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Bayer, J&J to Pay $28 Million in Xarelto Lawsuit

Bayer and Johnson & Johnson have both been ordered by a Philadelphia state court jury to pay $27.8 million to an Indiana couple after the jury determined the drugmakers failed to warn of internal bleeding risks associated with the blood thinner Xarelto.

Details of the Xarelto Lawsuit

According to Reuters, the lawsuit was filed by Lynn Hartman and her husband in 2015 and marks the first successful trial verdict in litigation against Bayer and J&J over Xarelto. The drugmakers won three previous cases in federal court.

The lawsuit claimed Hartman was prescribed Xarelto to prevent strokes as a result of atrial fibrillation. She took the drug for roughly one year before being hospitalized in June 2014 with severe gastrointestinal bleeding.

The trial was the first of roughly 1,400 Xarelto cases pending in the Philadelphia court and more than 18,500 cases are pending in federal court.

The jury awarded Hartman $1.8 million in compensatory damages and $26 million in punitive damages.

Side Effects of Xarelto

Xarelto is associated with several common side effects, including:

  • Dizziness
  • Headache
  • Nose bleeds
  • Coughing up blood
  • Back pain
  • Numbness
  • Difficulty breathing
  • Fainting

Since its introduction to the market, Xarelto has been mired in controversy. Currently, there are tens of thousands of lawsuits pending against Johnson & Johnson, Bayer, and Janssen Pharmaceuticals regarding Xarelto and its link to uncontrollable bleeding. In addition, there is currently no FDA-approved antidote to Xarelto — there is no reversal agent for uncontrolled bleeding caused by the blood thinner

Because there is no reversal agent, bleeds caused by Xarelto are oftentimes catastrophic and sometimes fatal. The lawsuits state that these pharmaceutical giants failed to sufficient warning of the deadly dangers associated with Xarelto.

Signs and symptoms of a serious bleed include:

  • Nose bleeds that happen often
  • Unusual gum bleeds
  • Heavier than normal menstrual bleeding
  • Red, pink or brown urine
  • Bright red or black stools
  • Coughing up blood or blood clots
  • Vomiting blood (vomit looks like coffee grounds)
  • Headaches
  • Pain and swelling at wound sites

 

 

FDA Pushes for Limbrel Recall Following Reports of Liver and Lung Injury

The U.S. Food and Drug Administration (FDA) is urging Primus Pharmaceuticals to recall its product Limbrel after reports of liver and lung injuries.

What is Limbrel?

Limbrel was initially marketed by Primus as “medical food” meant to address “the metabolic processes associated with osteoarthritis.” However, the FDA announced this week that it considers Limbrel to be an unapproved drug that comes with the risk of liver injury and an adverse lung condition.

Still, the FDA is powerless to remove the product from market as it lacks the authority to require Primus to recall Limbrel.

In November, the FDA issued a warning urging anyone taking Limbrel to immediately discontinue treatment with the drug. The FDA cited 194 adverse event reports, acknowledging that at least 30 were already found to be likely associated with the product.

Among the adverse events associated with Limbrel were:

  • Liver injury
  • Jaundice
  • Nausea
  • Fatigue
  • Hypersensitivity pneumonitis
  • Trouble breathing
  • Fever
  • Cough

What is Medical Food?

Medical food is a strictly defined regulatory category which includes products recommended by doctors because of certain nutritional components shown to help manage aspects of a disease or condition. The FDA has ruled that Limbrel does not meet the criteria necessary to be designated a medical food.

That has not stopped Primus Pharmaceuticals from advertising Limbrel as a medical food with it’s website claiming “unlike drugs, prescription medical foods generally do not cause severe adverse events or dangerous drug-on-drug interactions.”

Limbrel is currently only available by prescription.

ADHD Medications Linked to Risks During Pregnancy

Medscape reports that two large studies of pregnant women diagnosed with attention-deficit hyperactivity disorder (ADHD) found that stimulant medications used to treat the condition are associated with an increased risk of perinatal and placental abnormalities.

Possible Effects of ADHD on Infants

In a study lead by Ulrika Norby, MSc Pharm, PhD, researchers analyzed singleton births recorded in the Swedish Medical Birth Register (MBR) between July 1, 2006 and December 31, 2014. The final sample consisted of 964,734 infants, of whom 1,591 were exposed to ADHD drugs during gestation and 9,475 were born to mothers who used ADHD medications before or after, but not during, pregnancy. Stimulants accounted for roughly 92% of in utero exposures.

The rate of NICU admission among infants exposed to ADHD medications during pregnancy was noted to be higher than that of infants whose mothers had never used ADHD medications. A risk increase was also noted among mothers who used the medications before or after pregnancy.

