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Essure Removed from Market, Experts Question Payments from Bayer to Doctors

As Bayer announces its plans to remove the contraceptive device Essure from the market, experts are questioning the ethics behind Bayer’s paying millions of dollars to doctors.

Payments Made to Essure Prescribing Doctors “Looks Like a Bribe”

Last week, the United States Food and Drug Administration (FDA) expressed new safety concerns about Essure, and Bayer Pharmaceuticals announced that they would be pulling the device off the market on December 31.

To make matters more alarming, a CNN analysis of federal data found that between August 2013 and December 2017, Bayer paid 11,850 doctors $2.5 million related to Essure for consulting fees and similar services. While technically legal, these payments remain very controversial.

Three doctors were paid more than $100,000 by Bayer for services linked back to Essure.

In statements to CNN, a patients who suffered adversely from side effects related to Essure noted that her doctor was “very pushy” when prescribing the device.

Dr. Martin Makary, a professor of surgery and patient safety expert at Johns Hopkins Medicine, said that while payments from pharmaceutical company to doctors for research are not uncommon or unethical, he doubted that the more than 11,000 doctors paid by Bayer were involved in such work.

He added, “That looks like a bribe. That looks like gaming the system. That looks like the pharma company is paying of doctors.

Opinions Differ on Why Essure Was Removed from the Market

Bayer has announced that the reason they would be pulling the product is due to declining sales. adding that they completely stand by the safety of this product.

On Friday, Bayer published an “Open Letter to Patients and Providers About Essure,” which states that the company’s decision to stop selling Essure “was not based on concerns about the safety and efficacy of Essure. Essure has been on the market for more than 15 years and has been successfully used by hundreds of thousands of women.”

According to an FDA statement put out the same day, however, the device has been associated with “serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.”

So far, the FDA has received more than 20,000 adverse event reports from women using Essure, with 11,854 of those reports being filed in 2018 along.

Oddly enough, Bayer’s announcement also came just days before Netflix premiered a documentary about the dangers of Essure and other medical devices, “The Bleeding Edge.”

Essure Side Effects and Warnings

The FDA estimates that Essure has been used by more than 750,000 patients worldwide since it was approved on November 4, 2002. At the time, Essure was manufactured and marketed by Conceptus Inc., which Bayer acquired in June 2013.

From 2002 through 2017, the patient problems most frequently reported to the FDA were:

  • Pain/abdominal pain (21,215)
  • Heavier menses/menstrual irregularities (9,846)
  • Headache (7,231),
  • Fatigue (5,842)
  • Weight fluctuations (4,970)

According to the FDA, reported adverse events “cannot be interpreted or used in isolation to reach conclusions about the existence, severity or frequency of problems associated with devices” and “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.”

In April, the FDA restricted sales of Essure to only doctors who give patients FDA-approved patient education materials that describe the risks. The FDA also ordered a black box warning be added to product packaging in May 2016.

Have You Suffered An Injury from Essure? Call Thomas J. Henry

Defective and faulty medical devices have the potential to cause long-lasting and permanent damage in patients seeking treatment for their injuries and illnesses. In some cases, defective medical devices have caused fatal injuries, causing devastation to the victim’s family. At Thomas J. Henry, we will fight vigorously on you and your family’s behalf. We have the legal and financial resources necessary to properly develop your case and take on the large pharmaceutical and medical device manufacturers.

If you or a loved one have been injured by a medical device, call us today — attorneys are available 24/7, nights and weekends. Our firm has offices in Corpus ChristiSan Antonio, Austin, and Houston, serving clients across Texas and nationwide.

Viagra Trial Stopped After 11 Babies Die

The Amsterdam University of Medical Centre (UMC) announced the end of a clinical trial testing a new use for the pharmaceutical sildenafil, known commercially as Viagra, following the deaths of nearly a dozen babies.

About the Viagra Clinical Trial and the Resulting Deaths

According to reports, the popular erectile dysfunction drug was being tested on pregnant women with doctors hoping that certain properties of the drug, specifically those that improve blood flow, would stimulate the growth of placentas.

Typically, Viagra works by blocking an enzyme that breaks down a messenger compound that helps relax smooth muscles, like those that surround certain blood vessels. The resulting increased blood flow is useful in not only managing erectile function but also in reducing the severity of mountain sickness symptoms and in treating pulmonary hypertension.

What when wrong with the current trial remains a mystery; however, researchers noted that 11 babies died during or shortly after delivery with elevated blood pressure in their lungs. This is presumed to be linked to the drug,

Six other newborns were born with a lung condition that deprived them of sufficient oxygen.

