Texas Injury Lawyers Blog

Published on: May 29, 2013

FDA Proposes Change to Safety Approval Process of Metal-on-Metal Hip Replacement Implants

As previously reported by Carabin Shaw, there have been a number of hip replacement recalls in recent years, including recalls of the of the DePuy ASR Hip, the Biomet M2a Hip, the Stryker Rejuvenate and the ABG II, among others. These recalls brought attention to the potentially serious injuries that could be caused by metal-on-metal hip replacement implants.

The Food and Drug Administration (FDA) cites the following general risks for all types of hip devices:

• Hip dislocation
• Bone fractures
• Joint infection
• Nerve damage, including numbness/weakness
• Device breakage or loosening
• Differences in leg length
• Bone loss (osteolysis)

In addition, due to the friction caused between metal components, all-metal hip replacements may shed bits of metal, causing these additional specific injuries:

• Damage to the bone and tissue surrounding the hip joint
• Loose implants and loss of mobility
• Complications from metal in the bloodstream, including damage to the heart, kidneys, nervous system and thyroid
• Severe inflammation
• Pseudotumors
• Infections
According to The New York Times, manufacturers rarely tested metal-on-metal hip replacements before placing the devices on the market. Not surprisingly, the devices failed at high rates soon after being implanted. As a result, many patients were forced to undergo costly and painful procedures to replace the devices. Due in part to the high number of recalls and injuries, in January 2013, the FDA proposed a rule that would require that the manufacturers of metal-on-metal hip replacement implants prove that their devices are safe and effective before they could continue selling existing implants through the premarket approval (PMA) process. The proposal would also require that manufacturers obtain approval for all new metal-on-metal designs.

The new process differs from the current 510(k) approval process, which merely requires that a product be equivalent to another product already on the product. More specifically, the new pre-approval process will also require all-metal hip replacement manufacturers to submit clinical studies to the FDA prior to placing them on the market, something manufacturers are not required to do under the current approval process.

On April 18, 2013, Consumers Union sent a comment letter to the FDA signed by more than 11,000 consumers. The letter expressed support for the proposal’s requirement to necessitate all metal-on-metal to be reviewed through the FDA’s PMA process. At the same time, the letter also strongly urged the FDA to push all manufacturers of metal-on-metal hips to remove their products from the market.

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Published on: May 24, 2013

National Safe Boating Week : May 18-24, 2013

By Carabin Shaw

The National Safe Boating Council (NSBC) runs the North American Safe Boating Campaign each year. In advance of the kick off to summer, the week leading up to Memorial Day Weekend (May 18-24, 2013) is recognized as National Safe Boating Week.

As part of National Safe Boating Week, the U.S. Coast Guard initiated its “Wear It” campaign. The Coast Guard’s Safe Boating Campaign also advocates the following principles:

1. Wearing a life jacket saves lives.
2. Designate a driver. Sober boating saves lives.
3. Boater education saves lives.
4. Safe boats save lives.

The campaign hopes to educate the boating community about the importance of wearing life jackets and the various life jacket options available.

In 2012, an estimated 651 boating deaths were reported nationwide. Moreover, in 2011, the Coast Guard counted nearly 4,600 accidents that led to 758 deaths, 3,081 injuries and approximately $52 million dollars of property damage. Highlighting the importance of wearing a life jacket, 70% of those individuals involved in fatal boating accidents drowned, and 84% were not wearing a life jacket. Not surprisingly, the highest incidents of these accidents occur during the summer months of June and July.

A 21% increase in Texas boating accidents from 2010 to 2011 underscores the need for additional boating safety awareness. In Texas alone, 162 accidents were reported in 2012, with 32 fatalities reported. Texas Parks and Wildlife partnered with the Lower Colorado River Authority, the NSBC, the U.S. Coast Guard and other sponsors to promote the “Nobody’s Waterproof” campaign. The campaign is designed to increase water safety awareness and encourage the practice of safe boating. Texas also participates in the “Wear It” campaign.

