Georgia Injury Law Blog

Georgia Product Liability Lawyers Show You How to Shop for Safe Toys

The year’s biggest shopping season has begun, and millions of parents will be making the all-important decision - what to give the special little someone in your life. While choices are endless, there is always the question of safety.

For the last couple of years, there has been huge media and legislative attention on lead content in toys. The Consumer Product Safety Improvement Act set strict limits for lead paint on toys, and therefore, risks from lead contamination are now lower than they used to be. However, children continue to be at risk from toys with detachable parts, or sharp pointed parts that can pose penetration and choking hazards.

This month, the chairwoman of the Consumer Product Safety Commission assured Americans that toys in 2009 are much safer to buy than in 2007, when millions of children’s toys had to be recalled because of high lead content. Inez Tenenbaum is however, cautioning parents that they must also take care to buy age-appropriate toys.

WATCH, a child safety advocacy group has also released its annual list of Top 10 Worst Toys for 2009. The list includes toys that can cause blunt force and penetration injuries, as well as choking accidents. The list includes:

1.      Disney-Pixar Wall-E Foam Rocket Launcher

2.      Moon Board Pogo Board

3.      Curious Baby Curious George Counting – My First Book of Numbers

4.      Dark Knight Batman Figure

5.      X-Men Origins Slashin’ Action Wolverine

6.      Lots to Love Babies “mini nursery”

7.      Just Kidz Junior musical instruments

8.      CAT “rugged mini”

9.      Pucci Pups Maltese

10.Spy Gear Viper Blaster

The CPSC website also lists defective toys that have been recalled for safety reasons. We would encourage parents to check out the website, to make informed and safe choices.

The Georgia product liability attorneys at the Katz Law Firm represent victims injured through the use of defective products, including toys, pharmaceutical drugs, medical devices, automobiles and other consumer products.   

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Ford Inflatable Seatbelt Systems Promise to Reduce Risk of Injuries

As Georgia car accident lawyers, we are constantly monitoring new auto safety technologies that promise to keep drivers and passengers safe in an accident. Ford Motor Company has now announced the development of new inflatable seatbelt systems that we believe could be the next big thing in auto safety.

According to Ford, it will equip new Ford Explorers that are due to go into production next year, with the inflatable seatbelts in the rear seats. During a crash, the belt inflates and fills up with cold compressed gas. The gas is released after several seconds through tiny pores in the belt.

Ford’s new seatbelts offer the protection of both seatbelts and airbags, and promise to prevent injuries and fatalities in both front and side impact crashes.

Passengers in the rear seat tend to have a false sense of security that they will escape injuries in the event of an accident. For this reason, seatbelt usage among back seat passengers is very low with rates hovering around 62 percent, compared to about 80 percent for front seat occupants. According to Ford, studies have shown that the inflatable seatbelts are much more comfortable than traditional seatbelts, and this could encourage use of these seatbelts among backseat passengers.

Auto safety experts and Atlanta personal injury attorneys have welcomed Ford’s announcement. The automaker has had more than its share of safety scandals, including the Explorer rollover cases in the 1990s that ended in several people dead and hundreds more injured. With this new development, the automaker could salvage its reputation.

Over the past few years, Americans have shown a marked preference for cars with advanced safety technologies.  While many of these new features like Electronic Stability Control Systems are not available in all vehicles, the NHTSA is slowly encouraging manufacturers to make many of these features standard across all models. If the new inflatable seatbelts turn out to be as popular with customers as we hope, these could soon become a standard feature in all Ford vehicles in the future.

The Georgia car accident lawyers at the Katz Law Firm represent injured victims of auto accidents in Atlanta and across the state of Georgia.

Posted By Lisa Siegel In Product Liability | 3 Comments Permalink

A new report presented by a pediatric orthopedist at a pediatric conference in Washington is warning that newer models of child safety car seats, that double as baby carriers, may place children at a high risk of injuries. The risk comes from using the car safety seats outside the car. When these seats are placed on tables, counter tops, and soft surfaces like beds, the seats are likely to tip over injuring babies, and possibly suffocating them.

The report found that more than 8,700 babies suffer serious injuries every year when these car seats are used outside the car. Most injuries recorded in the study included head injuries, arm and leg fractures. The study looked at injuries that occurred between 2003 and 2007, and found that an estimated 680 babies a year suffered car seat injuries serious enough to require hospitalization. The researchers are calling for educating parents about the dangers posed when they use their car seats as baby carriers and baby beds, outside the car.

The use of car safety seats is estimated to have saved close to 9,000 lives over the past 30 years.  However, the amount of time a baby spends in a car seat has also increased. Placing a baby in a car seat for long periods of time can also lead to the development of a condition called container syndrome, marked by weak muscles and a flat shape to the head.

Defective Car Seats can Increase Risk of Injuries

None of this must be taken to mean that child safety seats are dangerous. If used properly and according to manufacturers’ specifications, car safety seats can mean the difference between life and death for babies involved in an accident. Make sure however, that you choose a good quality car safety seat made by a reputed manufacturer. Defective car seats can actually increase the risk of an accident for the baby. Also make sure that you refer to the CPSC list of recalled car safety seats before you make a purchase.   

The Atlanta product liability lawyers at the Katz Law Firm represent victims injured from defective car seats, faulty medical devices, dangerous pharmaceutical drugs, and other unsafe products 

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Nestle SA has announced a recall of its Toll House cookie dough because of fears of E. coli contamination linked to dozens of cases of food poisoning nationwide. About 47 varieties of the cookie dough have been included in the recall.

The Food and Drug Administration has warned consumers not to eat Toll House refrigerated and prepackaged cookie dough because of the risk of E coli contamination. The agency has asked consumers who may have any of the pre packaged cookie dough to throw these away. Consumers have been advised that they could face the risk of food poisoning even if they cook the dough, because the bacteria might be transmitted to their hands and cooking surfaces. According to the FDA notice, the contamination was exposed in a study conducted by the Centers for Disease Control and Prevention as well as state and local health departments.

So far, there have been 66 reports of illnesses from 29 states since March this year. 25 persons have been hospitalized and seven of these had suffered a complication called Hemolytic Uremic Syndrome [HUS] which can end in kidney damage and even death.  

E coli bacteria are transmitted through feces, and can spread through contaminated food and water. Symptoms include cramping, bloody diarrhea and vomiting. Most case of E coli infection can be treated in about a week. However in other cases, complications can develop. Around 5 to 10 percent of patients may develop a complication called Hemolytic Uremic Syndrome [HUS]. Symptoms include decreased frequency of urination, fatigue and paleness. Kidney damage may occur, and there may be other life threatening complications.

Persons who have recently eaten the dough must watch out for symptoms like abdominal cramps, diarrhea and vomiting. If any symptoms are seen, Georgia product liability lawyers would advise consumers to consult their physician immediately.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

The father of a boy who was injured when his Crocs shoes got caught in an escalator at an Atlanta Airport has filed a lawsuit against the company. The father Clark Meyer, is claiming $2 million in damages for injuries suffered by his son, identified only as “AM”.

According to the lawsuit, Meyer’s son was "severely and permanently injured" in the accident on July 15^th last year. On that day, the boy’s foot was snagged on an escalator at Hartsfield Jackson International Airport. The boy who was four years old at that time suffered at least three broken toes and cuts. In the lawsuit, Meyer alleges that the company was aware of the dangers to children wearing the popular Crocs shoes in 2005, but that didn’t stop the company from marketing the shoes targeting young children.

