GlaxoSmithKline Fraud In Connection With Zofran

In June 2012, GlaxoSmithKline (GSK)—maker of Zofran, also known as ondansedtron—plead guilty to federal criminal health care fraud. In a watershed claim, a whistleblower came forward claiming that GSK wrongfully promoted Zofran for off-label prescription to expectant mothers, while also paying kickbacks to the doctors who were prescribing it for such use. In what would was the single largest health care fraud recovery in U.S. history, GSK was levied $1 billion in criminal penalties $2 billion in civil penalties.

Zofran was originally approved by the FDA to help mitigate nausea and vomiting for patients being treated with cancer; but, GSK soon realized that Zofran could also potentially be used to mitigate morning sickness for expectant mothers in their first trimester. To that end, GSK instituted a scheme, where they promoted the drug not for its approved use, but also for this off-label use. Doctors who prescribed the drug were given kickbacks for doing so. Additionally, GSK was found to be suppressing clinical trial data that showed adverse effects of Zofran.

A Global Scheme
GSK did not just institute this scheme in the U.S.; they took it global. In China, GSK is still reeling from their fraudulent activities, where a Chinese court found GSK guilty of the same misconduct. The Chinese court also levied GSK a $490 million penalty.

Users of Zofran
Given the scope of GSK’s scheme, coupled with FDA approval of the drug in 1991, it is still unknown exactly when the scheme started. But, the reach of GSK’s scheme, and the number of patients affected is numerous.

Expectant mothers who were prescribed Zofran in their first trimester to treat morning sickness have an increased risk of a child being born with serious birth defects. Most recently in LeClair v. GlaxoSmithKline (February 2015), the plaintiff’s mother was a user of Zofran during her first trimester. Operating under the assumption that it was safe based upon the GSK’s failure to warn users of the risks, Ms. LeClair took Zofran which – must unfortunately – cause her child to be born with several congenital birth defects. Ms. LeClair seeks monetary and punitive damages for GSK’s failure to warn her of the adverse effects of Zofran.

A Drug Manufacturers Duty
Given the background unearthed during the FDA’s investigation of GSK, the investigation indicated that GSK knew in the early 1990s—soon after the drug was approved for its original use—that Zofran presented an unreasonable risk of causing birth defects. Nonetheless, GSK went forward with its marketing and sale of the Zofran, and is accused of having suppressed adverse clinical trial data. GSK is accused of breaching its obligations by failing to:

  • Ensure that Zofran was safe before offering it to the public
  • Warn the public of adverse side effects of Zofran
  • Be forthcoming to the FDA with information regarding adverse results from clinical studies of Zofran

Getting Help
Drug manufacturers are charged with providing drugs that are safe and effective for the prescribed treatment. When those obligations aren’t met—especially when the risks of the drug are not fully disclosed—the drug manufacturer may be found legally liable for injuries sustained by a patient using the drug. Pursuing damages related to your injury, you can potentially recover compensatory or punitive funds.

Contact our defective drug lawyers today, to schedule your free initial consultation to review your possible claim for damages. The law firms associated with Jacoby & Meyers are located across the United States, so that Jacoby & Meyers can assist you no matter where you are located, or where the injury occurred.

Jonathan Cianfaglione, student intern Jacoby & Meyers

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Federal Judge Presses Manufacturers of Yaz and Yasmin to Settle Lawsuits

Bayer, the manufacturer of the contraceptive drugs Yaz and Yasmin, have made little effort to the plaintiffs whose claims remain in lawsuits against it in federal court. However, in an attempt to move the process along, Federal Judge David Herndon issued a case management order in February.

First, a little background into Yaz and Yasmin. Both are birth control pills that contain drospirenone. which has been found to cause dangerous side effects in some women who use them. These side effects include excessive blood clotting, lung embolisms and death. A U.S. study of over 800,000 women who took Yasmin or Yaz found the risk of blood clots is three times higher than other contraceptive pills. There is also a large number of women who now have gall bladder disease as an undisclosed side effect of Yaz and Yasmin.

As a procedural move to thwart the prosecution of pending Yaz and Yasmin cases, Bayer has refused to waive venue requirements in order to prevent the trial court from beginning the bellwether process to select trials in the MDL. At this point, more than 12,000 MDL claims have been centralized in the Southern District of Illinois. Most of the cases involve arterial thrombotic event injuries or patent forman ovale injuries.

