Products Liability

The Death of a Young Baseball Player and the Lack of Statistics on Youth Sports Injuries

May 10, 2012 | Lebowitz & Mzhen

The tragic death of a 12 year-old Chicago-area boy in a baseball-related accident has brought attention to a lack of data tracking regarding sports injuries in children. Although researchers have extensively catalogued injuries in athletes at the high school level and up, no one is collecting information on injuries to younger athletes. Sports can be a cause of serious injuries in children, so having access to information and statistics could help not only parents, but equipment manufacturers assess risks and develop safer products.

A 12 year-old boy from Oswego, Illinois, Eric Lederman, died in April from an injury caused by a baseball hitting him in the neck. Lederman was playing catch with a teammate on the side of the field while warming up for a game on Thursday, April 12. The ball struck him in the neck, reportedly hitting his carotid artery. He immediately collapsed and was taken to the hospital. He was pronounced dead at the hospital just after 8:00 p.m. The cause of death was determined to be a cerebral hemorrhage caused by blunt-force trauma, and was declared an accident.

Improvements in Auto Racing Safety Mean Fewer Accidents, Less-Satisfied Fans

April 27, 2012 | Lebowitz & Mzhen

NASCAR races around the country have gone a remarkably long time without a serious crash. Some races have recently gone hundreds of laps without even a yellow caution flag, which requires drivers to exercise caution or slow down due to a hazardous condition on the track. Some observers have credited new technologies, including improvements in aerodynamics, with fewer crashes and, therefore, fewer injuries. At the same time, fans report discontent with the situation, and attendance has declined. While improvements in safety and a reduction in racing car accidents would seem to be a favorable goal, the Associated Press went so far as to call it a “fan’s nightmare.”

The AP reported last week that racers at NASCAR’s Sprint Cup had gone more than nine hundred miles without a crash. Out of the last four Sprint Cups, three were entirely free of accidents. Overall, races have had a third fewer caution flags compared to last year. All of the recent crashes reportedly occurred at one race at Martinsville Speedway in Virginia on April 1. Fans have reportedly reacted by staying at home in droves, and by complaining loudly when they do show up. The stands at Bristol Motor Speedway in Tennessee, for example, were reportedly half-empty for the race on March 18. All of this led champion racer Jimmie Johnson to note something that may have already been obvious to many fans and observers: that crashing is more important than racing for some NASCAR fans.

Racing observers have cited both technological changes and a self-perpetuating safety trend as possible causes for the recent bout of green flags, which signal safe track conditions. According to USA Today, one driver said that cautions sometimes “breed more cautions” by slowing down the overall pace and giving cars fewer chances to crash. This could mean that, over time, the amount of crashes will return to the expected level, but other factors may be in play as well.

FDA Wants to Investigate “Inhalable Caffeine” Further

March 30, 2012 | Lebowitz & Mzhen

A new product, described as “inhalable” or “breathable” caffeine, has drawn the attention of the U.S. Food and Drug Administration (FDA) due to questions about its safety and suitability for the marketplace. This is due partly to recent incidents involving injuries and deaths allegedly caused by high-caffeine energy drinks, as well as the mixture of caffeine-containing energy drinks with alcohol. The apparent popularity of these products among college students and other young people is also a cause for concern.

“Breathable caffeine,” currently marketed as the AeroShot, reportedly contains 100 milligrams of caffeine in a single “shot.” This is roughly the same amount of caffeine contained in a large cup of coffee. The device resembles an asthma inhaler. The owners of the company that produces the AeroShot state in interviews that the product is not intended for anyone under the age of 18, nor should it be mixed with alcohol.

The FDA’s concerns primarily involve the labeling of the product in regards to whether consumers should inhale, drink, or eat it. In a letter sent to the company on March 5, the FDA notes that product labels and the website prominently describe the product as “breathable.” At the same time, other statements and materials describe it as “ingestible,” and refer to it as a “dietary supplement.” FDA regulations require clear labeling of a product as either “breathable” or “ingestible.” A “breathable” product cannot be described as a “dietary supplement.”