It is the second such lawsuit filed in Atlanta in 2005 involving children and escalator injuries linked to the popular shoes. Crocs meanwhile has denied that the shoes cause any injuries.  The company blames faulty escalator design and the parents for the injuries suffered by children who wear their shoes.

In 2006, Crocs came under intense scrutiny by product liability attorneys and consumer safety groups after reports of the shoes being caught in escalators began coming in. The reports mostly involved young children, and the foot injuries have been severe. At the Atlanta airport itself, there have been multiple reports of shoe-related injuries, and almost all of them involved Crocs shoes.

The worries were severe enough for retailer American Girl to post signs in at least three of their stores, asking customers wearing crocs not to use escalators. According to the Consumer Product Safety Commission, there were more than 10,000 injuries related to escalator accidents in 2006, but only a few of them involved Crocs shoes. In 2008, the Consumer Product Safety Commission began alerting customers that soft sided shoes that were more pliable and malleable were likely to get stuck in escalators. However, the agency has never specifically mentioned Crocs in these injuries.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Toymaker Mattel has agreed to pay $2.3 million to settle allegations that it imported and distributed toys that contained lead levels in paints that were in excess of federal standards.

The Consumer Product Safety Commission announced the penalties, the highest ever for importation and distribution regulation violations by the agency, on its website. Mattel and its subsidiary Fisher Price, have been charged with importing toy that contained lead levels that were higher than the .06 percent by weight, mandated by federal laws. Mattel was charged with importing 900,000 toys that were non compliant with the standard, while Fisher Price, according to CPSC allegations imported more than 1.1 million toys that did not comply with those safety standards. With the fines, Mattel has put those allegations to rest. 

The lead toy recall crisis of 2007 has had several positive effects – Congress moved to equip the generally-regarded-as toothless CPSC with more powers to prevent such crises. This led to the implementation of the Consumer Product Safety Improvement Act, which sets standards for lead in children's products including toys, among other standards.

In the same week the penalties were announced, product liability lawyers learned of another serious defective children's product that has already had children being placed in dangerous situations. The CPSC has announced a recall of 5,000 cribs under the following brand names:

• Bonavita Hudson
• Babi Italia "Pinehurst" drop side cribs
• Bonavita "Cabana" drop side cribs

The cribs were manufactured in Vietnam and China, and were imported by New Jersey-based LaJobi Inc.

In the case of the Bonavita Hudson and Babi Italia Pinehurst drop side cribs, a defective pin can pop out causing the drop sides to detach suddenly, creating an entrapment hazard for infants. In the case of the Bonavita Cabana drop side cribs, the wooden slats can break or detach, again posing a strangulation or entrapment hazard to little children. 

The company has received at least 16 reports of slat failures, and at least 33 reports of drop side detachment. Two children apparently became entrapped in these dangerous gaps, and one child fell off the crib.  In all cases, no injuries were reported. Parents have been urged to stop using these three cribs immediately.

Posted By Lisa Siegel In Product Liability | 2 Comments Permalink

After Bausch & Lomb Inc. went private in 2007, the contact lens maker conducted a quiet recall of its ReNu with MoistureLoc solutions, without much fuss and away from the public glare.

As it now turns out, the company also quietly settled nearly 600 product liability lawsuits brought against it by contact lens wearers across the country, who contracted a fungal eye infection called Fusarium Keritatis. These persons claimed that the infection, which left some of them with permanent eye damage, was the result of using the ReNu with MoistureLoc multi purpose solution. Fusarium Keratitis is an extremely rare infection which means that when these cases of infection began to show up in 2005, ophthalmologists were not able to diagnose the infection correctly and treat it properly. As the result, 60 people suffered enough eye damage to require a cornea transplant, and at least 7 people lost an eye.

Several of these injured users have had their lives impacted dramatically by the infection. One race car driver in Colorado had to give up his passion for racing after he suffered severe eye damage. A Broadway actress who suffered scarring in her eye was also one of those who filed a product liability lawsuit against the company.

There is very little information on how the infection developed. The company has come under severe criticism from ophthalmologists and product liability lawyers, who believe Bausch & Lomb has effectively silenced the truth. The settlements were cloaked in a shroud of secrecy, and clinical findings have not been made public. However, there may still be hope. There are still several more product liability lawsuits pending against the company, and we, at the Katz law firm, hope that more information about the infections comes out then.

Meanwhile, the Food and Drug Administration has been jolted enough by the eye infection crisis to announce that it will be reexamining its testing standards for contact lens solutions.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Automaker Chrysler's bankruptcy proceedings are leaving more than dealers and workers worried. There's another class of people who have much to lose if the automaker goes under, and little attention has been paid to their plight.

We are talking about the people who have pending product liability lawsuits against the company. These people will find that their dreams of justice are shattered when the spoils are distributed. Plaintiffs who have filed product liability lawsuits against the company fall in the unsecured creditors' group. While secured creditors include people who have collateral, unsecured creditors include plaintiffs and other corporations. These creditors are low on the pecking order when it comes to payouts. The secured creditors will get first preference, leaving the remainder of the funds to be distributed among the unsecured creditors. Corporations that are included in the unsecured creditors' group are likely to demand priority for their funds; leaving plaintiffs with peanuts after all other debts are paid.

According to the New York Times, it's still not clear how these pending lawsuits will be dealt with. They could be sent back to the original courts for a decision, after which the plaintiff who have won or settled may be able to go to the bankruptcy court for their money.

For these people who have suffered injures because of Chrysler vehicles, the situation seems week. However, the number of such people could rise if General Motors, which has far more numbers of product liability lawsuits, files for bankruptcy too.

Chrysler insists that it will do everything it can to "maintain goodwill with our customers." The company could have done more than just pay lip service to people who have been injured because of their defective vehicles. According to experts, Chrysler could have intervened, asking the court to give pending lawsuits priority among the unsecured creditors. The company could have cited the need to maintain good customer relations for such a priority request. 

It seems to be a familiar scenario - consumer rights are trashed, and they can expect few people, except product liability lawyers to stand up for their rights.

Posted By Lisa Siegel In Product Liability | 1 Comments Permalink

General Motors and the National Highway Traffic Safety Administration have announced a set of three recalls for the new Chevrolet Camaro as well as several other models of pickup trucks and sports utility vehicles, because of auto defects.

The recalls involve a total of 43,824 vehicles. The Cadillac Escalade, Chevy Avalanche, Suburban, Tahoe, Colorado, the GMC canyon and Yukon are included in the first recall of about 27,118 cars. These vehicles have a faulty seal in the fuel control system that allows water to leak through, leading to short circuits, possible engine failures or stalling of the engine. The second recall involves 15,393 Traverse SUV’s for brake system compliance failure. The third recall involves 1,243 units of the 2010 Chevrolet Camaro.  The problem relates to a positive battery cable that can wear away, causing the vehicle to stall at the least, or cause an engine fire.

All three recalls have to do with serious safety problems in these vehicles. The Camaro in particular, is a highly anticipated model that seems to have already run into safety problems. There have already been at least four reports of problems with the worn out cable in these V-8 powered cars, although none of these incidents have resulted in injuries.

Auto manufacturers are required to inform the National Highway Traffic Safety Administration when there is a possible defect. In some cases, the agency may be forced to order for a recall. In any case, these defects may either be because of a safety issue, or because of a compliance failure with an existing federal guideline for safety. For a manufacturer, it actually makes more sense to recall the vehicles at the earliest signs of trouble, rather than wait till the problem has ballooned into a national safety crisis.

