's more, while the actual number of recalls is down, the number of child injuries has gone up by 7 percent. What that tells us is that some companies may not be issuing recalls when they should be.

The recall of children's products makes up about more than a third of all recalls. In fact, of the 310 total recalls last year, more than 120 of them were products made for children. Those included recalls of bunk beds and infant video monitors that resulted in deaths.

The low return rates are often the result of a company's inability to get the word out to parents. Many companies have started including customer contact cards, which is a step in the right direction, but it's still not producing the results it should be. Products purchased online generally have the best return results.

Consumers and potential victims of defective products need to know that a recall does not absolve a company of legal liability when their product injures or kills a child.

With regard to the defective strollers, it's not clear yet whether there have been any personal injury lawsuits filed, but it's likely they could be on the horizon.

The Kolcraft Contours Option strollers were made in China and sold in child specialty stores across the country and online for about $160 each.

Repair kits are being offered, though parents are encouraged to simply stop using the product immediately. And if you're child has been injured, an experienced lawyer can help.

Continue reading "Stroller Recall: Children Can be Hurt" »