Specifically, beginning in 1996, Sanofi and its affiliated companies / subsidiaries promoted a marketing scheme designed to push off-label uses for taxotere that were never formally approved by the FDA. An off label use refers to medication that is being utilized outside the approved uses on the FDA approved label. Specifically, Sanofi is alleged to have instructed their employees to lie about the safety and efficacy of Taxotere, so that the market for taxotere would expand into the off label market. Secondly, Sanofi is alleged to have engaged in a kickback scheme with doctors such that physicians would be encouraged to prescribe taxotere. The qui tam lawsuit has highlighted a very sophisticated scheme of bribery to push sales of taxotere to almost $1.5 billion dollars in 2004 alone. As a result of their sophisticated marketing and bribery tactics, thousands of women have become victims of toxic chemotherapy with taxotere. The most prominent and debilitating side effect from such toxic chemotherapy was alopecia caused from cancer treatment.

While temporary hair loss is expected to be a side effect of chemotherapy, permanent hair loss is most certainly an unacceptable side effect. Using false marketing materials and incomplete studies, Sanofi Aventis is alleged to have duped the public into believe taxotere was safer and more effective than its rival taxol and the defendants conveniently omitted warnings of permanent hair loss. Thousands of women mistakenly believed their hair would grow back only to learn the agonizing news of taxotere permanent hair loss. Sanofi Aventis is alleged to have been extremely aware that the rate of permanent hair loss associated with taxotere greatly exceeded any permanent hair loss associated with taxol.

To experience permanent baldness is an extremely agonizing experience, adding injury to insult for women undergoing breast cancer therapy. There are not only mental and emotional damages associated with permanent alopecia from taxotere, but economic loss as well in the form of inability to return to work as a result of suffering severe psychological trauma. Taxol, which did not cause permanent hair loss, was always available as an alternative chemotherapy drug for breast cancer. Yet women were simply not given that choice, because the warnings on debilitating taxotere side effects were effectively masked by a greedy pharmaceutical manufacturer. No woman given the information regarding taxotere and the equally effective taxol alternative, would have chosen taxotere over taxol, and risked permanent hair loss. Sanofi is alleged to have deceived women with sophisticated kickbacks to physicians that resulted in women believing taxotere was more effective at treating their breast cancer than taxol. The breast cancer chemotherapy market contained multiple drugs that were not only more effective than taxotere but also did not carry the massive risks of permanent hair loss. Please contact Baseluos Law firm to discuss your options regarding a chemotherapy drug lawsuit.

Bristol Myer Squibbs manufactures paclitaxel (taxol) , the major competitor to taxotere. However, Sanofi designed taxotere as a highly potent taxane alternative to its rival taxol. Since 1989, Sanofi through its subsidiary Aventis controlled and developed all patents related to taxotere. Sanofi enrolled patients in clinical testing trials beginning in 1990. This fact is critical because Sanofi is alleged to have withheld information and data from those tests from doctors (especially oncologists), patients, and the FDA. It should be noted that in 1994, the FDA’s Oncologic Drugs Advisory Committee panel unanimously recommended the rejection of taxotere, because the drug was deemed to be much more toxic than Bristol’s taxol, which had previously received FDA approval. The FDA recommended more testing on the side effects of docetaxel , the chemical name for taxotere. In May 1996, FDA finally approved taxotere, limiting use of taxotere to treat advanced or metastatic breast cancer after failure of prior chemotherapy.

After the initial FDA approval, Sanofi sought approval for expanded applications of taxotere. Specifically, Sanofi and its subsidiaries now claimed their drug was a more effective chemotherapy drug against breast cancer. Specifically, they now claimed taxotere was more effective than its rival taxol, and they reiterated such misleading comparisons in their marketing. Today, post market surveillance has shown Sanofi’s claims of superior efficacy to be fraudulent. A 2008 study in the New England Journal of Medicine measured the efficacy of taxol and taxotere and concluded that taxol was a more effective chemotherapy drug than taxotere. Despite overwhelming statements in a reputable medical journal, Sanofi continued to proclaim taxotere’s superiority. Their actions led to a stern warning letter from the FDA in 2009 in which the FDA cited Sanofi’s unsubstantiated superiority claims and overstatement of the efficacy of Taxotere. The FDA found Sanofi Aventis in violation of the Federal Food, Drug, and Cosmetic Act.