Unfortunately, as Georgia product liability lawyers know only too well, many auto companies even now, seem to think only in terms of the short term damage to their reputation and poor publicity that a recall will cause. The longer they wait to recall their defective vehicles, the higher the risks that people could be injured in accidents arising out of these defects. Driver negligence is still a factor in a majority of the car accidents that take place on our roads and highways every year, but a defective component in a vehicle can also play a part in causing serious injuries.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

In a month in which at least 34 weight loss products of a New York-based company were recalled by the FDA, the agency has issued another warning, this time to consumers who use popular weight loss supplement Hydroxycut, to stop using these immediately. The warning comes because of reported liver injuries in persons who took these products, including at least one death.

Hydroxycut has a lion's share of the weight loss supplement market with close to 9 million bottles reportedly sold last year alone. The supplement is popular with people on a diet because of its appetite suppressing properties. Besides, it is used widely by bodybuilders to define muscle tone. According to the FDA, some of the Hydroxycut products also have a serious side effect - they cause liver injuries. At least one person’s death has been linked to the weight loss supplement. A 19-year-old man reportedly died in 2007 from liver injuries. Also one person has had to undergo a liver transplant procedure after he suffered liver damage from using the product. According to the FDA, it has received at least 23 reports of liver injuries caused by the supplement.

The company that makes Hydroxycut, Canada based-Iovate Health Sciences has agreed to recall all Hydroxycut products, even though the FDA has linked only about 14 Hydroxycut products to liver injuries. The company however denies that the sole death was linked to its product in any way.

While drug makers are required to prove the safety and efficacy of their drugs before releasing them in the market, makers of nutritional supplements are not required to get FDA approval before releasing their products. The agency has little oversight over these products, and all it can do to protect the public from injuries is to monitor these supplements after they are released, and act when there are hazards reported.

This lack of oversight has in many cases, proved disastrous to users of these products. Product liability lawyers and consumer safety advocates have not forgotten the side effects of the Ephedra dietary supplement and the deaths resulting from its use.

It’s clear that the FDA must step in to increase it’s oversight over the nutrition and herbal supplement industry. Working after a supplement has been linked to injuries and deaths exposes potentially hundreds of thousands of people to serious health risks. Already there are concerns that there may be other products in the market that contain hydroxycitric acid, the ingredient in Hydroxycut that probably causes the injuries.  

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

A Ford Explorer trial involving a young woman, who suffered spine injuries in an accident involving a Ford Explorer, began in DeKalb County last week. Jessica Mundy, who was 22 years old when the accident took place, is claiming damages from Ford, alleging that a transmission design defect in her Explorer caused the SUV to suddenly shift from park to reverse. The accident left Mundy a quadriplegic.

Mundy claims she put her car in park, and got out to mail a package. The car ran over her, leaving her with a fractured spine. In January 2005, Ford had issued a repair service bulletin involving a transmission problem, and the alert covered a number of vehicles, including Mundy’s SUV. Her lawyer insists that the transmission repair which was conducted on her Explorer, could have contributed to the problem. The bulletin at the time warned owners, that transmission fluid could lead to their vehicles experiencing “delayed/harsh reverse engagements,” and asked owners to get a transmission fluid additive installed to correct the problem at their dealer. Another letter sent on April 2005 again reminded vehicle owners that if the vehicles were left to operate with the original factory-installed fluid, the danger of transmission shifting would actually increase.

More than 200 Ford owners have complained to the National Highway Transport Safety Administration about the transmission defect in the Explorer. In most of the complaints, there is a delay when the Explorer is shifted from park to reverse or from another gear to reverse. Other complaints have involved the vehicle slipping from park to gear, although Ford continues to deny that the complaints say any such thing.

The complaints filed with the NHTSA also report potentially serious accidents that have occurred because of the transmission defect. One complaint involves a child trapped under the vehicle when the Explorer started rolling in neutral. Other complaints call the Explorer a “public hazard” and insist that Ford was “doing absolutely nothing about it”.

This does concern Georgia personal injury lawyers. The Explorer in particular, has been linked to several safety risks. The SUV has been linked to a higher incidence of rollovers caused due to Firestone tire failures. In 2001, the company settled a lawsuit with a Texas woman who was paralyzed after an Explorer accident caused by a tire blowout, but the vehicles were never recalled.  

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

States Moving to Crack Down on Sale of Defective Old Tires That can Cause Accidents

An ABC News investigation last year revealed that thousands of motorists may be at risk for automobile accidents because their vehicles are fitted with aged tires that are older than the recommended age limit for tires. The investigation by “20/20” caught some of the biggest retailers in the country selling outdated and aged tires.  Now, states across the country are taking steps to ensure that retailers and dealers don’t fob old and weak tires on an unsuspecting motoring public.

The risk of a tire becoming dried out and prone to blowouts that can cause accidents increases after six years of age. The investigation, however found tires including some sold by Goodyear that were made in 1999 and 2002. Other investigations by ABC news affiliates around the county found outdated tires dating back to 1999 and 2001 sold at Wal-Mart. Old tires were also found at Wal-Mart stores in Florida, as well as Sears in New Jersey. Similar stories came in from across the county. The retailers including Goodyear and Wal-Mart insist that the age of the tire should not be taken as the most important factor in judging its safety.

Since the ABC investigation, several states have moved to enact laws that would prevent these old tires from being sold.

• In California, the death of a 12-year-old boy in a rollover accident after the separation of the tread on an old tire has galvanized lawmakers into action. A bill requiring tire dealers to disclose the age of the tire in writing to a customer before the tire is sold or installed has been introduced. If the bill is passed, it would also require tire dealers to retain their sale documents for a minimum of three years.
• New Jersey is also working on a law that would include an age disclosure clause.
• In Hawaii, senators have introduced a bill banning the sale of tires that are more than 6 years old.
• Suffolk County in New York has already adopted such a law, pending implementation.
• In New York, assembly members have gone one step further, and introduced a bill that would require tire manufacturers to mold the date of manufacture on both sides of the tire, in a clear and non-coded manner. Currently, the date of manufacture comes in a form of cryptic code that’s hard for a majority of consumers to decipher.

Not surprisingly, all these bills are being opposed by the tire industry.  They would like for such rules on manufacture date markings to be the same across the country, and all states. However, with the National Highway Traffic Safety Administration moving slowly to act on the problem, state lawmakers have no other option, but to pass legislation banning the sale of defective tires, to protect motorists in their own states. Are Georgia's lawmakers listening?  

Georgia accident attorneys and citizens' groups must demand that our legislators make efforts to prevent the sale of these old and defective tires here too. 

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

The Consumer Product Safety Commission (CPSC) has announced that Mega Brands America Inc. will pay a $1.1 million civil penalty to settle allegations that the company failed to inform the government about the dangers posed by its Magnetix building sets.

The defective toys were the subject of a recall in 2006 after a 22-month-old child died after swallowing tiny magnets that had come loose and fallen out of the toy. The first indication that Kenny Sweet's parents had that Kenny was sick was flu like symptoms. and shallow breathing. When he was taken to the hospital, his condition rapidly deteriorated, and he suffered a cardiac arrest. His left lung collapsed, and Kenny died soon after. His parents asked for an autopsy to find out what had happened to their precious little boy. The report arrived the next day, and the results were shocking. The coroner had found eight small magnets in Kenny's intestine. When Kenny’s horrified parents who suspected that the magnets could only have come from the Magnetix toys, checked the toy, they found several magnets missing.  