Additionally, ADHD medication use during pregnancy was associated with a higher frequency of:

  • Central nervous system disorders
  • Seizures
  • Congenital hypotonia
  • Preterm delivery

Second Study Shows Placental and Perinatal Effects

In the second study lead by Jacqueline M. Cohen, PhD, researchers evaluated the effects of ADHD on the risk of preeclampsia, placental abruption, fetal growth restriction, and preterm birth among women enrolled in Medicaid who delivered a child between 2000 and 2010.

The final cohort consisted of 1,466,792 women, 4,846 of whom use d stimulants for ADHD during pregnancy and 453 who used atomoxetine. The remaining 1,461,493 were in the control group.

After adjusting for various risk factors, stimulant use was associated with a relative risk for preeclampsia of 1.29, 1.13 for placental abruption, 0.91 for infants born small, and 1.06 for preterm birth compared with no exposure.

What Does This Mean for Expecting Mothers with ADHD?

According to Medscape, authors from both study agree that the increases are modest and any risk must be considered next to the severity of ADHD symptoms.

Norby, lead author of the first of the two studies, stated, “Poorly controlled ADHD symptoms might result in poorer adherence to antenatal care, an unhealthier lifestyle, and increased maternal stress that, in turn, can affect the fetus negatively.”

With that, Norby concluded that if the medication is essential in managing a woman’s ADHD symptoms, “we do not find that our results concerning neonatal complications justify abstaining from therapy.”

The lead author of the other study, Cohen, provided similar insight saying, “It is important to balance the benefits of treatment, which may improve functioning, including maintaining family relationships, adherence to prenatal care, and avoidance of substance abuse.”

 

 

 

 

Depakote Manufacturer Must Pay $38M Jury Award to Girl Born with Spina Bifida

Row of pharmaceutical drugs with a variety of colored pills on a table.

A jury award of $38M must be paid to a girl born with spina bifida, whose mother took the epilepsy drug Depakote, the Supreme Court of Missouri ruled this week. According to Law360, the ruling states that Abbott Laboratories Inc., the manufacturer of Depakote, failed to properly warn about the increased risk of birth defects associated with the drug’s usage during pregnancy.

About the Depakote Lawsuit

In 2003, Maddison Schmidt was born with spina bifida and other birth defects, leaving her with severe cognitive impairments and brain malformations. Schmidt, now 14 years old, is paralyzed and lacks bowel and bladder control. The lawsuit was filed in 2012 along with two dozen other similar cases against Abbott, alleging the company did not warn expectant mothers about the severe risk of birth defects associated with the dangerous drug.

The product’s label includes warnings of an increased risk of birth defects, estimating between one and two out of every 100 babies will be born with spina bifida or other neural tube defects. However, Schmidt’s lawsuit alleges that the pharmaceutical company was aware of medical studies that showed the actual risk of a baby being born with spina bifida to be greater than 10 percent.

Schmidt was awarded $38M, and an appellate court affirmed the jury verdict in late 2016. On September 12, 2017, the Missouri Supreme court upheld the ruling.

Children born to mothers taking Depakote are also at an increased risk of developing structural issues in the heart, head, arms, and legs as well as having a lower IQ than children exposed to other anti-epileptic drugs. Because malformations to the fetus occur within the first 30 days of pregnancy, a period of time when a woman may not know she’s pregnant, it is oftentimes too late to simply stop the use of Depakote to prevent the risk of spina bifida or other birth defects from occurring.

Abbot Labs Hit with Thousands of Lawsuits over Depakote

Abbott faces thousands of similar lawsuits surrounding its anti-epilepsy drug. In another case similar to Maddison Schmidt’s, a 10-year-old boy born with spina bifida was awarded $15M from an Illinois jury. In this case, the boy’s mother was taking Depakote to treat her bipolar disorder when she became pregnant.

During the trial, the former director of the Centers for Disease Control and Prevention’s (CDC) Division of Birth Defects and Developmental Disabilities took the stand as an expert witness for the plaintiff. He explained how the main ingredient in Depakote, valproic acid, greatly increases the risk of spina bifida developing in unborn children, and that doctors that prescribe the drug are not properly informed of the true risk of birth defects that the drug poses to pregnant women.

Spina bifida is a neural tube defect that occurs at birth, affecting the child’s brain, spine, and spinal cord. It occurs when the child’s spinal column isn’t closed completely during the first month of pregnancy. In serious cases of spina bifida, children can experience learning difficulties, intellectual disabilities, bowel and bladder issues, paralysis, and hydrocephalus.