In order to break the logjam, Judge Herndon targeted 33 Yasmin and Yaz cases to be selected for early bellwether trials. These could begin as early as May of this year. As a result, the delays that have prevented resolution of these remaining Yaz and Yasmin cases may finally have ended. The litigation will finally be able to proceed.

If you or a loved one has been harmed by the use of Yasmin or Yaz – or any other pharmaceutical drug – please contact Jacoby & Meyers to schedule your free case evaluation. We have the attorneys experienced to handle pharmaceutical litigation.

Toni Zeller Kohlbeck, student intern Jacoby & Meyers

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FDA Keeps Suicide Warning and Add Alcohol and Seizure Warning on Chantix

Chantix, (varenicline), is a nicotine-free pill that is supposed to assist in smoking cessation. While Chantix users might reasonably expect some nausea and sleep problems, Chantrix is also believed to cause psychiatric problems that can lead to suicide.

By 2009, the FDA released a warning about the risk of serious mental health events linked to the use of Chantix. These mental health events include risk of depression, hostility, and suicidal thoughts. A study published in the Public Library of Science Journal (PLoS), suggested that Chantix was eight times more likely to be linked to suicidal behavior than other nicotine replacement products.

Between 2007 and 2013, the Institute for Safe Medication Practices indicated that Chantix was associated with at least 2,748 adverse event reports submitted to the FDA involving suicide, self-injury or homicidal ideation. The next closest medication, which was the asthma drug Singulair, accounted for 835 cases during that same period; less than one-third the number linked to Chantix.

With the mounting proof that Chantix has severe side effects that were not disclosed to the public, Chantix lawsuits have been filed based upon the failure of Pfizer (the manufacturer) failing to warn patients or the medical community of the side effects of Chantix – including those who have committed or attempted to commit suicide while on Chantix.

In the last few years, there have been some settlements of the over 3,000 claims that have been filed. These first grouping of settlements occurred in a federal Multi-District Litigation in the U.S. District Court for the Northern District of Alabama. As of April 2014, only about 250 lawsuits remain unresolved. Pfizer had allocated $273 million to resolve over 2,000 lawsuits, and $15 million to resolve the rest.

In addition to adverse mental health effects, the FDA recently released a safety announcement on March 9, 2015 that Chantix has been associated with seizures and that some patients who drink while taking the drug may become aggressive, black out, or suffer from amnesia.

With this recent additional warning, it is likely that more lawsuits are on the horizon against Pfizer for users who have experienced adverse health effects.

If you or someone you know have experienced adverse health effects from using Chantix or any other pharmaceutical drug, you should contact Jacoby & Meyers. The attorneys associated with Jacoby & Meyers are experienced in litigating pharmaceutical drug cases and can provide you with the type of representation you deserve for your case.

Alexandra Bhatti, student intern Jacoby & Meyers

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Johnson & Johnson’s Failure to Warn Prompts Backlash from the Government, Insurance Companies and Consumers

Power morcellator lawsuits are progressing against manufacturer Johnson & Johnson. As early as 2006, manufacturer Johnson & Johnson noticed that there was an increased chance of the development of leiomyosarcoma (LMS) after hysterectomy or myomectomy procedures that utilized a power morcellator device. Dr. Richard Lamparter wrote to Johnson & Johnson about the increased risk of the morcellators caused LMS to spread in the body, and called for a warning to be added by the manufacturer. While Johnson & Johnson added a warning for physicians that there may be undetected cancer present, the notice was strikingly deficient because if failed to mention the increased risk of spread of cancer with the use of the morcellator.

The power morcellator is a surgical instrument that is used to remove large masses of tissue during laparoscopic surgery, which is designed to reduce the recovery time when compared to traditional methods. The instrument is inserted into the body through small incisions and is used to mince up the targeted tissue, which is then vacuumed out through the same incision.

THE ISSUE: When the morcellator is used, it breaks down the tissue into smaller fragments. If cancer cells are present, the cells are then spread through the pelvic and abdominal area. In other words, the power morcellators can be the instrument for the spread of cancer of the patient’s body.