In addition to the importance of wearing life jackets, it is essential to highlight the risks of driving a boat under the influence of alcohol. Driving a boat under the influence is just as dangerous as driving a car while impaired. It is illegal in all states to operate a boat while under the influence. According to the 2012 Recreational Boating Statistics released by the U.S. Department of Homeland Security and the U.S. Coast Guard, aside from Florida, the State of Texas had the highest number of boating accidents that cited alcohol as a contributing factor.

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Published on: May 15, 2013

Bicycling Safety Tips for You and Your Family

By Carabin Shaw

As summer approaches, you and your children will have more free time, which may mean more time for them, and you, to participate in outdoor activities, including bike riding.

According to the U.S. Department of Transportation’s National Highway Traffic Safety Administration, in 2011, 677 pedacyclists were killed and an additional 48,000 were injured in motor vehicle crashes. This accounts for 2 percent of the people injured in traffic accidents in the United States each year. In Texas, pedacyclist traffic fatalities accounted for 1.4% of all traffic accident fatalities in 2011.

To ensure safe bicycle riding for you and your children, it is important to familiarize yourself and your children with the state and local laws.

In the State of Texas, all bicyclists, including children, must follow Texas Motor Vehicle laws while using public roads in Texas–this means that a person riding a bicycle has the same rights and duties of any driver.
The City of San Antonio is embracing the popularity of bicycle riding in Texas through its adoption of the Bike Light Ordinance and Safe Passing Ordinance. The Bike Light Ordinance, which is the same as Texas state law, requires that all bicycles have a front white light and a rear red reflector or red rear light. Failure to comply with the ordinance can lead to a fine of up to $200.

In addition, the City of San Antonio also adopted the Safe Passing Ordinance to help increase safety for bicyclists. The ordinance establishes a requirement that all motor vehicle operators maintain a safe passing distance from bicyclists–generally, 3′ for cars and 6′ for commercial or large trucks. Failure to keep a safe distance from bicyclists pursuant to this ordinance can lead to a fine of up to to $200.

Other important state and local bicyclist laws to remember include:

• Like drivers, you must obey all traffic signals and signs.

• In the City of Antonio, unless you are a member of law enforcement or emergency personnel, you may not ride your bicycle on the sidewalk.

• Like drivers of motor vehicles, you must yield to pedestrians in crosswalks.

• Riding against traffic is illegal.

• Your bicycle should only be used to carry the number of persons it was designed to carry.

• You are required to always keep at least 1 hand on the handle bars.

• Your bike must be equipped with breaks.

• A bicycle in use may not be attached to a vehicle on the roadway.

• You must ride as far over on the right side of the road as practicable.

Failure to comply with any of these laws is a Class C Misdemeanor, punishable by a fine of up to $200.

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Published on: May 12, 2013

What is Distracted Driving?

By Carabin Shaw

Distracted driving includes activities such as eating, applying make-up, reaching into the backseat, using in-vehicle navigation systems and cell phone use. Yet, while there are many forms of distracted driving, all of which increase the likelihood of car crashes, cell phone use by drivers is the most deadly threat due to the fact that more drivers are engaging in cell phone use, and for longer periods of time. In fact, according to a 2012 survey conducted by the AAA Foundation For Traffic Safety, more than two in three drivers report talking on their cell phone while driving at least once in the past 30 days.

Cell Phone Conversations

The dangers of texting while driving receive the most attention in the media; however, using a cell phone to simply have a phone conversation, even with the use of hands-free technology, is also very dangerous. The National Safety Council estimates that 24% of all motor vehicle crashes involve cell phone use.

Additionally, drivers talking on handheld or hands-free cell phones are four times as likely to crash. Notably, a controlled driver simulator study conducted by the University of Utah found that drivers using cell phones had slower reaction times than drivers with a .08 blood alcohol content, the legal intoxication limit.

Traditional Texting vs. Voice-to-Text

In addition to having cell phone conversations while driving, approximately thirty-five percent of drivers admitted to reading a text or email while driving and twenty-six percent admitted to typing a text or email. What many people do not realize, however, is that voice-to-text may be just as distracting as traditional texting using your hands.

A study carried about the Texas Transportation Institute at Texas A&M University reveals that sending text messages via voice while driving can be just as dangerous as texting using your hands. Specifically, the study found that not only did it take drivers using voice-activated texting longer to send a message than traditional texting, but also that while texting (whether via voice or with fingers), a driver’s eye contact with the road decreased and response times were significantly delayed. Notably, and potentially the most concerning, is that drivers using speech-to-text devices felt like they were safer, despite the fact that the study revealed just the opposite: both types of texting are dangerous.

