San Antonio Injury Lawyer Blog

Every San Antonian and every Texan should be concerned about a case of huge importance currently being argued at the U.S. Supreme Court. Wyeth v. Levine ("Wyeth"), is a preemption case with major implications - not just for drug company's - but for every manufacturer of products that can seriously injure or kill our citizens.

In the Wyeth case a musician was given a shot of a Wyeth drug in her arm to treat symptoms associated with her migraine headaches. The shot caused her arm to turn gangrene and ultimately the arm was amputated. The musician alleged, among other things, that if Wyeth's label had warned of the risk of contracting gangrene she would not have taken the shot. Wyeth is arguing at the Supreme Court that the US Food and Drug Administration (FDA) had approved the label therefore they cannot be sued even if the label was deficient and did not contain the information.

In a startling revelation, documents recently released in a congressional investigation show that career officials at the FDA have argued against the issue of the FDA blocking consumer lawsuits against drug makers. These internal memos contradict the FDA’s position in the Wyeth case. In the Wyeth case the FDA has taken the position promoted by the Bush administration that the FDA label standards should trump state laws and prevent injury lawsuits. However some FDA officials have said that it’s wrong to assume that FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers.

This case is vitally important - if Wyeth wins this decision will be used by drug and medical device manufacturers to attempt to prevent Texas citizens from seeking compensation for losses and injuries when they are harmed by defective drugs or products that are regulated by the federal government. Hopefully, the revelation of the internal memos at the FDA will cause many people to question whether it is a sound policy to have federal government agencies giving immunity to drug and product manufacturers that cause grave injury just because they have been given a stamp of approval by an overworked and understaffed federal bureaucracy.

If the decision favors Wyeth, perhaps the US Congress will consider reversing the preemption doctrine pursued by the Bush Administration.

The Wall Street Journal reported these developments and much of this content was obtained from their article.

According to a recent study by the National Highway Traffic Safety Administration ("NHSTA") Seatbelt use in the United States stood at 83% in 2008. This is an increase of 1% over 2007. Seat belt use rose steadily throughout the 1980's and 1990's; however, in the last 5 years it has remained fairly constant at slightly over 80%.

Seatbelt use in Texas should be slightly higher because Texas is one of 27 States that allow the police to stop drivers for not wearing their seatbelts. However, occupants in pick-up trucks are the least likely to use seatbelts which, because of the large number of pick-up trucks in Texas, may negate the positive effect of the seatbelt law.

The study also explained that lap/shoulder belts reduce the risk of death of front seat occupants in an auto accident by 45% and the risk of moderate to critical injury by 50%. In 2006 it was estimated that seatbelts saved over 15,000 lives.

That "money-saving, high fuel economy" car you just purchased may come with hidden costs. Many Texas drivers, like automobile owners all over the country, are buying smaller, more fuel-efficient vehicles for their transportation needs.
However, one cannot look to fuel-efficiency alone when examining cost savings - what you save in fuel costs, you may pay for in additional insurance rates.

A study by Insure.com, an online insurance brokerage company, was recently reported in the Wall Street Journal (WSJ) and the study found that a 40-year old male driver buying a Mini Cooper (which reportedly gets 37 mpg) would pay over $400 per year more for insurance than if that same driver purchased a Toyota Sienna minivan (which reportedly gets 23 mpg). There are many more examples (Honda Civic vs. Honda CR-V; the Civic gets approximately 10 mpg more, but costs over $400 more per year to insure).

Small vehicles present greater opportunity for injuries when involved in wrecks.
Small vehicles are also more prone to being stolen, according to crime reports gathered by the National Insurance Crime Bureau (NICB). In addition to the traditional methods of rating insurance policies - such as the location of the vehicle, driving history, credit ratings, etc. - many insurance carriers are now bulking rates by make and model. Hybrid vehicles can be even more costly to insure. Many new hybrid models cannot use traditional "after-market" parts, and are therefore much more costly to repair if damages in an automobile accident.

All in all, looking solely at fuel savings is not the answer. Your safety should be the most important consideration; however, fuel savings (and therefore environmental savings) is also an important consideration but it must be balanced against the cost to insure the vehicle.