Child Born with Defects Related to Depakote Usage?

If your child was born with spina bifida or other birth defects after you took Depakote during pregnancy, contact our dangerous drug attorneys immediately. Thomas J. Henry has handled many product liability cases and is experienced in pharmaceutical litigation, achieving real results for injured clients and helping them get the compensation they need. Your child deserves to be compensated for the pain and suffering they have been through and the years of extensive medical care that will be required for the rest of their life.

Our firm has the resources and experienced attorneys necessary to take on pharmaceutical giants and hold them accountable for their dangerous drugs. Attorneys are available 24/7, nights and weekends. Call us today for a free legal consultation.

5 Users of Weight Loss Balloon Treatment Dead

Since 2016, five people who have used weight loss balloon treatments for obesity have died within a month of having them placed.

Details on the Weight Loss Balloon Deaths

CNN reports that all five of the people who died after the placement of their weight loss balloons did so within a month of receiving them; some even within a few days.

The U.S. Food and Drug Administration (FDA) has stated that they “do not know the root cause” of these patients’ deaths, and they put out a safety alert to the public to alert them of potential risks associated with the treatment.

Weight loss balloons work by being placed in an obese patient’s stomach and filled with saline in order to make the patient feel fuller, which then helps with weight loss.

Four of the patients were using the Orbera Intragastric Balloon System, while one was using the ReShape Integrated Dual Balloon System. Both companies, Apollo Endo-Surgery and ReShape Medical Inc., are now under investigation for other recent deaths that may be related to issues with the balloons.

Reactions from the Weight Loss Balloon Manufacturers

Apollo Endo-Surgery stated that they have “received no product liability-related claims” related to the deaths, and that between January 1, 2006 and March 31, 2017 there have been 21 reported deaths after the completion of 277,000 procedures.

ReShape stated that they are “committed to supporting the continued safe and effective use of the dual balloon” and are “proactively communicating with physicians about this FDA update”, and that if patients have any questions about the FDA’s update on the situation then they should speak with their physician.

The FDA made it clear that they were investigating both companies for the deaths, but they weren’t indicating that they were directly related to the procedures the patients received.

Jury Finds AbbVie Liable in AndroGel Misrepresentation Lawsuit

A U.S. jury found that AbbVie was liable in misrepresenting the possible risks of their testosterone replacement gel, AndroGel.

Details on the AndrGel Verdict

Reuters reports that AbbVie had to pay millions of dollars in damages to a man who had used AndroGel for five years and suffered a heart attack. The drug company was ordered to pay a sum of $150 million to Jesse Mitchell after he filed a lawsuit in 2014 against the company.

AndroGel is a testosterone replacement gel that is meant to be used by patients that suffer from hypogonadism, which is a drastic decline in testosterone levels after some sort of injury or illness.

While this drug is meant for treating low testosterone, it is frequently prescribed to men as a way to make them feel invigorated or to boost their sex drive. Many patients who haven’t even been clinically diagnosed with hypogonadism are often prescribed AndroGel by doctors.

Patients often don’t know the severity of the possible side effects associated with the drug, such as increased risk for heart attacks, strokes, or prostate problems, and these can be more severe in older patients.

The side effects are not seen as being able to outweigh the risks for many patients, as the gel usually doesn’t drastically change sex drive or general well-being, and use of the drug can end up being much more harmful than beneficial.

AndroGel’s Marketing Strategies

As more lawsuits started piling up for AbbVie relating to their AndroGel drug, they started to pump more money into their marketing campaigns.

In 2012 alone, AbbVie spent around $80 million on a marketing campaign for AndroGel, which led to around $1 billion in sales for the company that year. This didn’t help with the fact that many doctors see AndroGel as being over-prescribed as a treatment for low libido, which is marketed as a key symptom for low testosterone but not always safely or effectively treated with testosterone gels.

Millions of patients used a gel whose benefits did not outweigh the risks, but the drug and similar treatment options are still being marketed to men by pharmaceutical companies.

FDA Requires REMS for Immediate-Release Opioids

In an attempt to curb the growing opioid epidemic, the U.S. Food and Drug Administration (FDA) has ordered that drug manufacturers provide and pay for training for clinicians who prescribe immediate-release (IR) opioids. Similar regulations are already in place for extended-release (ER) opioids.

About the Opioid REMS Program

According to Medscape, the FDA has mandated that all IR opioids will now be subject to the same Risk Evaluation and Mitigation Strategy (REMS) program as ER formulations.

A REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product with the goal of ensuring that the benefits of the drug or biological product outweigh its risks.