The Risk of Clinical Trials

  • The new treatment being tested may not be as effective or as safe as existing treatments.
  • Drugs and medical devices in clinical trials may carry unexpected side effects.
  • These side effects may be occasional aches and pains or may result in serious adverse events including renal injury, cardiovascular complications, and even death.
  • As the clinical trials progress, drugs may be combined with other medications and dosages may be increased, resulting in increased risks.
  • Insurance and health care providers may not cover the costs of patient care during a clinical trial or injuries and side effects that may result from a clinical trial.

Have You Been Involved in a Clinical Trial?

If you have been involved in a clinical trial and have suffered injury or illness, ask yourself the following questions:

  • Did you understand all of the enrollment paperwork you signed?
  • Were you confused by the consent forms?
  • Did you have lingering questions about side effects?
  • Did your doctor fail to explain all the possible outcomes of the trial?
  • Were you told you had a problem and then told something different by another doctor?
  • Were you referred to several doctors during your initial treatment and/or after the trial?

Contact an Experienced Clinical Drug Trial Attorney

If you or a loved one has been the victim of a dangerous pharmaceutical drug or medical device, you may be entitled to compensation. You deserve dynamic representation from a law firm with the resources necessary to take on the pharmaceutical companies. Thomas J. Henry has a track record of helping clients receive record-breaking verdicts, settlements, and judgments.

Our firm has offices in Corpus ChristiSan Antonio, Austin, and Houston, serving clients across Texas and nationwide. Call us today for a free case review — attorneys are available 24/7, nights and weekends.

FDA Joins 22 Countries in Recall of Common Heart Drug

On Friday, the U.S. Food and Drug Administration (FDA) announced a recall for valsartan, a common drug that is used to control blood pressure and prevent heart failure. The announcement comes one week after 22 other countries recalled it because the drug contains a chemical that poses a potential cancer risk.

Details of the Valsartan Recall

According to the FDA, valsartan is off-patent and is used as a component of other generic medicines; however, regulators note that not all medicines containing the ingredient are involved. Specifically, the U.S. recall only includes versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide (HCTZ) combinatios sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

The director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, offered reassurance to consumers, saying “We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients.”

In Europe and Asia, Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled because they “do not meet our high quality standards.”

Pharmacies in the UK are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.

Details of the Valsartan Cancer Risk

The recall is due to the presence of the impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is an organic chemical that is in a family of potent carcinogens.

It has been used to make liquid rocket fuel, softeners, and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.

According to the United States department of Health and Human services, animal studies have shown that NDMA can be toxic and cause tumors in the liver, kidney and respiratory tract. It can also be potentially harmful to humans in certain quantities. Exposure to high levels can cause liver damage and is a probable human carcinogen.

Patients are advised to talk to their doctor if they are taking the medication. They should not discontinue taking medication without a doctor’s permission. Going off their medication without supervision could be dangerous, according to the American Heart Association.

The FDA’s investigation into the drug will continue.

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

 

Class I Recall Issued for Abbot HeartMate 3

A Class I recall has been issued for Abbott’s HeartMate 3 left ventricular assist devices due to possible twisting and eventual occlusion of the outflow graft which can create a risk of serious injury or death.

About the Abbot HeartMate 3 Recall

According to Mass Device, the HeartMate 3 devices are being recalled due to a malfunction in the outlaw graft assembly. The defect could result in the outflow graft twisting and occluding over time, which could cause stalled pump flow and a persistent low flow alarm in the system.

Such a reduction in pumping can lead to serious adverse events, including blood clots and death.

In total, the recall affects 4,878 units across the U.S. Recall units will have catalog numbers of 106524US, 106524, or 10652INT. All defective devices were distributed after September 2, 2014.

Class I Recalls Designate Serious Risk of Injury and Death

When issuing recalls, the U.S. Food and Drug Administration will assign a classification designating how serious recall is and the potential adverse health outcomes posed by the recalled product, drug, or device.

The classifications are as follows:

  • Class I: a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death.
  • Class II: a situation in which use of, or exposure to, a product may cause temporary or medically reversible adverse health consequences or where there is a remote probability of serious health consequences.
  • Class III: a situation in which use of, or exposure to, a product is not likely to cause adverse health consequences.

A recall is terminated only after the FDA deems the product no longer in violation of the law and no longer presents a health hazard to patients.

