Texas Injury Lawyers Blog

Published on: August 30, 2012

Fresenius Medical Care Accused of Failure to Warn Patients of Known GranuFlo and Naturalyte Risks

One of the country’s largest dialysis operators, German-based Fresenius Medical Care, was recently investigated by the nation’s Food and Drug Administration (FDA) in response to a number of patient deaths. Following the investigation, the FDA issued a Class I recall for the company’s Naturalyte GranuFlo Acid Concentrate and Naturalyte Liquid Acid Concentrate products. The products are used to aid in the elimination of waste during the hemodialysis procedure. According to the FDA, they may also potentially raise serum bicarbonate levels in patients undergoing dialysis. A higher serum bicarbonate level can lead to cardiac arrest and death in some patients.

Fresenius Medical Care treats more than one-third of the approximately 400,000 dialysis patients across the United States. The company also reportedly supplies many of the dialysis machines and pharmaceutical products used at other dialysis centers nationwide. In fact, an estimated 125,000 patients are treated using GranuFlo or Naturalyte in non-company medical care centers every year.

According to an FDA official, Fresenius Medical Care is accused of failing to warn dialysis patients of the potentially fatal risks associated with use of its GranuFlo and Naturalyte products. In 2010, 941 dialysis patients who were treated with GranuFlo or Naturalyte experienced cardiac events inside of a Fresenius Medical Care clinic. Despite that the company sent an internal memorandum to warn of the heart risks associated with its products to its own dialysis center doctors, Fresenius Medical Care allegedly failed to notify other dialysis centers or the FDA.

Steven Silverman, the FDA’s Director of Compliance in the Medical Devices Division, stated it was quite troubling that Fresenius Medical Care failed to warn its entire customer base about the health risks associated with the GranuFlo and Naturalyte products. The company’s Chief Medical Officer, Dr. Franklin Maddux responded that the health risks were too preliminary to warrant publication in medical journals and Fresenius Medical Care had no other avenues through which to communicate with outside doctors who were using the product.

In March 2012, Fresenius Medical Care finally issued a warning to customers regarding the alleged increase in heart attack risk associated with use of the company’s products. In May, the FDA issued a safety alert for products such as Granuflo. The following month, a Class I recall was issued for GranuFlo and Naturalyte. A Class I recall is issued when there is a reasonable likelihood that exposure to a drug or medical product will result in a serious health complication or death.

Potential GranuFlo and Naturalyte lawsuits are being evaluated throughout the United States for health risks that may be associated with use of the products. If you or a loved one suffered a cardiac event after being treated with GranuFlo or Naturalyte, you should contact a qualified personal injury lawyer as soon as possible.

Continue reading →

Published on: August 28, 2012

FMCSA Makes Improvements to Compliance Safety Accountability Enforcement Program in Texas, Throughout Nation

By Carabin Shaw

The nation’s Federal Motor Carrier Safety Administration (FMCSA) recently announced changes to the agency’s Compliance Safety Accountability enforcement program. The changes will reportedly allow high-risk bus and trucking companies to be more easily identified and compliance issues to be dealt with in a speedier fashion. According to Anne Ferro, FMCSA Administrator, the changes were designed to make existing safety programs more effective. Although the number of deaths in crashes that involved commercial vehicles declined by nearly 5 percent in 2011, approximately 4,000 people are killed in such collisions annually.

The Compliance Safety Accountability enforcement program changes include improved hazardous materials carrier compliance requirements, altering the way in which a driver’s hours of service are logged, weighing hours of service logbook violations equally whether paper or electronic, taking into account cargo load violations when determining vehicle maintenance compliance, and including equipment violations found during pre-trip inspections in safety evaluations. Additionally, one to five miles per hour speeding violations will be abandoned in favor of more recently implemented speedometer regulations, and the program will endeavor to more accurately reflect the inspection type on all recorded bus and truck violations. The Compliance Safety Accountability enforcement program changes are scheduled to take effect in December 2012.

