You Are Not Alone In Your Fight For Justice
June 25, 2010

Gardasil HPV Vaccine and Guillain Barre Syndrome (GBS)

As vaccines become more and more prevalent as a means of preventing illness and disease, we need to take a strong look at potentially devastating side effects from such vaccines.

Take for example the wonder drug known as Gardasil. Pharmaceutical juggernaut Merck has touted Gardasil as a significant step forward in the prevention of cancers, specifically cervical cancer. The majority of cervical cancers are believed to be linked to the Human Papillomavirus (HPV), in which HPV infections are suspected to be the major culprit behind cervical cancers and STDs such as genital warts.

The HPV vaccine is currently being given to girls and women between the ages of 9-26, and now Gardasil has recently become available to be used in boys and men between the ages of 9-26.

However, the data now seems to suggest that some girls who receive Gardasil to guard against cervical cancer may be at greater risk of contract Guillain-Barre Syndrome (GBS) , a rare neurological disorder that affects the peripheral nervous system. Individuals with GBS often experience paralysis that can start in the legs and slowly rise upwards to the upper body and face. In GBS, a person's immune system is essentially trying to destroy part of the person's nervous system.

A flu virus or illness can cause Guillain-Barre Syndrome (GBS) , but a vaccination or surgery can also create the conditions for GBS to occur.

In addition, there is research which now suggests that amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease may also be linked to Gardasil or the HPV vaccine. Lou Gehrig's disease is fatal and such a vaccine injury represents a wrongful death product liability suit . Researchers have determined that the timing of the ALS symptoms in conjunction with the receipt of the vaccine suggest a link between Gardasil and Lou Gehrig's disease.

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Merck has denied any link between Gardasil and GBS , but the data suggests otherwise. The Vaccine Adverse Event Reporting System , a joint effort between the Food and Drug Administration and Centers for Disease Control , indicated an incidence of over 50+ cases of GBS following HPV vaccination in the last 3 years. An overwhelming majority of the cases developed within 6 weeks after vaccination, with about 20 cases or so developing within the first 2 weeks of vaccination. The onset of symptoms within 2-6 weeks after vaccination is a classic timeline for GBS. Although the risk is low, the association between vaccines and GBS has been known to be an after effect since the mid-70s swine flu outbreak.

There are several law firms that are well positioned to handle Gardasil vaccine injury cases. You need attorneys who are specifically licensed in the Federal Court of Claims and handle cases due to vaccine injury. If you or a loved one have suffered a Gardasil vaccine injury and you need a Gardasil HPV Vaccine attorney , contact a law firm immediately.

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April 15, 2010

Texas Product Liability Lawsuits

A Texas product liability lawyer must be very mindful of House Bill (HB) 4, which has preempted the rights of personal injury victims. The purpose of this blog entry is to review some of the major changes associated with HB4 in Texas product liability law.

HB 4 had several major changes. First, it created a presumption of no liability in particular areas. It created a 15 year statute of repose. A statute of repose is similar to a statute of limitations, but usually the deadlines are enforced more strictly . For example, the statute of limitations would be tolled or delayed based on the discovery rule, which states that the clock on bringing a claim does not run until the injury could reasonably have been discovered, A statute of repose would not normally be tolled by the discovery rule. HB4 also created immunity for passive sellers.

The Texas Civil Practice and Remedies Code (CPRC) codifies these changes, including a presumption of no design or marketing defects in certain areas; a presumption of no marketing defects in specific Texas medical device / pharmaceutical drug injury cases; the creation of the 15 year statute of repose; and the establishment of passive seller immunity.

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CPRC 82.008 created a presumption of no liability for the formulation, labeling, or design of a product if the manufacturer or sellers follow mandatory federal regulations / safety standards. If the seller or manufacturer demonstrates that he complied with the mandatory standards or regulations, then the Texas product liability lawyer must overcome a presumption that the manufacturer / seller is not liable for any injury caused by some aspect of the formulation, labeling, or design of the product.