In a 2008 Texas Supreme Court Opinion the Court ruled that property damage or personal injury caused by large parts detached or separated from a motor vehicle are no longer covered by a persons uninsured motorist coverage. The style of the case is Nationwide Insurance Company vs. Elchehimi ("Nationwide Insurance Case").

In the Nationwide Insurance Case a station wagon collided with a drive axle and attached tandem wheels that had separated from an eighteen-wheel semi-trailer truck. The unidentified truck, which was being driven in the opposite direction across the divided highway, did not stop. Momentum carried the axle-wheel assembly across the dividing median where it struck the station wagon, injuring the occupants and damaging the car. Ordinarily, your uninsured motorist coverage protects you when a "hit and run" driver damages your vehicle and/or injures you or your occupants. Essentially, the person driving the other vehicle didn't stop, and therefore the other driver is considered uninsured since you have no way of identifying them or their insurance company.

Nonetheless, the Texas Supreme Court ruled that the Nationwide Insurance Company did not have to pay an uninsured motorist claim because the axle-wheel assembly which separated from an unidentified semi-trailer does not constitute a "motor vehicle," and therefore, does not fall within the terms of the policy and the Texas Insurance Code. The Court explained that: (1) motor vehicles are self-propelled (2) the collision was not a legally recognized substitute for the statute's actual physical contact requirement (3) adopting an integral part test (in other words, if an integral part of the vehicle separates and hits someone) would be unmanageable.

As a result of the courts opinion an injured party will not be compensated even though they were prudent and had purchased full coverage when they are injured by a detached vehicle part. This will allow insurance companies to avoid paying claims even though their insured was injured on the highway and had purchased full coverage. To expand on the Court's ruling consider the following: a vehicle owner knows that their rear bumper is about to fall off their car and they take that vehicle out on the highway anyway. They drive erratically, and the bumper flies off and into the windshield of the car behind them. Afraid to stop and face their responsibility, the wrongdoer speeds off before they can be identified. The injured person in the vehicle that was hit by the first car's bumper has available claim on their own insurance policy - even though they wanted and paid for extra protection for situations when an uninsured, negligent person causes them harm and then runs away from the scene.

The dissent in arguing that the injured party should be covered when a part flies off of another vehicle stated "We have repeatedly and consistently held that because the UM [uninsured/underinsured] statute is remedial, it should be construed liberally to give full effect to the Legislature's purpose in enacting it - to provide coverage to insured motorists."

It was recently reported in the Wall Street Journal (WSJ) that President Bush is attempting to use his last months in office to enact rules that will prevent consumers injured by dangerous products from seeking compensation. Issuing rules, rather than having Congress review and pass laws, the administration is attempting to protect corporations and is using federal agencies to affect these changes. The Food and Drug Administration (FDA), along with the Department of Transportation (DOT) and the Office of Management and Budget (OMB) among others, have sought to add rules that will preempt consumers from seeking compensation if a corporation follows federal guidelines when developing and marketing a product. While this sounds all well and good - the idea of having federal guidelines in place that must be followed and the prevention of requiring a company to try and follow up to 50 different states laws and regulations - the reality is quite different.

Federal agencies such as the FDA are under funded and understaffed. These agencies do not have the ability to evaluate the pitfalls and dangers in every product put before them, or every product placed in the market place. The result is that products that have not been properly tested, or that are inherently dangerous, can end up on store shelves. Each state has laws in place to protect it citizens and consumers. Supporters claim that preemption protects corporations from having to follow 50 different guidelines. However, the majority of states have similar laws that simply require a product manufacturer to exercise reasonable care in their efforts and these laws protect consumers when a company places a product that is inherently dangerous in the stream of commerce. Similarly, most states have laws that require a company to market, or advertise its products by providing reasonable warnings that need to be followed to use a product safely.

