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.

Five Potentially Dangerous Diet Drugs Approved by FDA

Angel Reyes III 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.

The Hidden Dangers Of Generic Prescription Drugs

Angel Reyes III Dangerous Drugs

hidden-dangers-of-generic-prescription-drugs-300x300When brand name prescription drug manufacturers learn that their product has caused harm to a customer, they are required to notify doctors and potential consumers by sending letters or by adding an additional warning to their product label. However, the same rule does not apply to the manufacturers of generic drugs.

Currently, brand name drug manufacturers face liabilities under the “failure to warn” legal theory that says if they do not act quickly enough to keep others safe, they are held responsible. Generic drug manufacturers don’t have to worry about that. Instead, generic drug manufacturers are not allowed to change the labels on their products until the brand name equivalent has done the same. Once a brand name manufacturer has developed a new label resulting from potential harm to consumers, the FDA must approve it before it can be put into place.

Does the 2013 Generic Drug Supreme Court Ruling Place Consumers In Danger?

In a case from 2013, the Supreme Court ruled that patients who claim to be harmed or injured by generic drugs cannot file failure-to-warn lawsuits against generic drug manufacturers who use the FDA-mandated labels. This means that generic drug companies are free from legal risk if their product causes any type of harm or injury to consumers.

The FDA is currently in the process of proposing a rule that will allow the makers of generic drugs to update their warning labels once they learn of the risks of their products. The FDA believes this new rule will allow both generic and brand name manufacturers to be held to the same legal obligations, as well as allow generic manufacturers to act ahead of brand names to keep their consumers safe.

If the new proposed rule is adopted without changes, generic drug makers will be required to update their labels and be liable against failure-to-warn lawsuits. The FDA hopes this new rule will cause generic drug makers to be more proactive in finding out when drugs are harming consumers and work to better warn those at risk.

The generic drug market makes up more than 80% of the prescriptions market in the United States. Currently, these manufacturers are opposed to the new rule proposed by the FDA. They believe the current system has worked well for the past thirty years and will continue to do so. Generic manufacturers warn that adopting the proposed rule will cause generic drug costs to increase by up to $4 billion a year and lead to confusion regarding warning labels for the same drugs. Generic drug makers believe the FDA should be the ones who decide whether or not warning labels need to be changed and to notify who needs to make the changes.

Both sides of the House warn of different risks involved with updating the rule. However, when it comes to the FDA, their sole purpose is to keep consumers safe. If a proposed rule aims to help protect consumers both physically and legally, it is the responsibility of the FDA to push for that to become a rule that all drug manufacturers need to follow.

No Science Behind Low T Therapy?

Angel Reyes III Dangerous Drugs

low-testosterone-problems-300x199It is tough to turn on the TV these days and not see an advertisement for testosterone replacement therapy at some point. Getting more popular by the minute, testosterone replacement therapy promises to help men who suffer from low testosterone, or low T, to gain back the chemical that made them the men they were in their glory days. However, despite the growing popularity, there is little evidence to suggest that this treatment works and is worth the risks associated.

Testosterone treatment promises to give men more energy, the libido of a 20-year-old, and ability to have the muscle definition they once showed off. However, these results come with hefty risks. The two most common and deadly side effects of testosterone treatment are prostate cancer and heart attack.

Low T Therapy Risks May Outweigh Benefits

In some men, testosterone can cause blood veins to constrict, which creates blood clots. Depending on where the blood clot occurs, this can cause pulmonary embolism or a stroke. Testosterone can also cause men’s red blood cell count to increase, making doctors recommend men on testosterone therapy give blood every few months.

When men are diagnosed with prostate cancer, they are given androgen blockers that suppress male hormones. These blockers help the over productive prostate to slow down and ensure a man’s cancer doesn’t worsen. With testosterone therapy, however, men receive extra dosages of hormones that can often lead to prostate cancer.

Heart attacks are one of the leading causes of death among men, and a common side effect of testosterone treatment. In 2013, researchers noted that when compared to men who are not taking hormone replacements, men who take testosterone increased their risk of a heart attack by 30%.