Steps Being Taken to Reduce Distracted Driving

Many steps have been taken to reduce the incidence of distracted driving, particularly, distracted driving associated with mobile devices.

For example, many states, including Texas, have enacted laws limiting the use of cell phones for some, or all individuals, while driving. According to the Texas Department of Transportation, in 2012, there were 90,378 traffic crashes in Texas that involved distracted driving. These crashes resulted in 18,468 serious injuries and 453 deaths. In fact, nearly one in four crashes in Texas involve driver distraction.

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Published on: April 25, 2013

As the Number of Emergency Visits Involving Energy Drinks Rises, Individuals and Groups Push the FDA for Increased Regulation

By Carabin Shaw

In March 2013, a group of doctors and researchers sent a letter to the Food and Drug Administration (“FDA”) urging it to take action to protect teens and children from the health risks associated with energy drink consumption. The letter specifically states that there is scientific evidence that the high level of caffeine in energy drinks–about 80 to more than 500 milligrams of caffeine, compared with amount 100 mg in a 5-ounce cup of coffee or 50 mg in a 12-ounce soda–have adverse health and safety consequences.

Indeed, in the eight years since energy drinks such as Monster, Red Bull, Rockstar, and 5-Hour Energy have been on the market, the FDA has reported six deaths and eighteen hospitalizations associated with the energy drink Monster alone. In addition, according to the FDA, 5-Hour Energy drinks have been cited in 13 deaths in the last four years. Moreover, federal data shows that the number of emergency department visits involving energy drinks doubled from 10,068 visits in 2007 to 20,783 visits in 2011.

According to the Drug Abuse Warning Network (DAWN), a public health surveillance system that monitors drug-related emergency department visits in the U.S., the majority of energy drink-related emergency department visits involved either adverse reactions or misuse or abuse of drugs. Although males make up two-thirds of the energy drink-related emergency room visits since 2007, emergency room visits doubled for both sexes from 2007 to 2011. Finally, of the 20,783 emergency room visits in 2011, 58% involved only energy drinks, while the remaining 42% involved other drugs as well.

Typical problems linked to excessive caffeine consumption can include anxiety, headaches, irregular heartbeats and heart attacks. Other possible side effects include:

Caffeine toxicity
High blood pressure
Withdrawal
Dehydration
Irritability
Insomnia
Death

Notably, effects of the energy drink are even more heightened in individuals that suffer from certain pre-existing or undiagnosed conditions, including heart problems, epilepsy, seizures, mood or behavioral disorders. Individuals who use certain medications or other supplements may also be at a higher risk of health complications.

Recent Lawsuits
These deaths and hospitalizations have led to an array of lawsuits against energy drink companies. Last year, the family of a 14-year old Maryland girl sued Monster Beverage, alleging that its energy drink was responsible for the girl’s death. The teenage girl went into cardiac arrest after drinking two, 24-ounce cans of Monster in a 24-hour period. Monster Beverage denies the allegations, stating that a team of physicians they hired to review the girl’s medical records found no evidence to show caffeine was a factor in the girl’s death, concluding that she likely died of natural causes.

In addition, a class action lawsuit was also filed against Monster Beverage by its shareholders, alleging that the company knowingly marketed, advertised, and sold the drink as a safe beverage despite its toxic mix of ingredients.

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Published on: April 23, 2013

National Highway Traffic and Safety Administration Investigations and Recalls May Not Accurately Represent Car Safety

By Carabin Shaw

In 2012, about 16.2 million car and truck owners received notification that their vehicles had safety problems and were being recalled. However, despite the high number of recalls, according to the Center for Auto Safety, changed auto recall accounting methods are raising questions about the productivity of defect investigations. Additionally, according to John Claybrook, former head of the National Highway Traffic Safety Administration (“NHTSA”), investigations by the agency are taking longer than they should, meaning many drivers could be driving unsafe vehicles without being aware of it.