Power morcellators are used in over 60,000 surgeries per year. The FDA’s Obstetrics and Gynecological Devices Panel of the Medical Devices Advisory Committee met in July of 2014 to consider statistics regarding the power morcellator. Data indicates that the spread of cancerous cells and intensification of the disease occurs in 25 – 64% of individuals who had undetected cancer. The FDA reports that 1 in 350 women may be at risk for the spread of cancer after procedures using the power morcellator. These patients are believed to have a decreased chance of survival compared to those that have undergone surgeries in which a power morcellator was not used.

LMS is not the only risk associated with the use of morcellators. Other concerns include injury to organs, such as the ureters, bowel, bladder, spleen, pancreas and major vascular structures surrounding the surgery site. Another long-term result includes parasitic growth of displaced tissue that can cause adhesions, bowel dysfunction and the dissemination of other undetected cancers.

Lawsuits include claims of negligence, fraudulent misrepresentation, failure to warn, failure to test properly, consumer risk, and failure to recall. The FDA issued an April of 2014 safety communication warning against the use of power morcellators for hysterectomy and myomectomy with uterine fibroids. The communication also included the statement, “Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.”

In response to the FDA warning in April 2014, Johnson & Johnson’s Ethicon Division suspended the sale and marketing of the power morcellator worldwide. The manufacturer followed this with a letter in July of 2014 urging the discontinuation of the use of the morcellators and asking they be returned to the company immediately. The company recalled three types of morcellators, the Gynecare Morcellex, the Gynecare X-Tract, and the Morcellex Sigma. Johnson & Johnson is not the only manufacturer of power morcellator devices.

In November 2014, the FDA mandated an even stronger warning that “the use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”

Recently, United Healthcare issued new limits on coverage for hysterectomies. The insurance company will not permit the use of power morcellators unless it is deemed “medically necessary”.

If you or a loved one has suffered an injury from use of a power morcellator during laparoscopic surgery, the attorneys associated with Jacoby & Meyers can help you receive compensation for your damages. Our lawyers can review the facts of your case to determine whether you have a valid claim.

Please contact the Jacoby & Meyers defective products attorneys today to schedule your free initial consultation.

Toni Zeller Kohlbeck, student intern Jacoby & Meyers

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Propecia & Proscar, and the Causal Link to Erectile Dysfunction

If you have prostate problems or suffer from male pattern baldness, the so-called “cure might be worse than the disease.” Two of the products that are often prescribed to treat these ailments – Propecia and Proscar – can have the undesired effect of causing erectile dysfunction.

Propecia is often prescribed to treat male baldness. Proscar is a drug prescribed to treat the symptoms of an enlarged prostate. Unfortunately, both drugs have been found to cause erectile dysfunction, decreased sexual drive, shrinking genitals, and pain in the genitals. Psychological issues caused by the drugs include depression, anxiety, and mental fogginess. To make matters worse, even when the initial use of Propecia or Proscar does not cause these adverse side effects, one needs to be careful because prolonged usage may still cause the adverse side effects.

Merck & Co. is the manufacturer of Propecia and Proscar. Both drugs contain the active ingredient Finasteride. It has recently been revealed that Merck has received over 400 reports of sexual dysfunction over the past decade from users of the drugs. In 2011, the FDA required Merck to change the label for Propecia and Proscar so that consumers of the drug would be aware of the possible side effects of erectile dysfunction, low libido, ejaculation and orgasm problems.

In the past few years, litigation has commenced on behalf of men who were not fully advised of the adverse effect of these drugs. On plaintiff, who was 25 years of age when he took Proscar, became disinterested in sexual activity and was unable to maintain an erection shortly after taking the drug. Most disconcerting, the side effects have not disappeared even after he has discontinued the use of Proscar.

In November of 2012, Merck announced that it was named in 265 lawsuits in New York and New Jersey over the sexual side effects of Propecia. Merck has made it clear they will be fighting these lawsuits, even though the company was aware of the drugs’ horrific side effects prior to its manufacturing of the drugs.

The attorneys at Jacoby & Meyers network of attorneys are experienced and dedicated to serving consumers who were injured by these and other dangerous drugs. If you or someone you know has taken Propecia or Proscar and experienced any of the serious side effects mentioned, then you need attorneys capable of taking on the large pharmaceutical companies like Merck.

