Texas Injury Lawyers Blog

Published on: July 17, 2013

Mutual Pharmaceutical Co. Inc. v. Bartlett. -U.S. Supreme Court Decision Shields Generic Drug Manufacturers from Liability in Product Defect Cases

According to the U.S. Food and Drug Administration’s (“FDA”) Center for Drug Evaluation and Research, a generic drug is a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. Although generic drugs are generally cheaper, since the FDA requires that the warning labels of generic drugs be identical to their brand-name counterparts, generic drugs have essentially been granted immunity to civil action resulting from the use of their drugs.

Unfortunately for consumers of generic drugs, a recent U.S. Supreme Court decision furthered strengthened this generic drug manufacturers’ immunity, finding that design defect law claims in state courts based on the adequacy of a drug’s warning are pre-empted by federal law. As explained below, the ruling not only creates an inconsistency in product defect law, but it also all but ensures that generic drug makers will not be held accountable for product defects, marking a victory for both drug industry and the FDA.

In Mutual Pharmaceutical Co. Inc. v. Bartlett, Ms. Bartlett suffered a severe reaction to the generic pain reliever drug, sulindac, made by Mutual Pharmaceutical Co. Inc. (“Mutual”). Even though Ms. Bartlett’s doctor prescribed her the brand name of the non-steroidal anti-inflammatory drug (NSAID), Clinoril, for shoulder pain, her pharmacist dispensed the generic form of the pain reliever instead. The drug caused her to develop toxic epidermal necrolysis (TENS), which led to 60 to 65% of her skin to either burning off or becoming an open sore. The condition left Bartlett disfigured, disabled and nearly blind.

Bartlett thereafter filed suit against Mutual in federal court in New Hampshire alleging that the generic drug, sulindac, had a design that made it dangerous for use. Like Texas law, New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe. A drug’s safety is evaluated in part by the adequacy of its warnings. Notably, at the time that Bartlett was prescribed the drug, sulindac’s label did not specifically refer to TENS or Stevens-Johnson Syndrome, another form of TENS.

The New Hampshire state court agreed with Bartlett, finding the generic drug was unreasonably dangerous and awarded Bartlett $21 million in damages. The Court of Appeals for the First Circuit affirmed. Nonetheless, focusing on the fact that Bartlett was provided the generic version of the drug, the U.S. Supreme Court held that the Federal Food, Drug and Cosmetic Act preempts state-law design defect claims against manufacturers of generic drugs. As a result, the U.S. Supreme Court reversed the decision of the Court of Appeals. If, however, Bartlett had been dispensed the brand name version of the drug, she would have had a cause of action against the brand name drug manufacturer, and would have been able to recover damages for her injuries.

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Published on: July 11, 2013

Summer is the Deadliest Time of Year for Teen Drivers in Texas and Nationwide

By Carabin Shaw

The risk of car accidents increases immensely during the summer months. Specifically, most car accidents occur during the period from Memorial Day to Labor Day. While July Fourth is historically the deadliest day on the roads, August is historically the deadliest month of the year for car crashes across the country. In addition, according to historical data tracked by the National Highway Traffic Safety Administration (NHTSA) from 1986 to 2002, Saturday and Friday are still the two deadliest days to drive, and rush hour from 3:00 – 6:00 pm remains the deadliest time to drive. Not surprisingly, the same held true as of 2010 as well.

More recently, research by Driving-Tests.org, an online learning site for new drivers, revealed that summer remains the deadliest time to be on the road. More than 27% of annual traffic fatalities occur during July, August and September. One possible reason for the increased number of fatalities in the summer may be due to the fact that according to AAA, teen driving increases by 44% during the summer months. Indeed, per the NHTSA, motor vehicle crashes are the leading cause of death for teens in the United States, accounting for over 35% of all fatalities for 15 to 20 year olds. While this statistic may not be all that surprising, the fact that driving while intoxicated is not the leading the cause of death for crashes involving teens might indeed be. Instead, over 75% of serious car crashes involving teens are due to “critical errors.”

Unfortunately for Texans, according to the NHTSA’s FARS Data, in 2011, Texas was the most dangerous state for drivers in the U.S. with over 3,000 traffic-related fatalities. Moreover, according to the Texas Department of Transportation, as is the case in the rest of the country, July and August were the two deadliest months for car crashes in 2012.

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Published on: June 25, 2013

Are You Complying With State and Federal Laws When it Comes to Water Safety and Keeping Kids Safe this Summer?

By Carabin Shaw

The start of summer means more time spent in and around swimming pools and lakes, which can mean more accidents and drowning deaths, especially for children.