The seller /manufacturer must show that the presumption of no liability is applicable. Keep in mind that the presumption is limited to formulation, labeling, or design. If a Texas citizen claims serious personal injury based on a marketing defect other than the labeling, than the presumption of no liability is not applicable. In addition, the mandatory safety standard or regulation must have been in effect at the time of the manufacture and be applicable to the risk that created harm.

To illustrate, Federal Motor Vehicle Safety Standard 207 governs seat back strength. The purpose of this federal law was to protect a passenger from injuries from a seat back failure and certain Texas seat belt injury cases. However, the regulation is not applicable to protect passengers who sustained injuries from a front passenger seat back failure. It is absolutely essential for a Texas personal injury lawyer to engage in a careful analysis of the federal safety standards in order to combat any rebuttable presumptions that may be created by Texas product liability laws.

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March 19, 2010

Products Liability Cases in San Antonio and greater Texas

In 2009, there were several major San Antonio and greater Texas pharmaceutical drug injury cases.

In Houston, an injured woman brought suit against Wyeth Pharmaceuticals claiming several prescription drugs used for her hormone replacement therapy had caused her serious personal injury. Her causes of action included failure to warn and design defects in the drug. The Appellate Division indicated that federal laws did not preempt the failure to warn claim, even if the FDA had approved the label's warnings. However, the cause of action claim for a design defect was dismissed on account the plaintiff had not proven a safer alternative.

In a Texas personal injury auto accident case in Houston, the injured driver sued the manufacturer of a truck for negligence and product liability claims. In these types of cases, the burden is on the plaintiff to show evidence of a safer alternative design. It is also critical that the injured plaintiff's expert have the training, experience, and special knowledge to comment on design defect and the use of safer alternative designs.

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In another Houston Texas pharmaceutical drug injury case, a woman sued her doctor and Wyeth Laboratories for injuries from the dietary drugs Pondimin and Reduc. She alleged personal injuries including heart damage. However, the case was dismissed. San Antonio and greater Texas products liability cases must be brought within 2 years after the person suffers the injury.

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February 1, 2010

Proving malpractice in Texas pharmaceutical drug and malpractice injury cases

In proving malpractice, a San Antonio Texas personal injury lawyer must be extremely careful in choosing his expert witnesses. Many a Texas pharmaceutical injury case or malpractice case has been dismissed for inadequate expert witnesses.

One potential downfall is that a defendant physician must have his principles tested according to the basic teachings of the school to which he belongs. For example, an osteopathic surgeon is generally judged on principles from the osteopathic school of medicine. The rule is known as the Bowles Rule and it states that a Texas medical malpractice plaintiff must generally provide an expert against the defendant doctor from the same school of practice.

There are exceptions to the Bowles Rule. For example, in Porter, a plaintiff suffered a serious spinal injury in Texas after a doctor negligently administered a spinal anesthetic. The defendant physician was from the osteopathic school of medicine. The plaintiff's expert was from a medical, not osteopathic school. On appeal, the Texas Supreme Court cited exceptions to the Bowles rule where the particular field of medicine is equally developed in all fields of practice and where the use of particular medical devices are common in all fields of practice. In Porter, the Court concluded that both the medical and osteopathic practices utilized the same way of administering the anesthetic and medical experts could testify against osteopathic physicians.

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In Borders, the Court excluded the testimony of plaintiff’s emergency physician expert testimony on ER treatment of a head injury which led to respiratory arrest. In the Texas wrongful death suit, the Court indicated that the ER expert was not competent to offer opinions that would counter the neurosurgeon experts for the defense.

In another case, parents sued on behalf of their child who contracted AIDS from a tainted blood transfusion. The parents sued for failure to screen the blood. Although plaintiff's expert held a degree in various disciplines including public health, he was not a trained doctor and did not consider himself an expert in blood banking or hematology. The plaintiff's expert simply could not testify as to the standard of care in the blood bank industry.

A plaintiff's expert must have the knowledge, skill, experience, training, or education to give an expert opinion not only on the duty and standard of care, but also as to specific causation. Otherwise, many San Antonio and greater Texas personal injury cases run the risk of dismissal with prejudice.

