Xarelto® Litigation Update – Johnson & Johnson and Bayer Settle for $775 Million

Xarelto® Litigation Update - Reyes Browne Reilley

MARCH 25, 2019 – Bayer and Johnson & Johnson have agreed to settle roughly 25,000 lawsuits that resulted from their blood thinner medicine, Xarelto®. Both companies will pay a sum of $775 million, split evenly between the two companies.

Both companies deny liability, and still stand behind their product albeit thousands of patients suffering from irreversible internal bleeding. Instead, they have decided to settle because of the extensive time and resources devoted to litigation.

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The Many Dangers of Off-Label Prescription Drugs

Dangerous Drugs

shutterstock_131047082-200x300A new drug is FDA approved and released on the market which is made to solve one medical issue, but also ends up helping in other ways. That’s generally a very good thing. That is, until the marketers get wind of it. One of the most common of these stories is Viagra. Pfizer was working on a drug to help with blood pressure and ended up with the little blue pill that solved men’s bedroom issues. Often these types of incidents end up for the better. However, there are potentially large risks involved when using a drug for something other than its intended use – even when it’s doctor prescribed.

One recent example of off-label drug use is the Low Testosterone therapy (Low T) craze. Low T therapy was first FDA approved as a way to treat men with hypogonadism, which affects the hormones developed in male genitalia. It didn’t take long for the pharmaceutical industry to figure out how to market “Low T” to every man over 40 who was grouchy or had lost a step to their 25 year old self. The resulting boom in the Low T industry (nearly $2B a year!) is now thought by many to be responsible for an increase of men experiencing heart attacks, strokes, and other circulatory problems as their slightly-worn ‘engines’ try to cope with an increased red blood cell count and thicker viscosity blood (known as polycythemia).

Off-label drug use is increasing, leading to more and more complications with prescription drug users. Off-label drug use means a medication is being used for something other than its originally intended purpose, as specified by the FDA. The sole purpose of the Food and Drug Administration is to regulate drug approval and make sure every drug is safe for people to use. However, the FDA has little say over how doctors actually prescribe the drugs.

More often than not, off-label drug use does not result in any negative side effects. However, as with many cases like the one with Low T, the results can be negative. Another FDA off-label example is the Da Vinci Surgical Robot. This device was originally FDA approved to improve a narrow range of laparoscopic surgical procedures. The Da Vinci surgical robot promised less pain, downtime, and discomfort for patient. Hospitals purchasing the device would often market it as futuristic, but to pay for the expensive systems, hospitals started using them for an ever-increasing number of procedures – which led to unintended consequences as more patients allegedly suffered various injuries at the “hands” of the da Vinci surgical robot. Another clear example of how a manufacturer’s marketing goals helped to re-interpret an FDA approval – and how consumers were made to suffer the consequences.

When it comes to any type of off-label medical use, most doctors should let their patients know the possible risks and rewards with each device or drug. Do yourself a favor and take the extra step of researching a drug or medical device’s original FDA approval.

 

Actemra, a Rheumatoid Arthritis Drug, Linked to Hundreds of Deaths

Dangerous Drugs

Tips-for-Living-with-Rheumatoid-Arthritis-01-1440x810-1024x576When a new remedy for rheumatoid arthritis arrived, ads called it a “unique” breakthrough that would “transform expectations” for patients and doctors.

Treatments for the disabling disease afflicting about 1.5 million Americans can have terrifying side effects, so doctors and patients were excited when Actemra reached the U.S. market in 2010. Unlike competing drugs, it wasn’t associated with heart attacks, heart failure, or life-threatening lung complications.

Since then, more than 760,000 patients have used the drug. The FDA has received 1,128 reports of deaths in patients taking Actemra, yet cannot determine if the drug was the direct cause of the deaths.

STAT, an investigative publisher in the medical and biotech fields, analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.

Most of those medications warn about these risks on their labels. Actemra does not. Roche/Genentech, manufacturer of Actemra, is accused of not carrying a warning label stating a risk of heart attack or stroke as possible side effects for patients who take Actemra.

