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Archive for the 'Products Liability' Category

GM Concede on Product Liability Question (Somewhat)

Wednesday, July 1st, 2009

After a national outcry against the shedding of liability for its vehicles by the “new GM,” the company has now reached a deal with the Obama administration to assume some liability for its vehicles.

Under the new terms, the automaker will now assume responsibility for injuries resulting from accidents that occur after the company’s bankruptcy proceedings have gone through. What that means is that consumers who suffer injuries from driving GM cars after June 1st will be able to sue the company. The automaker will also take on injury claims that relate to car accidents that occurred while the company was in bankruptcy court.

Earlier, the company in its bankruptcy terms had shed past and future liability for all vehicles manufactured by the company, as part of terms that would see the company sell off its assets to the new company that would evolve from the bankruptcy. That had sparked outrage from consumer safety advocates, product liability lawyers as well as state attorneys general, who had stringently voiced their opposition to those plans. The abandonment of all liability by the new company for defects in vehicles manufactured by the older pre-bankruptcy automaker would place consumers at a loss for their rights to sue for injuries or casualties. The debate raged for weeks and the automaker has now decided to assume liability in order to avoid a delay of the company’s restructuring.

However, persons who have pending product liability claims against GM as well as those who had won damages against the company before it filed for bankruptcy, would be left out of the new terms. These people will not be able to bring claims against the new GM. As we had discussed earlier, these creditors would still remain at the bottom of the heap along with the other unsecured creditors of the company. Claims that arise from GM’s dealership closures also will be left behind under the bankruptcy terms. State attorneys general and consumer advocates are trying to get the automaker to assume liability for pending product liability lawsuits as well as claims that had already been awarded damages before the company filed for bankruptcy. According to the Wall Street Journal, however, it doesn’t appear that the automaker will go that far. These people include several persons that have been severely injured because of vehicular defects in GM’s automobiles.

Over the past few weeks, we have covered GM’s bankruptcy and how it would affect product liability claims and lawsuits several times. These new terms and conditions that the automaker has agreed to are not completely what product liability attorneys have called for, but they are an improvement over the complete lack of liability that the company had enjoyed thus far. Last week, a report by an auto safety group made it clear how many persons would be left out of injury claims after the bankruptcy went though. According to the report that made use of claims data over a five-year period, there would be an average of 3,400 personal injury and wrongful death claims each year.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of product liability. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

The Reeves Law Group is not acting as legal counsel for any party in the matters discussed in this posting.

Mattel, Fisher Price Fined $2.3 million in Penalties for Lead Paint Violations

Wednesday, June 10th, 2009

In what is the highest ever civil penalty for violating CPSC import and distribution regulations, toy maker Mattel and its subsidiary Fisher Price will pay $2.3 million in fines for importing toys containing excessive levels of lead from China and selling these in the country.

Under the penalty settlement, the El Segundo, California-based toy maker and New York-based Fisher Price Inc., have agreed to pay the penalties to settle allegations by the Consumer Product Safety Commission that the companies knowingly imported children’s toys that contained lead levels in violation of federal laws into the country, and sold these. In 1978, federal laws placed a ban on selling children’s products, including toys, that contained more than .06 percent lead by weight in the paints or surface coatings. In 2007, Mattel was forced to recall millions of toys after they were found to have paints that exceeded lead-content limits. At least 25 toy models by Mattel and Fisher Price including several Barbie accessories and Sarge cars had to be recalled.

According to the CPSC, the civil penalty is the highest for “violations involving importation and distribution in commerce of a regulation product.” It’s also the third-highest for any kind of violation in CPSC history. Mattel and Fisher Price have now settled allegations that the former imported up to 900,000 “non-compliant toys.” These toys, including the Sarge car and Barbie accessories, were imported between September 2006 and August 2007. The Sarge car was recalled in August 2007, while the Barbie accessories were recalled in September that year. Fisher Price was alleged to have imported up to 1.1 million “non-compliant toys” including GEOTRAX locomotives, the Go Diego Go Rescue Boat and Bongo Band Toys. The GEOTRAX locomotive and Bongo Band were recalled in September 2007, while the Go Diego Go Rescue boat toys were recalled the following month.

