Washington DC Injury Lawyer Blog

Proposed Unique Identifier System for Medical Devices Could Improve Patient Safety

August 8, 2012 | Lebowitz & Mzhen

A new rule proposed by the U.S. Food and Drug Administration (FDA) would require most medical devices in the country to include a unique device identifier (UDI). This is a unique code system assigned to medical devices that, according to the FDA, would allow the agency to track problems with devices and develop more effective regulations to protect patient safety. Congress passed legislation, the Food and Drug Administration Amendments Act of 2007, that requires the FDA to promulgate regulations to implement a nationwide UDI system. The proposed rule will be open to public comment until November 7, 2012.

The FDA describes a UDI as a “unique numeric or alphanumeric code” assigned to a device. The UDI includes identifiers for the specific device and the device model, as well as production information including the serial number, the lot or batch number, and, if applicable, the device’s expiration date. The FDA is reportedly developing a database of “basic identifying elements” in UDIs that the public can access and review. A device’s UDI, the FDA says, will not include any personal identifying information about the person using the device.

Washington DC Wrongful Death Lawsuit Filed by Families of U.S. Citizens Killed in Drone Strikes

July 25, 2012 | Lebowitz & Mzhen

A wrongful death lawsuit filed in the U.S. District Court for the District of Columbia seeks damages from the federal government for the allegedly unlawful killings of United States citizens abroad. The families of several people killed overseas by unmanned drone aircraft are claiming violations of the decedents’ constitutional rights as U.S. citizens. Unlike many wrongful death lawsuits, this suit alleges violations of statutory and constitutional rights, rather than negligence, by the government. The lawsuit is sure to generate public controversy, particularly since the government asserted national security reasons for the drone attacks.

Nasser al-Aulaqi (sometimes spelled al-Awlaki) and Sarah Khan, with the assistance of the American Civil Liberties Union (ACLU), filed suit against federal government officials, including Secretary of Defense Leon Panetta and Central Intelligence Agency (CIA) Director David Petraeus, in mid-July 2012. Their complaint alleges that the federal government has engaged in targeted killings of suspected terrorists abroad since 2001. Anwar al-Aulaqi, an American citizen living in Yemen, was added to a “kill list” in late 2009 or early 2010, based on suspicion of terrorist activity or support.

On September 30, 2011, the complaint says, unmanned drones operated by the CIA and the Department of Defense fired missiles at a vehicle in Yemen containing Anwar al-Aulaqi. The blast killed al-Aulaqi and another U.S. citizen, Samir Khan. Another drone strike on October 14, 2011, also allegedly authorized by the defendants, killed at least seven people at a restaurant in Yemen, including another U.S. citizen, Anwar al-Aulaqi’s 16 year-old son Abdulrahman al-Aulaqi.

Sewing Needles Found in Sandwiches in Airplane Meals, One Passenger Injured

July 19, 2012 | Lebowitz & Mzhen

A bizarre discovery in several airplane meals has left one person injured and launched a two-country investigation. Passengers on several Delta Airlines flights found sewing needles in sandwiches included with the in-flight meals. The flights all originated in Amsterdam and were bound for the United States. Police in both the U.S. and the Netherlands are investigating the matter, as is Delta Airlines. All investigators are reportedly looking at the catering company that provided the meals.

Multiple Delta flights leave Amsterdam’s Schipol Airport for the U.S. every day. On July 15, 2012, it had seventeen such flights, and at least four of them had unpleasant surprises in the in-flight meals. On a flight bound for Minneapolis, a passenger bit into a hot turkey sandwich and reported feeling a “sudden jab” in the roof of his mouth. He said he thought it was a toothpick holding the sandwich together at first, but when he pulled it out of his mouth, he saw it was a one-inch long needle with sharp points on each end. A passenger and an air marshal on two different flights to Atlanta found needles. A needle turned up in a sandwich that had not been served to anyone on a flight to Seattle. The man on the Minneapolis flight, who declined medical treatment, appears to be the only injury.

“Failure to Warn” Claim Against Pharmaceutical Company Dismissed by Washington DC Judge

July 12, 2012 | Lebowitz & Mzhen

A federal district judge in Washington, DC has granted a pharmaceutical company’s motion for summary judgment in a lawsuit brought by a patient alleging the failure to warn of certain risks associated with the company’s drug. In Patteson, et al v. AstraZeneca, L.P., et al, the plaintiff allegedly suffered debilitating complications from prolonged use of the company’s anti-psychotic medication Seroquel. She filed suit against the company and her treating physician. The court granted AstraZeneca’s motion for summary judgment on the grounds that the company’s duty to warn of risks applied to the doctor, not the patient.