The FDA also expresses concerns about consumer safety in the absence of clear instructions about inhalation versus ingestion. If the product is intended for inhalation, ingestion could be dangerous, and vice versa. Very little research exists on the safety of inhaled caffeine products, which also worries the FDA.

Finally, the FDA notes concerns about the intended age of the product’s consumers and warnings about its use in combination with alcohol. While the company states that no one under 18 should use the product, some materials allegedly state the minimum age as 12. Marketing materials describe using the product when, for example, “study[ing] in the library,” an activity the FDA notes is most common among children and young adults. Publicity around the product featured on its website describes its use with alcohol as a “party drug.” This, according to the FDA, contradicts the company’s message that it should not be mixed with alcohol.

Doctors and Medical Device Companies Square Off on Questions of Liability

January 27, 2012 | Lebowitz & Mzhen

As medical devices grow increasingly sophisticated, disputes have begun to arise between doctors and medical device manufacturers over who bears the responsibility when a patient is injured by a device. In some instances, manufacturers try to hold doctors liable for using a device improperly, and in others doctors try to hold manufacturers liable if the device did not function correctly. Disputes such as these bring two different theories of liability together in unforeseen ways: medical malpractice and products liability. How these disputes are resolved could have an important impact on how courts assess liability in future malpractice cases.

American Medical News, a publication of the American Medical Association, reported last month on an orthopedic surgeon in Kentucky who implanted a pain pump in a patient’s shoulder to administer painkillers after reconstructive surgery. The patient later returned, complaining of shoulder pain. An examination revealed that the patient had developed chondrolysis, a condition that causes significant deterioration of joint cartilage. It can be caused by certain types of anesthetic if they are continuously administered into or near the joint. The pain pump had evidently caused the chondrolysis because of the type of anesthetic administered.

The patient sued the pump manufacturer, alleging that the company failed to warn the doctor of the risks of complications from this particular use of the pain pump. The manufacturer brought the doctor in as a third-party defendant and alleged that the doctor used the pain pump “off-label,” meaning in a way not intended by the manufacturer or approved by the Food and Drug Administration (FDA). The case is still in progress in Kenton County, Kentucky.

Doctors have a duty to their patients to provide diligent care. Because of their special training, they occupy a particular position of trust under the law and have unique responsibilities. They must rely, however, on a wide range of products and equipment in order to provide state-of-the-art care, which means they must rely on various warranties and assurances from third-party companies. These include pharmaceutical companies and medical device manufacturers. Doctors can only provide care to the best of their ability with the knowledge available to them. They are responsible for learning how to use medical devices such as pain pumps, but in the event that something goes wrong, the question becomes whether or not they used a device correctly or if the device was somehow defective.

Washington DC Dentist Warns of Dangers of Sports Injuries

December 14, 2011 | Lebowitz & Mzhen

A Washington, DC-area dentist recently warned about the importance of protecting children’s teeth and jaws from injury as they participate in fall and winter sports, noting the potential for serious damage and complications from fairly common sports injuries. The dentist, of course, recommends obtaining a custom-made mouth guard with the assistance of a dental professional. His advice demonstrates the importance of ensuring safe and reliable protection for children (and adults) who participate in sports, whether the protective device is store-bought or professionally-made.

Sporting goods stores and other retailers sell a variety of protective equipment, including mouth guards, pads, and braces. Almost any of these types of equipment are also available custom-made from medical professionals. The recent article focuses on mouth protection, but its advice applies to protection for the head, limbs, back, and more. Manufacturers of products offered for sale to the public have a duty to take reasonable steps to ensure that their products are fit for their advertised use.