In 2005, Mega Brands which was then known as Rose Art Inc reported Kenny’s death to the CPSC. However, the company failed to provide any information about how the tragedy had occurred, and instead, claimed that the magnets probably fell out because of aggressive use of the toy. On February 1^st 2006, the company again submitted a full report which did not mention any complaints it had received of the loose magnets falling out of the toy. In March, the company recalled close to 4 million units of the toy. The CPSC later discovered that when Rose Art had first reported Kenny’s death in December 2005, it has already receive more than 1,100 complains of magnets falling out of several magnetic toy models. These complaints had included at least one report of a child being injured after swallowing the magnet. By the time the company acted to recall the toys, the number of complaints had grown to more than 1,500 across 65 different models.

In April of 2007, the recall was expanded to include all magnetic sets, after more than 25 children had to be rushed to hospital emergency rooms with intestinal injuries from the ingested magnets. Several of these children required surgery to treat the intestinal perforations that had occurred.

Under law, Mega Brands should have reported to the CPSC within 24 hours of receiving information that indicated that there was a defect in the toy that could pose a danger of injury or death. Rose Art failed to do so, and as a consequence, several children suffered intestinal injuries. According to the CPSC, there are possibly millions of the recalled building sets still in existence in homes across the county. Product liability lawyers are encouraging Georgia parents who still have the building sets in their homes to get rid of these.

The Magnetix defective toys were just one among several defective toys and children’s products that have flooded the market since then. From toxic paints in children’s toys that expose children to lead poisoning to ingestible magnets, drawstrings that can choke a child as well as children’s products like defective cribs that can lead to suffocation and high chairs that are prone to seatback collapses, it's gotten to the point where parents simply can't take the safety of the product or toy that their child uses for granted.

If you have questions about your rights after injuries caused by a defective children's product, the lawyers at the Katz Law Firm can answer your queries. Contact a product liability lawyer at the Katz Law Firm for a free consultation.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Food and drug safety advocates and Georgia product liability attorneys have long called for a division of the Food and Drug Administration into separate agencies, each in charge of food and drug safety. These calls have gotten louder since the salmonella poisoning scandal earlier this year that's been linked to contaminated peanut butter. It’s obvious that the agency is over burdened, over stressed, and simply unable to handle the responsibilities of making sure that the food and medical products that Americans consume are completely safe to use.

Hopes for a split of the agency into separate divisions for food and drug safety received impetus last week when President Barack Obama named two health experts to top positions at the FDA. The President has tipped former New York City Health Commissioner Margaret Hamburg to be the agency's new commissioner. Joshua Sharfstein, a pediatrician has been picked by the President to be deputy commissioner. Sharfstein has long been a strong critic of health issues, including the safety of children’s cold medicines. FDA insiders believe that the President's choice of 2 respected health experts points to his being in favor of dividing the agency into two. The President has also appointed an advisory group which will be re-evaluating archaic American food safety laws, many of which are several decades old.

The FDA has traditionally focused on drug safety as its primary responsibility, and critics have complained that the issue of food safety comes up at the agency only when there is a crisis like the recent salmonella epidemic.  It has been apparent even to a casual observer that the FDA has too many responsibilities and too few resources. The drug industry is reportedly in favor of a split agency because it would lead to quicker drug approvals. Besides, having a single drug safety agency will mean better oversight over drug approvals, and more stringent following of approval processes.

There is no doubt that the FDA in its present state is chained by antiquated laws that compromise the state of our citizens' health. As a commentator puts it, it makes little sense that the agency responsible for inspecting peanut butter plants is also entrusted with the responsibility of monitoring the quality of super sophisticated medical devices costing thousands of dollars. The splitting up of the FDA into two will result in enhanced food and drug security, making Americans safer. It's an idea whose time has come, and as attorneys who constantly represent victims in food and pharmaceutical drug-related product liability lawsuits, we hope that the new administration will act to implement such a division.   

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Democratic lawmakers are planning to introduce legislation that would overturn a Supreme Court decision in February 2008 barring injured patients from suing a medical device company if the device had already received Food and Drug Administration FDA approval. In effect, the legislation promises to return patients their right to sue medical device makers for injuries sustained after using their products.

In February 2008, the Supreme Court ruled that injured patients or their survivors could not sue companies that manufactured medical devices that had FDA approval. Since the ruling was passed, judges around the country have thrown out several hundreds of lawsuits that were filed by patients and their families against manufacturers of defective medical devices. Now Henry A Waxman, Democrat from California and Frank Pallone Junior Democrat from New Jersey, have plans to introduce legislation that would overturn the Supreme Court decision. The Supreme Court ruling was based on the premise that approval by the FDA took preemption or precedence over product liability laws in individual states. Judges around the country have cited the Supreme Court decision as the reason for their dismissal of several medical device product liability lawsuits.

Since the Supreme Court ruling was passed, Atlanta product liability attorneys, pharmaceutical injury experts and patients' advocates have been vocal in their opposition to the law which essentially cuts off individual rights to justice in the event of an injury. It is important to understand how serious some of these injuries are. Defective Medtronic defibrillators have resulted in a massive shock being delivered to patients' heart, and there have been other serious injuries including burning and scarring injuries caused by malfunctioning joints and other devices. These injured victims used devices that were approved by the FDA, but can hope for little justice as long as the Supreme Court decision rules. The FDA has time and again failed in its duty to make sure that medical devices entering the market are free of defects. It has severe critics both within and outside the organization who are concerned about botched approval procedures, and even corruption at the agency. If the new Democrat-sponsored legislation passes, patients can hope for justice again.            

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

If it isn’t contaminated drugs, tainted milk products and lead painted toys that Georgia product liability attorneys constantly encounter, it's the prospect of being poisoned in your own home by defective drywall. The Consumer Product Safety Commission (CPSC) is investigating whether gases emitted from Chinese-made drywall pose a safety risk to house owners, including those in Georgia.

The investigation is linked to complaints of sulfur-like gases that were being emitted from the drywall, resulting in corrosion of electrical wiring and plumbing in a few homes in Florida. Drywall is commonly used in the construction of interior walls, and currently the CPSC has no standards for the material. The drywall that has been the focus of close to 100 complaints by homeowners in Florida to the state's department of health, was imported from China due to a shortage. The CPSC investigation will look at whether there are potential safety hazards in the use of the drywall, and whether a recall needs to be issued for the defective drywall. Besides Florida, the problem is expected to be particularly high in gulf coast states like Georgia, Louisiana and Mississippi. Parts of Louisiana and Mississippi that were badly ravaged by Katrina are likely to have several houses that were rebuilt after the hurricane, using the toxic drywall.

Symptoms of sulphur poisoning from the drywall include sulphur odors that are similar to the smell of rotten eggs. The house may have more problems with this electrical wiring and air conditioning systems that can’t be explained easily. Most importantly, people living in the house could be experiencing frequent respiratory tract infections, and unexplained dizziness.   

Frustrated home owners are already beginning to explore their legal options. The number of people discovering that they have drywall with sulphur toxicity around the country is increasing. If you suspect that your house has defective drywall (if your house was build between 2005 and 2008) you can call your health department to test whether there is a sulfur toxicity problem, and if it can cause health problems.  Besides suffering from respiratory problems and dizziness, home owners with the defective drywall could also find themselves having to tear down their homes to remove the material.

