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Legal Blog by Las Vegas based Richard Harris Law Firm

Filed under: Drug Injury

April 1, 2020

Can Vaping make me more susceptible to COVID-19?

At this early point in both the vaping trend, and in the advent of the COVID-19, most experts well tell you it’s too early to tell if a statistical correlation exists between the two. However,…

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At this early point in both the vaping trend, and in the advent of the COVID-19, most experts well tell you it’s too early to tell if a statistical correlation exists between the two. However, COVID-19 is fundamentally a respiratory illness, so it stands to reason that there may be a relationship, or at least that vaping can make the effects of COVID-19 much worse.

Vaping Illness

Here’s what we know. In 2019, a new respiratory illness was identified which had a direct
correlation with vaping. This condition seemed to be most related to vaping THC and cannabinoid oils (CBD). Beyond 2019’s outbreak of vaping illness however, it is too early to determine the long-term effects of vaping with many studies underway, but long from completion. However, the condition left real respiratory injury to those diagnosed with the vaping illness. Some believe that such injuries could lead to reduced ability to fight off other respiratory infections and illnesses, such as COVID-19.

COVID-19

While more recently, the advent of the COVID-19 pandemic has required medical providers, and medical researchers, to learn an entirely new (novel) condition to provide treatment and care for new patients who found that they were exposed to and suffering from the COVID-19 virus health effects. It must be said the evidence is preliminary, however, it appears that among those who are being admitted for treatment for COVID-19 are a larger group of younger people than expected. While most younger people ultimately recover from COVID-19 the question remains, what caused them to be susceptible in the first place?

So far deaths and serious illness from COVID-19 seem to be largely concentrated among older people who also have underlying health issues such as COPD, diabetes, cancer and other respiratory conditions. However, some younger people, among the same group who have adopted vaping as their nicotine dose of choice, also seem to be requiring hospitalization to a greater degree than expected.

No Smoking Gun

As stated previously, it’s too early to tell in both the development of vaping, and the current run of COVID-19 to be able to reference a study between the two which would find some statistical correlation, however, many in the field are making educated guesses. Dr. Nora Volkow of the NIH writes: “But we can make educated guesses based on past experience that people with compromised health due to smoking or vaping and people with opioid, methamphetamine, cannabis, and other substance use disorders could find themselves at increased risk of COVID-19 and its more serious complications.”

Dr. Joanna Cohen, of the Johns Hopkins Bloomberg School of Public Health states: “It’s so early in terms of the studies that are being done, but I think it’s certainly a possibility that vaping and inhaling foreign substances into your lungs could make you more susceptible to other lung infections, and I guess what I would suggest is that young people shouldn’t think that they’re immune to COVID-19, particularly if they’re vaping. You might just want to get checked to make sure that it’s nothing serious if you’re having any respiratory symptoms.”

The Richard Harris Law Firm sues vaping companies for injuries

While the connection between vaping and COVID-19 has not been established yet, it is clear that vaping can and has caused respiratory illness, among other injuries due to explosions and other unexpected behaviors of defective vaping pens. Our firm sues companies who market products which are dangerous to their users. If you have been injured due to a vaping accident or are suffering respiratory illness due to usage of a vaping product or another defective product, call our office today to discuss your case at (702) 213-9779.

Learn More:
https://time.com/5807214/vaping-coronavirus/
https://www.cbsnews.com/news/does-vaping-make-you-more-susceptible-to-coronavirus/
https://www.drugabuse.gov/about-nida/noras-blog/2020/03/covid-19-potential-implications-individuals-substance-use-disorders

Filed under: Drug Injury

May 25, 2019

Not For Human Consumption: the Dangers of SARM’s

[caption id="attachment_5003" align="alignnone" width="1254"] Young man flexing his muscles in the local gym[/caption] Nutritional Supplements have always been a hit or miss proposition.  Whether you achieve the promised effects of the products aside, they can…

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Young man flexing his muscles in the local gym

Nutritional Supplements have always been a hit or miss proposition.  Whether you achieve the promised effects of the products aside, they can do harm to you.  Many supplement manufacturers are less than honest about what’s in the products they market, with the ingredients label being only a shadow of the actual contents of the product inside the bottle.  It’s a huge marketplace, estimated to be about $60 billion within 3 years, that is largely unregulated.

What are SARM’s?

Selective Androgen Receptor Modulators (SARM’s) are products which promise a lot but may deliver something completely different.  Known as a legal alternative to steroids, SARMS are sold with a number of promises including enhanced energy levels, increased athletic performance, reduced anxiety, treatment of inflammation, increased muscle size and definition, and improvements in sexual performance.  Who wouldn’t want such a product?…and the product flies off the shelves at $50 to $80 per bottle at supplement stores and through online vendors.  However, there is no magic in a bottle, and you may be getting more than you bargained for.

Studies confirm: Buyer Beware

An October 2018 study in the Journal of the American Medical Association (JAMA) found that many supplements contain ingredients not listed on the bottle including pharmaceutical ingredients, such as sildenafil (the active ingredient in Viagra), sibutramine for weight loss, and synthetic steroids or steroid-like substances for muscle building.  It may be fine to take such ingredients, if you knew they were there, but the study found that in many cases, there was no disclosure of these substances on the label.  This increases the potential danger of interaction with prescription drugs that a user of SARM’s may be taking.  Since the product is not a prescription drug, many users may be tempted to overuse them, which increases the risks.