Consumers, under the legal theory of products liability, may be able to recover damages from the manufacturer of a product if that product causes them injury in certain circumstances. A manufacturing defect could be any sort of flaw occurring during the production of a product that makes it unsafe. A design defect is a problem inherent in the product that would have occurred before the product was ever produced or assembled. A marketing defect refers to the advertising of a product for some improper use. Any of these defects could cause an injury to a consumer, and could entitle the consumer to compensation for injuries.

Medical professionals, by virtue of their education, training, and unique position of responsibility to their patients, have a very high duty of care. Producing customized protective equipment for athletes places them into a position of responsibility for the design, manufacture, and marketing of these products. They therefore bear some potential liability for customized equipment along with the actual manufacturers.

The Consumer Product Safety Commission (CPSC), an agency of the federal government, monitors the safety of consumer products, issuing recalls for products it deems sufficiently unsafe. It enlists the cooperation of the manufacturers themselves when possible, but it has the legal authority to order a recall when necessary. The CPSC maintains records of recalls it has ordered or requested, organized by market segment. It has issued multiple recalls for sports equipment, including safety equipment for both adults and children, such as:

– Football helmet chin straps due to “laceration hazard,” November 3, 2011
– Ski helmets due to “head injury hazard,” July 21, 2011
– Baseball and softball gloves due to “presence of mold,” July 6, 2011
– Bicycle helmets due to “head injury hazard,” May 31, 2011
– Lacrosse gloves due to “violation of lead paint standard,” July 26, 2010

Players Sue NFL and Helmet Manufacturer over Head Injuries

November 3, 2011 | Lebowitz & Mzhen

Football, as the saying goes, is a contact sport. It may therefore come as a surprise to learn that a number of professional football players have sued the National Football League and helmet manufacturer Riddell over concussions suffered during games. In all, 125 former players have filed suit in at least five separate complaints, alleging that the NFL failed to properly warn players of the risks of head injuries and to provide support for retired players. Concussions in sports, particularly professional football, have received heightened scrutiny recently in both the media and in Congress, with many statistics suggesting that the number of concussions has increased significantly.

A concussion is a common type of brain injury caused by an impact with the head making the brain collide with the inside of the skull. This can lead to both physical and cognitive symptoms, ranging from headache and dizziness to disorientation and attention deficits. A person who suffers from a concussion may not lose consciousness, and many concussions go undiagnosed because the injured person does not realize the injury’s severity. Multiple concussions over time can cause significant brain damage, including memory loss and dementia. The NFL began to pay serious attention to concussions in 2009, and in February 2011 it announced new guidelines to gauge whether an injured player should continue to play.

The lawsuits consist of a class action suit and three personal injury suits in California state court and a case in a federal court in Pennsylvania. The suits essentially allege that the NFL has a duty to inform players of all risks reasonably associated with their job duties and to support players injured in the course of their job duties. In this situation, the players’ “job duties” involve practicing for and playing football. Lawyers for the players say that they hope to use the lawsuits to improve safety standards for all players, to prevent future injuries, and to get compensation for the players’ injuries.

To prevail on their claim, the players would have to prove that the NFL had knowledge of risks inherent in the game not available to an ordinary prudent person, and that the players did not assume the risk of injury by agreeing to play the game. An argument in the players’ favor, perhaps, is that they did not have the ability to refuse to perform certain job functions, since these would occur in the middle of games and players are contractually obligated to play.

Food and Drug Administration to Take Action on Food Safety in Restaurants and Stores

October 13, 2011 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) announced a series of initiatives in late September that it hopes will further ensure the safety of the food supply. The proposed measures, known as the Retail Food Safety Action Plan, would apply to food service establishments such as stores, restaurants, and schools. The Plan will focus on food safety rules at the state and local levels. It establishes a set of “model rules” to help managers in food service establishments handle food safety procedures, and standards for training personnel on food safety issues. The Plan follows a series of recent stories in the news about food contamination such as the recent cantaloupe recall.