Georgia Product Injury Attorneys

It seems like American consumers are being increasingly handed cheaply made foreign products which they end up paying the full price for anyway. Defective products are entering almost every aspect of our lives – from the food we eat, the medicines we take, the toys our children play with, and now it seems, even the houses we live in. We can’t wish away globalization, but as product liability attorneys we can demand that products manufactured abroad to cut costs meet the safety standards that apply to American-made products.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Earlier this month, we reported on Governor Sonny Perdue’s proposed legislation granting immunity from civil liability to pharmaceutical companies and medical device makers if their products had already received FDA approval. Earlier this month, a bill was introduced outlining many of the same proposals that the governor mentioned, and underscoring the fears of patients, civil justice advocate and Georgia product liability attorneys.

The Bill, Senate Bill 101 grants immunity to these companies from any injury lawsuit brought by Georgia residents if the injury was caused by a pharmaceutical drug or medical device that had FDA approval. It’s clearly aimed at attracting Big Pharma investment into the state with civil liability immunity being the Unique Selling Proposition (USP). What it essentially does, however, is sacrifice patients' rights to hold these companies accountable for injuries or deaths caused by their products. At the risk of sounding dramatic, we believe victims of device and pharmaceutical injury will be at the mercy of these companies.

The bill relies on a foundation that has been found to be increasingly fragile in recent years. FDA approval of drugs and devices has come under the scanner after several drugs and devices were forced off the market when injuries and risks associated with their use came to light. Do the names Vioxx, Heparin and Medtronic defibrillator leads ring a bell?

The FDA itself has admitted that it has been unable to cope with the increasing challenges of globalization, including its ability to inspect foreign facilities that manufacture ingredients used in pharmaceutical drugs.  In a dismal product safety scene like this, product liability lawsuits are the only thing protecting Georgia’s residents from dangerous drugs and medical devices. Take that away and you have a scenario in which the FDA continues to dither, and pharmaceutical companies are free to push inadequately tested drugs and devices into the American market.

The promise of more jobs and prosperity in Georgia also seems like a hollow one. Michigan, the only other state that has civil liability immunity for pharmaceutical companies, has actually seen a number of its pharmaceutical jobs move out of the state after the immunity bill was passed. So it’s fair for Georgia’s personal injury lawyers to ask our legislators- how exactly does Bill 101 benefit our people?

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

In the days since we were first informed that the nationwide salmonella food poisoning outbreak originated at a Peanut Corporation of America plant in Blakely, Georgia, the death toll from the outbreak has reached 9, the number of people sickened from salmonella tainted products has risen to 19,000 and food poisoning lawsuits have been filed.

Last week, Stewart Parnell, president of Peanut Corporation of America was summoned to Washington to testify at a congressional hearing. Meanwhile, skeletons have been tumbling at the PCA. Former employees at the Blakely plant have come forward to sing like canaries about the abhorrent sanitation practices at the plant. According to one employee, he once found baby mice inside a packet of peanuts. The same employee also claims that he has been witness to the practice of pasting new stickers on jars of old peanut paste, and has seen holes drilled by rats in sacks of peanuts. A new FDA report also indicates that management at the Georgia plant continued to ship out products that they knew had tested positive for salmonella contamination. According to the report, the company continued to retest its products until test results showed findings that were more to its liking - that the peanut butter was salmonella free.

The concern over products from the Georgia plant is so intense that the FDA has asked consumers to throw out any peanut butter products made at the plant over the past 2 years.

The fallout from the salmonella peanut butter scandal has been huge. Food poisoning lawyers are now adding punitive damages to their product liability lawsuits against Peanut Corporation America because of the fact that plant management continued to ship out peanut butter even after they had knowledge of its contamination.    

In Georgia, lawmakers have introduced a bill enabling health officials to conduct inspections of food processing plants.  The legislation would also mandate companies to report these inspection results to regulating authorities. In the nation's capital too, efforts to upgrade food inspection standards are being made. Several new bills are being developed to overhaul food safety standards in the country, and these include requiring companies to report their food testing results to state or federal authorities.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

A new report underscores the importance of car seats in saving infant and toddler lives in the event of an automobile accident. New research by a California group indicates that the chances of toddlers and infants dying in an accident drop by as much as 75 percent when they are strapped into these safety seats.

Of course we've always known that car safety seats are very effective at reducing fatality rates in children who tend to be the most vulnerable victims in the event of   a collision, but this study manages to hit home just how important these seats can be to protect their occupants. The two researchers who conducted the study, Thomas Rice and Craig Anderson, analyzed data from nearly 6000 accidents between 1995 and 2006, and compared the information to arrive at some startling statistics.  In the case of babies below the age of one year, the odds of dying in a crash declined by as much as 73 percent, while in the 1-2 year age group, the odds of dying went down by 76 percent. 2-3 years olds had a reduced risk of fatality that was close to 60 percent if they were properly restrained in a car seat.

Of course, it goes without saying that these benefits are only valid if the car seats are of high quality, and meet all safety standards for children's products. There's no point in having a child strapped in a seat with improper buckles that can snap open in the event of a collision, or one that has defective clips that can slip open, releasing the child from the safety of the seat. Child seats also need to be made of safe materials with sufficient padding that can actually cushion a child from the force of impact during a collision. Stricter standards and demands for more safety features by parents have led manufacturers to design and create safer car seats, but safety issues continue to crop up every year. The unfortunate fact is that these issues come to light only when there is an unfortunate accident that exposes the instability of a defective car seat.

Defective car seats are just one example of how manufacturers can renege on their responsibility to manufacture safe products for consumers. When a defective or dangerous product causes injuries, victims may be able to claim damages from the manufacturer as well as distributors or suppliers of the product. An experienced Atlanta product liability lawyer can help you recover compensation for injuries received from use of a defective product.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

The Georgia peanut butter plant at the center of the salmonella food poisoning crisis has a poor sanitation record, and has frequently been cited for health and sanitation violations, the NY Times (via Tort Deform) reports. Judging by the condition of the plant in our very own Blakely, Georgia, the media and food poisoning lawyers should not even be surprised that a nationwide outbreak of deadly salmonella poisoning has originated from this facility.

The Peanut Corporation of America plant has been cited several times since 2006 for health violations. Inspectors have frequently found the facility full of large gaping holes in its food security mechanisms. These include grease accumulation inside the facility, doors with large holes that a rat could easily squeeze through, and dirt and grime everywhere. The plant had areas caked with rust that could easily disperse and fall into food products, and poor sanitization of surfaces meant for food processing. Peanut butter packets were left lying around uncovered.   These violations continued even till 2008, when inspection reports continued to mention numerous violations. 

Dirty and unsanitary conditions breed rodents and insects. Animal feces are just one of the ways that the salmonellum bacterium spreads. The risk of infectious disease is the reason why food processing and preparation plants and establishments that serve food like restaurants, are put though numerous safety inspections. From the report in the Times, it seems like that the plant was a salmonellosis time bomb waiting to go off.  

While the plant was getting away with maintaining unsanitary conditions that would have been more at place in a Third World rubber factory than an American food processing plant, the FDA in its usual somnambular fashion, was debating when best to alert Americans that hundreds of thousands of packets of their favorite peanut butter contained the salmonella bacterium besides peanuts, salt and hydrogenated vegetable oil. The very first product liability lawsuit has already been filed in a Georgia court by parents of a Vermont boy who became sick after consuming the contaminated butter.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Product and pharmaceutical liability lawyers have been seriously worried about the impending outcome of Wyeth vs. Levine and the preemption doctrine.