After Mattel and several other companies were forced to recall their lead-tainted toys in 2007, Congress was finally galvanized into action. The recalls have led to the implementation of the Consumer Product Safety Improvement Act. The out cry against high levels of lead in children’s toys and other products has forced toy manufacturers to enforce stricter standards.

The lead-tainted toys scare focused attention not only on the dangers of the poor standards of imported toys, but also on the product safety standards of a whole range of products manufactured in foreign countries, especially China. For American manufacturers fighting to stay competitive in a globalized world, it has become easier to shift production and manufacturing facilities overseas where labor costs are much lower. However, we can’t deny that there has also been a drop in the levels of oversight of these foreign companies that manufacture toys, clothes, cribs, and other products that our children use. There have been contaminated drugs and tainted pet food. The American consumer has a right to expect that companies, who have no qualms about shifting production overseas, also make an effort to guarantee that their products are safe.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of dangerous products. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

The Reeves Law Group is not acting as legal counsel for any party in the matters discussed in this posting.

Army Doctor Falsified Medtronic Infuse Study on Injured Soldiers

Thursday, May 28th, 2009

An Army doctor, who was formerly at the Walter Reed Army Medical Center published a study that exaggerated the benefits of Medtronic’s Infuse bone growth product in treating severely injured soldiers. Dr. Timothy Kuklo, an Army investigation reveals, published the study that cited a far greater success in using Infuse for the treatment of injured soldiers at the facility than other doctors in the hospital. Dr. Kuklo is a paid consultant for Medtronic Inc., and the investigation has further fueled the already raging controversy over Medtronic’s promotion of unapproved use of its products.

Dr. Kuklo, the Army investigators have found, published a study that was submitted last year to the Journal of Bone and Joint Surgery in Britain. In it, he claimed staggering success results with Infuse at Water Reed. Other surgeons too had considerable success using Infuse on soldiers who suffered gaping wounds on their legs from explosions in Iraq, but they were nowhere close to the 92 percent success rate that Dr. Kuklo reported in his article. The study claimed to review GI’s who were treated with Infuse at Walter Reed between March 2003 and March 2005. Further, Dr. Kuklo forged signatures of four Walter Reed surgeons, claiming these four doctors were co-authors before submitting the article to the medical journal.

The inquiry was prompted by one of the four doctors whose signature Dr. Kuklo forged in his article. Lt. Col. Romney C. Andersen brought the issue to the attention of the Army last year. The Army apparently kicked off the investigation, and asked the Journal of Bone and Joint Surgery to retract the article.

Medtronic representatives have confirmed that Kuklo was a paid consultant to the company. Medtronic also seems to have financially supported the doctor in some of his research at Walter Reed. The company however, denies financing or reviewing the Infuse research study.

This isn’t the first controversy surrounding the Infuse bone growth product. As we reported a few months ago on our California Personal Injury Lawyer Blog, the family of a California woman has sued Medtronic in her death, claiming that the company’s representative pressured doctors to use Infuse during neck surgery. Neck use for Infuse is not approved by the Food and Drug Administration. Companies are not allowed to promote uses of a product that have not been approved by the FDA, but doctors can use their discretion to use a product for unapproved purposes. Last year, the FDA issued a safety alert warning that Infuse could result in breathing problems if used in neck surgeries.

Medtronic itself is no stranger to controversy. The company finds itself at the center of a storm over whether the company engaged in illegal promotion of unapproved uses of Infuse by paying physicians, a charge that the company has denied.  The Justice Department is investigating these charges. Senator Charles Grassley of Iowa, who is leading that investigation, has also now sent off letters to the Army, two medical journals including the Journal of Bone and Joint Surgery, as well as the Washington University in Saint Louis where Dr. Kuklo works.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of product liability. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

The Reeves Law Group is not acting as legal counsel for any party in the matters discussed in this posting.

Yamaha Rhino ATV Recalled, Sales Suspended

Thursday, April 2nd, 2009

Yamaha Motor Corporation has announced a recall of its Rhino side-by-side All Terrain Vehicles (ATV), and has agreed to suspend sales of the vehicles that have been linked to several ATV rollover accidents.