Currently, the REMS program for ER opiods requires that drug makers provide training for clinicians prescribing their ER opioid products and such trainings are paid for in full by the drug maker. Drug makers will not be required to do the same for immediate-release formulations.

When announcing the new mandate, FDA Commissioner Scott Gottlieb, MD, stated that “America is simply awash in immediate-release opioid products.” Gottlieb also cited data indicating that 90% of all opioid prescriptions in the U.S. are for IR formulations – this amounts to about 200 million IR opioid prescriptions ever year.

FDA Considers Further Regulations

In addition to the new REMS requirements for IR opioids, the FDA is also considering making the training mandatory.

While opioid REMS do require manufacturers to provide and pay for training, participation the training remains voluntary for clinicians.

Should the trainings be made mandatory, it could affect health care providers beyond clinician and include nurses and pharmacists involved in pain management.

Several physician organizations have openly opposed mandatory education.

1 in 5 Patients Suffers Antibiotic Side Effects According to Study

A new study by Johns Hopkins Medicine has found that one in five patients suffers side effects while taking antibiotics and several of those patients did not need the antibiotics they were prescribed.

20 Percent of Patients Suffer Antibiotic Side Effects

For the study, published in JAMA Internal Medicine, researchers analyzed data for 1,500 adult patients admitted to Johns Hopkins Hospital. They noted that in roughly 20 percent of the cases, patients experienced one or more side effects from the antibiotics they were given.

Additionally, the risks of suffering side effects continued to increase by 3 percent with each additional 10 days the patient was on the drug.

Among the most common side effects noted were gastrointestinal problems, kidney abnormalities, and blood-related adverse events.

Researchers Warn that Antibiotics Should Not Be Treated As Benign

According to researchers, the study adds to other evidence suggesting that doctors may be prescribing antibiotics to readily.

Pranita Tamma, an assistant professor of pediatrics at John Hopkins, says, “Too often, clinicians prescribe antibiotics even if they have a low suspicion for a bacterial infection, thinking that even if antibiotics may not be necessary, they are probably not harmful. But that is not always the case.”

In additionally, patients should ask their doctors about potential side effects and how to recognize them.

Opana ER Painkiller Pulled from Market at FDA Request

Last month marked the first time ever that the U.S. Food and Drug Administration (FDA) requested a drug company pull a painkiller of the market due to high potential for abuse. Endo International PLC announced Thursday it would abide by that request and stop selling Opana ER.

FDA Concludes Opana ER Too Risky to Stay on Market

Opana ER’s removal from the market is the final chapter in a series of moves against the drug.

In a March hearing, FDA advisers voted 18 to 8 against keeping Opana ER on the market. The agency reviewed the hearing and requested Endo stop marketing the drug in June.

While the drugmaker contended that the extended-release opioid is safe and effective when used as intended, the FDA has concluded that the drug is too risky to remain on the market, citing a shift from people crushing and snorting the pill to get high to injecting it instead.

In fact, Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to the sharing of needles.

This outbreak happened after a 2012 formulation change which was meant to make the drug harder to abuse. Endo wished to market the new formulation as abuse deterrent; however, the FDA denied Endo’s marketing request.

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.

 

 

Vascu-Guard Recall Closed Without Addressing Cause of Serious Adverse Events

In a release by the U.S. Food and Drug Administration (FDA), the agency acknowledged that neither regulators nor manufacturers have determined the root cause of issues with Baxter’s Vascu-Guard peripheral vascular patch.

The patches were previously linked to a number of adverse events and three potential patient deaths, resulting in a recall being issued – that recall is now closed.

About the Vascu-Guard Patch Recall

Mass Device reports that the Vascu-Guard patch is used in vascular reconstruction surgeries.

In September, the FDA said it had received reports of issues with intraoperative and/or postoperative bleeding and hematomas. Several of these instances required clinical interventions and three of the resulted in deaths.

All patient deaths occurred shortly after carotid endarterectomy procedures.

In their safety communication, the FDA stated that it was “concerned that the Vascu-Guard patch may not be performing as intended and that patients who are treated with the product may be at risk for serious adverse health consequences, such as severe bleeding, hematomas, and death.”

FDA Closes Vascu-Guard Recall, Unsure of What Caused Serious Health Issues

On July 6, the FDA acknowledged that the recall had been closed on June 23 but admitted that neither they nor Baxter discovered the root cause for the serious adverse events experienced by patients.

The FDA did recommend that healthcare providers continue to discuss the benefits and risks of Vascu-Guard as well as all other treatment options prior to CEA surgery.

The agency also requested that all adverse events related to Vascu-Guard patches be reported immediately.

 

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