The Department of Transportation’s NHTSA has the authority to issue vehicle safety standards and to require manufacturers to recall vehicles that have safety-related defects or do not meet Federal safety standards. Recalls are necessary when a vehicle or vehicle equipment (including tires) does not comply with a Federal Motor Vehicle Safety Standard or when there is a safety-related defect in the vehicle or equipment.

While manufacturers voluntarily initiate many recalls, auto companies are required to tell the NHTSA about claims they receive about serious injuries and deaths in their vehicles, so that NHTSA can then investigate the claims. Owners may also submit complaints to the NHTSA, prompting investigations.

Recall Accounting Methods Raises Safety Concerns

Due to budget issues, 28 NHTSA investigators handle every inquiry and complaint brought to the agency–meaning 28 individuals are responsible for investigating every automaker, truck maker or parts supplier.

In a recent New York Times article, David Strickland, current NHTSA administrator, argues that the limited number of investigators are sufficient due to new tools for data analysis, which allow the investigators to work more efficiently. Strickland added that NHTSA investigations resulted in 134 vehicle recalls in 2012, the second highest number since 1966.

According to the executive director of the Center for Auto Safety, Clarence Ditlow, however, the total number of recalls does not accurately measure the agency’s productivity since one inquiry can generate dozens of recalls. Specifically, federal auto safety regulators are counting what used to be considered multiple recalls as one recall. For example, 61 of the 131 recalls reported in 2011 resulted from one investigation involving aftermarket sunroofs–any car dealership or business that installed a sunroof was listed as a separate recall. As a result, the number of investigations actually being carried out is far fewer than expected based on the number of recalls.

Defect Investigations Taking Too Long and Kept Secret

In 2011, the U.S. Transportation Department reported that not all investigations were being completely in a timely fashion. At that time, the Transportation Department reported that 40% of those cases investigated missed the deadline by an average of six months. More recently, however, NHTSA’s investigations into possible defects and safety issues have been taking much longer than the agency’s own 12 months guideline. According to Claybrook, a safety investigation into 2002-2005 Ford Explorers and Mercury Mountaineers took 42 months–well over the agency guidelines of 12 months.

Perhaps even more concerning, is the fact that information about the investigations is only available to the public and news media through a Freedom of Information Act request. Even then, carmakers can still request the information they submit to the NHTSA be kept confidential. This means that car buyers may not learn the vehicles they own or are thinking about buying have raised safety concerns at NHTSA and among auto manufacturers.

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Published on: April 15, 2013

Anemia Drug Omontys Used to Treat Kidney Dialysis Patients Recalled Following Serious Allergic Reactions

By Carabin Shaw

Less than one year after the U.S. Food and Drug Administration (“FDA”) approved the Omontys (peginesatide) injection, pharmaceutical company Affymax, Inc. (“Affymax”) and its partner, Takeda Pharmaceutical Co. (“Takeda”), voluntarily recalled the anemia treatment for kidney dialysis patients after reports of fatal allergic reactions.

Since its approval by the FDA in March 2012, more than 25,000 kidney dialysis patients have used Omontys to treat anemia stemming from chronic kidney disease. Omontys was favored over other similar drugs because it only had to be infused once a month as opposed to other anemia drugs that often must be given more than a dozen times per month. Omontys also broke the previous monopoly that Amgen’s Epogen and Aranesp had on treating anemia in dialysis clinics. Notably, Epogen and Aranesp have also run into their own safety problems, including an increased risk of heart attacks and strokes associated with the overuse of the drugs.

Unfortunately, on February 23, 2013, the FDA revealed that it had received nineteen reports of anaphylaxis, three to five of which resulted in death. Other patients required prompt medical attention, including resuscitation, or hospitalization. Anaphylaxis is a severe allergic reaction. While the severity of the reaction varies from person to person, symptoms include flushing of the skin, hives, swelling of the tongue and throat, and difficult swallowing and breathing. Symptoms can be life-threatening or fatal.

According to the New York Times, approximately 0.02% of patients treated with Omontys have experience a fatal reaction following the first intravenous administration. Overall, approximately 2 out of every 1,000 patients had a hypersensitivity reaction. These reactions were surprising given that no cases of hypersensitivity were recorded in any of the clinical trials. As a result, the original Omontys warning label contained no warning of possible allergic reactions. By August 2012, however, the FDA was receiving reports about severe allergic reactions to the drug. Additionally, by Fall 2012, Affymax contacted the FDA about adding an updated warning label, cautioning of the risk of severe allergic reaction.