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January 21, 2010

Reliable Expert Testimony in Texas Personal Injury Cases

In the late 1990s, the Texas Supreme Court indicated that the substance of an expert's testimony must be considered, specifically the data the expert relies on to form his/her opinion. If the foundational data upon which the expert bases his opinion is unreliable, then the expert's opinion will be considered unreliable.

Very often, in Texas pharmaceutical injuries or Texas wrongful death cases from exposures to lethal substances, the Court looks at epidemiological studies of the substance's effect on a population. The study must demonstrate that the risk of disease or injury for the population of people exposed to the substance is twice the risk of the population contracting the same disease who have not been exposed to the substance.

To illustrate, if a disease naturally occurs in 6 out of 1000 people when they are not exposed to a certain drug or substance, then a study would have to show that more than 12 out of 1000 exposed to the drug or substance would suffer the disease. Another option is that the epidemiological study must show significant results at a 95% confidence level.

The Supreme Court detailed additional criteria known as the Bradford-Hill criteria before the court can draw any conclusion about causation on the basis of studies. On top of that, the plaintiff must demonstrate he or she is similar to the study members, including proof of exposure to the same substance, a dose level similar to the persons injured in the study, that the exposure occurred before the injury onset, and that the timing of the onset of injury is similar to the study members. The classic example is epidemiological studies for Texas benzene exposure cases and leukemia onset, which can be as long as 30 years after the exposure. The type of injury suffered by the plaintiff must obviously be the same as the study that shows the statistically significant risk.

One classic recent case occurred with the San Antonio Vioxx injury lawsuit against Merck. Upon being given Vioxx, the plaintiff suffered and died from a heart attack. The plaintiffs filed a Texas product liability claim against Merck, claiming design defect and marketing defects in Vioxx which caused a wrongful death. Merck moved to dismiss, arguing that the plaintiffs failed to introduce into evidence at least 2 statistically significant studies showing that the risk of a heart attack was twice as great with a person taking Vioxx. The plaintiff's experts demonstrated that before Vioxx, the plaintiff had a stable cardiac status. After taking Vioxx, the plaintiff developed two fresh clots in 2 different arteries, a type of problem caused by Vioxx.

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The bottom line is that in San Antonio personal injury cases , it is critical the expert has the qualifications and credentials to give testimony to overcome a motion for dismissal. Moreover, the expert's knowledge, skill, experience, training, and education must be in line with the specific case and causation questions.

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January 1, 2010

Non-Economic Damages in Texas Wrongful Death and Serious Personal Injury Cases

There are certain non-economic damage elements that a San Antonio Texas personal injury lawyer can obtain for you in varied cases including wrongful death, medical malpractice, and Texas trucking accidents.

For seriously injured Texas citizens, they may be able to recover damages for pain and suffering in San Antonio Texas auto accident lawsuits . In a wrongful death action, the surviving spouse, children, and parents of the deceased can recover mental anguish damages. Mental anguish damages are those damages that include a mental feeling of pain, such as those that emanate from grief, disappointment, shame, despair, and public humiliation.

In order to recover for mental anguish, a San Antonio personal injury lawyer must demonstrate that the plaintiff suffered a high degree of mental pain and distress that goes above normal worry, anxiety or embarrassment. Texas personal injury law does not require a showing of physical injury to recover mental anguish damages. There is no way to objectively measure mental anguish damages, and the jury has a great deal of discretion in the process. The plaintiff needs to prove to the jury the nature of the mental anguish, its duration, and its severity. The plaintiff must demonstrate a significant disruption in his daily routine as a result.

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Future mental anguish damages may be recovered upon a showing that there is reasonable probability there will be future mental anguish. Those plaintiffs with pre-existing emotional conditions can still recover mental anguish damages, although the defendant may argue that the mental anguish suffered by the plaintiff is due to pre-existing conditions.

Whether your family has suffered a Texas wrongful death or serious personal injury, it is incumbent on you to reach out to a San Antonio and greater Texas personal injury attorney as soon as possible.

