Articles Posted in Pharmaceutical Drug Injury

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.

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.

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.

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.

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.

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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