Prior to implementing the safety enforcement program changes, the FMCSA provided the public with four months during which to review and comment on the proposed changes. Approximately 14,000 bus and trucking carriers reportedly participated in the public preview. About 1,700 law enforcement officers also contributed their thoughts regarding proposed system updates. Further monitoring will allegedly be conducted by the FMCSA before the new requirements are made public.

When a tractor-trailer collides with a passenger vehicle, the resulting injures are often catastrophic or fatal. If you were hurt or someone you love was killed in a collision with an 18 wheeler, you may be entitled to financial compensation for your medical costs, suffering and pain, lost wages and benefits, temporary or permanent disability, and a variety of other damages. In some instances, you may also be awarded punitive damages. In the United States, the trucking industry is enormous. You shouldn’t have to fight them alone. If you were hurt in an accident with an 18 wheeler, you need an experienced Texas truck accident attorney on your side.

Continue reading →

Published on: August 19, 2012

More Than One-Quarter Million SUVs Recalled in North America Over Fire Hazard

By Carabin Shaw

Automobile manufacturers Isuzu and General Motors have issued a recall for more than one-quarter million sport utility vehicles (SUVs) in North America. Approximately 258,000 model year 2006 and 2007 SUVs sold or registered in 20 states, the District of Columbia, and Canada are being recalled over a power window and door lock switch defect that can potentially cause a fire in the vehicle. The recall includes the following models: Buick Rainier, Chevrolet Trailblazer, GMC Envoy, Isuzu Ascender, and Saab 97-X. Although several automobile brands are subject to the recall, each of the vehicles at issue was manufactured by General Motors.

According to documents published on the National Highway Traffic Safety Administration‘s (NHTSA) website, salt and chemical fluids used to clear icy winter roads may corrode the power window and lock circuit board located inside of the driver’s door. The power window switch in SUVs affected by the recall that are currently registered or were sold in Connecticut, Delaware, Illinois, Indiana, Iowa, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, West Virginia, and Wisconsin will be replaced by automobile dealerships at no cost to the owner. Additionally, General Motors spokesperson Alan Adler stated the company will replace the switch free of charge for anyone living in a state that is not subject to the current recall at the request of the owner.

According to General Motors, although the company has received reports of 28 vehicle fires caused by the faulty circuit boards no physical injuries resulted. The NHTSA has also received more than one dozen SUV fire complaints. The registered owner of any vehicle that is subject to the recall will reportedly receive a letter from General Motors requesting that an appointment be scheduled in order to replace the faulty switch.

Unfortunately, thousands of consumers are hurt or killed by dangerous or defectively manufactured products each year. Many such injuries are completely preventable. If you were the victim of an injury caused by a defective or dangerous product, you may be able to file a claim against the company that manufactured or distributed it. When a manufacturer or distributor fails to ensure their product is safe for consumer use, an individual who is injured may be eligible to receive financial compensation for medical expenses, lost wages, pain, suffering, and more. If you were hurt by a dangerous or defective product, you should contact a skilled Texas personal injury lawyer to discuss your right to recovery.

Continue reading →

Published on: August 13, 2012

Oil Refinery Explosions Place Workers and Nearby Residents at Risk in Texas and Nationwide

By Carabin Shaw

In early August, more than four thousand residents of the area surrounding a Richmond, California oil refinery were taken to local hospitals for exposure to unknown quantities of sulfur dioxide and nitrogen oxide following a fire at the facility. According to federal investigators, the explosion and resulting fire at the Chevron refinery was likely caused by a corroded pipe the company failed to replace following a safety inspection last fall. In addition to the smoke cloud that sent thousands to the hospital, more than one dozen workers were allegedly placed in harm’s way by the explosion.

A representative from the U.S. Chemical Safety Board stated the incident at the refinery began after a worker noticed a leak in one of the pipes. After the insulation surrounding the pipe was removed for inspection, a large vapor cloud reportedly formed. When workers realized the cloud had formed, they immediately left the area which ignited soon after. A similar incident occurred at the same facility in 1999. In response to the most recent explosion and fire, Chevron has set up an injury claim hotline.