Actemra might not be more dangerous than other arthritis drugs — many of which can have lethal side effects — but patients and doctors are misled into believing it might be safer because frequently reported, serious problems aren’t noted on its warning label.

In one striking example, obtained through the Freedom of Information Act, a doctor said no factor other than the drug could have explained a 73-year-old man’s fatal brain bleed two days after receiving an intravenous Actemra treatment. Another said of a 62-year-old German woman’s heart attack in 2014: “The company assessed fatal myocardial infarction as related to [Actemra].”

That company was Roche/Genentech.

The failure to warn the public, experts say, highlights the FDA’s inability to adequately scrutinize the safety of drugs after they have been approved, and to act promptly when potential danger signs appear.

“We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective,” said Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University. “The system is broken, and all the financial incentives are lined up to keep it broken.”

Our product liability attorneys represent those who have been injured by medical devices and medications such as Actemra. For more than 25 years, our firm has fought against insurance companies and manufacturers on behalf of those who were injured through no fault of their own.

To consult with a skilled DFW dangerous drug attorney about Actemra or other potentially harmful medication, fill out the free case evaluation form on this page, or call us at 214-526-7900.

FDA Asks If Faulty Blood Monitor Device Tainted Xarelto Clinical Trials

Blood Monitor Device Tainted Xarelto Clinical Trials

A new drug’s effectiveness and safety are tested and verified by studies and clinical trials conducted by independent third parties such as universities and scientific labs. From a drug company’s perspective, receiving the endorsement of a successful clinical trial is essential to successfully marketing a new drug. Drug companies and their salesman use the results of these studies and trials as sales tools to market the drug to doctors. A pharmaceutical company can make billions of dollars by developing a drug that is more effective than another, providing doctors with an incentive to buy one to replace the other. In 2015 alone, Johnson and Johnson made $1.9 billion dollars selling Xarelto, an anti-clotting drug used to treat patients who are in danger of having a stroke. The future of this drug is now in question, however, because one of the testing devices used in the clinical trial has been deemed to be defective.

The FDA has challenged the results of the Rocket AF clinical trial, led by Dr. Robert M Califf because a device used in the tests, the INRatio sold by Alere may have produced faulty results that favored the newer replacement drug Xarelto. Xarelto is an anti-clotting drug developed and manufactured by Johnson and Johnson and prescribed to millions of Americans since its approval in 2011. Warfarin, the drug it replaces, is a 60-year old medication prescribed to prevent strokes in people with atrial fibrillation. With Warfarin, the margin of error in prescribing the correct dosage was deemed exceptionally thin. Doctors had to weigh the risks of the patient having a stroke from prescribing too little with the risk of catastrophic bleeding caused prescribing too much.

It was brought to the attention of the FDA that the INRatio monitoring device had been recalled in 2014 because it was underestimating a drug’s side effect, a patient’s risk of catastrophic bleeding. The FDA is investigating whether the faulty device could have caused doctors conducting the clinical trial to give patients a higher dosage of warfarin than necessary, thus giving an advantage to Xarelto.

Legal briefs filed by lawyers in federal court claiming that their clients have been injured by Xarelto raised the question of whether Johnson and Johnson knew the devices malfunctioned while the clinical trial was underway. The brief also claims that doctors for the study had been complaining about the device to the leaders of the trial during the study.

Researchers at Duke Clinical Research Institute and the European Medicines Agency, Europe’s FDA, both concluded that the faulty device did not affect the trial’s outcome. Doctors in Germany questioned whether Dr. Califf’s nomination to the FDA played a role in the heightened scrutiny of the study.

Thanks to: NY Times

Are Testosterone Gel’s Modest Benefits Worth The Risk?

Dangerous Drugs

Are Testosterone Gel's Modest Benefits Worth The Risk?

Testosterone is a hormone produced naturally in the testicles beginning at puberty and gradually decreases after age 30. By the time a male reaches age 65 his testosterone levels are significantly lower, leaving some men feeling tired, lethargic, and with a reduced libido. As a treatment for this condition, doctors have been prescribing testosterone therapy, low-t for short, usually in the form of rubbing a gel on the body. The objective of the therapy is to restore a percentage of the testosterone lost due to aging. Men by the millions have been lured by slick advertising and have started taking the therapy. It has been said that given the frenzy over this new anti-aging treatment, some doctors prescribe the treatments without measuring a man’s testosterone to see if it was low in the first place.