Today, Michael Baseluos is a taxotere lawyer actively pursuing cases for taxotere victims who have suffered permanent and disfiguring hair loss in women. Breast cancer patients with alopecia after undergoing chemotherapy with taxotere are eligible for compensation. Sanofi Aventis failed to issue previously undisclosed warnings until December 2015. The original taxotere warning labels misled breast cancer survivors into believing they would recover their hair loss, when in fact there is permanent alopecia from taxotere. The FDA forced Sanofi to update their label to reflect the side effect of permanent alopecia after chemotherapy treatment. Since its first clinical trials, there is deep suspicion that Sanofi has know for almost two (2) decades about taxotere causing permanent hair loss. A little known fact is that Sanofi updated its warning labels of cancer treatment hair loss in Europe in 2005 and in Canada in 2012. Those same warnings were not revealed to US customers until December 2015. Taxotere Permanent Hair Loss (Alopecia) cases are now part of Multi District Litigation (MDL) in the US District Court, Eastern District of Louisiana assigned to Judge Englehardt, Chief Judge of the Eastern District of Lousiana.

Rather than being upfront about the lack of an ability to reverse a xarelto bleedout, defendants such as Jannsen Pharmaceuticals, Bayer, and Johnson & Johnson chose instead to hide this very important fact in the overdose section of the label. The unsuspecting Xarelto user is then subject to the blood thinner side effects that lead to life-threatening complications which lead to death.

The defendants, who are currently facing lawsuits in the Eastern District of Louisiana and Philadelphia Court of Common Pleas, are also alleged to have duped medical personnel including ER doctors and surgeons, as well as hematology and cardiac specialists. There are over fourteen thousand (14,000) lawsuits in the federal courts alone, and over one thousand (1,000) cases in the Philadelphia Court alone. One of the key differences between whether to file in the federal courts in Louisiana versus the Philadelphia Court of Common Please is the issue of ischemic strokes. This is a new condition in addition to the uncontrolled bleeding found in those injured from xarelto. An ischemic stroke is the result of a blood clot that clogs an artery leading to the brain. Such blood clots are often associated with the buildup of plaque in the arteries, a condition we often refer to as atherosclerosis. Ischemic strokes can be caused by clots in the neck (carotid artery) and other major arteries. While the Eastern District of Louisanca is not accepting xarelto stroke lawsuits, the Philadelphia Court of Common Pleas is accepting claims of stroke caused by rivaroxaban.

Another key difference is that the Philadelphia court is allowing efficacy claims on blood clot injuries that xarelto should have prevented. The argument is that due to xarelto’s one time per day dosing, the patient does not have the anticoagulant protection needed to get them through to the next dose, leaving them extremely vulnerable to xarelto bleedouts. The 1x per day design was simply a marketing ploy designed to help Jannsen, Bayer, and Johnson & Johnson get an advantage over the makers of Paradaxa and Eliquis, which need to be taken multiple times on a daily basis.

If you have a family member killed by xarelto, Michael Baseluos can help. A xarelto lawsuit can help get you or a family member injured by xarelto the compensation you deserve. To date, there have been over one hundred fifty (150) deaths from xarelto. With over $1 Billion in sales and well over a million prescriptions, Xarelto is a ticking time bomb for many patients who receive the drug to treat complications that might arise from atrial fibrillation. The FDA has received well over 2,000 complaints concerning side effects of taking xarelto, reflecting uncontrolled bleeding, hemorrhaging and death. Other side effects include gastrointestinal bleeding, intracranial hemorrhage, stroke, and death. Baseluos Law Firm (BLF) is assisting citizens nationwide in obtaining sizeable xarelto lawsuit settlement amounts.

Recently Drs. Hwang and Hun concluded studies of senior citizens who switched from traditional warfarin to the blood thinner rivaroxaban (pharmaceutical name for Xarelto). The researchers discovered the patients were at increased risk of vitreous hemorrhage or eye bleeds. In June 2015, a leading medical journal, JAMA Ophthalmology published their research detailing xarelto side effects of eye bleed injuries shortly after transitioning from Warfarin to Xarelto.