Despite numerous federal safety regulations, the explosion was just one of multiple recent refinery fires across the nation. For example, an early morning explosion and fire at a west Tulsa refinery owned by HollyFrontier Corporation awoke residents of the surrounding community on August 2nd. Although flames were apparently visible from six miles away, no injuries were reported. The cause of that fire is currently under investigation.

The California and Oklahoma refinery fires occurred less than one month after British Petroleum (BP) agreed to pay approximately $13 million in penalties for worker health and safety risks at the company’s Texas City oil refinery. In a follow-up investigation, the nation’s Occupational Safety and Health Administration (OSHA) issued 270 failure-to-abate notices for more than 400 process safety management violations after the agency learned BP did not correct many of the hazardous conditions that led to a refinery explosion that killed 15 workers in March 2005. According to Secretary of Labor Hilda L. Solis, the BP settlement was designed to establish a culture of safety at the company’s Texas City refinery. Additionally, she said the goal of the agreement was to save the lives of refinery workers.

Clearly, both employees and nearby residents of oil refineries are placed at risk whenever a big oil company such as Chevron or BP fails to exercise proper safety measures. Oil refinery accidents can be extremely complicated and the process for obtaining compensation for any resulting injuries can be difficult to navigate. If you or a loved one was injured as a result of an oil company’s negligence, you should contact a capable oil and gas accident lawyer as soon as you are able.

Continue reading →

Published on: July 31, 2012

Manufacturers Recall Thousands of Strollers Over Child Safety Hazards in Texas, Nationwide

By Carabin Shaw

Last week, approximately 223,000 child strollers manufactured by Peg Perego between January 2004 and September 2007 were recalled over an alleged strangulation hazard. The company’s Venezia and Pliko-P3 strollers reportedly place children at risk for becoming trapped between trays affixed to the front of the product when a harness attached to the stroller is not being used. According to Peg Perego, the risk for strangulation is greatest for children under one-year of age. Only those products that include a single cup holder in the tray are being recalled. Strollers that include a bumper bar or more than one cup holder are not included in the recall.

The Peg Perego recall was issued after six-month-old child in California was strangled and a seven-month-old child in New York was nearly strangled. The strollers at issue were manufactured prior to the January 2008 implementation of a new industry standard that requires more space between a stroller tray and seat. According to the company, the voluntary standard was created in an effort to reduce or eliminate strangulation hazards in child strollers. The strollers at issue were sold at several retail stores including Babies R Us and Buy Buy Baby. The recalled Peg Perego strollers can be identified by the fact that the company name and stroller model name are both printed on the side of each stroller.

Kolcraft Enterprises Inc. also recently issued a recall for certain strollers. The recall was issued in response to alleged falling and choking hazards associated with one of the company’s products. Although no injuries were reported, approximately 5,600 Contours Options LT Model Number ZT012 strollers sold between February and July 2012 were recalled after the company learned of potential product defects. According to Kolcraft Enterprises, a child riding in one of the recalled strollers may be subjected to a fall hazard if the front wheel assembly breaks or becomes damaged. Additionally, detached basket assembly nuts may pose a choking hazard to small children. The strollers involved in the recall were sold at a number of child specialty stores, Burlington Coat Factory, and online. The model number and manufacturing date of the Contours Options LT strollers can be found on a label on the leg of each stroller.

It is critical for all parents to be vigilant about the safety of any product designed for use by their child or children. Car seats, bicycle carrier seats, and strollers are frequently not as safe as parents may believe. Additionally, retrofitted safety attachments may not provide your child with enough protection. Parents need to remember that any product can pose a real danger to your child. If your child was hurt, disfigured, or even killed by a stroller or other product designed for children, you should contact a personal injury lawyer as soon as possible.