A 2017 study also found in JAMA, found that many products sold as SARM’s actually didn’t contain them.  Out of the 44 products included in the study, only half included SARM’s in the product, and over a third contained an unapproved drug.  25% contained ingredients not on the label, and 10% contained no active ingredient at all.

Are SARM’s sold in Las Vegas?

As reported by Darcy Spears of Channel 13 in a hidden camera investigation, SARM’s sold at a local Las Vegas supplement outlet, were actually labeled, “Not For Human Consumption” and yet, they were still for sale for humans.  After the investigation aired, however, that company made changes to their policies and they may be harder to find now.  Certainly, you may find something sold as a SARM product in Las Vegas, however, based on the above, whether that’s what you will get is still an open question.

The Richard Harris Law Firm represents those injured by Dangerous Products

Our firm has designated lawyers whose primary responsibility is representing clients who have been injured by dangerous products.  If you have taken an unregulated supplements or other dangerous products and were injured by their use, you may have a cause of action against the manufacturer of the products.  Call our office today to discuss your potential case at (702) 444-4444.

Learn more:

https://www.ktnv.com/news/investigations/high-price-of-performance

https://www.menshealth.com/health/a19543957/sarms-bodybuilding-supplements-not-safe/

https://jamanetwork.com/journals/jama/article-abstract/2664459?resultClick=1

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706496

Filed under: Drug Injury

April 18, 2019

Opioid Case Review

THE OPIOID CRISIS 50,000 people die in the United States each year due to opioid overdoses.  That is almost the equivalent of the total number of U.S. soldiers who died during the entire Viet Nam…

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THE OPIOID CRISIS

50,000 people die in the United States each year due to opioid overdoses.  That is almost the equivalent of the total number of U.S. soldiers who died during the entire Viet Nam war.  How did this happen?  At one-point in the not too distant past, opioid addiction almost exclusively resulted from the illicit use of street heroin.

Most of the opioid deaths today however are not your normal addicts looking for the heroin high or needing to stave off withdrawal.  Among today’s opioid deaths are those being treated for chronic pain, or recovering from surgery, and becoming addicted to opioids through prescriptions from their doctors.  What caused this epidemic to mushroom as it has, over the last 20-30 years?

A professor at Albert Einstein College of Medicine, Dr. Russell Portenoy, had much to do with todays problems.  He was an early advocate of using opioids for treatment of chronic pain.  Starting in the late 1980’s, Portenoy threw his support for this treatment in medical journal articles, at physician conferences, and with regulators, indicating that the drugs were safe and would not lead to addiction, even though the drugs he was advocating were very similar chemically to heroin.

His message was received, and doctors began to increase their prescriptions of Oxycontin, Percocet, Vicodin, Percodan, and Demerol, among others, for prescription treatment for the millions of patients suffering from chronic pain.  Dr. Portenoy was recently named as a defendant in lawsuits brought by municipalities and states throughout the country attempting to hold opioid manufacturers responsible for the cost of treatment and rehabilitation for victims.

Dr. Portenoy has recently agreed to change sides and is offering to testify for the plaintiffs and to provide records of payments from the manufacturers and to reveal the manufacturers roll in this matter.  The manufacturers, who include Purdue Pharma, Endo, Abbvie, Johnson & Johnson (J&J), and Validus Pharmaceuticals, have made billions by aggressively promoting the use of these drugs.

The exposure of the manufacturers is enormous. Purdue Pharma recently settled with the state of Oklahoma, agreeing to a $270 million payment to the state, of which $102 million will be used to establish a new National Center for Addiction Studies and Treatment to be located at Oklahoma State University in Tulsa.  While this may seem small in comparison to the billions that Purdue took in, this is just one state and only one manufacturer.

In Cleveland Ohio, cases from around the country have been consolidated into a Multi-District Litigation designated MDL 2804.  Even though this MDL was begun just over a year ago, there are currently over 1,700 cases in this MDL, many being government entities and State Attorneys General, seeking reimbursement for increased costs to treat and rehabilitate patients with addiction.  Many individual patients are also included in this MDL.  Additionally, over 300 cases are progressing in state courts across the country.  While Purdue may have dodged the bullet in Oklahoma, there is still a long way to go, and many more states and patients with claims to be heard.

The Stackler family who owns the privately held Purdue Pharma, have increased their personal wealth by $4 billion through their aggressive marketing of opioids.  Purdue and the other manufacturers are being held liable for aggressively marketing the drugs through payments to “third parties,” lobbying to block state legislatures and regulators from restricting opioid use, all the while minimizing the dangers of addiction that could result from these drugs.  J&J in addition to reckless and deceptive marketing, actually owned a poppy producer in Australia, and a U.S. import company which brought he raw materials to the U.S. to make the product.

The manufacturers are being accused of conspiring with each other, committing fraud, being negligent, and are expected to attempt to reach a global settlement which includes indemnification from future claims.  The first bellwether case is scheduled for October 21.

The Richard Harris Law Firm represents victims of Dangerous Drugs

If you or a loved one have been injured or died due to a dangerous drug, call our office today to discuss your potential case at (702) 444-4444.

Learn More:

https://www.reuters.com/article/us-usa-opioids-litigation-exclusive/exclusive-pain-care-specialist-agrees-to-testify-against-purdue-other-drug-makers-court-documents-idUSKCN1RJ0PG

https://www.npr.org/sections/health-shots/2019/03/26/706848006/purdue-pharma-agrees-to-270-million-opioid-settlement-with-oklahoma

https://www.nytimes.com/2019/01/30/health/opioid-lawsuits-settlement-trial.html

Filed under: Drug Injury

December 26, 2018

Taxotere and Permanent Hair Loss

Chemotherapy is one of the most effective treatments for a wide range of cancers, but it comes with an often-traumatic side effect: hair loss. Patients who experience hair loss lose hair all over their bodies,…

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Chemotherapy is one of the most effective treatments for a wide range of cancers, but it comes with an often-traumatic side effect: hair loss. Patients who experience hair loss lose hair all over their bodies, but it typically regrows after treatment ceases.