Up until recently there was no official clinical study to review to see if testosterone therapy was indeed effective. A clinical study recently published in the New England Journal of Medicine found that using testosterone therapy achieved only moderate results. The benefits were not in energy levels, improved physique or physical fitness as is often advertised, but instead limited to modestly increased sexual performance, less than that of taking one Viagra or Cialis pill. Moreover, the study was too small to address the most important issue of whether using testosterone increases one’s risk of heart disease and prostate cancer.

Of the 790 men over age 65 that received testosterone and not the placebo, the risks for prostate cancer may have significantly increased. One of the more dangerous factors of taking testosterone is that it increases one’s PSA levels, the same markers that are recorded in a standard screening for prostate cancer. It is difficult now for testing to distinguish between PSA levels elevated by testosterone therapy or those increased due to the onset of prostate cancer. This is true not only in the study’s participants but also in the testosterone therapy taking population in general.

Men of all ages should be aware that the FDA has warned of the potential health risks of taking low-t therapy and will be conducting further research. Testosterone therapy may pose a potential increased risk of heart attack for men of any age. According to unofficial studies, men under 65 with a history of heart disease had a two-threefold increase in the risk of Myocardial Infarction over men who received no treatments. For men over age 65, the risk increase was also two-fold for those without a history of heart disease.

Given the modest benefits of engaging in testosterone therapy and the potential health problems that it may cause, it might be wise to wait until more data is forthcoming before considering testosterone therapy as a treatment for a decrease in libido or other age-related conditions.

if you or a loved one suffered severe complications after Testosterone therapy, you may be eligible for financial compensation. Contact the skilled Dallas dangerous drug attorneys at the Reyes Browne Reilley Law Firm by completing the short case review form on this page, or call us at 214-526-7900 to receive a free and confidential testosterone lawsuit consultation.

Thanks to: NY Times

New Analysis Says Antidepressant Paxil Is Unsafe for Teenagers

Dangerous Drugs

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The benefits of taking the anti-depressant drug Paxil have always been marginal at best and the serious consequences of it’s side effects have been either misrepresented or downplayed. When an initial study of the now-popular antidepressant was conducted on 100 patients with depression-related psychological issues, patients were given 3 different pills and the results of their mood recorded. The first group was given Paxil. The second group was given the existing leading prescription antidepressant, and a third group given a placebo. Results of the study concluded that there was no discernible difference in a standard depression questionnaire given all of the patients. Paxil did rate better on another test of mood measures but this was only on a secondary level.

As a result of this study and alot of “marketing spin” on the study’s results, Paxil was able to become the drug of choice for physicians and as demand post 2001 surged for antidepressants for young people, prescriptions surged by 36% from 2002-2003. Once the study was published in the Journal of the American Academy of Child and Adolescent Psychiatry however, the results of the study and the glaring omissions of the drug’s dangerous side effects came under closer scrutiny. Those analyzing the study concluded that the results were “not at all convincing and that serious side effects had been played down.” In addition, there is ample indication that evidence and inferences to the drug’s serious side effects were misrepresented by the study.

The study concluded that in 5 of 6 events that were labeled as “emotional liability” included suicidal thinking or suicidal behavior, but were not presented as such. Although no actual suicides occurred, there were a number of suicide-related incidences by the patients ranging from an overdose of Tylenol (taking 80 tablets), to Paxil overdoses after stressful events like arguing with a parent.

While no actual suicide statics are available, doctors analyzing the study feel that the benefits of taking the drug have been overstated, and that the increased suicidal tendencies of several of the younger patients in the study warrant the release of data on a “patient-level” to see if others were negatively effected by the drug and have had increased suicidal tendencies.

Johnson and Johnson Targeting Small Children with Risperdal?