The Rhino has been linked to hundreds of injuries and at least 46 deaths across the country in rollover accidents. The Consumer Product Safety Commission and Yamaha Motor Corp. have announced a free repair program for Rhino models manufactured since fall of 2003. These include more than 120,000 of Rhino 450, 660 and 700 models. The CPSC is urging owners of the Rhino ATV to discontinue use immediately. Owners have been asked to contact their nearest Yamaha dealer for free repairs that will be conducted on the vehicle to make it safer. All sales of Rhino ATVs have been temporarily suspended until the vehicles can be repaired.

More than two-thirds of Rhino ATV accidents involved cases where the vehicle rolled over on the occupant. These ATV rollover accidents have resulted in serious injuries that include crushing injuries. The repairs of the vehicle will include installing a spacer on the rear wheels and removing the anti-sway bar in the rear to decrease the risk of a rollover. The repairs are also expected to allow for better handling and control of the vehicle. Yamaha will also include additional safety features to ensure that drivers and passengers’ arms and legs are restrained inside the vehicle through the installation of passengers’ handholds and half doors. This is expected to reduce the severity of crushing injuries when passengers’ arms and legs are crushed beneath the vehicle during a rollover.

Rhino ATV accidents have received extra attention because of the fact that the vehicle has rolled over even when the driver has turned at low speeds. All Terrain Vehicles are popular with the young and with people who work on farms and ranches precisely because they are meant to be driven on rough terrain. Yamaha and other ATV companies have promoted their ATV as being suitable for use on all kinds of terrain. The Rhino, however, is prone to roll over even when it’s driven on relatively level terrain.

For years, Yamaha has received complaints about rollover accidents that have resulted in severe injuries and even fatalities. Rhino owners have suffered catastrophic injuries including those to the hands and legs. The Rhino in its current form comes with no protection for the occupants of the vehicle in the event of a rollover. This means that when the vehicle flips over, occupants in a reflex action put their legs out to prevent a tip over. They end up with severe injuries to their limbs, sometimes resulting in amputations.

Even with all these reports about Rhino ATV rollover accidents, Yamaha until now has done precious little to fix the problem and address consumer concerns. For years, experts have warned about the poor design of the Rhino that included a narrow elongated body and a too-high center of gravity that places it at an increase risk for rollover accidents. The company has now finally taking some steps to ensure that people are spared the risk that their ATV’s pose.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of product recalls. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

Holding Companies Responsible for Foreign-Made Defective Products may Protect Consumers

Tuesday, March 17th, 2009

It’s hard to remember a time when the American consumer was in greater danger from defective and dangerous products than the present. It seems like lead-painted toys, contaminated drugs and other defective products have become a far too common feature in the lives of ordinary Americans. Whether you are buying a crib for your child or a new car, safety is of paramount concern to the consumers, and yet too often, products that end up in consumer hands prove to be unsafe, and even dangerous.

When you look back at some of the most high profile product recalls in the U.S in recent months, you will find a common thread running through most of these products – they were all manufactured at overseas plants.

Globalization is here to stay for better or worse, and these frequent defective product scandals reveal the “worse” aspect of it. American consumer safety agencies like the Food and Drug Administration and the Consumer Product Safety Commission have been found to fail all too frequently when it comes to assuring the safety and quality of products introduced into the American market, or getting these defective products out of the market quickly enough in the case of obvious danger. While the agencies themselves suffer from bureaucratic lethargy and lack of resources to ensure that only safe products make it into the market, there is also the question of holding foreign companies accountable for the quality of the products they manufacture.

It may not be practical to expect the FDA to inspect each and every single batch of medications that arrives in the U.S. Likewise, it is not possible to inspect every single toy, child equipment, or other consumer products that are made abroad. The only way to ensure that globalization continues to work the way it’s meant to is to hold local companies, that are responsible for importing and distributing products inside the U.S., responsible for the quality of products they import. These companies are better placed to monitor and inspect the production chain at the foreign plants they import from. All too often American companies who source products from overseas get away with washing their hands of the matter when these very same foreign-made products are found to be harmful to American children and families. If costs are being cut in an effort to boost bottom lines, then that cannot be at the expense of American consumers.