Contact an Experienced Medical Device Recall Attorney

Defective and faulty medical devices have the potential to cause long-lasting and permanent damage in patients seeking treatment for their injuries and illnesses. In some cases, defective medical devices have caused fatal injuries, causing devastation to the victim’s family. At Thomas J. Henry, we will fight vigorously on you and your family’s behalf. We have the legal and financial resources necessary to properly develop your case and take on the large pharmaceutical and medical device manufacturers.

If you or a loved one have been injured by a medical device, call us today — attorneys are available 24/7, nights and weekends. Our firm has offices in Corpus ChristiSan Antonio, Austin, and Houston, serving clients across Texas and nationwide.

FDA Restricts Sale of Essure Birth Control Device

The U.S. Food and Drug Administration (FDA) announced they are restricting the sale of Bayer AG’s implanted birth control device Essure. The decision comes two years after the agency ordered Bayer to put a severe warning label on the product.

Details of the Essure Sale Restriction

According to Reuters, the FDA ruled that some women were not being adequately informed of the risks associated with Essure prior to getting implanted. The new restrictions will limit the sale of Essure to healthcare facilities that provide full information about the device’s risks and benefits.

Among the risks associated with Essure are:

  • Hysterectomy
  • Depression
  • Abdominal pain
  • Abnormal uterine bleeding
  • Device migration
  • Perforated organs
  • Ectopic pregnancy

Essure was originally approved by U.S. regulators in 2002, but it received a black box warning in 2016 following thousands of complaints.

Essure Subject of more than 10,000 Lawsuits

The FDA decision could prove vital to some 10,600 lawsuits pending against Bayer in the U.S. Those lawsuits allege Bayer was aware of the risks associated with Essure, but failed to warn sellers, doctors, and regulators of the dangers.

The FDA revealed in March that is had received roughly 12,000 medical reports concerning Essure in 2017 – more than 90 percent of those reports mentioned issues around device removal.

Currently, there are an estimated 750,000 women using Essure worldwide with about 70 percent of users based in the U.S.

Hurt by a Defective Medical Device? Contact Thomas J. Henry

Defective and faulty medical devices have the potential to cause long-lasting and permanent damage in patients seeking treatment for their injuries and illnesses. In some cases, defective medical devices have caused fatal injuries, causing devastation to the victim’s family. At Thomas J. Henry, we will fight vigorously on you and your family’s behalf. We have the legal and financial resources necessary to properly develop your case and take on the large pharmaceutical and medical device manufacturers.

If you or a loved one have been injured by a medical device, call us today — attorneys are available 24/7, nights and weekends. Our firm has offices in Corpus ChristiSan AntonioAustin, and Houston, serving clients across Texas and nationwide.

 

 

MS Drug Zynbryta Pulled from Market Worldwide

Prescription medication bottles with multiple pills of various colors

Biogen and AbbVie have announced that they will be removing Zinbryta (daclizumab), a treatment for relapsing multiple sclerosis (MS), from the market due to growing concerns about the drug’s safety.

About Zynbryta’s Market Removal

According to Medscape, the drug has been linked to reports of severe liver damage and immune-related conditions.

The announcement on the withdrawal came the same day that the European Medicines Agency (EMA) announced it would be conducting an “urgent review” of Zinbryta (daclizumab)  in reaction to seven cases of serious inflammatory brain disorders in Germany and one case in Spain.

Biogen and AbbVie stated that the nature and complexity of the adverse events made it impossible to accurately characterize Zinbryta’s benefit/risk profile. Both companies felt the market withdrawal would be in patients’ best interests.

Zinbryta was approved in the U.S. in May 2016; however, with the approval, the Food and Drug Administration (FDA) recommended the drug only be used in patients who have not responded to prior therapies.

Side Effects of Zinbryta

The following adverse events have been associated with Zinbryta:

  • Infection of the nose, throat, and sinus
  • Bronchitis
  • Depression
  • Urinary tract infection
  • Anemia
  • Fever
  • Trouble breathing
  • Disease of the thyroid gland
  • Breast tumor
  • Diabetes
  • Failure of small intestines
  • Hepatitis
  • Suicidal thoughts
  • Liver failure
  • Pancreatitis
  • Seizure
  • Death

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

FDA Adds Boxed Warning to Ocaliva Following Dosing Errors

The U.S. Food and Drug Administration (FDA) has ordered a boxed warning and dosing table be added to the liver disease drug Ocaliva (obeticholic acid) following reports that the medication is being incorrectly dosed daily instead of weekly to patients.