Continue reading →

Published on: July 27, 2012

Merck Drug Propecia Linked to Long-Term Side Effects in Texas and Nationwide

By Carabin Shaw

New research published in the Journal of Sexual Medicine this month found that unwanted sexual side effects related to the anti-baldness drug Propecia may continue even after patients stop taking the drug. The study, conducted by researchers from George Washington University, asked 54 men who claimed they experienced side effects such as erectile dysfunction, shrunken genitalia, a lowered sex drive, depression, and anxiety after taking the drug for a period of at least three months about the length of time it took for their condition to improve. The author of the study, Dr. Michael Irwig, found that 96 percent of the men interviewed stated they continued to experience sexual problems more than one year after they stopped taking Propecia. According to Dr. Irwig, the results have led him to believe the drug may have inflicted permanent damage on some patients.

Propecia, or finasteride, was initially developed in 1992 by drug manufacturer Merck to treat men who experience issues related to an enlarged prostate. The drug blocks the body’s ability to create certain hormones that can contribute to hair loss in men and was approved for use in 1997. Although Merck reportedly informed the nation’s Food and Drug Administration (FDA) that some men experienced sexual side effects during clinical trials, the FDA’s website reports those side effects went away after patients stopped using the drug.

In 2011, the FDA required drug giant Merck to place a warning label on Propecia that states some men will experience sexual side effects that continue even after they stop taking the drug. The warning label was reportedly required after the FDA received over 400 reports of sexual side effects, about 60 of which failed to resolve within three months after patients stopped taking the drug. Earlier this year, the FDA required additional label warnings regarding specific sexual dysfunction disorders.

Merck has stated publicly that there is no evidence Propecia causes any sort of long-term sexual dysfunction and the drug’s label effectively warns patients regarding possible side effects related to taking it. According to Dr. Irwig, the number of patients who experience sexual side effects after taking Propecia is likely only around three percent of the overall population. Still, he stated that means thousands of men across the nation are affected because the drug is so commonly prescribed. Additionally, he said there is no way to predict who might be affected by Propecia.

Possible Propecia lawsuits are currently being evaluated throughout the United States due to a reportedly higher risk for sexual side effects such as shrunken genitalia, infertility, erectile dysfunction and neurological problems that lasted for more than three months after the drug was discontinued. If you or your loved one experienced sexual or other long-term side effects after taking Propecia or another prescription drug, you should discuss your case with a knowledgeable personal injury attorney.

Continue reading →

Published on: July 17, 2012

Sports-Related Brain Injuries May Speed Up Cognitive Decline Associated With the Aging Process

By Carabin Shaw

Recently, many news reports have focused on the long-term effects that concussions may have had on professional athletes. For example, a number of former National Football League players are currently suing the organization over health complications allegedly related to brain injuries they sustained while playing professional football. The short-term effects of concussions and other brain trauma on children and teens who engage in contact sports have also been reported on in the news to varying degrees. Now, researchers are also beginning to study the long-term effects of a brain injury on recreational athletes.

In May, researchers from the University of Montreal published a study that examined the brains of former athletes who played contact sports approximately 30 years ago. Each of the study participants was considered healthy and physically active. Prior to the study, no one complained of symptoms related to cognitive impairment such as memory loss despite that many of the research participants experienced at least one concussion while engaged in a sporting activity in their youth. Researchers performed brain scans on the former athletes and administered both short and long-term memory tests. According to researchers, the brains of those participants who had experienced concussions in their youth appeared to be biologically older than the brains of those who had not suffered brain trauma. In fact, the brains of 50-year-olds who had been concussed were structurally similar to the brains of 60-year-old study participants who had not experienced such a trauma.

According to Steven P. Broglio, Professor of Kinesiology at the University of Michigan, the premature aging results are alarming. He stated that his own research has also demonstrated that brain injuries such as concussions may speed up cognitive deterioration. Additionally, Dr. Broglio found that college students who suffered concussions while playing sports experienced a decline in cognitive abilities that still existed several years later.

Dr. Kevin M. Guskiewicz of the University of North Carolina at Chapel Hill has also studied the effects of sports-related concussions. He stated the effects of a brain trauma tend to vary from person to person. While some athletes will experience cognitive decline from only one concussion, others may not. Dr. Broglio and other researchers are currently planning to begin a long-term study that would monitor the effects of a sports-related concussion on individuals from onset into old age.