The prospect of additional liability because of defective products may be able to better ensure the safety of products manufactured overseas than any inspections done by federal agencies. This is not to say that federal agencies like the FDA should wash their hands of their responsibilities all together. However, increased inspections of the kind that are necessary will cost hundreds of billions of dollars in additional funding to accomplish. With the financial meltdown and a budget deficit, it doesn’t look like the funding will be available any time soon. Until such time however, stronger civil liability for American companies for defective products manufactured overseas can help.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of product liability. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

New Legislation to Return Right to Sue Device Makers

Wednesday, February 25th, 2009

When a Supreme Court ruling in February 2008 declared that the Food and Drug Administration’s approval of a medical device would grant civil liability immunity to the medical device maker in the event of injuries caused by the device, it essentially eliminated a person’s right to seek justice in case of such injuries. Now however, patients who have been injured through the use of FDA-approved devices have a ray of hope. Democratic legislators are reintroducing laws that will seek to nullify the 2008 ruling and grant patients the right to sue device makers again.

The two House members, Frank Pallone Jr. of New Jersey and Henry Waxman of California, are planning to reintroduce legislation aimed at returning the rights of patients to sue medical device makers back to them. Since the 2008 Supreme Court ruling, hundreds of patients around the country injured by devices ranging from defective Medtronic defibrillator leads that caused a massive shock to the heart, or alternately, simply failed to emit life-saving shocks to the heart, and other complex internal devices that have malfunctioned with horrific results, have been unable to claim their right to compensation from these device makers through a product liability lawsuit. In January this year, a Minnesota judge threw out hundreds of lawsuits relating to injury caused by Medtronic’s defibrillators, and in February, another judge in Wisconsin dismissed a lawsuit brought by a man who had to have a risky and painful surgery to remove his Medtronic heart device after warnings of its malfunctioning were issued by the company. In both cases, the judges said they were unhappy with the way that American consumers were being left defenseless in the face of the injuries, but they had no choice but to dismiss the lawsuits because of the pre-emption rule that gave precedence to the FDA’s approval over a state’s laws.

The FDA has faltered badly in the last couple of years, seemingly stumbling from one drug-related disaster to the next. It has received censure from congressional bodies who have expressed concern at the way the country’s foremost drug safety agency continues to bungle, and has been criticized by California product liability attorneys for its failure to monitor the safety of medical devices before they are introduced into the market. We have seen all too often how the agency has been unable to strictly regulate its processes, and has had its approval processes tarnished by allegations of corruption from within the organization. In short, we can hardly depend on the FDA to be able to safeguard our safety and consumers who use FDA-approved devices must have recourse to justice if these devices leave them with injury. In a situation where the FDA’s failures continue to tumble out of the agency’s closet at an alarming frequency, it’s extremely unfair to patients to have no option for legal action in the event of injuries related to use of the device. As product liability attorneys we hope better sense prevails, and that the new legislation is passed quickly.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of product liability. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

Child’s Death Probe May Look into Defective Washer Design

Friday, February 6th, 2009

Investigators looking into the death of an Orange County girl who was killed inside her family’s washing machine, have ruled that the death was the result of an accident.

4-year-old Kaylee Ishii climbed into the front-loading washing machine at her home. Her toddler brother appears to have turned on the appliance, causing her to tumble inside the machine for several minutes. Her mother found her a few minutes later. She was rushed to the hospital where the doctors attempted to resuscitate her for up to five hours. She died soon after.

Doctors who treated the girl have admitted that they found the death highly “unusual.” Washers and dryers pose suffocation threats to very young children, and have been the cause of several injuries caused to little children, but very few of these warrant a visit to the emergency room.

Meanwhile, a probe into the girl’s death is expected to center around the defective design of the washing machine. The switch for the Kenmore 417 machine was located about 20 or so inches off the ground, which led to the young toddler brother of the girl being able to switch it on without any problem. The US Consumer Product Safety Commission has already announced a probe into the design of the machine. There have been at least three deaths involving children who climb into top loader machines, but Kaylee’s death is the first one that involved a front loader washing machine. The machine’s design has also been called into question by others who debate the safety of washers that cannot be stopped or can be stopped with great difficulty when the cycle is on.