However, one popular chemotherapy drug is linked to permanent hair loss. Taxotere was approved by the U.S. Food and Drug Administration in 1996 to treat cancers of the head, neck, stomach, prostate, and lungs. A 2013 U.K. study found that up to 15 percent of women who took Taxotere to treat their cancers experienced permanent hair loss.

Sanofi-Aventis, Taxotere’s manufacturer, issued a warning concerning permanent hair loss—or irreversible alopecia—on the labels of the medication in the European Union and Canada beginning in 2005. But the warning wasn’t added to Taxotere packaging and labels in the U.S. until several years later, putting thousands of patients at risk for permanent hair loss.

Did You Experience Permanent Hair Loss? You Deserve Compensation.

Being diagnosed with cancer and undergoing the often-debilitating treatment process can be stressful and traumatic. Side effects such as nausea and hair loss only make it more difficult for patients, but for some, the latter is permanent—leading to anxiety, reduced self-esteem, and depression.

At Richard Harris Personal Injury Law Firm, we believe that anyone who suffered permanent hair loss after taking Taxotere should be fairly compensated. If you or someone you love experienced irreversible alopecia due to Taxotere usage, call us today for a free consultation.

Filed under: Blog, Drug Injury

October 18, 2018

Zostavax Shingles Vaccine Linked to Serious Side Effects

When you get a vaccine, you typically don’t expect to actually get the disease the vaccine is meant to prevent. But many users of Zostavax, a vaccine manufactured by Merck & Company to prevent shingles…

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When you get a vaccine, you typically don’t expect to actually get the disease the vaccine is meant to prevent. But many users of Zostavax, a vaccine manufactured by Merck & Company to prevent shingles (herpes zoster), have reported contracting recurring cases of a more severe form of shingles than normal, which is more difficult to treat. Side effects of this strain of shingles includes nerve damage, stroke, and even death.

Five months after receiving the Zostavax vaccine, a New York man named Norman Sukkar was hospitalized and diagnosed with acute transverse myelitis (inflammation of the spinal cord). He was left unable to walk as a result, and he has filed a lawsuit against Merck & Company in New Jersey.

Another plaintiff, a woman, filed suit in Pennsylvania when she developed blurred vision, dizziness, and headache within 24 hours of receiving Zostavax in 2014. She is still suffering from right eye injuries, elevated blood pressure, dizziness, and other physical and emotional injuries.

Side Effects of Zostavax

Our lawyers are now accepting cases from those who suffered these side effects within one to two years after being treated with Zostavax:

  • Autoimmune disorders such as Guillain-Barre Syndrome, chronic inflammatory demyelinating polyneuropathy, Meniere’s disease
  • Bell’s palsy (facial paralysis)
  • Cardiovascular events
  • Congestive heart failure
  • Death
  • Hearing loss
  • Herpetic neuralgia (nerve damage)
  • Myelitis (spinal cord inflammation)
  • Pneumonia
  • Postherpetic neuralgia (PHN) (Pain continues after Shingles blisters subside)
  • Encephalitis (brain inflammation)
  • Stroke
  • Vasculitis
  • Vision problems including blindness, eye infections, retinal damage, acute retinal necrosis

What is Shingles?

Shingles is a viral infection that causes a blistering rash and deep nerve pain. The rash can develop on the back or side of the body, or on the face. Shingles, also known as herpes zoster, is caused by the same virus that causes juvenile chicken pox. It is believed that the chicken pox virus recedes into the nervous system and is reactivated in adulthood by weakened immune function due to stress and other factors, although the mechanism for reactivation is not well understood. Those who have developed shingles are less likely to have recurrence, although it is possible.

What is Zostavax?

According to Zostavax.com, “Zostavax is a vaccine that is used for adults 50 years and older to prevent Shingles (also known as zoster).” “Possible side effects include redness, pain, itching, swelling, hard lump, warmth, or bruising at the injection site, as well as headache.” “Zostavax contains weakened chickenpox virus.”

However, many patients have suffered other, more severe side effects than those itemized on the Zostavax website. Zostavax is administered through a one-time shot given by your doctor. It is reported to be little more than 51% effective in preventing shingles. The Centers for Disease Control and Prevention (CDC) is now recommending a newer and more effective vaccine for shingles, called Shingrix, which is 98% effective against shingles for patients between 50 and 69 years old.

Zostavax was approved by the U.S. Food and Drug Administration (FDA) in 2006. Since then over 36 million doses of Zostavax have been given through 2017. Merck & Company generated $749 million in revenue from sales of the vaccine in 2016 alone.

Zostavax Lawsuit History

Several hundred Zostavax lawsuits have been filed against Merck & Company nationwide. Most are filed in California and New Jersey state courts. Over one hundred have been filed in federal courts. In August 2018, New Jersey consolidated approximately 800 state court cases into a Multi-County Litigation. The roughly 100 federal cases have been consolidated into a Multi District Litigation. There are 111 cases at the federal level as of September 2018.