According to the Texas Department of Family and Protective Services (DFPS), as of June 11, 2013 there were 27 reported child-drowning deaths in Texas in 2013. The latest reported incident occurred June 15, 2013, when a four-year old drowned in the pool at an apartment building in Lewisville, Texas. Unfortunately, this was the second such incident in less than a week — a three-year old drowned in North Texas on June 13th in a pool at a private residence. On a positive note, the number of drowning deaths in Texas may be down from last year. The DFPS reported a total 74 drowning deaths last year, with a combined 30 deaths in June and July. Notably, 37 of these fatalities occurred in swimming pools, and children ages 2 and younger accounted for over 50% of the total fatalities.

Some safety tips from DFPS to prevent fatalities similar to the ones described above include:

1. Never leave children alone around water — this includes swimming pools, wading pools, drainage ditches, creeks, ponds, and lakes.

2. Keep an eye on children who are swimming or playing in water. They need an adult or certified lifeguard watching them at all times.

3. Make sure access to swimming pools is secure. Use fences (self-closing and latching), and water surface alarms.

4. Store water toys away from the water when not in use so they don’t attract small children.

5. Don’t assume young children will use good judgment and caution around water.

In addition, if you are a business or property owner, it is important to determine whether or not your pool or spa is considered “public” or “semi-public” pursuant to the San Antonio City Code. All public and semi-public swimming pools and spas are regulated by the City of San Antonio. According to the City Code, a semi-public swimming pool is: (1) Any privately owned swimming pool or spa that is open to the general public for a fee, or (2) any swimming or wading pool, spa or sauna, serving a private club, motel, hotel, apartment building, school, child care facility, recreational or physical fitness facility, institution, home owner’s association, or other similar activity or structure, the use of which is limited to members, residents, students, or clients and their guests. All public and semi-public swimming pools or spas located within the City of San Antonio must have a pool license.

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Published on: June 24, 2013

Reviewing Texas State Laws Regarding the Safe Handling of Hazardous Materials Following the West Fertilizer Plant Fire

By Carabin Shaw

According to an article published by the San Antonio Express-News, there are 16 fertilizer production sites in Texas similar to the West Fertilizer Co. plant that received nationwide attention after it caught fire causing approximately 60,000 of ammonium nitrate to blow up, killing 15 people and injuring more than 200 in April 2013. In addition, Texas state officials also revealed that 129 facilities in Texas store at least 5 tons of ammonium nitrate and other potentially explosive materials. Even though some of the 16 plants are located in rural areas away from schools and residences, the incident at the West plant brought attention to the current federal and state law regarding the arguably insufficient regulation of potentially hazardous chemicals.

Notably, West Fertilizer was fined in 2011 for failing to safely transport potentially lethal tanks of anhydrous ammonia. In addition, the Environmental Protection Agency fined the company for failing to failing to maintain adequate risk management plans and venting ammonia into the air without obtaining permit. Finally, according to OSHA documents, the West Fertilizer was last inspected in 1985.

On June 17, 2013, the Texas House Homeland Security and Public Safety Committee held a second hearing since the West Fertilizer Co. plant fire, hoping to prevent another such disaster. During the hearing, lawmakers, including Rep. Joe Pickett who is the chairman of the House Homeland Security and Public Safety Committee, reviewed the existing rules in place for the safe handling of hazardous materials to determine whether Texas state laws need to be more strict and whether more oversight is needed.

Various agencies bear responsibility for oversight in the regulation and operation of facilities such as the West plant, including the Department of Public Safety, the Texas Division of Emergency Management, the Emergency Management Council, the Office of the Texas State Chemist, the Texas Commission on Environmental Quality, the Texas Department of Agriculture, the Department of State Health Services, and the Texas State Fire Marshall’s Office. Representatives from each of these agencies were invited to testify at the initial April 30th hearing and the June 17th hearing.

Unfortunately, an investigation following the West explosion revealed that no one of the state agencies list above had or exercised oversight of potentially dangerous facilities. This is the case despite the fact the federal law requires businesses to report their inventory of certain toxic and hazardous materials to state and local officials.

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Published on: June 19, 2013

Navigating Work Place Injuries

By Carabin Shaw

Navigating Work Place Injuries

With more and more drilling activity occurring across the Eagle Ford Shale and the economy doing better here in San Antonio, we are seeing more and more individuals injured on construction sites, work sites and oil well drilling sites.

Workplace injuries and deaths make up a large part of litigation handled by many personal injury attorneys. According to the United States Secretary of Labor, every year nearly 4 million people suffer a workplace injury, from which some never recover.

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Published on: June 13, 2013

Texas Ranks Third in the Number of Dog Bite Claims Reported by State Farm

By Carabin Shaw

The American Veterinary Medical Association estimates that the dog population in the United States reached approximately 70 million in 2011. This means that over 35% of the U.S. population has a dog. Unfortunately, this also leads to a high incidence of dog bites and dog attacks.