About the Ocaliva Black Box Warning

Medscape reports that Ocaliva is prescribed to patients with moderate to severe primary billary cholangitis (PBC) and that the incorrect dosing results in an significantly increased risk of serious liver injury.

In a safety communication, the FDA addressed the issue saying that the dosing errors have resulted in cases of liver decompensation, liver failure, and death. In order to correct the issue, the FDA is clarifying current recommendations for screening, dosing, monitoring, and managing PBC in patients with moderate to severe liver disease taking Ocaliva.

In addition to the boxed warning and dosing table, the FDA said that it will also require Ocaliva carry a medication guide for patients that informs them about the past dosing issues and the risk of such errors.

Additional Guidelines Issued to Healthcare Professionals and Patients

Beyond packaging and label changes, the FDA advises clinicians to take the following actions when treating a patient with Ocaliva:

  • Routinely monitor patients for biochemical response, tolerability, and PBC progression.
  • Closely monitor patients who are at an increased risk of liver decompensation.
  • Make sure both patients and caregivers are educated on the symptoms of worsening liver function.
  • Temporarily stop treatment with Ocaliva if the patient displays evidence of worsening liver function.
  • Consider stopping treatment in patients who have experienced clinically significant liver-related adverse reactions.

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry Injury Attorneys immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

New York City Files $500 Million Lawsuit Against Opioid Drug Companies

New York City has filed a $500 million lawsuit against prescription opioid manufacturers and distributors in an effort to hold them accountable for their alleged part in New York’s opioid epidemic.

About the New York Opioid Lawsuit

According to the lawsuit, the current opioid epidemic was caused, at least in part, by manufacturers’ marketing of the drug.

Additionally, New York City alleges that crises has placed a burden on the city as it must cover increased substance use treatment services, ambulatory services, emergency department services, inpatient hospital services, medical examiner costs, criminal justice costs, and law enforcement costs.

NBC 4 New York reports that more than 1,000 people died of opioid overdose in New York City in 2016, marking the highest number of opioid-related deaths on record for the city.

New York City is not the first to file such a lawsuit. More than 200 lawsuits have been filed against drug companies by local communities across the nation, including communities and cities in California, Illinois, Kentucky, Ohio, New Jersey, and West Virginia.

The vast majority of the lawsuits have already been consolidated into multidistrict litigation. It is unclear if New York City’s lawsuit would join the MDL.

Dangers of Opioid Painkiller Abuse

  • The U.S. Centers for Disease Control and Prevention records about 14,800 prescription painkiller deaths every year – this is more deaths than those attributed to car accidents or gunshot wounds
  • Perhaps more alarming is that the rate of painkiller abuse has increased by 300 percent between 1999 and 2010. The rate of abuse is especially high among women, increasing 400 percent during the same time span.
  • When used during pregnancy, opioid painkillers can lead to birth defects including:
    • Spina Bifida
    • Hypocephaly
    • Conoventicular septal defect
    • Hypoplastic left heart syndrome
    • Atrial septal defect
    • Tetralogy of fallot
  • Nearly 1 in every 33 babies is born with a birth defect according to the CDC.  Birth defects are the leading cause of death in infants, and account for more than 20 percent of all 5,600 infant deaths each year.

 

FDA Issues Safety Alert for Zoll LifeVest Wearable Defibrillator

The FDA has issued a safety alert for the Zoll LifeVest 4000, an external, wearable cardioverter defibrillator, saying it may fail to deliver appropriate therapy for potentially fatal arrhythmias.

About the Zoll LifeVest Defibrillator Safety Alert

According to Medscape, the LifeVest 400 may deliver appropriate shocks as a result of “a fault that prevents the device from charging its high-energy capacitors.”

The defect can occur when the device displays a warning to “Call ZOLL for service, Message Code 102.” The FDA says that the warning “does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately.”

The company reports that 33,670 device have been distributed as of November 2017. The above message has displayed on roughly 0.1% of the devices.

Zoll says it is aware of one death associated with the device’s failure to deliver treatment after the message appeared.

What Are Common Causes of Medical Device Defects?

Recalls occur when a medical device is defective or a risk to a patient’s health (or both). A device is considered to be recalled if the manufacturer takes actions to correct or remove the device that violates FDA law. In some cases, the recalled device may not necessarily need to be removed from a patient, or the risks of removal outweigh the risk of leaving it in place.

