Wrongful Death

Published on: April 15, 2013

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

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: February 11, 2013

NHTSA Statistics Reveal Downward Trend in Traffic Fatalities

By Carabin Shaw

The most recent report from the U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA) revealed astounding statistics. The bad news is that there were 32,367 highway fatalities nationwide in 2011. The good news is that these figures are the lowest they have been for over six decades. The last time they were at that level was in 1949. These numbers continue to dictate a downward trend in the most recent years and a 26% decline in traffic deaths since 2005.

Unfortunately, these glowing statistics are of little comfort to Texas families who have lost loved ones in accidents. As our San Antonio wrongful death lawyers have known, the data confirms that our state accounts for almost 10% of all highway fatalities and 40% of those are alcohol related.

State and national agencies continue with their efforts to educate the public about ways to save lives. Some examples of successful campaigns have been “Buckle Up,” “Click It or Ticket,” “Move Over,” “Don’t Drink & Drive” and “Drive Sober or Get Pulled Over.”

Nationwide, alcohol impaired fatalities declined in 2011 by 2.5%, claiming 9,878 lives compared to 10,136 in 2010. These fatalities involved the operator of a vehicle or motorcycle who had a blood alcohol content (BAC) of .08 or higher. The 9,878 drunk-driving deaths reported in 2011 represented 31% of the overall total.

Texas, New York, South Carolina and Tennessee led the group of 27 states that experienced a decline of 30 or more alcohol-related highway deaths. Colorado, Florida and New Jersey all had increases of 30 or more alcohol-related traffic deaths. Connecticut, North Carolina, Tennessee, Ohio and Michigan led the group of 36 states that marked reductions in the number of overall fatalities.

Some other findings reported were:

• Fatalities declined by 4.6% for occupants of cars, pickups, SUVs and minivans.

• Fatalities increased for occupants of 18-wheelers (20%), cyclists (8.7%), pedestrians (3%) and motorcycle riders (2.1%).

Compared to all the other states, Texas clearly led the pack accounting for nearly 10% of all traffic fatalities reported nationwide. In 2010, Texas reported 3,023 total fatalities. There were 42% (1,270) related to alcohol. In 2011, Texas had a total of 3,016 fatalities, with 40% (1,213) being alcohol-related. Only Hawaii (44%) and North Dakota (44%) had more traffic fatalities related to alcohol than Texas.

These statistics are frightening for every mother and father who fears the worst when their teenagers are out at night and every husband or wife who sees their loved one leave on a road trip.

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Published on: January 28, 2013

Pradaxa May Cause Uncontrollable Internal Bleeding

By Carabin Shaw

Pradaxa was first released into the market in 2010 by German pharmaceutical giant Boehringer-Ingelheim. The drug immediately reached blockbuster status by notching over $1 billion dollars in sales. In its initial stages, Pradaxa was thought to be a next generation drug that would replace the most common drug used to prevent strokes and blood clots, Coumadin, better known as Warfarin.

Coumadin is a blood thinner that has been the primary drug of choice for nearly 60 years to treat atrial fibrillation, or irregular heart rate, and prevent strokes that are associated with atrial fibrillation. One of the disadvantages of Coumadin is that it requires patients to undergo continual blood tests so that dosage adjustments can be made, if necessary.

The optimum dosage will serve to prevent strokes by thinning the blood but not thinning it so much as to cause a bleed. If the dosage is too high and a bleed results, Vitamin K and fresh frozen blood plasma can be given to the patient to reverse the effects and slow the bleeding.

Pradaxa was supposed to be more effective than Coumadin, safer and easier for patients to use. It would also not require the continual blood work regime. Unfortunately, that proved not to be the case. Pradaxa turned out to be a more dangerous substitute for Coumadin.

If a bleed occurs while using Pradaxa, there is no reversal. Simply put, traumatic bleeding cannot be stopped. Often it is even impossible to perform life-saving surgery because excessive bleeding during the procedure might prove to be worse than the initial trauma. Tthe widespread use of Pradaxa is filled with high risk for the patients who use it.

Initially the health risks of using Pradaxa were not provided to the public, specifically that traumatic bleeding cannot be stopped since there is no available reversal agent. This was documented in an issue of the Journal of Neurosurgery in March of 2012, which concluded that once the internal bleeding begins there is not much that can be done to stop it.

The FDA launched an investigation regarding the safety of Pradaxa in December 2011. There was no recall of the drug mandated. However, in September 2012, the Journal for the American Medical Association initiated new demands for a Pradaxa recall, due to the fact that perhaps the FDA overlooked the side effects of internal bleeding as it rushed to approve the drug.