Notably, both the FDA and the drug companies reported that the serious allergic reactions occur within 30 minutes of the drug being administered for the first time. There have been no reports of such allergic reactions in subsequent doses or in patients that completed their dialysis sessions. In fact, according to the press release issued by the drug companies, the most common adverse reactions in clinical studies of patients treated with Omontys were dyspnea, diarrhea, nausea, cough, and arteriovenous fistula site complication.

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Published on: April 10, 2013

Cruise Ship Safety Reminders For Texas And Beyond

By Carabin Shaw

When the Carnival Triumph cruise ship broke loose from the Alabama Cruise Terminal with approximately 800 crewmembers and workers still onboard in early April, it was just the latest in a series of highly publicized maritime incidents taking place in the past several months. Earlier this year, an engine on the Carnival Triumph, which set sail from Galveston, Texas, caught fire and left the cruise ship without electricity and adrift in the Gulf of Mexico for four days. With no air conditioning, cold food, and toilets that would not flush, conditions on the ship became potentially toxic for the more than 4,200 passengers and crew aboard the ship. In fact, at least 16 Texans that were aboard the Triumph that sailed out of Galveston, Texas, are suing Carnival Cruise Lines for exposing them to unsafe, unsanitary and unreasonable living conditions for five days.

Unfortunately, fires, mechanical malfunctions, norovirus outbreaks, and even the sinking of ships have been occurring with increased frequency. In fact, the same week that the engine fire ignited on the Carnival Triumph in February 2013, three other Carnival ships became disabled following mechanical malfunctions. In addition, since November 2010 more than 10 cruise ship fires have been reported in the media. This number does not even account for the minor, and still potentially dangerous, fires that are not reported to the media.

While the United States has been attempting to address issues regarding cruise ship passenger safety through congressional hearings during the past decade, regulation can be difficult since many major cruise lines are incorporated in foreign countries and thus avoid U.S. labor laws and safety regulations. Moreover, though cruise ships are supposed to file guidelines set forth by the International Maritime Organization, the organization does not have the authority to enforce its own guidelines or impose fines. As a result, unlike the U.S. commercial aviation industry, which is under the tight supervision of the Federal Aviation Administration, cruise lines go largely unregulated.

Despite this overall lack of supervision, however, the Vessel Sanitation Program (VSP) at the Centers for Disease Control and Prevention (CDC) provides some oversight by carrying out unannounced inspections of cruise ships, monitoring and controlling the introduction, transmission, and spread of gastrointestinal illnesses on cruise ships, and providing health education to the cruise ship industry and general public. The VSP has jurisdiction over all cruise ships with over 13 passengers that have a foreign itinerary with U.S. ports.

In 2012, the CDC reported at least 16 norovirus outbreaks. In response to the reported norovirus outbreaks, which cause vomiting and diarrhea, the VSP advises cruise ships to:

• Increase cleaning and disinfection procedures according to their outbreak prevention and response plan;
• Make announcements to both notify onboard passengers of the outbreak and encourage case reporting;
• Collect stool specimens from ill passengers and crew for submission to the CDC lab;
• Make twice daily reports of gastrointestinal illness cases to the VSP; and
• Consult with CDC on plans for future passenger notification procedures and disembarkation plans for active cases, and infection control procedures.

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Published on: March 25, 2013

March is Brain Injury Awareness Month

By Carabin Shaw

The Brain Injury Association of America (BIAA) marked Brain Injury Awareness Month this March. The purpose of Brain Injury Awareness Month is to promote early and equal access to care for all individuals suffering from a brain injury and promote brain injury awareness across the United States. It is important to remember that a brain injury can occur anytime, anywhere, and can happen to anyone.

The BIAA defines a traumatic brain injury (TBI) as a “blow, jolt or bump to the head or a penetrating head injury that disrupts the normal function of the brain.” TBIs frequently require expert trauma care, specialized rehabilitation and lifelong disease management.