Dangerous Drugs

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While Johnson and Johnson enjoys an excellent reputation as one of America’s leading medical companies, it might surprise some people to discover that over 90% of Johnson and Johnson’s net income is derived from sales of pharmaceutical drugs and medical products and not “shampoo and baby powder” that has branded the company “squeaky clean”. And while you’ll rarely hear this coverage in the local media, Johnson and Johnson is coming under fire and losing lawsuits for the way they have marketed their billion-dollar antipsychotic drug Risperdal.

A Philadelphia jury recently awarded the family of a young autistic boy $2.5 million in damages stemming from the side effects of using Risperdal, claiming the drug causes him to grow 46DD breasts from age 12.

Because of fears that Risperdal causes hormonal disorders like this the FDA prohibited Johnson & Johnson from promoting the drug to treat children. The company was also prohibited from marketing it to treat the elderly because it was feared Risperdal causes strokes and diabetes as well as other ailments.

Johnson and Johnson attributes half of its sales of Risperdal to young children and the elderly. Risperdal had been and is continuing to be promoted by J & J salespersons as a treatment for most types of behavioral disorders in children, and dementia and restlessness in the elderly.

Court documents revealed that Johnson and Johnson had been illegally targeting doctors who specialized in treating young children and the elderly. Salespeople have largely ignored the FDA warnings and marketed the drug with free samples to doctors who obviously treated young children.

Johnson and Johnson has settled thousands of claims regarding the illegal promotion of Risperdal, Federal government cases, and criminal complaints spending upwards of $3 billion. Currently over 4000 cases against J & J and Risperdal are pending.

If you have a loved one who is currently taking the drug Risperdal and are experiencing adverse side effects, you may have a case against the drug’s maker Johnson and Johnson, your doctor or others involved. Please give our law firm a call.

Five Potentially Dangerous Diet Drugs Approved by FDA

Dangerous Drugs, In The News

Five new and potentially dangerous weight loss drugs have been approved by The U.S Food and Drug Administration after rejecting every single new weight loss drug for the previous 13 years.

In the five weight loss drugs that have been approved, the potentially harmful side effects include suicidal thinking, increased heart rate, increased cancer risks and others. In addition, there is no proof that these FDA-approved diet drugs do anything to improve the health problems that obesity caused in the first place such as a higher risk for heart disease and other cardiovascular issues like high blood pressure, heart attacks and strokes. Below is a list of the five new weight loss drugs recently approved by the USFDA and a brief description of what they are supposed to do and their potentially dangerous side effects.

Five Newly-FDA Approved Weight Loss Drugs

  1. Orlistat – Orlistat is a lipase inhibitor which means that it is supposed to prevent fat from entering your blood stream by preventing the enzyme lipase from breaking down the fat. The excess fat is excreted and not absorbed by the blood causing side effects such as gassiness and oily bowel movements. There have been reports of severe liver damage by about a dozen people. The symptoms of potential liver damage include yellowing skin, yellow eye whites, dry, itchy skin, and dark yellow urine.
  2. Lorcaserin – Lorcaserin tricks the brain into feeling that you are full. Drowsiness, head aches and constipation have been side effect reported by those who use the drug. When taken in conjunction with other drugs used to treat depression, increased thoughts of suicide are said to possible occur.
  3. Phentermine – This drug is known to cause birth defects such as cleft palette when taken by pregnant women and increased suicidal thoughts. Other commonly reported side effects include high blood pressure, sleeping disorder and nervousness.
  4. Bupropion – Bupropion is sold under the brand name Contrave and was rejected in 2011 by the FDA because of concern over the drug’s effects on one’s cardiovascular health. As with other weight loss drugs it’s primary effect is to trick the brain into thinking that you are full. And as with the other weight loss drugs that’s not the only trick it can play on the brain. The drug has earned the strictest of the FDA’s warning, a “black box label” because of it’s causing increased suicidal tendencies.
  5. Liraglutide – Liraglutide helps promote the production of insulin by the pancreas and is sold under the brand name Saxenda. This drug also has a black box warning as it has been shown to cause tumors in lab rats. People with a family history of cancers are advised against taking this drug.