Unfortunately the many patients taking Pradaxa for their atrial fibrillation are exposed to this danger of internal bleeding. The safety of Pradaxa was called into question shortly after usage began in the U.S. Some 542 deaths and 3,781 side effect problems were linked to the drug in 2011.

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Published on: January 22, 2013

Study Says Obese Are 80% More Likely To Die In A Car Crash

By Carabin Shaw

According to a study of data accumulated by the National Highway Traffic Safety Administration (NHTSA), obese drivers have a higher probability of dying in a car crash than those who are of normal weight. In fact, their chances of death in an accident are 80% higher than those who weigh less.

Transport safety researchers Thomas Rice and Motao Zhu related their findings in an online publication of the Emergency Medicine Journal.

Since one out of every three American adults is considered to be obese, this new study is alarming. Interestingly, the study revealed that obese females were at an even higher risk of being a car crash fatality than their male counterparts.

Time will only tell whether this study will invoke changes by automobile manufacturers to make vehicles safer for obese drivers.

The study that covered a 12 year period from 1996 to 2008, examined 57,500 car crashes. The data included all of the deaths that occurred within 30 days of the accidents.

One finding illustrated the fact that obese vehicle occupants in general had a host of other health problems that reduced the probability of surviving a serious injury. The other finding was that seat belts do not properly interact with the human body when one is obese. Simply put, the lower body of an obese driver continues to go forward in a crash while the upper body is held back. This is because the excess padding and abdominal fat cause a delay in the time it takes to tighten against the pelvis.

Obesity was determined by body mass index (BMI). A BMI of 30 and over is considered to be obese. A BMI of 18.5 is considered to be normal.

Some conclusions reached were:

• A driver with a BMI of 30 to 34.9 was 21% more likely to die in a crash than a driver with a normal BMI.

• A driver with a BMI of 35 to 39.9 was 51% more likely to die in a crash than a driver with a normal BMI.

• A driver with a BMI of 40 or higher was 80% more likely to die in a crash than a driver with a normal BMI.

Another finding in the study was that underweight men were more likely to die in a crash than those with a normal BMI. Underweight men were those with a BMI of less than 18.5.

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Published on: January 18, 2013

Toyota Settles “Sudden Acceleration” Case In Utah

By Carabin Shaw

The Toyota Motor Company has agreed to settle one of its “sudden accelerator” product liability cases in Utah that killed two people and injured two other family members. The case was set to go to trial in February. Details of the terms of the settlement were not disclosed.

In December, Toyota agreed to settle hundreds of claims in a class action for individuals who declared that they suffered economic losses due to a recall of millions of its cars because of sudden acceleration issues. That settlement was reported to be for more than $1 billion.

However, hundreds of other plaintiffs who are suing for serious personal injuries and wrongful death were not included in that massive deal. Those cases are pending and the Utah case was one of the bellwether cases set to go to trial first. Typically, bellwether cases are large cases based on the same theories of recovery, which judges and lawyers use as guidelines for evaluating cases that follow.

The Utah settlement was reached for an accident that involved Paul Van Alfen, his wife, son and his son’s fiancee, Charlene Jones Lloyd. Their accident occurred on November 5, 2010, on I-80 close to Wendover, Utah. As they were traveling on the interstate, their Toyota Camry suddenly accelerated, went through a stop sign at the bottom of an exit ramp and struck a wall. Skids evidenced Van Alfen’s attempt to stop the vehicle as it left I-80.

The accident resulted in two fatalities, Van Alfen and Lloyd. Van Alfen’s wife and son received injuries.

An investigation conducted by the Utah Highway Patrol revealed that the collision occurred because the accelerator was stuck, causing the Camry to suddenly accelerate.

Other settlements have recently been reported, including one involving a retired Los Angeles police officer and another involving a California Highway Patrol officer. In the latter case, the patrol officer and his entire family were killed near San Diego in 2009 when their Lexus suddenly accelerated, hit speeds of over 120 miles per hour, flipped and burst into flames. Investigation revealed that the accelerator had been mashed down by an improperly sized floor mat.

Toyota issued a statement that the recent settlements should not be an indication of what’s to come for other pending lawsuits. In other words, Toyota is going to pick and choose the weaker cases that they take to trial and settle the larger, stronger headline cases.

The company continues to stand behind the safety and integrity of their cars, while blaming these tragic accidents on driver error, faulty floor mats and faulty accelerator pedals.