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December 25, 2009

How to Rebut Texas Product Liability Presumption of No Liability

Texas Civil Practice and Remedies Code (CPRC) 82.008 creates a rebuttable presumption of no liability in certain Texas product liability personal injury cases. However, section 82.008(d) makes exceptions for certain manufacturing flaws o defects from the rebuttable presumption.

If the seller has properly demonstrated the presumption, then it is up to the Texas personal injury lawyer to demonstrate that the standard / regulation was not strong enough to safeguard the public from unreasonable risk of injury or damage. The other option is to prove that the manufacturer, either before or after he commenced marketing the product, kept information or misrepresented information to the federal government. Such withholding or misrepresentation of information would have altered the federal government's creation of a proper safety standard.

In almost every Texas products liability case, the defense attorney premises his defense on his client's compliance with government standards. Counsel will claim that ultimately the government gave the seller a de facto seal of approval. In response, the Texas personal injury lawyer will counter that the federal government’s standard has always been a minimum floor and is often outdated and incapable of creating safety.

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Another tactic is to attack how the manufacturer communicated with the government about the adequacy of a safety regulation. Such a tactic will open up a tremendous amount of discovery about not only the product itself, but exactly what the manufacturer told the government about how to construct its standard. It is a somewhat confusing wording on the legislation, because it almost puts the manufacturer in a type of watchdog role on the government’s standards.

Under the bill, there is no exception to the presumption of no liability if the manufacturer misleads or omits key information about its products under the applicable regulations. This key provision allows plaintiff's counsel to obtain all communication between the manufacturer and government as to all information the manufacturer gave the government as well as any communication related to the government's regulation in general. You may recall that during the Vioxx litigation, there were allegations that Merck withheld key research data from the government that reflected an increased incident of serious cardiac injury.

CPRC 82.008(c) also creates a presumption of no liability if the formulation, labeling, and design of the products had to acquire a pre-market licensing or approval from the federal government. Provided the federal government gave pre-market licensing / approval of the product's design, risks, and benefits, then there would be a presumption of no liability.

A Texas serious personal injury attorney would attack this presumption by demonstrating that the standards of pre-market licensing could not have protected society from unreasonable risk of serious personal injury. Another option is to show the manufacturer withheld information from the government that was material to the product's performance and caused the plaintiff's injury. Withholding information must be relevant to the product's performance and causally related so that you may be successful in a Texas product liability lawsuit.

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December 17, 2009

Compliance with FDA Requirements in a Texas Medical Device Lawsuit

In a Texas pharmaceutical injury or medical device lawsuit, where the lawsuit centers on a failure to warn, TX Civil Practice and Remedies Code (CPRC) creates a presumption of no liability if the warnings associated with the product were not approved by the Food and Drug Administration (FDA) .

There are several ways a Texas medical device injury lawyer can overcome the presumption of no liability, First, he can show that the manufacturer deceived the FDA by omitting or distorting required information needed for pre-market government endorsement and licensing. Any deception in the withholding or distortion of information must be material to the Texas serious personal injury claim and the element of causation is present.

Another way to overcome the presumption of no liability is to demonstrate continued sale of the drug or medical device after the FDA mandated market removal or no longer endorsed the product.

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Another way to overcome the presumption of no liability is to demonstrate "off label" use. An off label use occurs when doctors and drug companies begin using a pharmaceutical to treat a problem for which it did not originally receive government approval. If in fact, there was off label use, the presumption of no liability disappears. There are elements of proof associated with off label use. The injured plaintiff must prove that the healthcare provider and / or drug company promoted, advertised, or prescribed the off label use; the injured party used the product as it had been recommended, promoted, advertised, or prescribed; and there was a causal connection between the injury and the recommendations, promotion, advertisement, or prescription of the product.

Another way to overcome the presumption of no liability given compliance with the FDA requirements is that the defendant, either before or after pre-market government approval / licensing, bribed a public official in violation of 18 U.S.C. Section 201 and such conduct precipitated FDA warnings of the product to be substandard.

