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.

Third Bard Avaulata Bellwether Set for Trial, With More Cases On The Way

Angel Reyes III Dangerous Drugs, Personal Injury

illiegal-send-text-to-a-driver_61336417-300x200The tens of thousands transvaginal mesh cases have come to be one of the longer-running mass tort litigations in the history of such suits. These cases are more than 50,000 in number, and span the United States court system. Common to all of these cases are the complaints by affected plaintiffs of complications following the use of transvaginal mesh products to treat pelvic organ prolapse (when organs drop against the wall of the vagina) or female stress urinary incontinence. Among the various complications that have been complained of include pain during sex, erosion of vaginal tissue, infection, and even death.

In one of the most massive pre-trial consolidations of mass tort litigations in U.S. federal court history, pre-trial proceedings in seven different multi-district transvaginal mesh lawsuits have been consolidated before Judge Joseph Goodwin in the Southern District of West Virginia. Judge Goodwin will be overseeing discovery in these proceedings in order to avoid duplicative discovery in the various MDLs, to avoid conflicting rulings from judges and generally to increase the overall efficiency of the process. Also pursuant to these goals, bellwether programs have been established where certain cases will proceed to trial earlier in order to determine various aspects of these cases, how they will proceed to trial, and perhaps even if they will proceed to trial at all.

Several Bard Avaulta transvaginal mesh lawsuits are among these bellwether trials, and three have been set for trial dates in federal court beginning in July 2013. One has ended in a $2 million damage award, including punitive damages intended to punish Bard Avaulta and deter future indiscretions, another has settled, and a third originally scheduled to begin in November 2013 has been delayed several times and will now commence on May 19, 2014.

Of course, the bellwethers are only just the beginning, and now Judge Goodwin has outlined a procedure for 200 cases to go through case-specific discovery no sooner than 2015. The parties have been instructed to select cases that will proceed to trial within this next batch of 200, and at that point the parties will spend the remainder of 2014 in discovery on those cases so that trial can commence in 2015 after dispositive motions have been filed. Selection of these cases will be informed by considerations somewhat different from those of the bellwether cases, as the latter are perhaps more instructive in determining the outcome of later cases. This next batch of 200 will have a much more impactful financial outcome as opposed to a legal one, and will force the litigants to address slightly different concerns in selecting the cases that will next proceed to trial.

That said, many of these cases will find themselves back in U.S. District Courts throughout the country if and when Judge Goodwin determines that they be remanded for purposes of proper venue. At that point, the specific factual issues in each of these cases will be addressed before a fact-finder, unless the cases find their way to settlement before that time.

Ultimately, these TVM cases will not be disposed of for years to come, but with the three Bard Avaulta cases nearing resolution, they are certainly well on their way. Whether the third Bard Avaulta bellwether litigation will have substantial legal implications for the later cases to come remains to be seen.

Interested in the options available to those injured by transvaginal mesh? Contact our experienced team of dangerous medical device lawyers today.

Cases Consolidated in Androgel Litigation

Angel Reyes III Dangerous Drugs

testosterone-lawsuit-250x170

One such pharmaceutical — Androgel — is made by a company called AbbVie, a spinoff of Abbot Labs. The drug has been shown to address the problems associated with hypogonadism and that, together with the important nature of that condition has led to massive success of the drug. In 2010 the drug made $650 million in revenue, and by 2012 more than $1.2 billion,  and perhaps as high as $2 billion according to the New York Times. AbbVie’s advertising of the drug also amounted to a whopping $80 million in 2012.

While the drug has exhibited certain benefits for those with hypogonadism, studies have also shown that use of the Androgel drug can increase the risk of heart disease, stroke, and death by as much as 30%. As a result of the allegedly negative effects of the drug AbbVie has been hauled into court in a number of different Androgel lawsuits, many of which were filed in the Northern District of Illinois. Approximately 30 of those lawsuits were recently consolidated before the Hon. Matthew F. Kennelly as of March 14, 2014.

This is not the first time that AbbVie has been hauled into court over the Androgel product. In 2014, AbbVie was the subject of a U.S. Supreme Court case—FTC v. Actavis, Inc., 133 S. Ct. 2223 (2013)—in which AbbVie was found to be potentially violated anti-trust law when it paid makers of products that compete with Androgel to delay the introduction of those products to the marketplace. Now, AbbVie is being sued on products liability grounds, namely that the product is contributing to harm to men that use the product and even to women that come into contact with the product. Among the claims being brought by the plaintiffs in these various cases are allegations that AbbVie failed to warn consumers about the potential risks of the drug though they were known at the time of distribution, and negligence in the creation of the product itself.

Those allegations are not entirely without merit. When Androgel’s maker—Unimed Pharmaceuticals—was going through Food and Drug Administration (FDA) Approval, it disclosed to the FDA the results of various studies that must be conducted as a condition precedent to market approval. Yet it is possible that AbbVie downplayed the risk of heart disease and other negative implications of the drug in order to obtain market approval and generate sales.

Now, the allegations are being weighed in federal court with the consolidations of these various lawsuits in the Northern District of Illinois. Procedurally, it remains to be seen whether additional cases from other districts will be consolidated into those proceedings in something akin to Multi-District Litigation. That may place additional pressure on AbbVie to settle the claims and avoid a finding of liability for the drug-maker, particularly in the wake of the negative outcome in  FTC v. Actavis, Inc.

Have you or a loved one been adversely affected by Androgel or another Low-T supplement? If so, contact our team of trial-ready dangerous drug lawyers today.

Coloplast Acuerda a pagar $16 Millones en Restitución por Inserciones de la Malla Vaginal

Angel Reyes III Dangerous Drugs

030714-meshColoplast A/S pagará $16 millones para resolver demandas relacionadas con sus productos de malla vaginal. En más de 400 casos, las mujeres estaban buscando restitución por lesiones que ellas sufrieron mientras estaban usando los productos. Cada demandante recibirá alrededor de $40,000 en restitución.

Coloplast, con sede en Humlebaek, Dinamarca, también fabrica bolsas para la orina y para la ostomía, destinadas a pacientes que se recuperan de una cirugía. En el 2012, la Administración de Comida y Medicamentos de los EE.UU ordenó a los fabricantes de malla vaginal juntar datos acerca de las complicaciones derivadas de estos aparatos, incluyendo el daño al órgano.

Los demandantes en el caso han acordado no hablar públicamente sobre el acuerdo con Coloplast.

Los dispositivos son usados para sujetar los órganos internos, para el tratamiento del prolapso pélvico orgánico o para prevenir la incontinencia urinaria. Más de un millón de mujeres han usado el dispositivo desde 1999. Muchos usuarios sufren dolor y lesiones por el uso de la inserción. Los registros de la corte mostraron demandas por molestias, incontinencia, sangramiento, infección y otras quejas.

Coloplast era uno de los cinco fabricantes de inserciones de malla vaginal que se reuniría con abogados para discutir cómo resolver de mejor manera las 29,000 demandas. Johnson y Johnson no participó en las negociaciones. Esa compañía dejó de hacer los dispositivos cuando se presentaron las primeras demandas. Los gerentes corporativos de Coloplast hicieron el anuncio oficial de la negociación durante un anuncio de intercambio en la bolsa de valores.

Demandas similares están en proceso contra otros fabricantes de inserciones de malla vaginal. Estas acciones pueden resolver un acuerdo global por lesiones causadas por las inserciones de malla vaginal.