Call 800-977-5614 or complete the free case evaluation form to have an experienced dangerous drug attorney Jacoby & Meyers review your case.

Gregory Posch, student intern Jacoby & Meyers.

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Savaysa

Savaysa (edoxaban) is an oral anti-clotting drug that was approved by the FDA in January 2015 for the prevention of stroke and non-central-nervous-system systemic embolism in patients with non-valvular atrial fibrillation. Atrial fibrillation is a medical condition characterized by irregular and an often rapid heartbeat. As a result, this condition commonly causes poor blood flow in the body, leading to the formation of blood clots. It also increases the risk of stroke.

Unlike Xarelto, Savaysa contains explicit warning from the outset that it may cause “serious and potentially fatal bleeding.” Unfortunately, there is no treatment that is proven to reverse this adverse effect of using Savaysa. Other listed side effects include anemia (low red blood cell count), rash, abnormal liver function tests.

Another serious risk from using Savaysa occurs when use of the drug is prematurely discontinued. According to a press release from the drug’s manufacturer, “premature discontinuation of the drug increases the risk of ischemic events.” Ischemia is a disease characterized by an interruption in the blood flowing through the arteries to a tissue, organs, or an extremity (such as the arms, hands, legs, or feet). If left untreated it can damage body tissue, organs, and lead to death. For this reason, it is suggested that discontinuation of Savaysa is substituted with another anti-clotting drug.

In addition, Savaysa is not recommended for patients with a history of bleeding (pathological bleeding) given the potentially fatal bleeding that could occur; and patients with mechanical heart valves, or moderate to severe mitral stenosis (a disorder where the heart’s mitral valve does not open causing a restriction of blood flow) due to the lack of trial research concerning the drug’s interaction in patients with these conditions. Others who have increased risks of injury are nursing mothers (it is recommended to discontinue using the drug or discontinue nursing), patients with impaired renal function (impaired ability of the kidneys to filter waste from the body), and patients with a hepatic impairment (impaired liver function).

While Savaysa has been recently approved by the FDA and will arrive on the market with an apparently adequate amount of warnings, potential litigation may arise where doctors prescribe the use of Savaysa without taking into account a patient’s individual medical history or failing to provide adequate warnings of the potential side effects.

If you use Savaysa and suffer any of the serious side effects discussed here, you may be entitled to compensation for your injuries. The attorneys associated with Jacoby & Meyers can help you get the assistance you need in evaluating your case.

Please contact our defective drug lawyers today to schedule your free initial consultation. Jacoby & Meyers has offices nationwide.

Zachary Mayberry, student intern Jacoby & Meyers.

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New Hope for Plaintiffs Who are Harmed by Generic Drug Manufacturers

For the first time in years, Plaintiffs who have been harmed by generic drugs have new hope that they claims can be heard in court. In a major victory for plaintiffs, the United States Supreme Court denied to review a decision by a California appellate court who ruled that when a generic manufacturer fails to update warning labels as required.

For the first time in years, Plaintiffs who have been harmed by generic drugs have new hope that they claims can be heard in court. In a major victory for plaintiffs, the United States Supreme Court denied to review a decision by a California appellate court who ruled that when a generic manufacturer fails to update warning labels as required for the brand counterparts, a plaintiff can prosecute a defective product claim against the generic manufacturer.

The California decision was in a case called Teva Pharmaceuticals USA INC v. Superior Court. In that case, Olga Pikerie sued Teva Pharmaceuticals USA Inc. after she allegedly suffered injuries from ingesting the generic form of the medication Fosamax. Fosamax is used to treat osteoporosis in women specifically caused by menopause. It is also prescribed to men and women for treatment of osteoporosis caused by taking steroids. It works by slowing bone loss.

The complaint alleged that Ms. Pikerie was prescribed and used Fosamax and alendronate sodium from 2006 to 2011. In April 2011, Ms. Pikerie suffered a left femur fracture as the result of taking Fosamax or its generic form, alendronate sodium.

The complaint asserted several claims including strict liability and negligence. The primary allegation of the complaint was that while the labels of the brand name version of the drug were updated, the generic drug manufacturers failed to update their labels accordingly. The generic drug manufacturers demurred to the complaint claiming that under the Pliva, Inc. v. Mensing (decided in 2011), federal law preempted state law on all of the relevant claims.