The plaintiff, Kay Patteson, sought treatment from Dr. John Maloney, also a defendant in the lawsuit, in May 2006, according to the court’s ruling. She complained of “anxiety, depression, chronic insomnia, and serious alcohol abuse and dependence.” After other drugs did not alleviate her insomnia, Dr. Maloney prescribed the anti-psychotic drug Seroquel for off-label insomnia treatment. Patteson’s symptoms improved at first, but then began to worsen in April 2007. She began to suffer “progressive weakness in her lower extremities and difficulty walking.” Several physicians could not determine the cause of her condition, although Dr. Maloney reduced her Seroquel dosage during this time. Most doctors attributed her symptoms to the large number of stressors in her life.

New National Safety Standards Issued for Children’s Play Yards

July 5, 2012 | Lebowitz & Mzhen

New safety standards set by the U.S. Consumer Product Safety Commission (CPSC) affecting “play yards,” portable playpens for infants and toddlers, will begin in December. Play yards are currently subject to voluntary safety standards, but the new standards will be mandatory for all manufacturers. During the four-year period ending in December 2011, according to the CPSC, play yards were involved in the deaths of over sixty children and injuries to nearly two hundred more. Play yards have reportedly been the subject of over twenty recalls during a twenty-five-year period. The new standards are part of a comprehensive set of reforms to children’s product safety known as Danny’s Law, named for a child who died due to a play yard collapse.

A typical play yard is a portable crib or playpen composed largely of mesh. In addition to acting as a crib for infants and toddlers, it can provide them an enclosed area in which to play. Children have died when a collapsing play yard traps them, while trapped under a mattress or other component, or by strangulation from straps attached to the sides. Some deaths resulted when children climbed out of a play yard and drowned in a nearby pool. The most common incident, according to the CPSC, involves a side rail collapse. In addition to the danger of a child getting out of the play yard after a collapse, it can also cause strangulation if a child’s neck is caught in the side rail. Side rail collapses account for up to ninety percent of reported play yard incidents and as many as one-third of play yard-related deaths. A side rail collapse reportedly caused the death of Danny Keysar, the namesake of Danny’s Law, in 1998 in Chicago.

Supreme Court Rules for Baseball Player in Sports Injury Case on Issue of Litigation Costs

June 28, 2012 | Lebowitz & Mzhen

A professional baseball player, Kouichi Taniguchi, brought an unusual claim to the U.S. Supreme Court. Taniguchi sued a hotel over an injury he sustained falling through a deck. The hotel won the case, and obtained a judgment against Taniguchi for “interpretation costs,” per a provision in federal law. Taniguchi fought this all the way to the Supreme Court, which ruled in his favor in May. The case demonstrates the complex nature of expenses in litigation, and how far some parties will go to get a non-prevailing party to pay, or how far a party will go not to have to pay. The amount in dispute was just over $5,000, which makes the case even more remarkable when one considers the cost of taking a case to trial, let alone to the Supreme Court.

Taniguchi is a professional baseball player from Japan. He reportedly played for Tokyo’s Yomiuri Giants, but left after only seven games due to an injured shoulder. He also played minor league ball in the United States for a time. In November 2006, he visited the Marianas Resort and Spa in Saipan. Saipan is an island in the Northern Marianas Islands, an unincorporated, organized territory of the United States in the Pacific Ocean. During a tour of the hotel, Taniguchi fell through a deck, sustaining injuries.

FDA Issues Warnings About Dog Treats Causing Illness

June 21, 2012 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) has issued a series of warnings about dog treats imported from China. Complaints of illnesses began coming in to the FDA in November 2011. It has now received more than one thousand reports relating to imported “chicken jerky” products. The situation presents a clear issue of products liability, since one or more manufacturers are producing goods that are not fit for their intended purpose. It also raises a question of damages. The most direct victims are family pets, but the possible damages generally do not match the loss a dog owner would feel if a pet gets sick or dies due to a contaminated or defective product.

Chinese-made pet products were at the center of another crisis in 2007, when pet food manufacturers reportedly used wheat flour contaminated with melamine. Thousands of dogs became ill or died, tons of dog food were recalled, and several pet food executives in both the U.S. and China faced criminal charges. When reports of sick dogs started coming in November, the FDA began testing chicken jerky treats for melamine and other contaminants. It issued a “cautionary update” to consumers at the time, identifying the possible symptoms and noting that some reported illnesses might be unrelated to the chicken jerky. By February 2012, the FDA had received more than five hundred reports of sick dogs.

In April, when the total number of illnesses had exceeded six hundred, the FDA sent inspectors to China to visit the plants that produced chicken jerky products. The agency had already conducted extensive chemical and microbial tests but reportedly had not isolated a cause for the illnesses. Pressure continued to mount through the spring to find a solution.