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Published on: January 16, 2013

Texas Department of Transportation Blames Distracted Driving For Fatal Crashes

By Carabin Shaw

According to the Texas Department of Transportation, the East Texas rural roads are deadlier than traveling on other major thoroughfares and interstates. This news is released as new crosses are being erected at the scene of yet another fatality near Longview.

Even though the number of fatal crashes has gone down in recent years, over 50% of the fatalities in the surrounding five counties around Longview since 2007 have been one vehicle accidents. This has led the Department of Transportation to conclude that distracted driving is the culprit in these collisions.

Further evidence in support of this conclusion is the fact that only one death occurred in more than 90% of the fatal accidents. In the five county area including Gregg, Rusk, Harrison, Panola and Upshur, there has not been any single accident since 2007 that resulted in more than three fatalities.

Jean Dark, with the Texas Department of Public Safety (TDPS), stated that the reason is simply because most accidents occur on farm-to-market (FM) roads and involve only one car or pickup striking a tree, after leaving the road. This contrasts with multi-vehicle crashes on interstates. She explains that the difference is the tremendous impact that occurs when a vehicle strikes a stationary object such as a tree. It just “doesn’t give like another car would.”

The Department’s data indicated that 54% of all the accidents in the five county Longview area involved a single vehicle leaving the road, striking an object or flipping over. Only 38% of the wrecks involved two vehicles.

Dark said drivers just have to “pay attention to driving,” because if someone isn’t, it “can change your life.” For example, on two-lane FM roads, the oncoming traffic is separated from you by nothing more than a center stripe. You trust the other driver is paying attention and will stay on their side of the road. Unfortunately, sometimes they are distracted and they cross over into your lane.

Accidents resulting in fatalities have been around long before all of the gadgets we now have to distract us, such as cellphones, smartphones, iPads, iPods, headphones and GPS, just to name a few. Nationwide statistics show that distracted driving is one of the major causes of traffic fatalities. The TDPS data indicates that there were over 100,000 vehicles involved in accidents caused by distracted drivers in 2009 and new data is expected to confirm that those figures are continuing to rise.

Many of the crashes are the result of drivers trying to text message while driving. In 2009, the Texas Legislature passed a law which prohibits the use of any type of wireless device in a school zone. Another attempt to get a law passed to ban texting while driving is going to be on the table again during the 2013 legislative session. In 2011, Governor Perry vetoed a texting ban proposal.

Studies have shown that the use of a cellphone and texting while driving are equally, if not more dangerous, than driving while intoxicated.

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Published on: December 21, 2012

West Texas Dust Storm Causes Major Accidents

By Carabin Shaw

The Texas Department of Public Safety (TDPS) reported that a severe dust storm close to Lubbock caused multiple accidents early in the afternoon on Wednesday, December 19, 2012. There were 23 vehicles involved in the chain-reaction pileup injuring some 17 people and killing one.

TDPS Cpl. John Gonzalez said that the visibility was so bad that “you couldn’t see past the hood of your vehicle.” Winds with gusts of 55 miles per hour or so stirred up the sand and dust from dry fields making it impossible to see the stopped vehicles already involved in accidents on the southbound side of I-27. He said that there were a series of collisions that happened simultaneously in “domino fashion”, when drivers’ visibility went to zero.

One man was killed when his SUV rear-ended an 18 wheeler that had been involved in an accident. Some 17 other people were injured in the crashes but none of them were serious or life threatening. The majority of the injured people were taken to the University Medical Center in Lubbock for treatment and then released.

The accidents and the visibility concerns caused the TDPS to close I-27 in either direction for about five miles from Abernathy to New Deal for six hours. Once the interstate was opened to traffic, a TDPS bulletin was released warning of the dangerous driving conditions between Lubbock and Amarillo.

Landowners were being advised to plow their fields so that the loose sand would not blow off so easily during wind storms, after the prolonged drought.

This is the second major interstate pileup in Texas in the last thirty days. The other occurred on Thanksgiving Day just west of Beaumont, Texas. The cause of that massive chain-reaction accident was fog, resulting in near zero visibility at around 9:00 a.m. Some 150 vehicles were involved in that series of accidents that injured more than 100 people and killing two, when their SUV was crushed by an 18 wheeler.

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Published on: December 3, 2012

Thanksgiving Day Pileup: Deadly Evidence of Accidents At Interstate Speeds

By Carabin Shaw

It was about 8:45 a.m. on Thanksgiving morning, the most traveled day of the year, when one of the most horrific accidents in Texas occurred on Interstate 10 outside of Beaumont. The weather conditions were extremely foggy and cars were apparently slowing down due to the lack of visibility. Deborah Leggio, 60, and her husband Vincent, 64, were killed when their Chevrolet Suburban traveling eastbound was struck from the rear and crushed by an 18 wheeler, which ended up on top of their vehicle. Ultimately, some 140 to 150 vehicles were involved in the pileup.