Types of actions that result in a medical device recall include:

  • Inspecting the device for issues
  • Repair
  • Adjusting settings
  • Relabeling
  • Destroying the device
  • Notifying patients of a problem with the defective device
  • Monitoring patients for issues

The FDA is in charge of monitoring all medical devices and drugs available for consumer use. In most cases, a company, including manufacturers and/or distributors, will usually recall their medical devices on their own or voluntarily. However, if a medical device is associated with significant health problems or death, the FDA can legally require a company to recall a device immediately.

When a company recalls a medical device, they will:

  • Contact the customers who received the product from them, and takes steps to reach others who need to be notified usually by press release.
  • Supply information to help users identify the product and take steps to minimize health consequences.
  • Take action to prevent the problem from happening again.

 

Texas Girl, 6, Experiences Hallucinations, Rare Side Effects from Tamiflu Medication

Prescription medication bottles with multiple pills of various colors

According to CBS 11, a six-year-old girl in Allen, Texas, suffered from hallucinations after taking Tamiflu to treat her influenza diagnosis. The girl’s parents say she ran away from her school and believe that she tried to crawl out of her second-story bedroom window in an attempt to harm herself.

After bringing the girl to the hospital following the incident, a doctor told them that rare side effects are possible with Tamiflu (oseltamivir), including nervous system problems such as psychosis. One emergency room physician says less than one percent of patients taking Tamiflu experience these kind of severe adverse events.

The Tamiflu drug label contains several warnings, including neuropsychiatric events, particularly in pediatric patients. The label states that these patients may be at an increased risk of confusion or abnormal behavior early in their illness and to monitor for signs of this type of behavior.

In addition, the warning label describes additional postmarketing reports of delirium and abnormal behavior that lead to injury, and in some cases fatal outcomes, in flu patients receiving Tamiflu. These reports were mostly from pediatric patients taking the drug in Japan, however, the label states that the contribution of Tamiflu to these injury events have not been established.

Serious skin or hypersensitivity reactions can also occur when taking Tamiflu. Tamiflu’s indicated usage is for patients who have exhibited symptoms of the flu for no more than 48 hours.

The six-year-old girl’s family told CBS 11 that they will be filing a report with the Food and Drug Administration (FDA) regarding the event.

Other Cases of Severe Side Effects while Taking Tamiflu

Forbes notes that this is not the first time a report of Tamiflu-induced hallucinations reached national news.

  • In 2009, an article in the Daily Mail described the experiences of two children who were administered Tamiflu for a swine flu diagnosis. The children suffered from hallucinations, high fever, and vomiting.
  • In 2012, a woman wrote an article in Time regarding her son’s behaviors after taking the drug. Her nine-year-old son experienced nightmares, babbling, and was convinced he was being chased as he ran around their house.
  • In 2015, a case report in Clinical Pscyhopharmacology and Neuroscience described a patients severe symptoms, including mood swings, suicidal feelings, auditory hallucinations, and insomnia.

In 2005, a massive string of incidents in Japan involving Tamiflu garnered the FDA’s attention. More than 100 cases of neuropsychiatric events were reported, including the deaths of 12 children who had taken Tamiflu. The potentially harmful drug was banned for use in teenagers after multiple incidents of teens jumping from second-story windows and other suicidal behaviors.

Tamiflu’s manufacturer said that the available data did not suggest that the incidents in patients taking the drug were higher than those who were not. The FDA conducted a review and did not conclude that there was a causal relationship between Tamiflu and pediatric deaths.

Although the severe side effects of Tamiflu are rare, some believe that the true efficacy of the drug is still unclear. According to Forbes, reviewers of the drug’s trials found evidence of publication and reporting biases, and all of the trials were sponsored by the drug’s manufacturer. No placebo-controlled trials were conducted by an independent source. Although a review of the studies found that Tamiflu reduced the duration of symptoms by about a day, the drug was not found to reduce the risk of hospitalization or transmission of the influenza virus.

According to the six-year-old girl’s parents, the approximately one day of symptom relief from the flu is not worth the possible side effects that their child encountered.

Injured by a Dangerous Pharmaceutical Drug?

If you or a loved one have suffered severe side effects or were injured after taking a pharmaceutical drug, contact Thomas J. Henry immediately. Our attorneys have experience handling cases involving dangerous drugs and medical devices. You may be entitled to compensation for your injuries, medical costs, lost wages, and other damages caused by an unsafe medication. Call us today and speak with an attorney. We are available 24/7, nights and weekends to evaluate your claim and provide you with a free case review.

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