Baseluos Law Firm is currently engaged in the representation of multiple women throughout the United States who have suffered from alopecia caused from cancer treatment. The primary defendant is Sanofi Aventis, who is suspected to have known for the last two (2) decades that its chemotherapy product taxotere caused permanent hair loss in breast cancer victims. In fact, a former employee of Sanofi Aventis filed a qui tam lawsuit against the company in 2015. A qui tam lawsuit is a type of civil suit in which company whistleblowers bring cases under the False Claims Act. The whistleblower in the Sanofi Aventis case assists the government in stopping fraud by Sanofi Aventis, by exposing the company’s illegal marketing tactics and illegal bribes to physicians to push taxotere.

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.

Baseluos Law Firm is currently assisting plaintiffs throughout the country to recover injuries sustained by women with breast cancer who underwent chemotherapy and suffered permanent alopecia (hair loss) from taxotere. Lawsuits are currently being filed against the makers of taxotere, Sanofi Aventis, in connection with the design, development, and marketing of this cancer prescription.  Taxotere, part of the drug family known as taxanes, is used in the chemotherapy treatment of various cancers, with a primary emphasis on breast cancer. The taxanes are part of a family of chemical components known as diterpenes produced naturally from plants.

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.

Xarelto uncontrolled bleeding continues to wreak havoc as more and more families are filing wrongful death actions in federal court. Michael Baseluos is a blood thinner lawyer who is well versed in xarelto bleeding problems. The pattern is all too familiar. Uncontrolled bleeding leads to death. The defendant manufacturers are alleged to have engaged in scheme to defraud the public by intentionally misleading the public and doctors about the inherent defects of xarelto, which include lack of an antidote to rivaroxaban, the technical name for xarelto. Xarelto hemorrhages are on the rise along with uncontrolled internal bleeding due to the lack of an antidote. The original FDA approved warnings did not contain any mention of the lack of an antidote.

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.

Although Guillain Barre Syndrome is thought to be the result of an infectious illness in the weeks prior to the onset of GBS (Over 60% of GBS cases are associated with prior acute infection by several bacterial species and viruses),  the Federal Court of Claims has come to accept that GBS can also be caused by vaccination, specifically the influenza / flu vaccination. The objective in filing a claim with the Vaccine Injury Compensation Program (VICP) is to demonstrate the substantially probability that the influenza vaccine activated the immune system against components of the nervous system similar to its activation by viral  or bacterial  infection in non-vaccinated  GBS cases.

The most commonly proposed mechanism for the development of autoimmune disease is molecular mimicry. This is a strong theory advocated by neurologist experts in arguing for the role of flu vaccination in the development of GBS. Molecular mimicry refers to a situation where the pathogen and host (ie. the human body) share nearly  identical antigens, which induces an antibody and T cell immune response that is cross reactive, meaning the antibody reacts with similar sites across a wide spectrum of proteins. There are multiple ways in which an immune response can become cross-reactive.   The strongest evidence for the molecular mimicry hypothesis has come from discoveries in research with jejuni strains, the most  common pathogen associated  with GBS.

A neurologist expert in a vaccine causation case will argue that it is substantially probable that the influenza vaccine triggered the immunological  reaction  that  causes GBS or variant Miller  Fisher Syndrome by  molecular mimicry or non specific activation of the immune system. The immune system could  recognize the vaccine and the victim may share nearly identical antigens, which induces an antibody  and T cell immune  response that  is cross reactive. Many Special Masters, who review and decide GBS flu cases filed in the Court of Federal Claims, are aware of molecular mimicry, and the theory is generally widely accepted as a basis for causation. Lately, the Department of Health and Human Services has accepted the link between flu vaccine and GBS provided there is no evidence of an alterative form of causation such as a gastrointestinal or upper respiratory illness. Consequently, GBS flu cases are proceeding much more quickly through the Vaccine Injury Compensation Program without the need for neurology experts. Baseluos Law Firm is well versed in the handling of GBS flu vaccine injury cases, and has obtained settlements of several hundred thousand dollars each for individual claimants.