In December, this blog discussed the case of Wyeth and Levine and federal/state preemption issues.  We await the United States Supreme Court's decision on this issue.  Meanwhile, the FDA is having to answer to these problems.  

The New York Times is reporting that the U.S Food and Drug Administration may be launching criminal investigations into complaints made by several scientists against agency officials. The complaints go back to November of 2008 when the House Energy and Commerce Committee received a letter from scientists at the FDAs Center for Devices and Radiological Health division. The letter made serious allegations that management at the CDRH had been interfering with the process of approving medical devices. The scientists complained that they were being "forced" into rushing ahead to approve devices, bypassing standard procedures. The letter galvanized the ECC committee to launch an enquiry. Now, nine scientists who had made that complaint have written a letter to President Obama alleging that FDA officials may launch criminal investigations into those complaints. The letter states that it is "an outrage that our agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress."   

The FDA hasn’t bothered to confirm or deny these reports.

Just 2 weeks ago, the Government Accountability Office (GAO) released a report of federal agencies that were in need of major improvement. The FDA was included in the list, and part of the reason was its sloppy approval procedures for medical devices that have resulted in unsafe and defective devices being rushed into the market. The GAO’s findings correspond with the claims made by the CDRH scientists, and should be enough reason to us to worry about any preemption doctrine that would snatch away a consumer's rights in case he suffers an injury from a defective device approved by the FDA. The entire premise of preemption is based on the logic that the FDA can be trusted to guarantee the safety of the devices it approves. However, as we are beginning to see in the increasing numbers of defective drugs and devices being released into the market, as well as evidence from the agency's own scientists that the approval processes are being several compromised, the FDA stamp of quality is hardly something we can rely on.

Taking away a patient's right to hold a company responsible for injuries caused by its defective product would finish off the last hope that consumers have for safety and reliability in the medical devices they use. The FDA fails the American consumer far too often – let’s hope the Supreme Court doesn’t.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

The year 2000 was the year of several dangerous toy recalls, many of which were the focus of product liability lawsuits around the country. This list of the 10 most dangerous toys of 2008 includes toys that pose hazards of choking and aspiration, lead contaminated toys as well as those that are prone to fire and burn hazards.

It isn’t clear if the list is in any particular order of danger or number of injuries caused, but it kicks off with Air Hogs RC Helicopters that came with the danger of exploding lithium-powered batteries. Many of the toy related scares of 2008 - and there were plenty of them – were linked to children being able to remove the detachable magnets from toys, and swallow these. Several dozen children were rushed to emergency rooms with perforated intestines, after swallowing magnets that later began to stick to each other through intestinal walls. Most of these injuries required surgery. The toys that came with magnets attached included earrings that contained a small magnet inside, and these make it to the list too. Other noteworthy defective playthings include backpacks containing off-the-chart levels of lead contamination, balloon sets, Dora the Explorer Lamps (which are actually electrical items and not really play things, but try explaining that to kids who see their favorite Dora on the lamp, and want to play with her), and high decibel High School Musical Rockerz.

Also on the list are children's toys containing phthalates, a chemical compound that is often mixed with plastic to make it softer. These have been found connected to reproductive problems in male children, including a drop in testosterone levels, as well as genital abnormalities. Linking phthalates to these disorders has been the easy part – the challenge lies in finding out what products contain these chemicals, present as they are in a variety of consumer products, from air fresheners to teething rings. Phthalates are never mentioned in the list of ingredients, which means that most of us who use these cosmetics, perfumes, cleaners, and toys risk being exposed to them every day. Expect to hear more reports of injuries and illnesses associated with phthalates use in toys in 2009.

We hardly expect the toys our children play with to explode during play, or damage their hearing with the kind of high decibel sounds they come with. Yet these very basic safety principles seem to fall by the wayside time and again when it comes to introducing a new toy in the market. Often, it falls on Atlanta toy injury lawyers to take up the cause of holding manufacturers responsible for their negligence in introducing these dangerous toys.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Seattlepi.com has an interesting story about how well we can expect our federal agencies to ensure that the food that makes it to our tables is safe to eat. The focus of the story is but naturally, the salmonella food poisoning crisis that has engulfed the country with 6 deaths connected to the epidemic so far.

The biggest source of concern to American consumers in this latest crisis, the report says is the manner in which the Food and Drug Administration dragged its feet for more than three months before confirming an outbreak. The latest crisis that has involved the agency's food safety protocol has had consumer safety advocates, food poisoning lawyers as well as the public, wondering how the FDA which found out weeks ago that the Georgia plant of Peanut Corporation of America was the source of the particular strain of Salmonella found in the contaminated peanut butter, could have waited so long before they even confirmed the source. The FDA continued to mouth the same line - that the peanut butter in question was only sold to restaurants, nursing homes and food companies, but they still have not released a list of all Peanut Corporation of America clients who may have received the contaminated butter. The FDA's outdated practices mean that manufacturers are rarely forced to recall their products. The agency prefers to rely on voluntary recalls by companies, and in many cases, these are too late to prevent severe illnesses.

More companies meanwhile are queuing up to announce recalls of their products that contain peanut butter. General Mills has recalled 2 varieties of snack bars because butter used in the snacks came from the Peanut Corporation of America. Other companies including Perry’s Ice cream Company, Food Lion Cookie, Hy-Vee Inc, have all removed their products containing peanut butter from store shelves as a precautionary measure because of the fear that these could contain traces of the contaminated butter.

What's important to note is that these companies are not being asked by the FDA to recall these products, but are doing it voluntarily. You may wonder what exactly it is that the country's premier food safety agency does to justify its existence, when the number of people sickened by Salmonella contamination that surfaced in September has crossed 470 with 6 people dead and at least 90 hospitalized? Citizens, the media and food poisoning lawyers have no problem being up in arms when contaminated products made overseas make it to our table, but it is time to admit that we do have a food safety crisis of our own going on in the U.S.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Eli Lilly & Co. has agreed to a settlement with federal regulators that will include a fine of $615 million to settle criminal lawsuits, and a further $800 million to resolve civil litigation related to injuries caused by its anti psychotic drug Zyprexa. That makes the total fine amount to close to $1.5 billion, said to be the largest criminal fine for an American company. The company will plead guilty to one misdemeanor charge, and will not plead guilty to wrongdoing in any civil case.

The punishment is for the company's indulgence of off-label use of its Zyprexa medication. Off-label use is the promotion of a drug by a company for purposes other than that for which it has been approved. It's not prohibited for doctors to prescribe drugs for purposes other than that for which it was specified, but pharmaceutical companies are expressly forbidden from promoting such off label use of the drug. 

Zyprexa is an anti psychotic drug that is meant for use by patients who suffer from schizophrenia or bipolar mania, but that didn’t stop Eli Lily from promoting the product as a sleep medication for elderly dementia patients. Between 1999 and 2003, thousands of Eli Lilly representatives were urged to promote use of Zyprexa for use in dementia patients. Documents produced in court have shown that the company greedily pushed Zyprexa to treat a variety of disorders that it was never approved for, including aggression, dementia and dementia related to Alzheimer's Disease. The company began promoting the medication in assisted living facilities and long term care nursing homes. Effects of the medication like weight gain were already becoming evident, but Eli Lilly's representatives pooh poohed these, saying these were part of the benefits of taking the medication. Representatives were urged to market the drug for symptomatic treatment, even in cases where the drug had not been approved. Incidences of patients dying from heart attacks and infections after using the drug began to surface, and finally in 2006, the FDA ordered the company to have strong warning labels that cautioned patients of the drug's risk for elderly patients. Since then, the company has paid out $1.2 billion in settlement of at least 32,000 injury claims that were brought against it. This new settlement is in addition to the previous one.