Statistics and Facts about Brain Injuries

According to the BIAA, approximately 1.7 million Americans sustain a brain injury each year. In fact, TBI is the leading cause of death and disability among children and young adults, and it is the fourth leading cause of death overall. Indeed, in Texas alone, more than 144,000 Texans sustain a TBI each year. In addition, excluding veterans and military service members, more than 5,700 Texans are permanently disabled every year from a TBI, and approximately 440,000 Texans (2% of the state population) live with a disability caused by a TBI. The Center for Disease Control and Prevention (“CDC”) estimates that TBI rates are higher for males than females in every single age group, and children aged 0 to 4, young adults aged 15 to 19, and adults aged 65 years and older sustain more TBIs than other age groups.

Unfortunately, per the Texas Brain Injury Alliance, less than 1 in 20 people with a TBI will receive the rehabilitation they need. At the same time, high incidences of TBIs can be costly for individuals, their families, and the nation as a whole. Specifically, direct medical costs and indirect costs such as lost productivity of TBI totaled an estimated $76.5 billion in the United States in 2000.

While falls are the leading cause of a TBI for individuals 65 and older, transportation-related injuries are the leading cause of traumatic brain injuries among those individuals younger than 64. Notably, more than 50% of all motor vehicle accidents resulting in traumatic brain injuries involve alcohol. It is also worth noting here that these numbers do not take into account the incidence of certain types of brain injuries, such as stroke, infectious disease, aneurysms, seizures, and toxic exposure.

Preventing Traumatic Brain Injuries for High Risk Groups

Each year, one out of three adults ages 65 and over falls. These falls can lead to moderate to severe head trauma. To reduce the chance of falling and suffering a TBI, the CDC recommends that older adults:

• Exercise regularly;
• Ask their doctors to review all of their medicine (both prescription and over-the- counter) to identify medicine that may cause drowsiness and/or dizziness;
• Have their eyes checked at least once a year; and
• Make their homes safer by reducing tripping hazards, adding railings, and increasing light.

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Published on: March 24, 2013

How to Stay Safe this Easter

By Carabin Shaw

Easter can be a time for fun, great food, candy, little toys, and Easter egg hunts. However, certain safety issues arise each Easter. Specifically, from a food safety standpoint, Easter can be the single most dangerous holiday. To help ensure a safe Easter for all Texans this year, follow the safety tips provided below.

Candy & Toy Safety

Easter baskets are a big part of Easter. However, certain gifts inside these baskets may create safety hazards. To prevent choking, the University of Texas at San Antonio Police Department recommends refraining from putting the following candy and food in Easter baskets: (1) hard, round candy; (2) thick and/or sticky candy; (3) candy with nuts; (4) caramel; (5) sour candy; and (6) jaw breakers. Since children’s airways are higher and narrower than an adult’s, these candies can create a choking hazard.

Along those same lines, make sure that all Easter toys and dolls are free of choking hazards before placing them inside any Easter basket. In addition, as the fake grass often used in Easter baskets is not easily digestible, it is important to keep it away from young children. Finally, some children have nut allergies that are very serious, so be sure to check with parents before offering chocolate bunnies or other candies that may contain nuts. To protect those children with peanut allergies, be careful to read the label of contents of any chocolate included in the baskets. Even though many packages read “pure chocolate,” the chocolate may have been in contact with nuts or peanuts during their preparation or packaging.

Egg Safety

Many Easter celebrations involve Easter egg hunts. Although eggs are nutritious and a big part of this holiday celebration, it is important to remember that unbroken, clean, fresh shell eggs may contain Salmonella Enteritidis (SE) bacteria that can cause foodborne illness. In order to ensure that your children remain safe this Easter there are some important safe handling methods to remember when preparing, decorating, cooking or hiding Easter eggs.

First, when purchasing your eggs, always purchase from a refrigerated case. In addition, don’t buy out-of-date eggs and be sure to choose eggs with clean and uncracked shells. Eggs should be refrigerated as soon as possible after purchase. Once you bring your eggs home, they should be kept in their carton and placed in the coldest part of the refrigerator, not in the door. Raw in-shell eggs can be kept in the refrigerator a maximum of three to five weeks.

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