These cases accuse Merck & Company of distributing a dangerous product with serious side effects, that the side effects are serious and can cause death, failing to warn patients and medical providers of the potential side effects of Zostavax, and that Merck & Company lied about the safety and effectiveness of Zostavax in order to generate revenue from this faulty product.

The Richard Harris Personal Injury Law Firm is Your Nevada Zostavax Lawyer

Drug manufacturers have a legal obligation to distribute products that are safe, and they must disclose side effects to patients and medical providers which they knew or should have known about prior to distributing the product. Zostavax is a drug which has serious side effects that the manufacturer, Merck & Company, has not warned of, and in fact which they deny. If you were given the Zostavax vaccine since 2006 and developed any of the side effects listed within one to two years after the vaccination, you may be entitled to compensation for your injuries. Call the Richard Harris Personal Injury Law Firm today to discuss your case at (702) 444-4444.

Filed under: Blog, Drug Injury

July 26, 2018

Onglyza® Heart Failure Cases Increasing

Onglyza® (saxagliptin) is an oral medication prescribed for the treatment of Type 2 diabetes, otherwise known as Adult Onset Diabetes. It has been linked by studies to serious side effects, which can result in heart…

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Onglyza® (saxagliptin) is an oral medication prescribed for the treatment of Type 2 diabetes, otherwise known as Adult Onset Diabetes. It has been linked by studies to serious side effects, which can result in heart failure and death. In April 2016, based on studies that found users of the drug were 28% more likely to develop heart failure than users receiving placebo, the U.S. Food and Drug Administration (FDA) required makers of the drug to include a label warning of increased risk of heart failure.

Onglyza and Kombiglyze® XR were jointly developed by Bristol-Myers Squibb (BMS) and AstraZeneca (AZ) and are jointly marketed by both companies. Saxagliptin, the active ingredient in both drugs, is part of a class of drugs known as DPP-4 inhibitors, which were designed to control high blood sugar in patients suffering from Type 2 diabetes.

Regulatory History

Approved by the FDA in 2009, Onglyza was initially hailed as the biggest breakthrough in diabetes treatment since insulin. As early as 2011, consumer groups began warning users to discontinue use of the drug until side effects could be further evaluated.

Based on studies, such as those published in the Journal of the American Medical Association (JAMA), which found that users were more likely to be hospitalized for heart failure, and another published in the New England Journal of Medicine (NEJM) that showed users were 30% more likely to be hospitalized for heart failure, the FDA required labeling changes that warned medical providers and patients of the increased risks. The labeling requirement went into effect in April 2016.

In 2015, Express Scripts, a national prescription drug insurance provider, dropped Onglyza from its National Preferred Formulary, the most widely used formulary in the U.S. Express Scripts coverage guidelines affect which drugs are insured for over 25 million Americans.

Legal Actions

In 2015, a lawsuit was filed alleging that the plaintiff’s father, who had commenced use of the drug in 2010, died of heart failure in 2013. The suit blamed the manufacturers for marketing a drug but failing to warn medical providers and patients of its dangerous side effects.

Currently, there are 210 Onglyza cases at the federal level, which have been consolidated into a multi-district litigation (MDL), MDL 2809, presided over by Judge Karen Caldwell in the Eastern District of Kentucky.

The number of cases has been increasing with some predicting that it may number over 1,000 cases.

The Richard Harris Personal Injury Law Firm Represents Those Injured by Onglyza®

If you or a family member were prescribed the diabetes treatments Onglyza or Kombiglyze XR prior to April 2016 and later developed heart failure, contact our office to discuss your case. You may be entitled to compensation for your injuries. Call our office today at (702) 444-4444.

Learn More:

https://www.fiercepharma.com/pharma/az-bms-slapped-14-lawsuits-over-onglyza-heart-failure-risks

https://www.prnewswire.com/news-releases/onglyza-heart-failure-lawsuits-move-forward-as-federal-litigation-issues-first-practice-and-procedure-order-bernstein-liebhard-llp-reports-300611609.html

http://www.rxdangers.com/drugs/onglyza-heart-failure/

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Filed under: Blog, Drug Injury

May 17, 2018

Nexium®, Prilosec, Prevacid®, and Kidney Damage

Life is stressful, and in many cases, that stress shows up in our stomachs in the form of heartburn and other stomach distress. That’s ok, because we can just go to the corner drugstore and…

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Life is stressful, and in many cases, that stress shows up in our stomachs in the form of heartburn and other stomach distress. That’s ok, because we can just go to the corner drugstore and pick up some medication for the acidic stomach. Our society has been doing it for years since the advent of antacids, such as TUMS® and Rolaids®, among others. These medications neutralized stomach acid and could be taken frequently, with many users taking multiple tablets until the heartburn subsided with little effect on overall health.

However, these habits do not apply to some of the newer heartburn medications, which actually reduce or block the production of stomach acid by inhibiting the body’s mechanisms which produce acid. In fact, overuse of newer heartburn medications has been shown to have serious and sometimes dangerous side effects.

In particular, overuse of Nexium®, Prilosec, and Prevacid® has led to serious and sometimes fatal side effects due to the effects they have on other body systems. These drugs have been linked to higher risks for decrease in bone density, dementia, kidney disease, and heart attacks.

While these medications in prescription and over-the-counter (OTC) strengths are some of the top-selling meds in the U.S. with annual profits of $14 billion, there has been little effort by the manufacturers to explain to users that the drugs must be used as little as possible and discontinued at the earliest time that symptoms subside.

Why are these drugs different?

