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

Angel Reyes III Dangerous Drugs, In The News

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

Angel Reyes III 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

Angel Reyes III 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 an 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.

Diabetic Drug Amputations Caused by Johnson & Johnson on the Rise

Angel Reyes III Dangerous Drugs

f4494f65e8f1617ce83d871aeb3c61_jumbo-238x300The U.S. Food & Drug Administration told Johnson & Johnson to include new warning labels on its diabetes drug Invokana, as well as variations of the drug sold under the brand Invokamet and Invokamet XR.

This latest requirement from the federal regulatory agency comes on the heels of other legal troubles faced by the corporation. Just two weeks ago, a jury awarded $110 million to a woman in Missouri who claimed that that J&J’s popular talcum powder products cause ovarian cancer.

The new black box warning informs individuals that they could face a higher risk of needing an amputation after taking Invokana (known generically as canagliflozin) or one of its derivatives. This comes from two large clinical trials, both of which demonstrated that the diabetes medication causes a significantly increased risk of leg and foot amputations. Black box warnings are the highest level of required warning for drugs manufactured and sold in the U.S.

According to the FDA safety communication released, the clinical studies showed that amputations were nearly twice as common in patients who took canagliflozin versus those who received a placebo. The studies, known as CANVAS and CANVAS-R, which were conducted by Johnson & Johnson as part of a larger cardiovascular study, shared similar results. The company had been hoping that the studies would show Invokana to be safe, but instead they revealed a need for even greater caution.

This is not the first time that Invokana has been the subject of safety concerns. In the past, the diabetes drug has been the subject of a number of lawsuits due to the drug’s side effects, including the increased risk of amputation.

If your leg, foot or toe was amputated after you took Invokana or Invokamet for type 2 diabetes, you may have the right to sue the maker of these drugs, Janssen Pharmaceuticals, Inc., a Johnson & Johnson company. Find more information in the Reyes Browne Reilley site, here.

Man Charged With DUI Of Caffeine

Angel Reyes III Dangerous Drugs, In The News

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“Don’t drink and drive,” a phrase in which the meaning is understood as do not consume alcohol and operate a motor vehicle.

A California man named Joseph Schwab has a case that challenges that understanding completely. He has been charged with driving under the influence of a drug – caffeine.

Mr. Schwab was arrested on August 5 of last year after being pulled over by a California alcoholic beverage control agent in an unmarked car. The agent claimed Schwab’s driving indicated he was driving under the influence.

A breathalyzer revealed a blood alcohol content of 0.00%.

Convinced he was on something, authorities took Schwab to jail and drew blood, which was tested in a laboratory. The blood test came back negative after it had been screened for cocaine, opiates, oxycodone and all kinds of other drugs few people can pronounce. Never one to give up, law enforcement sent the sample out to another laboratory, presumably to see if they could find anything in the blood.

They charged Schwab with driving while impaired after finding only caffeine in his blood, at which time the authorities decided to pursue the case against him.

Interestingly, the district attorney’s office insists that Schwab is not being prosecuted on the basis of the caffeine in his system.

I assure you that defendants in this country have the right to know the charges against them and the basis of those charges. It’s a fundamental right of our legal system. Schwab’s attorney has asked for any evidence beyond that which is mentioned above, which reports all drug findings to be negative except for caffeine–and so far she has been given nothing.

Because California defines the term “drugs” so broadly, a theoretical case could technically be brought before the court. They are many substances with the potential to affect your brain, nervous system or muscles. And if you have those “drugs” in your system and they prevent you from operating your vehicle in the same manner as a sober person, then you are impaired. Could coffee do that to you? Seems possible. So could many cold and allergy medicines too.

Meanwhile, Schwab’s attorney has asked the court to throw out his case so he can get on with his life.

 

Testosterone Bellwether Trials Set

Angel Reyes III Dangerous Drugs

Reyes Law - Dallas Texas

Testosterone replacement products bring in billions for drug companies each year. Some experts say that number could reach $5 billion by 2017.

Critics say drug companies pushed misleading ads to men seeking the fountain of youth.

In 2014, the consumer watchdog group Public Citizen petitioned the FDA to include a black box warning on safety labels. The agency initially responded to the petition by saying the FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. But in 2015, the FDA reconsidered and ordered drug makers to add stroke and heart attack warnings to labels and safety information.

Now, eight lawsuits that allege testosterone drugs caused heart attacks and blood clots will be heading to trial in 2017, according to court documents.

In August of this year, U.S. District Judge Matthew Kennelley signed an order selecting four heart attack and stroke claims and four blood clot cases for bellwether trials. The outcome of these cases could likely influence future litigation in more than 6,000 testosterone lawsuits pending before Judge Kennelley in The Northern District of Illinois.

These eight bellwether cases allege AbbVie, the maker of AndroGel, knew about the risk of cardiovascular issues such as heart attack, stroke and blood clots but did not warn patients and doctors, among other claims.

“The parties should assume that the Konrad case (Case No. 15 C 966) will be the first case tried, assuming it survives until trial,” Judge Kennelley wrote in his order. “The Court reserves for later determination the sequence of the remaining cases.”

Jeffrey Konrad’s lawsuit is the first scheduled for trial in 2017.

“To obtain the greatest benefit from the bellwether process, the cases selected for bellwether trials should offer guidance to the majority of other cases in the litigation,” plaintiff’s attorneys wrote in the initial bellwether proposal in July 2016. “The purpose of selecting initial trial cases from a large pool of bellwether discovery cases is to learn and test general issues for the benefit of all—the Court, Plaintiffs, and Defendants.”

Reyes Browne Reilley is a Dallas, Texas based Martindale-Hubbell AV-Rated personal injury law firm. Our Dallas personal injury lawyers have a nearly combined 100 years experience representing plaintiffs in personal injury, business, and dangerous prescription drug & device litigation. Call us today for a free consult to find out more.

Thanks to: drugwatch

FDA Asks If Faulty Blood Monitor Device Tainted Xarelto Clinical Trials

Angel Reyes III Dangerous Drugs, In The News

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?

Angel Reyes III 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 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

Angel Reyes III 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?

Angel Reyes III 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.