There has been some controversy over whether a State District Court judge can determine if material information was withheld from the FDA so that plaintiffs can overcome the presumption of no liability. One district court judge granted summary judgment in a Texas Vioxx case on the basis that the FDA is the only entity that can make a determination about whether a manufacturer was deceptive in the warnings information it provided. There have been several follow up cases which have criticized the decision.

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November 14, 2009

Gardasil Vaccine Injury and GBS After Effects

A growing number of vaccinations including the influenza vaccine and now the newly minted Gardasil vaccine against the cervical cancer Human Papilloma Virus are increasingly suspected of causing the Guillain-Barre Syndrome (GBS).

GBS is a disorder of the neurological system characterized by uncontrollable muscle twitching, fatigue, and symptoms reminiscent of a recent stroke. Recovery does occur but in some case people may continue to have strong debilitating effects over a lifetime. Pulmonary complications and debilitating fatigue are the most common residual after effects.

Gardasil specifically is creating a special set of side effects that mirror the symptoms of GBS, including numbness and tingling, hair loss, extreme fatigue and weakness, and encephalopathy (seizures). Over 16 million does of Gardasil have been distributed to combat cervical cancer, but there continue to be questions about the side effects.

A vaccine injury lawyer can obtain a damage reward to cover important areas including medical expenses, income loss, long and short term care, permanent disability, and the loss of occupation. In addition, in the event of a loss of a loved one, vaccine product liability lawsuit and / or medical malpractice suits may be in order.

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One suggestion to develop a model of those individuals who are most likely to develop GBS following vaccination in order to take the necessary precautions against vaccinating such individuals and lower the incidence of vaccine injury. The fact that Gardasil has been expanded to cover males teens only underscores the need to practice better preventive medicine.

Because the Vaccine Adverse Event Reporting System (VAERS) is a voluntary system, there is a greater possibility that the incidence of GBS following vaccinations such as Gardasil is being grossly underreported and there may be a greater incidence of side effects and vaccine injury.

A Gardasil lawyer can work with you in filing a suit for vaccine compensation and if necessary a Gardasil lawsuit against the pharmaceutical companies such as Merck.

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February 21, 2009

Texas Personal Injury Experts : Building Your Case with Daubert-Proof Injury Experts

More often than not, a Texas personal injury attorney will need to employ an expert in a complex personal injury case, especially those involving complex auto accidents or product liability cases. The United States Supreme Court has decided several landmark decisions that define acceptable experts and their testimony. Those cases include Daubert v. Merrel Dow Pharmaceuticals and Kumho Tire Inc. v. Carmichael . However, the plaintiffs' bar is discovering that more experts are being disqualified at an alarming rate.

Many times, once the plaintiff's expert has been disqualified, the defendants will win on summary judgment, because the plaintiff can no longer prove causation. Texas has tightened standards in some cases. For example, some Texas courts have taken the position that a substance alleged to be cancerous, such as benzene, must have evidence indicating a 100% increase in the cancer rate over the general population. In other cases, judges have been known to exclude animal studies of product exposure as being unreliable despite the fact that animal studies are routinely used in Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) risk assessments.

In the past, courts often looked favorably on the local certified engineer or registered professor to testify on behalf of the injured plaintiff. That is no longer the case. These days, especially in the area of products liability and testimony regarding a defective product, the only acceptable expert will be one who was involved in the design of a similar product.

In addition, a test of basic scientific principles by a local expert may not be acceptable to the court on account that the test is not recognized by the scientific community and has not been deemed a reliable test in a peer reviewed journal.

As you can see, it is very likely that experts and their scientific evidence which the courts once accepted, could now be excluded. Once a court excludes an expert, then defense lawyers take the exclusion order to other courts where that expert will testify and try to use the order to disqualify the expert again.

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To properly navigate this growing system of expert exclusion, a San Antonio and Texas products liability attorney must have experts who were previously employed in a similar industry (for example, the pharmaceutical industry) and who were involved in the design of a similar product. Rigorous research is needed to make sure the peer publications are strong enough to back the expert opinion and that his method of research is accepted as a reliable. The more scientific evidence published by the expert in a journal of his / her peers, the more likely, the expert will be Daubert-proof.

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