Nexium, Prilosec, and Prevacid are part of a class of drugs called Proton Pump Inhibitors (PPI). PPIs work by diminishing the amount of acid generated by glands inside the stomach.

A recent Stanford University and Houston Methodist Hospital study found that not only do PPIs stop stomach acid pumps from creating acid, but they actually stop all cells in the body from creating acid, which hampers the body’s ability to rid itself of damaged proteins. Researchers believe this explains many of the complications that result from PPI overuse. John Cooke, MD, PhD, and chair of Cardiovascular Disease Research at Houston Methodist declared, “I think we now have a smoking gun.”

In June 2017, the medical journal Kidney International published a study which indicated that long term users of PPIs were at increased risk of Acute Kidney Injury (AKI) and chronic kidney disease (CKD).

Regulatory Actions

Since 2010, the U.S. Food and Drug Administration (FDA) has increasingly required manufacturers to disclose warnings of possible side effects connected to use of PPIs.

  • 2010 – FDA requires PPIs to include information regarding increased risks of fractures of the wrist, hip, and spine due to PPI use.
  • 2011 – FDA Safety Communication warns of possible low magnesium levels for users taking PPIs for a year or longer leading to muscle spasms and irregular                                             heartbeat.
  • 2012 – FDA warns PPI use can lead to Clostridium difficile-associated diarrhea.
  • 2014 – FDA warns that taking PPIs for three years or longer can cause B12 deficiency.
  • 2014 – FDA requires PPI manufacturers to include warning of increased risk of interstitial nephritis on product labels.
  • 2016 – FDA requires label changes to include risk of lupus erythematosus, a condition in which the body’s immune cells attack other cells or organs.

Lawsuits Status

At the federal level, there are currently over 2,000 cases, which due to similar questions of fact and law, have been consolidated into a Multi-District Litigation (MDL). The case, MDL 2789, Proton-Pump Inhibitor Products Liability Litigation, will hold a “Science Day” during the week of May 17 where presentations on the medical and scientific issues connected to PPIs which are likely to be heard during the litigation will be discussed. Settlements of these cases are still some time away, but the pre-trial discovery is continuing.

The Richard Harris Law Firm is Nevada’s PPI Lawyer

When PPIs were first introduced, they were prescription only, but were later introduced as OTC (no prescription needed) drugs. Unfortunately, little to no education or warning was given to users of this class of drugs to differentiate them from other heartburn treatments. Even though connections between PPI use and kidney side effects have been known since 2004, the manufacturers did not add warning labels addressing the potential kidney problems until the FDA required it in 2014.

Cases allege that the manufacturers withheld this information from patients and medical providers and in fact heavily marketed the drugs as safe to use in order to support sales of this popular product. Manufacturers have a responsibility to provide safe products to patients and can be liable for failure to warn users of potential dangers. If you have taken a PPI for a year or longer and have suffered kidney problems, call our firm today to discuss your potential case at (702) 444-4444.

Learn More:

https://www.webmd.com/heartburn-gerd/news/20160608/proton-pump-inhibitor-health-risks#1

https://www.kidney-international.org/article/S0085-2538(17)30005-4/fulltext

https://www.drugwatch.com/proton-pump-inhibitors/lawsuits/

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Filed under: Blog, Drug Injury

May 10, 2018

Abilify® Settlement Negotiations Underway

Abilify® Settlements Reached With Three Plaintiffs We talked about Abilify® (aripiprazole) and its connection with impulsive gambling previously on this blog. We also reported that the manufacturers, Bristol-Meyers Squibb (BMS), and Otsuka Pharmaceutical Company, had settled…

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Abilify® Settlements Reached With Three Plaintiffs

We talked about Abilify® (aripiprazole) and its connection with impulsive gambling previously on this blog. We also reported that the manufacturers, Bristol-Meyers Squibb (BMS), and Otsuka Pharmaceutical Company, had settled a $19.5 million claim by 41 state Attorney Generals and the District of Columbia due to illegal marketing of the drug to patients with conditions for which the U.S. Food and Drug Administration (FDA) had not approved the drug for treatment.

Defendants Bristol-Meyers Squibb (BMS) and Otsuka Pharmaceutical Company have now settled three cases which were scheduled to go to trial in the second half of 2018. These cases are three of more than 800 cases in the federal court system which, due to similar questions of fact and law, have been consolidated into a Multi-District Litigation (MDL). These three cases were designated “bellwether” cases since the jury reaction to evidence and the trial outcomes would have significant influence on the potential outcomes of the remaining cases.

Terms of the settlement have not been disclosed as of this date, and it is unclear and unlikely that these settlements will have any bellwether effect on the remaining cases. The presiding judge in this MDL has set another round of bellwether trials for 2019.

At the state court level, other Abilify cases are pending in New Jersey state courts. Bellwether trials could begin in New Jersey state court later in 2018.

What is Abilify®?

Abilify is a medication used to treat depression, bipolar disorder, and schizophrenia. It is one of a class of drugs known as dopamine agonists and affects the dopamine and serotonin levels in the brain. It is intended to balance those levels but has been shown to have the unintended side effect of compulsive behaviors related to eating, shopping, high-risk sexual behaviors, and gambling. These behaviors have been observed to begin after commencing Abilify treatment and stop abruptly upon cessation of use of the drug.

Abilify is the top selling drug in the United States and generated $6.4 billion in revenue in 2013. It is sold worldwide, and these behaviors have been reported in studies published by the National Institutes of Health (NIH) in 2015 and the British Journal of Psychiatry (BJPsych) as early as 2011.