Although the effects of a brain injury can be obvious, they can also be difficult to detect. Individuals who suffer a concussion or other brain injury may experience seizures, have difficulty speaking, or have trouble with balance and motor skills. Over time, the victim of a brain injury may experience memory loss, an inability to concentrate, mood swings, and other lifelong problems. The costs related to treating the many symptoms of brain damage can be astronomical. If you suffered a concussion or other brain injury in an accident, you should contact an experienced brain injury lawyer.

Continue reading →

Published on: July 6, 2012

Johnson & Johnson to Stop Selling Pelvic Surgical Mesh Products in Texas, Throughout Nation

By Carabin Shaw

Johnson & Johnson has announced it will phase out the sale of four mesh surgical products used to treat pelvic prolapse, hernia, and bladder control problems in women. Johnson & Johnson’s Ethicon unit will reportedly stop selling Gynecare Prosima, Gynecare TVT Secur, Gynecare Prolift, and Gynecare Prolift+M by the end of the first quarter of 2013. Although the company maintains that each of the products are safe for use, the nation’s Food and Drug Administration (FDA) has warned consumers in the past about potential health and safety issues related to the products.

Approximately 75,000 patients had surgical mesh implanted in order to prevent pelvic prolapse last year. Patients in several states have filed hundreds of products liability lawsuits over pain, infection, and scarring allegedly caused by the vaginal mesh products. The FDA previously warned that 10 percent of pelvic mesh consumers will experience exposure or erosion of the mesh within one year after surgery. More than half of those women require at least one follow-up surgery. Oftentimes, more than one surgery is required. Additionally, the FDA stated there was no reason to believe the implants are associated with a better outcome than traditional pelvic prolapse surgery.

Because other similar surgical mesh products were already approved for use by the FDA, vaginal mesh was approved via the FDA’s fast-track process. The process generally leads to faster approval because it requires less stringent safety testing than traditional approval routes. Earlier this year, the FDA ordered six companies, including Johnson & Johnson, to conduct a safety review of vaginal mesh products. In a public statement, Johnson & Johnson announced it would not recall the company’s pelvic mesh products. The company also stated its decision to discontinue the sale of the products was due to market conditions and was unrelated to safety or efficacy.

Potential pelvic surgical mesh lawsuits are currently being evaluated throughout the United States due to a reportedly higher risk for side effects such as infection, bleeding, urinary incontinence, vaginal scarring, and pain for patients who were implanted with the products. If you or a loved one experienced medical complications after receiving a pelvic mesh implant, you should contact a skilled San Antonio lawyer experienced with transvaginal surgical mesh cases to discuss your rights.

Continue reading →

Published on: June 25, 2012

Documents Suggest Pfizer Intentionally Withheld Key Celebrex Safety Information in Texas, Nationwide

By Carabin Shaw

Recently released emails and other internal documents suggest the Pfizer Corporation intentionally withheld key safety information related to the company’s pain relief drug Celebrex. With annual worldwide sales in excess of $2.5 billion, the drug is one of Pfizer’s best selling products. Last year, Celebrex was prescribed to about 2.4 million people in the United States alone. Celebrex is the last of the COX-2 inhibitor pain relief drugs on the market. Other such pain drugs, including Vioxx, were removed from pharmacy shelves worldwide over reported safety issues and concerns.

The incriminating documents were unsealed by a federal judge in a securities fraud case against Pfizer brought by company shareholders. The documents tend to demonstrate that Pfizer officials decided to withhold important study data from the public. Company executives reportedly began analyzing ways to attack safety study results before at least one research study was completed. The company also allegedly ignored warnings from employees and outside consultants to disclose the fact that Pfizer was relying on incomplete safety data.

As prior studies tended to demonstrate Celebrex was no better at relieving pain than other common drugs such as ibuprofen, Celebrex’s chief benefit was the drug’s purported ability to relieve pain without causing stomach upset. One email from a company research director to a fellow employee expresses happiness after learning attendees at a large medical conference “swallowed” Pfizer’s story that the drug was safer on patient stomachs than other drugs on the market “hook, line, and sinker.” Pfizer, however, reportedly failed to alert the audience that the company only presented the results of a portion of the study.