Low testosterone treatment centers, including the Low T Center chain of clinics, claim that the rewards of testosterone treatment are worth the small risks. They claim that their centers regularly test men before they receive their treatment, ensuring their bodies can handle the hormone therapy. Centers like this claim that the positive results are easy to see, and that the reward of feeling and looking younger far outweigh the risks, even if that risk is death in some cases.

Low T is an actual medical condition called hypogonadism. Hypogonadism can be both secondary, where it the pituitary gland stops telling testicles to make testosterone, and primary, where the testicles stop producing testosterone. Hypogonadism affects roughly 7% of men under the age of 60, and 20% over the age of 60, despite advertisements for Low T treatment saying it is a common thing. Doctors believe men should only seek out testosterone therapy if they have hypogonadism or defective testicles, meaning sometimes men are just aging and don’t need to get injections or take pills.

The battle of whether or not Low T therapy and treatments should continue is far from over. On one side, doctors believe men just age naturally and losing hormones happens to everyone, just as it does to women. On the other side, Low T treatment clinics and drug producers believe that this is an issue men can and need to solve.

Before doing any sort of drastic treatment that alters the chemical make up of your body, go to your doctor for a full evaluation. You may be one of the unlucky ones whose body responds negatively to these treatments. For the most part, is it worth the risks to try to still bench more than 200lbs?

Low-T Drugs May Be Doing More Harm Than Good

Angel Reyes III Dangerous Drugs, In The News

low-testosterone-may-cause-harm-300x198Low-testosterone drugs are one of the most heavily prescribed drugs on the market, as low-T affects millions of middle-aged men. While low-T drugs have been available to the public via prescription for years, a September 2014 panel for the Food and Drug Administration recommended that drug manufacturers look into whether the drugs may increase users’ risk of heart attack and stroke.

Dangerous Side Effects of Low-T Drugs

The biggest concern facing those who take low-T drugs is the increased risk of stroke, heart attack, and death. A 2013 study published in the Journal of the American Medical Association monitored 8,709 men with low testosterone who underwent a coronary angiography in the Veterans Administration health system between 2005 and 2011, 1,223 of whom started low-T therapy after the coronary angiography.

Of the patients receiving testosterone therapy, 67 died, 23 had myocardial infarctions, and 33 had strokes. Overall, the men who took testosterone therapy were at about a 30 percent increased risk of adverse outcomes like those mentioned compared to the group that did not undergo the therapy.

A study published in 2014 in PLOS One also found an increased risk of heart attack among younger men with pre-existing heart disease and in older men who took testosterone therapy compared to those who did not.

Meanwhile, women exposed to low-T drugs – such as through contact with men using the drugs – may develop masculine characteristics (such as facial hair). Furthermore, exposure of a pregnant woman to the drug may cause harm to the unborn fetus. For children, exposure may cause enlarged sexual organs, aggressive behavior, advanced bone growth, increased sexual drive, and more.

The FDA Takes Action on Low-T Drugs

In 2014, the FDA stated that it was monitoring the risk from low-T drugs. One concern specifically mentioned – in addition to the studies detailing the increased risk of heart problems, stroke, and death – was the number of men taking testosterone therapy drugs. The FDA reported there had been a 65 percent increase in the number of sales of low-T products between 2009 and 2013, bringing into question the number of men taking the drugs for lifestyle reasons as opposed to medical reasons.

In response to the increase in the number of men taking the drug, as well as the studies revealing the potential harm of low-T drugs, the FDA announced in September 2014 to add language to labels restricting the drugs’ intended use. Furthermore, the FDA has asked outside experts to investigate the use of low testosterone drugs in certain patients – and whether or not current evidence still supports the use of low-T drugs for said patients – as well as the potential risks of taking these drugs. It also recommends manufacturers study the potential risk.

Common Low-T Drugs

There are a variety of low-T drugs currently on the market. Below is a list of common testosterone therapy drugs.

  • Androderm
  • AndroGel
  • Axiron
  • Delatestryl
  • Fortesta
  • Striant
  • Testim
  • Testred

What to Do if You’ve Been Prescribed Low-T Drugs

If you were prescribed low-T drugs and experienced negative medical side effects as a result, such as a heart attack or stroke, get help from a legal professional, as you may be entitled to compensation for damages. If your health complications were a direct result of your low-T medication, you may be able to recover damages like medical expenses, pain and suffering, and more.