Eli Lilly's greed for profits at the cost of the health of thousands of patients isn’t the first instance of corporate greed by a pharmaceutical company, but it was astonishing in how widespread and audacious the unscrupulous practices were.  Too often, pharmaceutical companies throw ethical practices to the wind, instead choosing to boost bottom lines, even when it's evident that such practices could put the lives of thousands of patients at risk. In cases like this, victims can claim compensation for their injuries through a product liability attorney who can help evaluate the damages suffered, and the company's liability in causing these.  

If you have been injured or fallen sick because of a defective medication, then you may be able to claim damages for your suffering. Contact a product liability lawyer at the Katz law to evaluate your options for compensation.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

According to the Department of Public Health, five cases of the salmonella food poisoning that have been reported across the country have been found in Georgia. A few days ago, the Centers for Disease Prevention and Control announced an outbreak of salmonella poisoning in 42 states. The outbreak apparently occurred between October to December, and has sickened close to 400 people. One elderly woman who died during the period had been infected at the time of her death, but it hasn’t been confirmed if she died because of the poisoning. 

Now, fresh reports confirm that a brand of peanut butter has been traced as the source of the contamination. Batches of King Nut and Parnell's Pride peanut butter that were distributed by King Nut Cos, and supplied to schools, nursing homes and restaurants, have been recalled. The batches were only sold to institutions, and were not available directly to the public. The company apparently only distributed the product which is manufactured by Peanut Corporation of America. The link was traced when tests conducted by the Minnesota Department of Agriculture and Health on the peanut butter batches revealed a match with the strain of salmonella Typhirium type that has been responsible for the outbreak.

Symptoms of salmonella poisoning include abdominal cramps, fever and diarrhea. In cases of serious infection, hospitalization may be required. The symptoms are particularly acute in the case of children, elderly or those who have weakened immune systems. In serious cases, the infection may spread to other parts of the body, and death can result.

The most common sources of contamination are meat, fresh produce, eggs and dairy products. Non pasteurized milk, semi cooked or uncooked meat and eggs are frequently traced to such outbreaks. People who work in the food processing or preparation industry like restaurant workers, or employees of meat packing plants, or in the case here, a peanut butter manufacturing company are required to be extra careful when it comes to maintaining personal hygiene, because of the possibility of salmonella contamination spreading to customers.

Almost always, salmonella contamination can be traced to carelessness or negligence at some point in the chain, from the moment a product is made, to its delivery into the hands of the customer. In order to claim compensation in case of illness due to salmonella poisoning, a personal injury lawyer will have to prove that that the illness was caused because of the careless actions of the persons responsible for ensuring that their products were safe, and that the illness caused by this contamination was severe. If you have been sickened as a result of the salmonella food poisoning outbreak in Georgia, the product liability attorneys at the law firm of Robert N. Katz can help you evaluate your situation and your options for compensation. Contact a Georgia food poisoning lawyer at the Katz law firm for a free review of your case.

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

The United States Supreme Court heard oral argument in November in a case called Wyeth vs. Levine. The case comes out of a Vermont Supreme Court decision. Diane Levine was a musician who suffered from migraine headaches. A physician’s assistant administered the drug Phenergan during a “push-IV” injection. The PA accidentally injected the drug into Levine’s artery instead of a vein. This caused tissue necrosis, gangrene, and the eventual amputation of her hand and forearm.

The drug Phenergan, manufactured by Wyeth, had a warning label that warned of this risk if the drug was injected into an artery. The Federal Drug Administration (FDA) had approved the label. Levine warned that the label did not warn of the risks associated with hitting an artery during a push-IV.   A Vermont jury awarded Levine $6.8 million against Wyeth. Wyeth argued that the approval by the FDA constituted pre-emption by federal law of state law tort claims. The Vermont appellate courts upheld the verdict, and Wyeth appealed at the federal level. 

The United States Supreme Court is now considering whether federal law supersedes state law in drug labeling cases. Currently, state law could supercede federal requirements if new information became available about the drug or the FDA failed to disclose certain risks. In this case, however, Wyeth knew of the risk of harm and did in fact warn of the risk. The risk of harm caused by injecting into an artery is a 1 in 20 million chance of a gangrene adverse reaction.   Levine argues the warning should have been stronger, specifically that the push-IV method increased the risk of hitting an artery.  

The issue here is really whether the FDA sets minimum standards that states are free to enhance through tort liability or whether the FDA makes decisions that states are bound to follow?   Federal preemption is one of the hardest fought battles in products liability law. This question will determine whether FDA approval of drugs will prevent patients from suing drug companies when the drug in questions received an FDA approval.   

Wyeth argues that removing preemption will result in drug companies listing all possible harm on their labels, causing an undue burden on these companies and possibly lessening the value of information available to the user.   Plaintiffs’ attorneys argue that federal preemption will effectively cause patients to lose their right to sue drug companies for harm caused by the drug. 

One problem with giving so much power to the FDA is its inherent ineffectiveness. Currently, the FDA is under funded and understaffed to handle the $1.5 trillion dollars worth of goods it must inspect and evaluate. Drug companies can now pay user fees to speed up approval of their products. Further, drug companies bankroll one-fifth of the FDA budget. Arguably, a rush for approval compromises the quality of oversight. Thus, it is not surprising that drug companies want the FDA to have the last word on drug safety.   As Maggie Mahar said in her Healthbeat blog: there is no easier regulatory process to navigate than the one you control. 

The Journal of the American Medical Association wrote recently in support of Levine that “the drug and device regulation system is at best an inexact and incomplete science.” More is learned about drugs once millions of people start taking them. This information is often more useful than that conducted in the limited trials done by the FDA during the approval process. Drug companies often learn about the dangers caused by their drugs once they are at market; and they do not often report these findings back to the FDA after approval. 

Thus, a victory for federal preemption means that the drug companies that are fast tracking their drugs through the FDA’s process cannot later be held accountable for harm their drugs cause. Hopefully, the Supreme Court will see through this problem. We shall see.   

If you have a claim or think you have a claim for products liability involving a drug company or drug product, contact the law firm of Robert N. Katz for a free, private consultation.            

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

Drug manufacturer GlaxoSmithKline won a significant ruling this week in the Third Circuit of the United States Court of Appeals in Colaccio vs. Apotex. SmithKline, the manufacturer of the anti-depressants Paxil and Zoloft, defended two separate state tort claims that the manufacturer failed to warn of the risk of suicide from taking the drug. Plaintiffs product liability suits failed. 

In a split decision, the Third Circuit ruled that federal regulatory law pre-empted state tort law claims in cases against manufacturers of anti-depressants for failure to warn of the risk of suicide.  

Anti-depressants are drugs known as selective serotonin re-upate inhibitors (SSRIs). The drugs block the re-absorption of serotonin into the brain. Serotonin is a natural body chemical that regulates mood, sleep and appetite. By blocking the re-absorption the brain cells get an extra dose of a feel-good chemical. Some experts believe that the increase in serotonin causes a drop in the natural chemical dopamine. Dopamine regulates cognition and behavior.

In 1991 the Food and  Drug Administration (FDA) Advisory Panel showed that there was no causal link between anti-depressants and suicide or violent behavior. However, in 2003 a subsequent FDA panel issued a Public Health Advisory for Paxil, Zoloft and other SSRIs urging health care providers to be on the lookout for worsening of depression and the onset of suicidal behavior in the beginning stages of drug therapy or if dosage amounts change. Although none of the drug trials showed an increase in suicide, the FDA has asked drug manufacturers to issue stronger labels.   However, given the lack of scientific data, strong warnings are not required.