Scientists and professors from John Hopkins published a study in the April 2015 issue of BMJ (originally known as the British Medical Journal) in which they investigated the risk of gastrointestinal bleeding associated with anticoagulants. The researchers concluded that there could be a “more than twofold higher risk of bleeding with rivaroxaban compared with warfarin.”

Bayer AG and Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) marketed Xarelto as a one time daily (1x per day) medication. The idea of a once daily dosage was done to appeal to consumers and lure them away from the competitor manufacturers of Pradaxa and Eliquis. Yet studies have confirmed that the intensity of Xarelto’s anticoagulant properties largely decreases over the course of the day, leaving Xarelto users in serious danger of internal bleeding , uncontrolled bleeding , and hemorrhages . The defendant manufacturers absolutely never warned the prescribing doctors over the drop in blood thinner effectiveness, forming a large basis of “efficacy claims” in the federal courts.

Another largely unsound and deceptive business practice of the manufacturer defendants was to market Xarelto as being better than Warfarin due to their claims that a routine blood test was unnecessary for Xarelto users as compared to warfarin users. These claims have now undergone major scrutiny as it has been demonstrated that xarelto bleedout incidents would have been seriously diminished had blood monitoring taken place. In fact, Xarelto manufacturers had actually developed a blood testing device to use in conjunction with Xarelto but chose not to actively push that device for fear it would discredit their prior claims of no blood monitoring and diminish profits. Downplaying or out rightly rejecting the need for blood monitoring is a major part of the case against the manufacturers for failure to warn which has led to xarelto fatalities and serious side effects .

In our prior blog entry on the learned intermediary doctrine , we discussed the key element of whether the prescribing information given to the doctor adequately allowed medical providers to weigh the risks and benefits of prescribing Xarelto. A strong argument can be made that in fact prescribers were seriously misinformed about the effectiveness of rivaroxaban and xarelto side effects.

Baseluos Law Firm is offering free consultations for anyone in the United States who has suffered a severe bleeding event, gastrointestinal bleeding, cerebral hemorrhaging, or even death from Xarelto.

In reality, if pharmaceutical manufacturers can show that they adequately informed the doctor of the risks of their drugs, then the manufacturers can shield themselves from product liability suits, even if ultimately patients do not receive any warnings. In reviewing manufacturer warnings, it is tempting to analyze the FDA Black Box Warnings and the Medication guide, both of which the FDA approves. A Black box warning appears on a prescription drug label and highlights life threatening or serious adverse effects for the consumer. Medication Guides are paper copies that accompany prescription medicines which deal with both general and specific information on harmful or threatening drug effects. However, a Xarelto lawsuit lawyer is more interested in the FDA approved prescribing information ie. Determining what manufacturers provided to the prescribing doctors.

Xarelto / Rivaroxaban belongs to a class of drugs known as NOACs – Non Vitamin K Dependent Anticoagulants. Other drugs in this class include Pradaxa and Eliquis. These specific NOACs were all evaluated against warfarin, a traditional anticoagulant, and underwent clinical trials and obtained FDA approval. Moreover, Xarelto defendants like Bayer AG and Janssen Pharmaceuticals touted NOACs and being more effective and safer than Warfarin, employing direct to consumer advertising (DTC). Interestingly, only the USA and New Zealand permit DTC advertising of prescription drugs.

To successfully succeed on a pharmaceutical liability suit, it is critical that a xarelto attorney prove the prescribing physician did not have enough information as to the risks and benefits of xarelto upon drafting the prescription. As Xarelto litigation develops, the key component for a xarelto law firm is to prove the doctor would never have prescribed rivaroxaban (the official medical term for xarelto) had they had a complete picture of the risks of xarelto bleeding problems. A xarelto lawsuit based on inadequate or misinformation communicated to physicians focuses on three (3) major areas. The first area is whether the manufacturer sufficient communicated risks of xarelto as a blood thinner or whether doctors commonly knew the risks of rivararoxaban. The second area is whether rivaroxaban manufacturers accurately communicated the benefits of the blood thinner without exaggeration. The final area is whether the manufacturer in any way misled the prescribing doctor about the risks or benefits of xarelto.