The FDA is cooperating with the National Association of County and City Health Officials (NACCHO) to promote best safety practices at the local level. It hopes to get local governments to implement its Voluntary National Retail Food Regulatory Program, a series of standards developed by the FDA to encourage uniform food safety protocols nationwide.

The Plan also includes amendments to the 2009 Food Code, the most recent set of standards put out by the FDA. The Food Code is typically revised every few years. The proposed amendments include:
– Food establishments should have a plan for responding and cleaning up if an employee is phyiscally ill near where food is served, prepared, or stored.
– Food establishments should have clear standards about bare-handed contact with prepared food by employees.

– They should have consistent standards for how to display meat and poultry.

The FDA is an agency of the U.S. Department of Health and Human Services. It is responsible for promoting public health by supervising and regulating food products, pharmaceuticals, medical devices, cosmetics, and other products commonly used by the public. It also enforces various laws related to public health. It regulates safety for most food products, although many meat products fall under the Department of Agriculture’s jurisdiction. FDA review and approval is a critical step towards getting a product to market in the pharmaceutical and food industries.

Food safety and quality control are vital tasks in promoting public health and preventing certain diseases. Food-borne illnesses such as salmonella and E. coli can result from poor food quality or lack of standards. Injuries can be severe, ranging from sickness and lost time at work to serious hospitalization or death.

Children’s Jewelry Manufacturers Agree to Limit Cadmium Levels

October 7, 2011 | Lebowitz & Mzhen

The Consumer Product Safety Commission has approved new voluntary limits on cadmium levels in children’s jewelry. A move to regulate cadmium began in 2010 after a recall of bracelets and pendants at Wal-Mart stores. The new standards represent a national consensus among manufacturers and importers of children’s jewelry as to the need to address the toxic metal. A series of mandatory limits has already developed through state regulation and litigation, but this new standard represents the first national standard.

Cadmium is a metal element that occurs as a byproduct of various industrial processes. For years cadmium was used in steel and plastic production and as a pigment, but use has declined considerably. It is still used in some batteries and solar panels. Cadmium exposure has been linked to a number of health problems, including flu-like symptoms, acute kidney problems, pulmonary emphysema, bone disease, and possibly cancer. Dangerous exposure can occur even with trace amounts of cadmium.

Wal-Mart stores recalled children’s bracelets and pendants from their stores in January 2010 due to concerns that they might contain cadmium. Children could receive dangerous doses of cadmium if the jewelry were placed in a child’s mouth, even without actually swallowing the product. Some Chinese companies use cadmium in jewelry production because of prohibitions on using lead. An American company, Tween Brands, reached a settlement in California in March 2011 in which it has agreed to eliminate cadmium from all of its products by January 2012. The settlement agreement only applies to the state of California. Different standards among U.S. states may have led to repeated and inconsistent testing of products, which has led to the current push for national standards.

Safety Recalls of RV’s in Washington DC

September 6, 2011 | Lebowitz & Mzhen

Recalls have been issued in the Washington, DC area for recreational vehicles from four different manufacturers: Spartan Chassis, Navistar, Dutchmen Manufacturing, and Winnebago Industries. The reasons for the recalls include problems with the exhaust system, defective headlight fuses, faulty ventilation, and possible fuel or propane leaks. Any of these conditions could severely impact the operation of the RV and threaten the safety, or even the lives, of drivers, passengers, and others on the road. Dangers include electrical failures, fires, and even carbon monoxide poisoning. RV owners should review the recall information carefully to see if their vehicles are affected.

An RV can be a great source of adventure and recreation, but RV’s also carry their own unique risks. RV’s are different from other automobiles: obviously they are larger and heavier, and they handle differently than other vehicles on the road. Automatic transmission and power steering may be standard features of today’s RV’s, but they require care and attention. An inexperienced driver should take care when operating an RV and take the time to learn how to operate the vehicle safely.