In Pliva, the United States Supreme Court held “any claims that a generic drug manufacturer should have included stronger warning labels than those approved for use on the equivalent brand name drug are preempted by federal law.” The Court also held that under federal law, generic drug manufacturers must ensure that their labels are identical to that of brand name manufacturers and cannot add any additional warnings. Essentially, generic drug manufacturers must comport the information on their labels including warnings to the standard set or changes made by brand name drug makers (of the same drug) as mandated by the FDA.

Teva in Contrast to Pliva
In Teva, the trial court and California Court of Appeal ruled that in contrast to the Pliva decision, Ms. Pikerie’s complaint alleged that generic drug manufacturers had failed to update their labels along with the updates implemented by brand name manufacturers and in doing so failed to warn of specific dangers associated with the drug. Given the gravity of the Teva decision, generic drug companies appealed to the California State Supreme Court who declined to review the decision. The defendants followed with an appeal to the U.S. Supreme Court for review but it was not granted.

The Implications
The highest Court’s decision not to review could open the door for more litigation against generic drug manufacturers who fail to update their labels in time, along with the brand name manufacturer’s updates. This decision could signal a shift in the tide for more claims to be heard under state law against the generic manufacturers.

Experienced Representation and Here to Help
If you or a loved one has suffered an injury due to taking a dangerous prescription drug, the attorneys associated with Jacoby & Meyers can help you receive compensation for your damages. Our lawyers can review the facts of your case to determine whether you have a valid defective drug claim.

Please contact the Jacoby & Meyers defective drug lawyers today to schedule your free initial consultation.

Zachary Mayberry, student intern Jacoby & Meyers.

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Actos – the Cancer Causing Diabetes Treatment – Continues to Take Multi-Million Dollar Hits

Actos, (pioglitazone) is an oral medicine prescribed to patients who suffer from Type II Diabetes and is used to help control blood sugar levels. In 2011, the FDA announced that it would be reviewing the side effects of Actos after one study suggested that Actos patients faced a “disproportionate risk” of bladder cancer. The FDA eventually issued a warning saying that Actos was linked to increased risk of bladder cancer, especially after being used for a year or more.

Actos has been at the center of more than 8,000 lawsuits across the United States, including 3,500 that were consolidated in Louisiana.

April of 2014, the Louisiana federal jury ordered Takeda and Eli Lilly & Co. to pay more than $9 billion in damages. Eli Lilly & Co. and Takeda had a joint marketing agreement for the sale of Actos in the United States from July 1999 to April 2006. The significance of this $9 billion verdict cannot be underestimated because it was one of the bellwether cases among the 3,500 cases that were consolidated in the multidistrict litigation in Louisiana. The jury found that the manufacturers hid the risks of getting cancer from Actos from the plaintiffs, Terrence and Susan Allen. The trial judge reduced the verdict to $36.8 million, which still represented one of the largest pharmaceutical verdicts in recent years.

October of 2014, Takeda took yet another hit for $2 million in favor of plaintiff Frances Wisniewski, who similarly claimed that the manufacturer failed to warn her of the risk that Actos causes cancer. Unfortunately, Wisniewski got bladder cancer as a result of using Actos. The jury took 5 hours to deliberate and returned the $2 million verdict, based upon Tadeka’s failure to include adequate information about the potential links to bladder cancer on the warning labels.

Most recently, on February 12, 2015, a Philadelphia jury rendered a $3.65 million verdict in favor of another person who got bladder cancer from Actos. The plaintiff, John Kristufek, sued Takeda and other company subsidiaries claiming they concealed knowledge of Actos’ unreasonably dangerous risks from him, his physicians and other consumers. The complaint said that Kristufek was diagnosed with bladder cancer in August 2009, after having ingested Actos for about four years.

With thousands of lawsuits pending, it can be expected that the million dollars hits will keep on coming at Takeda.

If you or someone you know took Actos and were later diagnosed with bladder cancer, it may have been the result of your Actos usage. You should contact the experienced Jacoby & Meyers Actos attorneys for a free case evaluation.

Alexandra Bhatti, student intern Jacoby & Meyers.

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