It would be foolish to treat this as anything other than the defective design problem that it appears to be. It doesn’t make sense that a 15-month-old child could actually reach up and switch on a washer that his four-year-old sister has just managed to crawl into. Shouldn’t there be a mechanism that allows the washer to detect when the load that is inside is not dirty laundry, but a live, four-year-old child, weighing several dozens of pounds? And if an emergency should occur when the machine does start with a child inside, shouldn’t there be a way to shut down the machine immediately? How does a manufacturer get away with installing a switch that’s just 20 inches off the ground?

Household appliances have made our lives much easier and more comfortable, but they also come with certain dangers. For instance, the risk of electrocution form faulty or exposed electrical wiring is a very real one in washing machines, driers, electric stoves, and ovens etc. Washers and refrigerators may also be subject to tipping hazards when a large appliance falls over when a weight is applied to one side of the appliance. Some appliances may be poorly designed, with a tendency to be unstable and fall over. Still others may result in fires and explosions, causing burn injuries. The Consumer Product Safety Commission announces dozens of recalls every month related to household appliances not just for their deign defects, but also manufacturing flaws that pose risk of injury.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of defective products. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

Defective Bassinet Lawsuit Filed Against Disney in Los Angeles Court

Tuesday, January 6th, 2009

The family of a child who died in a strangulation accident in a bassinet has filed a lawsuit in a Los Angeles Court against the Walt Disney Company. The product liability lawsuit alleges that the company allowed the Winnie the Pooh-featuring bassinets to continue to be sold despite the death of a baby earlier in a bassinet from the same line.

The bassinets which feature the much-loved Disney character were recalled after the Consumer Product Safety Commission directed Simplicity Inc., to pull all bassinets off retailer shelves. The design defect that caused the recall was located in the drop side of the bassinet, which created a gap that could cause strangulation hazards to an infant. The couple who filed the lawsuit alleges that their 6-month-old daughter Kennedy Brotherton Jones was trapped in such a gap, and was strangled to death in August of last year. The recall was announced after their daughter’s death. Now, the lawsuit against Disney alleges that the company did nothing to stop the sale of the defective bassinets in spite of another bassinet-related death a year earlier. Just 11 months before Kennedy’s death, a 4-month-old infant in Missouri had been killed in a similar accident in a Simplicity bassinet of the same design that killed Kennedy.

This lawsuit has brought into the spotlight the issue of whether companies that license their images and brands to manufacturing companies can be held liable when these very same products turn out to be defective. Disney doesn’t seem to think so. A lawyer for the company says that the company couldn’t be held accountable for any mishaps or deaths that arose out of the use of a product that featured a Disney-licensed image. The company was not responsible for the safety of these products – that was the sole responsibility of the company that manufactured these products.

This seems to be a case of Disney having its cake and eating it too. Disney seemed to have no trouble licensing out its merchandising rights for billions of dollars every year, so we fail to see why the company shouldn’t take some of the responsibility when one of those licensing rights turns out to be a stinker.

The lawsuit is yet another in a series of such claims in recent years, involving children’s products, like defective car seats, cribs, strollers, playpens and high chairs. Parents buy these products expecting that their little bundles of joy will be safe and comfortable in these. You don’t expect a pretty pink bassinet to conceal hidden defects that strangle your child to death, and you shouldn’t have to. The number of babies crushed by drop sides collapsing unexpectedly, suffocated between the slats of their crib sides and slipping out of car seats is simply too many to ignore. Although most products these days are manufactured in accordance with stringent design standards for safety, product liability lawsuits like these keep reminding us that our children may still be unsafe where they should be the safest.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of product liability. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

Newport Beach Skydiving Accident Kills Woman

Monday, January 5th, 2009

There is still mystery surrounding the death of Newport Beach skydiver Brooke Baum, who died on the 26th of December in a skydiving accident in Perris. Baum was an experienced skydiver with more than 500 jumps on her record. Her parachute failed to open, leading to the fatal fall.

According to the OC Register, on that fateful day, Baum and three of her friends jumped out of an airplane together. As they moved away from each other, each of them managed to pull their ripcords, and deploy their parachutes. Baum’s parachute failed to deploy. A reserve chute did deploy when Baum was just a few hundred feet away from the ground, but it was too late for the 33-year-old adventure sports enthusiast to avoid the bone shattering impact of crashing into an open field. She was declared dead at around 11:43 am at the point where she crashed to the ground.