Regulatory bodies in other countries, such as Canada and those in the European Union, required warning labels and notification of medical providers about these side effects in 2012, so Abilify’s manufacturers were well aware of the potential side effects but didn’t publish any such warning to patients or medical providers in the U.S. until required to do so by the FDA in 2016.

Lawsuits filed by plaintiffs in the MDL allege that BMS/Otsuka knew about the potential risks associated with use of the drug but withheld that information from the U.S. market—their largest market for sales of the drug—in order to maintain sales and maximize profits rather than protecting the users of the drug from its devastating side effects. Plaintiffs have reported excessive gambling losses, loss of employment, and divorce, which they maintain may not have occurred had the manufacturers added proper warning labels and informed medical providers of the risks.

Richard Harris Law Firm is Nevada’s Abilify® Lawyer

The Richard Harris Law Firm is evaluating cases where patients have been prescribed and treated with Abilify and have significant, documented losses due to gambling while under treatment with the drug. If you have experienced this, call our firm today to discuss your case at (702) 444-4444.

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Filed under: Blog, Drug Injury

April 26, 2018

Tasigna® Leukemia Medication Linked to Atherosclerosis

Lawsuits are mounting in the U.S. from patients or their surviving families against Swiss pharmaceutical manufacturer Novartis Pharma Stein AG due to complications suffered after use of their leukemia treatment Tasigna® (nilotinib). Lawsuits allege that…

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Lawsuits are mounting in the U.S. from patients or their surviving families against Swiss pharmaceutical manufacturer Novartis Pharma Stein AG due to complications suffered after use of their leukemia treatment Tasigna® (nilotinib). Lawsuits allege that use of Tasigna causes “severe, accelerated, and irreversible forms of atherosclerosis.” Atherosclerosis is a cardiovascular disease that causes plaque to form inside the arteries, and is a cause of peripheral artery disease, limb amputation, and death. Furthermore, it is alleged that Novartis has known about these risks, but has suppressed that information from patients and medical providers in the U.S.

What is Tasigna®?

Tasigna is a treatment for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML). It is part of a class of drugs known as tyrosine-kinase inhibitors which block a protein called Bcr-ABL to stop the growth of cancer cells. Tasigna sales are estimated to be over $2.5 billion per year.

Peer Review Finds Link to Atherosclerosis

The drug was approved by the U.S. Food and Drug Administration (FDA) in 2007. By 2011, peer review journals began reporting on clinical studies that found that use of the drug caused increased risks of atherosclerosis. As a result of such studies, in 2013, Health Canada, that country’s equivalent to the FDA, required Novartis to add warning labels to the product associating use of the drug with the increased risk of atherosclerosis. No similar warning has been added to the drug being sold in the U.S., in spite of Novartis’ awareness of the potential problems.

In 2013, the journal Leukemia reported that patients treated with Tasigna had higher rates of arterial disease than those being treated with imatinib.

Study results published in the American Journal of Hematology in 2016 also found increased risk of peripheral artery disease and sudden death in users of Tasigna.

What is Atherosclerosis?

A disease of the arteries, atherosclerosis causes plaque buildup inside the arteries, narrowing the path of blood flow and resulting in reductions in oxygen-rich blood to the heart and throughout the body. When plaque builds up, pieces of plaque can break off and are carried by the blood stream to other parts of the body causing blockages and complications. Some side effects of atherosclerosis are heart attack, stroke, coronary heart disease, chest pain, peripheral artery disease, limb amputation, and death.

Legal Action

The first Tasigna wrongful death lawsuit was filed against Novartis in 2016 by the surviving family members of Dainis Lauris. Mr. Lauris took Tasigna beginning in 2012 and continued it for just over a year before his femoral artery closed off completely due to atherosclerosis. He also suffered a 40-60% narrowing of the coronary arteries, and a 70% narrowing of his cerebral arteries. Once his oncologist read a medical journal linking Tasigna to atherosclerosis, he took him off the drug, but the damage was done, and Mr. Lauris died in March 2014.

Another case filed in February 2018 involves a Washington man, Bruce Becker, who developed a stroke soon after being prescribed Tasigna. Mr. Becker, who did not have any atherosclerosis conditions at the time he was placed on Tasigna, quickly developed the condition, which resulted in a stroke.

The Richard Harris Law Firm is Nevada’s Tasigna® Attorney

Users of the Leukemia treatment Tasigna are reporting complications due to the use of the drug. Peer journals are finding increased risks of developing atherosclerosis due to the use of the drug. The manufacturer of the drug, Novartis, is aware of the links between this drug and increased incidents of atherosclerosis in users, yet they have failed to provide warnings to patients and doctors in the United States. This is in spite of Canadian drug regulators requiring warning labels be placed on all sales of the drug in Canada. Perhaps Novartis doesn’t want to disturb their multi-billion-dollar revenue stream in the massive U.S. market.

If you or a loved one has been prescribed Tasigna for leukemia and developed atherosclerosis resulting in heart attack, stroke, amputation, or death, we are interested in speaking with you about your case. Call our office today at (702) 444-4444.