At Reyes, Brown, & Reilley, our attorneys can provide you with more information about how to prove a low-T drug harmed you, how to file a claim for damages, and what types of compensation you may be eligible to recover. To speak to a trial-ready Dallas dangerous drug attorney about your case today, call our offices now at 214-526-7900.

Enhancement Medical Recalls Expression Gel for Undocumented Concentration

Angel Reyes III Dangerous Drugs, Medical Devices

08192014The Food and Drug Administration (FDA) has announced a recall of all units of Expression 1.5cc gel used in intranasal splint procedures. The gel, manufactured by Enhancement Medical, may have been manufactured without proper monitoring of the concentration of hyaluronic acid. Improper concentrations of active ingredients can cause adverse reactions in patients.

An initial recall of certain lots of Expression gel was issued in August 2013 after Enhancement Medical received 68 complaints of patients experiencing the following adverse effects after use.

  • swelling.
  • lumps.
  • firmness.
  • pain.
  • bruising.
  • redness.
  • itching.
  • discoloration.
  • and, development of hard nodules.

 

Enhancement Medical’s analyses of the recalled lots found that the adverse reactions were due to a hyper-concentration of hyaluronic acid. Further investigation led Enhancement Medical to recall all units since the original manufacture date of August 15, 2012 after the company was unable to confirm that the final concentration of all units of Expression gel contained the correct concentration of hyaluronic acid.

The FDA is also tracking cases where Expression gel was used as a dermal filler to fill facial wrinkles, a use for which the gel is not approved. Health care providers have been alerted to discontinue use of Expression gel for any reason and return any unused product to the manufacturer.

Medical device and drug recalls typically take place only after the FDA has received complaints of adverse reactions. It is important for patients and medical professionals to report unusual or severe side effects as soon as possible to help the FDA and manufacturers determine whether or not the product is defective or dangerous.

Low Testosterone Therapy – First The FDA, Now An MDL?

Angel Reyes III Dangerous Drugs, In The News

guy-pain-300x200Lately testosterone replacement treatments have been under fire for their deadly side effects. As a result, law makers are consolidating testosterone cases under the umbrella of what is known as a Multi-District Litigation (MDL) as innumerable injured men searching for attorneys to help them pursue cases against the manufacturers of these products. The MDL vehicle will consolidate cases surrounding the harmful effects of testosterone replacement drugs. So what exactly does it mean to be a part of a MDL? Does it mean the same thing as being a part of a Class Action?

Being a part of an MDLis different than being a part of a Class Action, despite some shared characteristics. An MDL is a ‘Mass Action’ whereby Plaintiffs share some of the necessary expenses in lawsuits filed against manufacturers of a certain products that have caused a large group of claimants to suffer injuries. For the purpose of judicial economy, the cases are grouped together for discovery and pretrial purposes and are consolidated in a certain federal court. In a Class Action Lawsuit, cases are filed on behalf of a group of people and all members of the class who meet certain qualifications will share in the pre-trial costs and in the ultimate settlement. Whereas, in a MDL, once the pretrial work is complete, a person will be evaluated as an individual, and settlement values will differ depending on the circumstances of each individual person and case.

Why is there a Testosterone MDL Forming?

Testosterone therapy has become a common treatment for men experiencing a certain condition that develops as men age. This condition, called hypogonadism or low testosterone, is defined as a general drop in testosterone levels, which often causes men to feel fatigued, depressed, or have a decreased sex drive. In an effort to reverse low testosterone, or Low T as it has been coined, men in the last decade have turned to testosterone replacement therapy. Despite the promise of bringing men back into their prime, many testosterone replacement products are now under fire because of the harmful side effects coming to light including an increased risk of stroke and life threatening cardiac events. Based on the large number of injuries, and therefore cases stemming from testosterone use, a panel of federal judges has ordered all testosterone product lawsuits to be filed nationwide in a centralized MDL.

If you have suffered a stroke, a heart attack, or a blood clot while using testosterone or have a family member that passed away while using testosterone, please contact one of our dangerous drug / defective medical device attorneys who can answer any questions about your possible case and will help find the best course of action for you.