It’s only normal to suspect that when a large corporation’s profits are at stake, the testing standards of new drugs may be slackened, compromised and lowered. Since none of the new drugs do anything to cure the underlying problems caused by obesity it appears that their approval has more to do with the multi-billion market for weight loss drugs and less to do with helping people to regain their health. Drug company lobbyists have but pressure on the FDA in the amount of about $60 million to convince drug testers that the benefits of these five drugs outweigh their potential harmful side effects.

If you or a loved one are experiencing adverse side effects after taking a newly-approved weight loss drug, or any other weight loss drug you need to seek immediate medical attention. Please give our trial-ready Dallas dangerous drug attorneys a call for a free consultation during which time we will evaluate if you have a case against the drug company or others. We are zealous in our representation of clients who have been injured by the negligence of large companies seeking to make profits at the expense of the health and well-being of other and if we accept your case will represent you with our all-out efforts. Please call Reyes Browne Reilly today!

10 Dangerous Prescription Drugs on the U.S. Market Today

nodrugs-300x225Prescription drugs aren’t always safe. In fact, the U.S. Food and Drug Administration has recalled a number of prescription drugs and many drugs are under review because research has linked the drugs to dangerous side effects. Here’s a list of 10 potentially dangerous prescription drugs on the U.S. market today.

Low Testosterone Drugs

Research has linked low testosterone drugs to an increased risk of heart attack and stroke. Researchers published their results in November 2013 in the Journal of the American Medical Association as well as in PLOS One in 2014.

Ambien

The FDA warns that after taking this drug, patients may get out of bed while not fully awake. The patient may then do an activity without being aware of doing it such as sleep driving or sleepwalking.

Selective Serotonin Reuptake Inhibitors (SSRIs)

One of the major potential side effects of SSRIs is reduced blood clotting abililty. These are the most prescribed SSRIs.

  • Prozac
  • Zoloft
  • Paxil
  • Lexapro

Methotrexate

Methotrexate has some severe potential side effects. While rare, cirrhosis of the liver is a possible side effect, though this is more likely in patients who already have existing liver problems or who are taking other drugs that may be toxic to the liver, reports the American College of Rheumatology. The drug may also increase the risk of serious birth defects if women take the drug while pregnant.

Avandia & Actos

Avandia and Actos are diabetes drugs. Avandia may present an increased risk of heart attack and Actos may present an increased risk of heart failure and bladder cancer. In fact, the FDA restricts doctors from prescribing Avandia unless other diabetes medications have failed to be effective.

Corticosteroids

Prednisone and other corticosteroid medications can be effective in treating a variety of medical conditions. But there are certain side effects of which patients should be aware. There are different delivery methods for these drugs (oral, inhaled, injected, etc.) and the side effects depend on the type of delivery.

Some examples of side effects of oral corticosteroids include the following.

  • Glaucoma
  • Cataracts
  • High blood pressure

Pradaxa

Pradaxa is a blood-thinning drug that doctors prescribe for its anti-clotting benefits. But there is no antidote to the drug like there is for Warfarin, where doctors may administer vitamin K to reverse the effects if necessary. This can put some patients at risk of bleeding-related deaths.

Xanax

Xanax is a type of tranquilizer drug used to treat anxiety. Unfortunately, such drugs are widely abused and linked to serious dependency issues. It is also an FDA category D drug, meaning that it can cause harm to an unborn baby so pregnant women should not take it.

Statins for Cholesterol Reduction

Statins help patients lower their cholesterol, but some may come with potentially serious side effects. Some may suffer muscle pain and in rare cases, rhabdomyolysis.

Rhabdomyolysis is muscle damage that may also cause the following.

  • Liver damage
  • Kidney failure
  • Death (in the most severe cases)

Beta Blockers

Researchers publishing in the European Heart Journal found that beta blockers may be responsible for 800,000 deaths in Europe over a five-year time period. However, the journal retracted the article because it did not undergo a peer review.

Contact an Attorney if You Suffered Harm from a Dangerous Drug

If you suffered harm because of a dangerous drug, talk to an expert DFW dangerous drug attorney to review your legal options for recovering damages. Contact the team at Reyes, Browne & Reilley today at 214-526-7900.