Internal emails suggest the company chose to massage data and cherry pick results in an effort to make Celebrex look safer. Pfizer officials stated the company had no intent to deceive the public regarding the drug’s safety and claimed the drug’s track record of safety speaks for itself. According to Pfizer, approximately 33 million patients in the U.S. have taken the drug. Still, there is reportedly no clinical proof Celebrex is less likely to harm a patient’s stomach than other pain relief drugs. Pfizer’s decision to withhold safety data was made public in 2001 when the federal Food and Drug Administration released the entire results of the stomach safety study.

In 2004, Vioxx, manufactured by the drug company Merck, was withdrawn from the market after safety studies linked it to an increased risk of heart attacks. Some of the Vioxx safety studies also suggested using Celebrex increased a participant’s risk for heart complications. In response to such concerns, Pfizer began a now six-year-old research study designed to evaluate Celebrex’s effect on the heart. The study is not scheduled to conclude, however, until May 2014. That is the same month the drug’s patent will expire and Celebrex sales are expected to plummet.

Potential Celebrex and Vioxx lawsuits are currently being evaluated throughout the United States due to a reportedly higher risk of heart attacks and other health complications such as Stevens-Johnson Syndrome. If you or a loved one experienced heart, gastrointestinal, or other medical complications while taking a COX-2 inhibitor pain relief drug, you should contact a skilled Texas personal injury attorney as soon as possible.

Continue reading →

Published on: June 18, 2012

Recent Study Suggests Random OSHA Inspections Decrease Texas Worker Injuries

By Carabin Shaw

A study recently published in the journal Science suggests federal workplace health and safety regulations in the United States save lives without affecting a company’s profit margin. The study examined data from hundreds of California work sites subject to random Occupational Safety and Health Administration (OSHA) inspections over a ten-year period. Although critics of OSHA argue federal safety regulations are too costly, the study found federal inspections not only reduced workplace injury claims, but also failed to have a negative impact on profits or sales. In the four years following an OSHA inspection, workers’ compensation expenses at companies that were randomly inspected were an average of $355,000, or 26 percent, less than those at businesses that were not inspected.

Michael Toffel, co-author of the study and Harvard Business School Professor, stated it was ironic that the same companies who claim OSHA kills jobs are actually reaping a benefit in the form of reduced injuries and workers’ compensation costs from the inspections. He also said if OSHA inspections throughout the nation created a similar benefit, businesses in the U.S. are gaining about $6 billion in added value from the federal safety program. Toffel believes that number may actually be low as it does not take into account other savings from expenses such as loss of production costs following an accident.

According to Marc Freedman, Executive Director for the Labor Law Policy at the U.S. Chamber of Commerce, OSHA inspections are not problematic for most businesses. Instead, he stated the way in which inspections are conducted and the dynamic between a company owner and OSHA inspectors is the issue. Freedman believes inspections under the current administration are conducted in such a way as to increase penalties. Others disagree, stating OSHA inspections are conducted by law enforcement officials who are bound to note each and every workplace safety violation regardless of political pressure from the White House.

The maximum penalty OSHA may assess for each serious safety violation, when an employer knew or should have known a safety violation would likely result in a worker’s death or serious physical injury, is $7,000. In general, penalties are assessed at an average rate of $1,000 per serious violation. OSHA officials also reportedly take into consideration a company’s safety record and other factors when determining financial penalties. Based upon his research, Toffel believes safety tends to increase following random OSHA inspections because inspectors discuss the problems and potential solutions with companies. Instead of focusing on the violations, Toffel said managers become eager to create solutions that will increase worker safety.

The Occupational Safety and Health Act of 1970 created OSHA to decrease worker injuries and fatalities. Under the Act, employers must comply with certain safety-related requirements such as providing workers with training, information about safety hazards, and copies of safety test results. Employers must also provide a workplace that is reasonably free of safety hazards. When a serious workplace accident occurs, OSHA will normally investigate whether an employer complied with established safety standards at the work site.

Continue reading →

Texas Injury Lawyer Blog