GBS can be one of the most debilitating, difficult neurological reactions following vaccination. A client with GBS who comes to Baseluos Law Firm is often burdened by long rehabilitation stays, invasive surgery including lumbar puncture and Intravenous Immunoglobulin (IVIG), and new restrictions on their ability to produce income and lead a normal life. The Vaccine Injury Compensation Program will demand that a petitioner suffer residual symptoms of their injury for at least six months after their injury or major surgery. Often, GBS vaccine injury victims have no problem meeting the 6 month threshold as the various tingling, numbness, foot drop, temperature sensitivity, and general fatigue can linger for years after the first line of treatment. GBS vaccine injury victims often have strong claims for past and future suffering, past and future income loss, and past and future out of pocket medical costs.

In the course of recovery, the GBS victim will eventually walk without assistance. However, they may still continue to experience residual symptoms, including excessive fatigue, especially when exercising as well as fasciculations, which are brief, spontaneous contractions of the muscles. Michael Baseluos has witnessed GBS clients who even years after their initial vaccine injury, still experience  paresthesia in both hands and easily fluctuating blood pressure  and heart rate than prior to GBS.  Rippling of the muscles under the eyelids and over the  cheek along with intermittent diarrhea may also be present. White matter changes on the MRI is another tell tale sign of GBS sequelae, or long term consequences related to Guillain Barre.  These findings are suggestive of autonomic dysfunction.   There is no cure for the disorder, but several treatments can ease pain and reduce the duration of the illness. Most people recover completely from even the most severe cases of GBS. GBS survivors will return to some normalcy but these type of residual symptoms can still persist, forming a strong basis for compensation for future pain and suffering, income loss, and out of pocket medical costs.

In cases where the client was healthy before a flu shot, the government has a much more difficult time arguing that  influenza infection, upper respiratory or gastrointestinal infection are the culprits behind Guillain Barre Syndrome. About two thirds of GBS cases have an antecedent infection within six weeks prior to symptom onset, generally an upper respiratory tract infection or gastroenteritis.   Epstein-Barr  virus, Mycoplasma pneumoniae, Campylobacter jejuni and cytomegalovirus, are some of the non-vaccine infectious agents.

In this blog entry, we discuss serious injury and wrongful death from drunk drivers . Often, this driver carries no or minimal insurance. Baseluos Law Firm strives to maximize all sources of insurance coverage to compensate the seriously injured. To do this, Michael Baseluos and his investigators search for all factors behind the intoxicated driver including how the driver received his alcohol. Traditionally, it was not necessarily unlawful to sell or provide alcoholic beverages to adults. However, many states including Texas have passed laws called “dram shop acts” which assesses liability against establishments that supply alcohol to drivers who negligently injure others persons or property.

For a liquor provider, the basic Texas dram shop liability act investigates several factors including whether the provider broke the law in selling or giving the alcohol to the DWI driver; whether such alcohol was the proximate cause of his intoxication (oftentimes, the drunk driver has received alcohol from a number of providers prior to a major accident); whether the provider knew or should have known that the defendant DUI / DWI driver was below the legal age of 21 or heavily intoxicated at the time the alcohol was furnished; whether it was objectively obvious the person was intoxicated or was underage at the time; and finally, whether the intoxication level was the primary driving factor behind a DWI / DUI death or serious injury.

The seminal case that has driven the enactment of dram shop liability laws was a NJ case called Rappaport v. Nichols , which held that a bar could be held legally liable for furnishing alcohol to an underage or visibly intoxicated individual who thereafter commits a DWI / DUI offense that kills or seriously injures pedestrians or other drivers.

Xarelto case filings are skyrocketing as over 3300 cases have now been filed in Louisiana under Multi District Litgation No. 2592 headed by Judge Fallon  or the Philadelphia Court of Common Pleas, overseen by Judge New. Acute and deadly bleeding events have affected thousands of individuals and their families as new information reveals that the manufacturers engaged in deceptive marketing while concealing evidence of xarelto bleeding problems.

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. eye-1542065

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.”

One of the most vital aspects of the xarelto class action is the application of the “learned intermediary doctrine”. A common misperception by the public is that a pharmaceutical manufacturer like Bayer or Janssen Pharmaceuticals (the current defendants in the multidistrict litigations in Pennsylvania and Louisiana) has a duty to warn xarelto users regarding the risks hemorrhages, strokes, and bleedouts. This is a misconception.

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.

The number of cases of people injured by the prescription drug Xarelto is steadily increasing as the blood thinner has been linked to gastrointestinal bleeding and strokes. There is currently a multidistrict litigation (MDL) in the Philadelphia Court of Common Pleas, where Judge New has categorized the plaintiffs injured from xarelto into three major categories.

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.

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