AllState recently ranked America’s 200 largest cities based on frequency of car collisions, ranking Washington, DC 193rd out of 200. Auto accidents are a serious problem. Numerous accidents in the Washington, DC area and elsewhere have involved RV’s. The past month has been an unusually dangerous one on DC-area roads, with multiple serious accidents and fatalities, so the news of the RV recalls is critical for driving safety.

If an RV is involved in an accident due to a defect in the vehicle’s design, construction, or marketing, the manufacturer may be liable for damages caused by the defect under the theory of products liability. A design defect is one where the product may work, but is dangerous to use because of an error or omission that occurred before the product was ever built. A construction or manufacturing defect most likely happened when the product was assembled or produced, and may cause the product not to function correctly. A marketing defect involves incorrect or insufficient instructions or guidance on how to use the product safely, or a failure to warn consumers about some dangerous characteristic of the product. The defects noted in the RV recall appear to be design or manufacturing defects.

An injured person making a claim of products liability may recover damages due to product defects for property damage, medical expenses, lost wages, and pain and suffering. Products liability is often a matter of strict liability, meaning that a manufacturer may be liable for damages even if it did not know of the defect. In claiming products liability, an injured person should look at the manufacturer of the product as well as any distributors and retailers responsible for marketing the product.

Washington DC Defective Medical Device Cases: Surgical Mesh Can Cause Serious Side Effects

August 31, 2011 | Lebowitz & Mzhen

The US Food and Drug Administration is proposing that surgical mesh products be subject to tougher regulations. The mesh products, which are placed in the vagina to treat pelvic organ prolapse and stress urinary incontinence, can cause serious injuries. In an update to its 2008 advisory warning that transvaginal mesh products can serious complication, last month the federal agency announced that these complications are not rare.

If you or someone you love has experienced bleeding, organ perforation, infection, urinary issues, and severe pain after undergoing a transvaginal mesh procedure, you may have reason for filing a Washington DC products liability case against the manufacture of the surgical mesh products. These medical devices are currently manufactured by about nine companies, including Boston Scientific Corp. and Johnson & Johnson.

Now that the FDA believes that the severity and rate of injuries related to surgical mesh to treat POP repair are serious enough to raise questions about the safety of these medical devices, the federal agency is proposing that new mesh products go through a premarket review process. This would require companies to conduct studies examining a product’s effectiveness and safety before it is approved. Right now, mesh products are subject to the 510(k) process, which is less rigorous.

According to consumer advocacy group Public Citizen, of the almost 300,000 women who underwent surgery for pelvic organ prolapse in 2010, nearly 67,500 women underwent procedures involving a mesh product that was implanted in their vaginas. From these transvaginal procedures, federal regulators received 1,503 reports of complications, such as mesh implant erosion and pelvic organ injuries. Also, surgical mesh-related complications may require a woman to undergo more surgeries, which can place her at risk of additional complications and decrease her quality of life.

Our Washington DC personal injury lawyers represent clients that have sustained injury, illness, infection, or died because the medical device they used proved unsafe, dangerous, defective, and/or worsened their condition or health.

Public Citizen calls for a ban of surgical mesh devices, NJ.com, August 25, 2011
FDA Planning Tougher Regulations For Surgical Mesh, The Wall Street Journal, August 31, 2011

Related Web Resources:

FDA

Pelvic Organ Prolapse, Web MD
Stress urinary incontinence, NIH

More Blog Posts:
Are Some Children Undergoing Unnecessary CT Scans?, Washington DC Injury Lawyer Blog, May 11, 2011
Dangerous Medical Device?: Woman Files Cold Therapy Lawsuit Against DeRoyal Industries Alleging Tissue Damage, Maryland Accident Law Blog, June 18, 2011
US Lawmakers Seek to Reinstate Right to Sue Medical Device Makers for Personal Injury and Wrongful Death, Maryland Accident Law Blog, February 19, 2009