By utilizing rule making authority, the administration and the federal agencies are avoiding the oversight and review of congress, and further, are implementing rules that cannot be simply undone. Although avoiding the review process to enact these rules, a lengthy federal review is necessary to retract these rules, making the process seem backward. Some examples of recent rules that have been enacted include: October 8, a Department of Transportation issued rule that limits the number of seatbelts auto manufacturers can be required to install in vehicles
AND then prohibits suits for injuries and losses suffered if a passenger is hurt as a result of not having an available seatbelt; currently, the Office of Management and Budget, together with the Federal Railroad Administration is seeking to add federal preemption into a tank car rule; and the Food and Drug Administration has extensively tried to enact rules that would prevent patients and consumers from bringing claims when harmed by drugs that have been "approved" by the FDA. A rule was entered that requires manufacturers to make mattresses that burn more slowly, but also prohibits a person injured in a mattress fire from bringing a claim against the manufacturer. Similarly, rules require railroad car manufacturers to use stronger materials and construction efforts, but prevent a suit if a railcar catches fire.

All in all, consumers are being told, essentially, "trust the government, we will keep a watchful eye on the corporations that manufacture the products you buy." Unfortunately, time and time again, it has been proven that the federal bureaucracy is not capable (due to lack of funds and lack of personnel, if not due to allegiance to the corporations that fund political campaigns) of adequately protecting all consumers; however, if you are injured the federal agencies have decided that you are not entitled to investigate or seek a review of the manufacturing process that may well have caused your injury.

Source: Mundy, A., "Bush Rule Changes Could Block Product-Safety Suits" Wall Street Journal, October 15, 2008

O.J. Simpson’s recent conviction brings to mind the paradox that occurred when he was found not guilty of murdering his ex-wife but was found responsible for the murder in a civil suit and was ordered to pay millions in damages.

This occurs because in a criminal trial the prosecution must prove their case beyond a reasonable doubt while in a civil suit the plaintiff only has to prove the case by a preponderance of the evidence. This allows a defendant to be found not guilty in a criminal trial but also have a different jury hear the facts in a civil trial and award damages. Most cases that involve both criminal and civil allegations are not nearly as sensational as the O.J. Simpson trial but many involve criminal conduct such as drunk driving.

An example would be when a defendant is in an accident and is also charged with Driving While Intoxicated. If the Defendant is ultimately found not guilty of the DWI or has the case dismissed it is still possible for the plaintiff in a civil suit to prove that the defendant was driving while intoxicated. Bringing forth evidence of the DWI in the civil case is done to clearly establish liability (fault on the drunk driver) and to enhance and highlight the conduct complained of, to seek full redress and compensation in the civil personal injury case.

It is important that your civil lawyer understands the science and statutes regarding DWI. Only with a thorough knowledge of these issues can they be effectively brought before a judge or jury in a civil lawsuit. Likewise, if the drunk driver became intoxicated or impaired at a bar or nightclub, that establishment may have responsibility towards the innocent victim. This is known as Dram Shop Liability. It takes experience and resources to understand the science behind blood-alcohol content, the consumption rate and the rate at which alcohol leaves the blood stream, and the likelihood that a bar tender or other club employee knew or should have known by the actors conduct that they were already intoxicated but were nonetheless served more alcohol.

Federal regulatory agencies have become increasingly lax in their enforcement of rules and regulation that have been enacted to protect consumers. Many agencies have relied upon self regulation and enforcement which is essentially no regulation. The recent meltdown in the United States financial sector is some evidence that companies and individuals cannot be left to self-regulate.

It's a sad fact that federal regulatory agencies have become to closely aligned to the industries they are supposed to regulate for the public's well-being.

One of the most important regulatory agencies, the U.S. Food and Drug Administration (FDA), has become particularly lax in ensuring the health and safety of those who take medication and rely on properly functioning medical devices.

In an attempt to provide additional oversight in this critical area a small group of Senators introduced the Medical Device Safety Act of 2008.

The proposed legislation would allow victims of faulty medical devices to sue for injuries in state courts even if the medical device had been approved for use by the FDA. Such legislation, would not be needed if the FDA would perform its traditional regulatory role.

The United States Supreme Court recently ruled 8-1 that a federal law, the Medical Device Amendments of 1976, preempts state laws that provide for stricter standards for medical devices than does the federal statute. The Supreme Court Opinion stated that tort laws disrupted the "federal scheme" and that the FDA is the sole determining body to approve medical devices. This essentially makes it impossible to sue the company that manufactured the defective product.