Xarelto in particular was tested against Warfarin to obtain FDA approval, and marketed as being more effective and safer than Warfarin. Despite no antidote for uncontrolled bleeding caused by Xarelto (as opposed to warfarin which uncontrolled bleeding could be controlled by Vitamin K), Janssen and Bayer heavily marketed Xarelto. It should be noted that the pharmaceutical manufacturers did include a warning in the FDA approved prescribing information that a specific antidote for rivaroxaban was not available. An argument can be made that such warnings were inadequate.

However, the most damning aspects of the prescribing information were inadequate representations of the benefits and safety of Xarelto over warfarin. Specifically, scientific research now reflects xarelto is not as effective as warfarin. The manufacturers exaggerated the benefits to push greater prescriptions. Nor is xarelto safer than warfarin given the major risk of unsafe bleeding events. It should also be noted that the xarelto dosage of 1x per day leaves Xarelto users with diminished protection against coagulant protection for extended periods of time. If you are considering a lawsuit from xarelto side effects, please contact Baseluos Law Firm immediately.

The first category consists of plaintiffs who suffered a gastrointestinal or rectal bleed after taking the drug known as rivaroxaban (Xarelto) to reduce the risk of stroke or embolism (an obstruction in a blood vessel due to a clot or foreign matter that becomes stuck in the blood stream).

The second category of plaintiffs are those individuals who took the blood thinner to treat deep vein thrombosis (DVT), a blood clot formed in a vein. If the clot travels through the bloodstream, it can eventually block an artery in the lungs, leading to pulmonary embolism (PE). The most common scenario for this category are plaintiffs who underwent hip or knee replacement surgery. Those plaintiffs using xarelto to treat DVT or PE and who thereafter suffer uncontrolled bleeding from gastrointestinal or rectal internal bleeding are part of this second category.

The third category of plaintiffs involve individuals who suffered atrial fibrillation and took xarelto to minimize the risk of stroke and thereafter suffered a hemorrhage and / or brain bleeds. Atrial fibrillation is a type of arrhythmia that affects the rhythm of the heart.

The recent order signed by Judge New, Case Management Order No. 11, can be reviewed here .

Judge New has scheduled ten (10) bellwether trials over the course of 2017. It is not cost effective to take thousands of cases to trial in pharmaceutical product liability suits. Bellwether trials are intended to be test cases to determine if the defendants are liable for xarelto fatalities and serious side effects. If the cases proceed well on behalf of the plaintiffs in these trials, then defendants are likely to agree to a mass settlement for the several thousand plaintiffs injured from xarelto.

The Philadelphia Court of Common Pleas is not the only jurisdiction hearing Xarelto injury cases. Currently, a federal multidistrict litigation (MDL) on Xarelto bleedouts is being held in the Eastern District of Louisiana in New Orleans before the Honorable US District Judge Fallon. A multidistrict litigation (MDL) is a unique federal legal procedure that accelerates the process of handling complex pharmaceutical drug liability cases. Attorneys on both sides can exchange key documents and questions regarding a manufacturer’s negligence and whether the drug injured plaintiffs can be resolved in an organized , efficient manner. Defendants in the federal MDL include Bayer Healthcare and Janssen Pharmaceuticals. In the federal MDL, Judge Fallon has also scheduled bellwether trials in the Eastern District in 2017.

Judge New in Philadelphia Court of Common Pleas is specifically allowing Xarelto Efficacy Claims, which represent blood clot injuries as a result of xarelto failing to prevent blood clots. The efficacy claims revolve around xarelto’s 1x per day dosing schedule. The argument is that the anticoagulant ability to prevent blood clots wore off before a patient could take the next dose of xarelto. The marketing ploy of a one dose per day is alleged to have been done by Bayer and Jannsen simply to gain an advantage over other rivals whose own blood thinners required multiple daily doses such as Eliquis and Pradaxa.

These types of efficacy claims are currently not being accepted by Judge Fallon in the federal MDL on Louisiana.

Michael Baseluos is a Xarelto attorney currently assisting those individuals who have been injured from xarelto.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.