A veteran police officer for more than 25 years, Jefferson County Sheriff Deputy Rod Carroll, 46, heard an emergency call about the multi-vehicle accident and he responded. Even though Deputy Carroll is a paramedic, he was not prepared for what he was about to witness.

When he arrived at the scene, he stated that the area was so foggy that it was impossible to see more than ten feet in any direction. He reported that there were cars on top of cars, 18 wheelers with massive damage, vehicles in the median and on the side of the interstate with damage and personal articles spread along the roadway.

Deputy Carroll related that the collision scene was over a mile long, with twisted metal making it difficult to determine what type of vehicles were involved. The scene was filled with officers and rescuers, including people who had been involved in the massive pileup, trying to pull victims from their vehicles and give them aid. He said “it was like a Third World Scene”, not knowing what to expect as he walked through the wreckage.

Initially, it is believed that the first collision occurred on the eastbound side of the interstate and westbound collisions followed. Every ambulance in the area was busy transporting some 80 t0 90 individuals to local hospitals. There were 10 to 12 victims who were listed as serious to critical.

The westbound lanes of Interstate 10 were closed for approximately five hours and the eastbound lanes were shut down for over eight hours, while the investigation and cleanup continued.

With most highways in the United States now allowing speeds of 70 to 75 miles per hour, Texas has gone to even a different level. A 41 mile toll road from Austin to San Antonio is going to have an 85 mile per hour speed limit. There is an 80 mile per hour speed limit for some highways in West Texas. The problem is that the higher the posted speed limit, the faster people think that they can drive over the limit without being ticketed. People are now testing their radar detectors and driving at speeds ranging from 85 to 100 miles per hour on interstates.

Unfortunately at speeds like this when something goes badly wrong, such as rain, fog, another accident, a blowout or a distracted driver, the result is going to be massive and more lives will be lost.

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Published on: November 15, 2012

Houston Innovation Reduces Fatality Rate In Wrong Way Crashes

By Carabin Shaw

There always seems to be a series of fatalities across the country on New Year’s Eve, caused by someone driving on a freeway traveling in the wrong direction. During 2012, Houston had several wrong way crashes that occurred back to back on I-45 near the Woodlands. In August 2012 alone, Atlanta had five fatalities that were linked to wrong way crashes. Over a five year span, Georgia has had over 100 people killed in similar accidents.

Notwithstanding increased signage to warn drivers that they are going the wrong way and other improved markings, people still get on the freeways headed in the wrong direction. Without a doubt, most of these collisions are caused by drunk drivers.

Following a wrong way triple fatality that happened in Houston, Texas on New Year’s Eve in 2008, the Harris County Toll Road Authority began to search for some way to solve the problem.

Its toll technology company, TransCore, had to start from scratch, since there was no model to follow. Whitt Hall, Vice President of TransCore, said that the company built a system to detect when cars were traveling the wrong way on exit ramps. The system uses speed radars to detect the location of someone entering the freeway on an exit ramp. This sends a warning to the toll authority’s command center, programmed cameras activate at the location and a dispatcher alerts an officer to respond immediately. Simultaneously, message boards are activated to warn drivers in the area of a wrong way driver and to move over and stop.

Assistant Chief Randy Johnson, who is with the Harris County Toll Road Authority, said that “we have told all of our officers not to chase a wrong way driver, but to get yourself in a position to deploy a spike strip.”

Costing $335,000 for an installation in 19 locations, the system is not cheap. However, the results are extremely impressive. Since it was installed four years ago, the 17 mile span has had 100 wrong way drivers without a single accident.

In order to resolve false alarms when it is raining hard or gusty winds blow objects the wrong way the toll authority is going to spend another $500,000 to install sensors in the pavement.

In addition to winning various awards, there has been much interest from Mexico, Columbia and China. The Texas Department of Transportation (TXDOT) has spent $500,000 in San Antonio to utilize the same system by installing radar devices, message boards and flashing signs on the most dangerous freeway stretches.

For Atlanta, the cost to recreate Houston’s system on I-285 would be roughly $3 million. For now, they rely on drivers calling 911 to report a wrong way driver. Unfortunately, the time difference is deadly between a sensor advising of a wrong way driver and getting a 911 call.

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