Read More:

https://onlinelibrary.wiley.com/doi/abs/10.1002/ajh.22051

https://www.ncbi.nlm.nih.gov/pubmed/23459450

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26659a-eng.php

http://egslitigation.com/wp-content/uploads/2017/03/0087-Second-Amended-Complaint-3-16-17.pdf

https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2018-02-26-Complaint.pdf

https://www.corporatecrimereporter.com/news/200/novartis-to-pay-390-million-to-settle-false-claims-charge/

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Filed under: Blog, Drug Injury

April 19, 2018

Invokana® Cases Heading to Trial in 2018

Dangerous side effects due to the use of the prescription drug Invokana® have been identified. Since the last time we wrote about Invokana less than a year ago, the number of Invokana cases in the…

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Dangerous side effects due to the use of the prescription drug Invokana® have been identified. Since the last time we wrote about Invokana less than a year ago, the number of Invokana cases in the federal court system has increased from 288 to the current count of almost 1,000. As of December 2016, the federal level cases, due to similar questions of fact and law, were consolidated into a multi-district litigation (MDL) presided over by U.S. District Judge Hon. Brian Martinotti in the district of New Jersey for pre-trial discovery and motions.

Under the MDL system, several cases of a particular MDL are selected as bellwether cases to gauge how juries react to facts presented at trial. The first of these bellwether cases regarding Invokana is scheduled to begin September 2018. The results of these bellwether cases will have a large influence on how the remaining cases may settle. If the bellwether cases go for the plaintiffs (i.e. the injured parties), they could cause the manufacturers to settle with some or all remaining cases. If the bellwethers go for the defense (the pharmaceutical manufacturers), the remaining cases may be remanded back to the original court for trial completion, or the injured parties may drop their cases.

The bellwether trials have a huge impact on the viability of the remaining cases, and cases should be brought forward prior to the bellwether trials in order to be sure that the facts of your case receive full consideration from the court system.

Invokana® Background

With its active ingredient canagliflozin, Invokana is a drug prescribed to treat type 2 (adult onset) diabetes. Manufactured by Mitsubishi Tanabe Pharma of Japan, it is licensed in the U.S. to Janssen Pharmaceuticals, a division of Johnson & Johnson, for marketing and distribution. It is in a class of drugs known as sodium-glucose costransporter-2 (SGLT2) inhibitors.

SGLT2 inhibitors reduce glucose in the body by blocking a component of the kidney that returns glucose to the bloodstream. When the SGLT2 inhibitor is working, the function is suppressed, and blood glucose being removed from the bloodstream and redirected to the urinary system where it exits the body as a result.

While Invokana was the first SGLT2 inhibitor approved by the U.S. Food and Drug Administration (FDA) in March 2013, several other products also containing canagliflozin have been approved since. These include Jardiance®, Farxiga®, Glyxambi®, and Xigduo XR, among others. A sister product of Invokana, called Invokamet®, combines canagliflozin with metformin, a blood thinner.

Problems Associated With Invokana®

Since its FDA approval in 2013, hundreds of adverse side effects have been identified from use of the drug, including kidney damage and failure, diabetic ketoacidosis, urinary tract infections, pancreatitis, and even amputations of limbs, among others. None of these side effects were discussed or warned about, neither in literature distributed by the drug manufacturers to the general public nor to medical providers.

Since 2015, the FDA has continually required that warnings of these side effects be added to product literature, as the side effects were discovered by the FDA and third parties. The FDA tracks adverse events through their own system, called the FDA Adverse Event Reporting System (FAERS). A summary of the warning history of Invokana follows:

  • 9/10/2015 – FDA requires warning regarding increased risk of bone fracture and decreased bone mineral density due to Invokana use
  • 5/15/2015 – FDA requires addition of warning regarding increased risks of diabetic ketoacidosis, a condition which causes high acid levels in the bloodstream, and serious urinary tract infections
  • 6/14/2016 – FDA strengthens warning of kidney injury due to use of Invokana
  • 10/5/2016 – FDA requires addition of warning regarding acute pancreatitis
  • 5/16/2017 – FDA requires addition of warning regarding increased risks of leg and foot amputation in patients who use canagliflozin medications Invokana and Invokamet

Many other peer review journals, such as Quarterwatch, published by a pharmaceutical watchdog group called the Institute for Safe Medication Practices (ISMP), and the New England Journal of Medicine (NEJM) have published reports of studies indicating a high correlation between use of the drug and dangerous and severe side effects suffered by patients.

The Richard Harris Law Firm is Your Nevada Invokana® Lawyer

Bellwether cases regarding dangerous side effects due to the use of Invokana will be starting in September 2018. Warnings of these potential side effects were not included in product literature distributed to the product by the product manufacturers for several years after they began distribution until required to do so by the FDA. Drug manufacturers are required to adequately test products before they begin distribution of a new product and warn potential patients and medical providers of dangerous side effects. Since this was not done, lawsuits against the manufacturers of Invokana are mounting.

If you have documentary proof that you took Invokana, such as a prescription bottle or insurance statement of benefits paid, and suffered an amputation after beginning use of the drug Invokana or other SGLT2 inhibitors, the lawyers of the Richard Harris Law Firm want to discuss your case. You may be entitled to significant compensation. Call us today at (702) 444-4444.

Read More:

http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-March-15-2018.pdf

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January 25, 2018

Is Testosterone Replacement Therapy (TRT) a case of selling snake oil?

If it were, the traveling salesmen of yesteryear would be envious. Testosterone Replacement Therapy (TRT) treatments have generated billions of dollars in revenue, with estimates of over $5 billion in 2017 alone. These products are…

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If it were, the traveling salesmen of yesteryear would be envious. Testosterone Replacement Therapy (TRT) treatments have generated billions of dollars in revenue, with estimates of over $5 billion in 2017 alone. These products are manufactured and marketed by several manufacturers who have promoted the products with claims of increased energy, improved muscle mass, and enhanced sexual performance, among others.