Indeed, a report released by State Farm on May 15, 2013, revealed that there are approximately 4.7 million dog bite victims each year. Dog bites are not only a serious health and safety issue that can cause injury and even death, but dog bites can also cost dog owners, insurance companies, and the nation a great deal of money. In fact, the Insurance Information Institute estimates that in 2012, insurers across the country paid nearly $489 million in dog bite claims.

At the same time, the U.S. Centers for Disease Control and Prevention (CDC) says 800,000 Americans seek medical attention annually for dog bites. Of those injuries, nearly half require emergency room treatment. According to Prevent the Bite, a nonprofit organization devoted to dog bite prevention, many of those injuries are to children. The organization reports that from 2001 to 2011, dog bites were the ninth leading cause of nonfatal unintentional injury to children ages 5 to 9 (512,638) and tenth for children ages 10-14 (412,895).

In 2012, State Farm alone paid about $108 million in dog bite claims in 2012. Although dog bite claims were down by 2.1% in 2012 from 2011, Texas (along with three other states on State Farm’s Top 10 states for dog bite claims–Illinois, Indiana, and Georgia) reported more claims. Notably, according to the report, Texas ranked number three in the United States for State Farm dog bite claims, behind only California and Illinois. Specifically, 236 claims were made in Texas alone, costing State Farm an estimated $4.3 million.

Summer can be the most dangerous time of the year for dog bites as kids, neighbors, friends, relatives and pets interact more frequently. The National Dog Bite Prevention Coalition and the CDC provide various tips to prevent dog bites, including:

1. Do not leave a baby or small child alone with a dog, even if it is a family pet.
2. Never put your dog in a position where it feels threatened.
3. Put your dog on a leash in public.
4. Do not play aggressive games with your dog (e.g., wrestling).
5. Do not approach an unfamiliar dog.
6. Remain motionless (e.g., “be still like a tree”) when approached by an unfamiliar dog.

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Published on: June 10, 2013

Wrong Way Drivers on Texas Roads

By Carabin Shaw

Wrong Way Drivers – Info and Stats on the Idiots that can Kill You

Drivers, some may call them idiots or drunks or other applicable names – who somehow manage to travel the wrong way on a restricted roadway such as a freeway represent a significant risk of catastrophic injuries or death to you, your family or friends.

While wrong way driving crashes are less frequent than other types or causes of auto accidents, these head-on collisions usually result in serious, life-altering injuries and deaths to all individuals involved.

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Published on: June 9, 2013

The Most Common Reason Behind Medical Malpractice Lawsuits is Mistake in Diagnosis

By Carabin Shaw

According to a recent article in The New York Times, citing a study published online by BMJ Quality & Safety on April 22, 2013, most medical malpractice settlements and damage awards were the result of diagnostic mistakes. In fact, the study, which was compiled using the National Practitioner Data Bank, found that among the 350,706 paid malpractice claims analyzed from 1986 to 2010, diagnostic errors appeared to be the most common, most costly, and most dangerous types of medical mistakes.

More specifically, the report found that diagnostic errors were the leading type of paid medical malpractice claims (28.6%), and accounted for the highest proposition of total payments at 35.2%. Additionally, diagnostic errors accounted for 33.8% of the disabilities and almost 40% of the deaths that resulted in medical malpractice payments. Notably, more diagnostic errors were outpatient than inpatient (68.8% vs. 31.2%). However, inpatient diagnostic errors were more likely to be lethal (48.4% vs. 36.9%).

After diagnostic errors, treatment errors and surgical mistakes accounted for the second and third highest reasons for payouts. All other errors combined, including birth injuries and other obstetrical errors, medication mistakes, monitoring mistakes and anesthesia mistakes, accounted for only 20% of payouts total.

Moreover, a study of 190 errors at a VA hospital system in Texas found that, while many diagnostic errors involved common diseases such as pneumonia and urinary tract infections, 87% of these errors had the potential for “considerable to severe harm”, including “inevitable death.” A commentary on the Texas VA study revealed that misdiagnosis is not limited to hospitals. The commentary estimates that “with more than half a billion primary care visits annually in the United States . . .at least 500,000 missed diagnostic opportunities occur each year at U.S. primary care visits, more resulting in considerable harm.”

Dr. David E. Newman-Toker, a senior author of the study and an associate professor of neurology at John Hopkins, stated, “this is a major health problem”, and “physicians, hospitals, and insurers all need to contribute to fixing it.” Indeed, problems with misdiagnosis are not a new problem. In 1991, the Harvard Medical Practice Study found that misdiagnosis accounted for 14% of adverse events and that 75% of these errors involved negligence such as failure by doctors to merely follow up on test results. Furthermore, a 2009 report funded by the federal Agency for Healthcare Research and Quality found that 28% of 583 diagnostic mistakes reported by doctors were life threatening or had resulted in death of permanent disability.

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Published on: May 29, 2013

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

By Carabin Shaw

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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