From documents obtained through discovery in the civil jury trials, SmithKline was aware that a small number of people could become agitated or violent while on the drugs. Despite this knowledge, no warning was placed on the label. Experts believe that the drug may cause a side effect known as akathisia. Akathisia causes overwhelming mental and physical restlessness. Some medical experts believe this causes patients to be sufficiently energized to harm themselves or others.

In the recent two cases on appeal before the Third Circuit, one district court held that the plaintiff’s product liability claims were pre-empted by federal regulatory FDA rulings. Another district court ruled the opposite, federal law did not pre-empt a state tort suit. In the majority opinion, the Third Circuit held that the FDA was a regulatory agency specifically mandated to scientifically assess the nature of drugs and the warning required. The court held that state tort law could not pre-empt federal law, and therefore the state suits on the failure to warn could not go forward.

The dissenting opinion argued that in many ways the FDA is an imperfect agency as it receives much of its data from the drug manufacturers. Discovery in state tort lawsuits provides a different way for third parties to raise questions about new and existing drugs. The dissent argued that policing drug companies is helped through tort suits, which act as a companion investigative tool for the FDA. 

However compelling the dissent argument, as it stands, where drug manufacturers are not required to place a warning label on drugs, plaintiffs have no ground for suit on the issue of failure to warn.

Antidepressants account for $14 billion a year of wholesale drug revenues in the United States. When the best-selling and most profitable drug poses a risk of suicide, drug manufacturers have a strong incentive to quash warning claims. Often there exists a clash between the manufacturers marketing tactics and the well-being of the consumer. Regulatory agencies must be above the tactics of drug companies. The pharmaceutical industry is regulated because drugs can cause serious harm and drug companies, with their financial conflict of interest, cannot be relied upon to serve the public interest. 

At this point in the legal field, however, for consumers of anti-depressants drugs it is “buyer beware.”

If you have a product liability claim against a drug manufacturer, contact Robert N. Katz for a free private consultation.    

Posted By Lisa Siegel In Product Liability | 1 Comments Permalink

Former Mitsubishi President, Katsuhiko Kawasoe, was sentenced in Japan last week for professional negligence for his role in covering up defects in Mitsubishi trucks in cars over a three-year period from 1997 to 2000.  Apparently, the auto manufacturer hid defects in its clutch system on several models of trucks and cars.  The defect caused the brakes to fail.  In some cases, occupants were killed in collisions caused by the faulty system.  Wrongful death suits arising from these collisions uncovered the scandal.

Mitsubishi hid reports of defects, choosing to secretly repair the cars when brought into dealerships rather than issue a product recall that would have protected consumers.  When news of the cover-up came out, sales plummeted, and company officials were forced out in disgrace.  Subsequently, those officials were charged with professional negligence and criminal violations for falsifying reports and failing to take proper recall measures.

In the United States, the National Highway Transportation Safety Association (NHTSA) has issued its 2007 recall report. Automobile recalls increased in 2007 by thirty percent from the previous year.  Manufacturers issued 588 recalls, affecting almost 15 million vehicles. 

Recalls have increased over the last seven years partly due to the Federal TREAD Act (Transportation Recall, Enhancement, Accountability and Documentation) passed in 2000.  The TREAD Act was enacted after congressional hearings established that recalls of defective tires could have occurred sooner if the NHTSA had obtained reports of tire problems from the manufacturer in a timely manner.  The Act arose in response to the recall of 10 million Firestone tires in 2000.  However, the Act covers only tires. 

Ford Motor Company issued the most recalls in 2007.  Daimler/Chrysler came in second for the total number of recalls.  General Motors and Toyota, both covering a large part of the auto sales market, had a decline in the number of recalls issued.

Ford felt the sting in 2007 when it recalled 3.6 million vehicles for a faulty cruise control switch that lead to fires.  Combined with recalls in past years for the same defect, this was the largest recall ever. 

Volkswagen recalled nearly a million 2007 Beetles for a faulty brake light switch.  Sales of the Beetles fell by thirty percent as well.

Recalls hurt manufacturers directly with unexpected costs and indirectly with a decrease in sales and harm to the overall brand.  However, recalls benefit consumers by identifying problems before accidents occur.  Ultimately, recalls should lower product liability claims. 

In the past, some automobile manufacturers, as the Mitsubishi scandal detailed, put corporate costs over consumer safety.  With strong federal regulation and adherence to safety requirements, hopefully, in the United States, manufacturers will bear the cost of product defects in the recall arena rather than through product liability litigation.

However, if you believe that you may have a product liability claim or if you were in an auto accident that may be related to a product defect, contact the law firm of Robert N. Katz for a free, private consultation.  

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink

In Georgia there is a doctrine known as Res Ipsa Loquitur, which translated means “the thing speaks for itself.”   Some things are so manifestly the result of someone’s negligence that a jury can infer negligence on the part of the defendant.   In other words, the evidence proves the point.   For example, a scalpel left in the stomach of a surgery patient infers the negligence of the doctor.   Also, a barrel of flour falling out a second story window infers the shopkeeper’s negligence. When applied, this doctrine creates an inference of negligence that the defendant must affirmatively disprove.

 To apply this doctrine in a negligence case, the plaintiff must usually show:

1. That harm would not have occurred without someone’s negligence;
   
2. The “thing” which caused the harm was under the exclusive control of the defendant; and
   
3. There is an absence of a reasonable explanation as to how the harm occurred.

 
Over the course of my practice, many accident victims will tell me that in addition to being hit by a negligent driver of another automobile, their own car failed to protect them in the accident.   For example, the seatbelt did not hold or the airbag did not deploy.   These clients will often question me about adding a product liability suit to the auto accident claim against the negligent driver.

 This week the Georgia Court of Appeals in Millers vs. Ford Motor Company upheld the grant of summary judgment (a motion filed by the defendant that defeats the plaintiff’s case before it ever gets to trial) to the automobile manufacturer, Ford Motor Company. In that case the plaintiffs alleged that the seatbelt and side air bag in their Lincoln Town Car were defective and contributed to their injuries when they were struck by another car. 

 The court held that the plaintiffs failed to show that the seatbelt and side air bag were defective when they left the defendant manufacturer.   The court ruled that mechanical devices sometimes get out of working order without any negligence on anyone’s part.   Also, once a car leaves the manufacturer, the manufacturer no longer has control over the car and cannot be liable for subsequent repairs or tampering with the vehicle. 

In a product liability suit, the plaintiff must show:

1. There was a defect in the product that varied from its intended design;
2. The defect existed when it left the manufacturer; and
3. The defect was the cause of the plaintiff’s injuries.
   

This concept is called “strict liability.”    If the plaintiff fails to meet the burden of proof, the court will likely grant summary judgment, dismissing the case without a trial. 

Product liability suits require a good deal of pre-litigation investigation in order to determine if a truly defective product exists. Plaintiffs must be prepared to show the condition of the car following the purchase (all repairs, alterations etc.) and should usually rely on expert testimony to prove negligent manufacture. After the filing of suit, extensive discovery will be necessary to prove a product defect. Consultation with an attorney will best help you determine if the facts in your case “speak for themselves.”  

Posted By Lisa Siegel In Product Liability | 0 Comments Permalink