The Courts Ruling subjects patients to possible death or debilitating conditions resulting from faulty medical devices approved by the FDA, while denying them the recourse of seeking compensation for damages in state courts. The Courts use of the word "scheme" correctly describes how the system works in the real world. In the current system a drug or medical device manufacturer develops a drug or device that if approved by the FDA may make the company billions of dollars and the executives millions of dollars in bonuses. The company seeking approval submits its studies for the drug or device to the FDA and the FDA reviews the material. Obviously, the drug or device company's desire is to get an approval with as little research and restriction as possible. Upon approval by the FDA the drug or device company is essentially shielded from any harm caused by its product. As we have previously noted in other articles the FDA is understaffed and under funded. This results in the FDA having to rely upon the information given to them by the parties seeking approval.

The medicine/device industry vigorously opposes the legislation precisely because it has been able to duck behind the FDA shield to deflect claims by patients harmed by medical devices that didn't live up to the government's seal of approval.

Public advocacy groups have chronicled an increasing list of patients seriously injured by faulty medical devices over the last decade. Among the devices: Trident prosthetic hips, Prodisc spinal implants, Medtronic and Guidant defibrillators, St. Jude's Silzone-coated heart valves and Sulzer's hip and knee implants.

We believe the bill would ensure safer products by allowing personal injury lawyers to file lawsuits against manufacturers at the state level. Even officials at the FDA have questioned the agency's ability to monitor and ensure the safety of medical devices.

Enactment of the Medical Device Safety Act of 2008 would be a good first step toward correcting the lax enforcement that leads to serious injuries and deaths for patients who put their trust in the miracles of modern medicine. Obviously, you cannot protect the public when you do not have the funding or the staff to regulate and at the same time you remove the threat of being held accountable in Court.

San Antonio has always suffered from a large number of train accidents. Recent accidents in San Antonio have resulted in death and injury as well as the evacuation of large areas because of the hazardous cargo.
A recent train crash in California highlights how dangerous trains can be if not operated correctly. The investigation in the deadly train collision that killed 25 people in California and injured many more continues to get more complicated, with new facts coming to contradict findings by the National Transportation Safety Board (NTSB).

In the California train accident, it’s hard to establish who was responsible for the accident or what can be done to prevent future train accidents. Some contend it was a human error, others believe the lack of an adequate technology to stop human errors from causing such accidents is to blame and some even point to the long hours in isolation suffered by the engineers.

The technology, which could stop trains from missing a red light, is relatively expensive, and railroad companies have not wanted to adopt its use. Safety regulators have also temporarily banned the use of cell phones by train operators during shift hours. And some train operators require two engineers.

Three witnesses said they saw the commuter train had a green light just before the collision with the freight train. This contradicts what the National Transportation Safety Board concluded, whose investigation revealed that the commuter train missed a red light.

The investigation by the National Transportation Board initially revealed that the commuter train engineer was sending text messages from his cell phone immediately before the impact. According to investigators, he exchanged text messages with teenage railroad enthusiasts; this is believed to have distracted the engineer.

Investigators in the train accident believe the accident was preventable, and all the drastic measures being taken now are just another sign that it takes a tragedy for the necessary safety measures to be taken.

The Food and Drug Administration (FDA) has recently classified a “warning” sent out by Medtronic, Inc. to health professionals as a Class 1 recall. A Class 1 recall is the most serious type of recall order issued and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death. The device being recalled is an implantable pump that delivers drugs into the body. The product technical name is: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit. This is an illustration of a typical intrathecal medicine delivery system.

Patients receive infused drugs (typically for pain management) through the pump, and it was recently reported in the Minneapolis Star-Tribune that 83 patients have been identified as having pumps with improper connections, and one patient has died.

Patients are urged to immediately contact their physicians regarding these devices. The connections, if improper, can cause leaking of pain medication into the body, with the potential for fatal overdose.

Earlier this year, Medtronic the FDA considered a warning issued by Medtronic regarding another of its infusion devices, and also determined that the issue warranted a Class 1 recall. The Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps were recalled after a letter was sent reporting inflammatory masses at the site of these pumps – also used for pain management, as well as cancer treatment infusion.

If you have any questions or concerns regarding medical devices and cannot find answers through the FDA website, contact an experienced attorney and seek advice.