Low Testosterone Might Not Be So Bad After All

Angel Reyes III Dangerous Drugs

man-cyclingTestosterone therapy is used by many men in order to boost hormone levels. Many patients believe the treatments will provide them with a new youth. Some specialists advertise more vitality and a better romantic life for men undergoing Testosterone replacement therapy. However, those treatments can carry their own risks, and dangers.

Most adult males have testosterone levels between 300 and 900 nanograms per deciliter of blood. Experts say hormone treatments are unlikely to help men who have testosterone levels in the normal range.

Testosterone is important both to provide a better love life for males, and for general health. A normal concentration of the hormone is known to be essential for preventing diabetes, osteoporosis and obesity.

However, hormone replacement therapy is also shown to lead to an increase in heart attacks in those who start the program. The risk is most prevalent among men over the age of 65 and those under 65 who have a previous history of hearth disease.

A new investigation of heart attacks among those men who received the treatment examined medical records of over 55,000 men. About 20 percent of these patients were over the age of 65. This was the largest study group ever examined for a correlation between heart attacks and testosterone therapy.

Study of the relationship between the hormone therapy and heart risk was profiled in the online journal Plos One.

Stakes Are High In Fresnius Medical Care Suit

Angel Reyes III Dangerous Drugs, Medical Devices

hemodialysis-patient-300x200With more than 650 cases filed against Fresnius Medical Care the stakes are growing ever higher in what may soon become the Fresnius Dialysis Multi-District Litigation. These cases—all of which allege patients suffered cardiac arrest or death as a direct result of the problems with Granuflo or NaturaLyte dialysate systems—have been filed in federal courts throughout the U.S., which may initiate a “bellwether” trial program in order to streamline claims pursuant to a more efficient resolution of the proceedings.

The cases are not particularly diverse insofar as they all allege similar failures by Fresnius to warn patients of Granuflo and NaturaLyte acid concentrates used during hemodialysis treatment. That lack of diversity in their legal claims renders the cases more susceptible to consolidation before a single Multi-District Litigation panel, which can address the issues raised in one proceeding so that the same issues need not be addressed for the first time by various judges throughout the country. While the decisions of the first “bellwether” cases are not binding upon later cases (meaning the outcome does not have to be the same), they are instructive. Furthermore, the earlier bellwether cases can lead to global settlements that will avoid the costs of additional litigation. The MDL process also reduces the likelihood that similar cases will have different outcomes, a situation that can result in discord among the various decisions of the federal courts and forum shopping by litigants.

The circumstances surrounding the litigation are suspect at best. The allegations surrounding the Fresnius dialysis solutions were encouraged, if not initiated, by an internal Fresnius memorandum that was leaked to the Food and Drug Administration (FDA). In 2011 Fresnius conducted an internal review of the products at their own clinics in an effort to determine if and to what extent there were negative effects associated with the acid concentrates used in the dialysis systems. Fresnius identified 941 instances of cardiac arrest during dialysis treatment in 2010 alone, but failed to provide that information to non-Fresnius clinics using those products.

Now, patients that underwent dialysis at non-Fresnius locations but using Fresnius products are pursuing legal action against the company for failure to warn about the potential defects in its products. Although Fresnius did eventually provide a warning letter to non-Fresnius healthcare providers regarding the potentially negative effects of the drug in March 2012, for many that was too little too late. Nevertheless, the FDA determined that warning to constitute a recall of GranuFlo and NaturaLyte products, which only lends further credence to the plaintiffs’ claims in these proceedings.

The parties are currently discussing the possibility of proceeding with Multi-District Litigation, which involves selecting test cases that will likely proceed to trial, and will have the potential to determine the outcome of the cases not selected, whether by settlement agreement or persuasive precedent. Each side will be allowed to select a certain number of cases, and each party will likely select the cases they are most likely to win. That said, the parties remain deadlocked on which cases will go to trial first, an important issue when considering that later cases will be easily influenced by earlier decisions. While cases are often factually distinguishable, these cases all revolve around similar claims, and federal courts are typically not interested in disagreeing on the law lest they be reversed on appeal. As a result, the battle over which cases come first is not likely to end without a fight on either side.

Ultimately, it remains to be seen whether the bellwether program will go ahead as planned. Case management conferences to be held in the near future may determine the outcome of that battle, and will likely have an impact on the legal war to ensue.