Complaints from pet owners and veterinarians have reportedly led to three brands: Waggin’ Train, Canyon Creek Ranch, and Milo’s Kitchen. The first two brands, according to MSNBC, come from a company in Nanjing, China. Both companies maintain that their products are safe. Milo’s Kitchen has reportedly acknowledged settling a claim after a customer complained about a sick dog. The American-based companies are the most likely targets for litigation. Even though companies in China might be more directly liable, U.S. courts have little to no authority over them.

Washington DC Injury Prevention Ranks High in National Survey

June 14, 2012 | Lebowitz & Mzhen

A study of injury-related deaths conducted by a national healthcare advocacy group, the Trust for America’s Health (TFAH), ranks the fifty states and the District of Columbia based on ten “key indicators.” These key indicators relate to laws, regulations, and initiatives undertaken by state governments. According to TFAH, they represent the effectiveness of state efforts to prevent fatalities due to injuries.

Washington DC scored highly in the study, with seven of the ten key factors. In terms of total number of injury-related deaths per 100,000 population, the District of Columbia did not fare as well compared to many states, with a rate slightly above the national average. The study’s authors stress that they cannot say with certainty why any one state has a lower rate of injury-related fatalities than any other state, but their key factor analysis offers a good set of guidelines for assessing state efforts to promote injury prevention.

TFAH’s study, prepared with the assistance of the Robert Wood Johnson Foundation, a philanthropic organization that supports health care, examined statistics for injury-related deaths over the past twelve or more years. It drew a distinction between injury-related deaths and deaths from both communicable and noncommunicable disease, calling injury-related deaths a serious but largely hidden public health crisis. The study divided injuries into several categories based on the type and cause of the injury, including vehicular accidents, falls, blunt-force impacts, cutting or piercing wounds, burns, poisoning, drowning or suffocation, gunshot wounds, and “unclassified.” TFAH developed its list of key factors based largely on the cause of injury, such as accident or intentional violence.

Student Detained by the DEA and Forgotten for Five Days Demands $20 Million, Claims Torture

June 7, 2012 | Lebowitz & Mzhen

A San Diego student who spent five days locked in a holding cell after agents of the Drug Enforcement Administration (DEA) apparently forgot about him has sent a claim for $20 million in damages to the DEA’s general counsel in early May. The letter, a copy of which is not publicly available, may be a preliminary step to a formal lawsuit against the U.S. government. A lawsuit could claim negligence on the part of DEA agents, as well as civil rights violations, either of which would entitle the claimant to compensation for damages.

Daniel Chong, a 23 year-old student, was arrested during the early morning of Saturday, April 21, 2012, when he was attending a party at a friend’s house in celebration of “4/20,” an unofficial holiday celebrating marijuana. DEA agents reportedly raided the party and arrested Chong and several others. They took Chong to the local DEA office to be interviewed. Chong was told that he would be released that day, and he was taken to a five-by-ten-foot holding cell to wait for a ride home. No one came for Chong for five days.

Employees at the DEA office apparently forgot about Chong for five days. Chong had no food or water and no toilet, and his hands remained cuffed behind his back. He said that he could hear people outside and that he kicked at the door and screamed for help, but no one came. By the third day, he said he was hallucinating cartoon characters who spoke to him. He drank his own urine at least three times. He found a packet of white powder in a blanket, which he consumed, presumably thinking it might be food. He reportedly broke his glasses in an effort to commit suicide, going as far as trying to carve a message into his arm.

CPSC Announces Nationwide Recall of Inflatable Pool Slides, Citing Danger of Sudden Deflation Causing Injury or Death

May 29, 2012 | Lebowitz & Mzhen

https://www.youtube.com/watch?v=mnoqiV2ysnkAn inflatable pool slide designed for use with in-ground pools is subject to a nationwide recall, according to a recent announcement by the U.S. Consumer Product Safety Commission (CPSC). The pool slide, described as a “Banzai in-ground pool water slide,” poses a risk of injury to users because of sudden deflation and instability. At least one person died from injuries sustained when a slide deflated suddenly, and several more suffered severe neck injuries.

The pool slide has a blue base and a yellow slide. It has the words “Banzai Splash” on either side in a wave-shaped orange, blue, and white logo. The slide inflates to a height of six feet. A hose can attach to the top of the slide so water runs down the slide surface. It is designed to sit on the side of an in-ground pool, so users can slide into the water. This pool slide model was sold nationwide at Wal-Mart and Toys R Us stores between January 2005 and June 2009, with a typical retail price of $250. Hong Kong- based Manley Toys manufactured the slides in China. Toys R Us and Wal-Mart have agreed to accept returns of the product and will provide a full refind.

Federal pool slide safety standards require a slide to be able to support at least 350 pounds without any deformation. The recalled slide reportedly deforms under considerably less weight. This may cause the air in the slide’s base to displace, making the slide unstable. It could tip over or even deflate as a result. The slide allegedly did not undergo sufficient safety tests when it was imported to the United States.