For Baum’s community of fellow skydivers and adventure seekers there are plenty of questions as to why the parachute failed to open. There have been suggestions that she never made the attempt to open her chute. The reserve chute that opened was supposed to open at 750 feet off the ground to give her a safe landing. However, that didn’t happen, and the reserve chute only opened when she was a few hundred feet from the ground, and too close to avoid impact. Drugs or alcohol are not suspected to be a factor here, and toxicology reports have not been conducted by the Riverside County Coroner’s Office because they were deemed not necessary to determine the cause of death.

The Federal Aviation Administration is now conducting an investigation into the tragedy. They will be looking at a number of factors including the manner in which the parachute gear was packed. Meanwhile, Perris Valley Skydiving, the recreation center where Baum took the last skydiving jump of her life had two other fatal accidents this year. In one accident, the victim became unconscious during the jump because of a pre-existing heart condition. In the other fatal accident however, equipment failure was determined to be the cause of the accident.

Baum’s equipment no doubt holds clues to what exactly happened that Friday morning. Investigators will likely make a thorough inspection of her gear to ascertain the reason for the accident. After all, this was a woman with over 500 skydiving jumps to her credit, and hardly a novice. What should have been a routine jump has ended in tragedy, and it’s only fair that questions be asked of the skydiving center here.

For the most part, a skydiver’s jump is only as successful as his or her equipment. Any failure of parachute or harness can mean tragic consequences. Skydiving accidents are comparatively rare, and you have a greater chance of being injured in a car crash driving home than you would have falling to your death during a skydiving jump. But that doesn’t mean that any accidents or fatalities can be taken as a matter of averages or chance. If there was any defect in the equipment, or failure on the part of the center to provide safe sky diving conditions, then a product liability lawyer or an Orange County personal injury lawyer will be able to file damage claims on the family’s behalf.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of product liability. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

California Family Sues Medtronic Over Infuse Product

Wednesday, December 10th, 2008

Medtronic is facing a lawsuit in Los Angeles, California by the family of a woman who died after the company’s Infuse bone growth product was inserted in her neck. The lawsuit alleges that the death occurred because the product was used in ways that were not approved by regulators.

74-year-old Shirley Nesbit was treated with the Infuse product during a surgery in August, and developed problems soon after. She went into a coma and died a few days later. Her family alleges in the lawsuit that the Medtronic representative placed pressure on the doctor performing the surgery to use the Infuse product in her neck. Usage on the neck is considered an off-label use in the case of Infuse, which has been a runaway success since its introduction in the market in 2002. The FDA only allows it to be used on surgeries in the lower back and during dental treatments. In fact, as recently as July of this year, the FDA had issued warnings to doctors against attempting to use Infuse on the neck.

Medtronic’s woes are worsened by the whistleblower lawsuits of two of its former employees who allege that the company paid physicians thousands of dollars to pressure them for off-label use of the product. It’s not illegal for doctors to use a medical product for purposes that have not been approved by the FDA, but it’s illegal for a company to promote such use. The FDA recently warned that use of Infuse on the neck could cause serious complications. The pressure of the product could cause swelling of the neck and throat that could interfere with normal respiration. That’s exactly what seems to have happened with Nesbit. Soon after she was treated with Infuse, she developed a swelling in her neck, and this led to breathing difficulties. By the time a breathing tube could be inserted into her airway to facilitate breathing, precious minutes had been wasted. She had been deprived of oxygen for a while, and slipped into a coma.

Nesbit’s family claims that a representative of Medtronic was present at the surgery, and pressured the doctor to use the procedure on her neck, even though there had been warnings against it. Both the doctor and the company deny that there was any pressure on the doctor at the time of surgery. Medtronic admits that their representative was present at the procedure, but says that it’s normal practice to have a representative present during the surgery to advise the surgeon.

The lawsuit is the first one that’s related to off-label use of Infuse, which has become a controversial topic in recent months. The practice of pharmaceutical companies and device makers pressuring doctors to promote their products is not a new phenomenon, and we have almost come to accept the unholy nexus that these companies and physicians seem to have. That Medtronic seems to have placed undue pressure on the physician to promote off-label use of Infuse is a matter of concern, especially since the product is so widely used. People who have been experiencing problems after Infuse treatment should consult with a California product liability lawyer to ascertain their options.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of product liability. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.