We discussed testosterone replacements treatments on this blog over a year ago. Since then, much has occurred with over 6,500 federal level cases regarding various TRT products. The federal cases have been consolidated into a Multi-district Litigation (MDL), and some of the early trials, also known as bellwether cases, have awarded extremely large settlements.

Out-of-Court Settlements

There are additional trials against these products and their manufacturers at the state court level in many states throughout the U.S. One of those trials in Pennsylvania has settled prior to trial commencement. Defendants evaluate the results of the early trials to determine whether to settle or proceed to trial. Auxilium Pharmaceuticals settled in early January 2018 on a claim against their product Testim for allegedly causing a stroke for a user of that product.

Eli Lilly, has reached a global settlement in all outstanding federal cases for their product, Axiron, prior to their first trial commencing. The previous early trial results have apparently prompted the company to settle rather than face upcoming trials. Details of this settlement are not yet known, but as of December 21, 2017, Eli Lilly and the nearly 500 plaintiffs who filed claims for Axiron complications, have been granted a 45-day stay for the parties to reach a Master Settlement Agreement.

Early Trial Results

The early trial results are mixed, but juries have awarded several large settlements so far:

July 2017

In the first federal bellwether trial, a jury awarded the plaintiff $150 million in punitive damages against AbbVie Inc., for their product Androgel. The judge set this result aside, and ordered a new trial since the jury awarded no compensatory award to the plaintiff. Compensatory damages are awarded to compensate the plaintiff for medical and other expenses associated with the injuries suffered, and punitive damages are awarded to punish the defendant for wrongdoing, and most civil cases of this type award both. The new trial has not commenced at this point.

October 2017

In the second federal bellwether trial against AbbVie’s Androgel, the jury awarded $140 million in compensatory damages, and added $140 million in punitive damages against Abbvie for recklessly endangering the lives of users of Androgel. The judge president over this trial has ruled that evidence in this trial may be used in future trials. Additional trials against AbbVie are scheduled in 2018.

November 2017

A jury in the third federal level bellwether case found in favor of Auxillium and cleared the company of liability in causing the heart attack of a user of Testim. Cases included in the MDL will settle based on the merits of the individual cases, and other trials against Auxilium and Testim are scheduled to commence in 2018.

More bellwether trials are scheduled against these, and other manufacturers of TRT product in 2018.

The Richard Harris Law Firm is Nevada’s Testosterone Therapy Injury Lawyer

The risk of cardiac events have been known as a possible side effect of testosterone treatments for several years. Studies continue to find this correlation, and one study reported in the New England Journal of Medicine (NEJM) in 2009 of 209 men with a mean age of 74, had to be disbanded due to adverse cardiac events in the study participants.

Early trial and out-of-court settlements seem to favor the users of the products in making valid claims of injury due to use of these products. If you have been prescribed a testosterone replacements product, and later suffered cardiac problems, such as blood clots, heart attack or stroke, you may be entitled to compensation for your injuries. You have a limited time to file as pharmaceutical companies are beginning to settle. Call us today to discuss your situation and our lawyers will review your potential case, at (702) 444-4444.

Read More:

https://www.law360.com/articles/997820/auxilium-settles-1st-philly-testosterone-case

https://www.drugwatch.com/2018/01/04/eli-lilly-reaches-testosterone-therapy-settlement/

https://www.mayoclinic.org/healthy-lifestyle/sexual-health/in-depth/testosterone-therapy/art-20045728

https://www.healthline.com/health/low-testosterone/natural-boosters#bottom-line

https://www.theatlantic.com/health/archive/2013/04/should-the-modern-man-be-taking-testosterone/274663/

http://www.bmj.com/content/345/bmj.e4967#alternate

http://www.nejm.org/doi/full/10.1056/NEJMoa1000485

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November 2, 2017

UPDATE: Taxotere Trials Set for September 2018

We’ve previously discussed the breast cancer chemotherapy drug, Taxotere (Docataxel) on this blog. This product is marketed and distributed by Sanofi S.A., a French pharmaceutical manufacturer, which also identifies itself as Aventis. The product has…

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We’ve previously discussed the breast cancer chemotherapy drug, Taxotere (Docataxel) on this blog. This product is marketed and distributed by Sanofi S.A., a French pharmaceutical manufacturer, which also identifies itself as Aventis. The product has been marketed as a “superior” chemotherapy preparation, when no evidence of such superiority exists.

Evidence has been collected and is being presented in some 1,600 lawsuits in the federal court system, against Sanofi/Aventis, showing that one of the side effects of the treatment has not been sufficiently disclosed to patients and medical providers, which leaves users of the drug completely hairless. Alopecia Universalis, is the condition, and many users of Taxotere found that after using the drug, not only did they lose head hair, but all body hair… permanently.

Federal Taxotere Cases Consolidated

The Taxotere cases at the federal court level, due to similar findings of facts, have been consolidated into a Multi-District Litigation (MDL) for purposes of pre-trial discovery and pre-trial motions. This case, known as MDL 2740, is being heard before Judge Kurt Engelhardt in the Eastern District of Louisiana. Judge Engelhardt has scheduled the first “bellwether” trials to begin September 24, 2018.

Bellwether trials are set for a limited number of cases to track jury reaction to evidence, and to gain an outlook on the potential outcome of future trials. The procedures and rules governing the trials have been outlined by Judge Engelhardt, in his Case Management Order No. 8, with the first case to commence on September 24, 2018, and four additional trials during 2019. The bellwether trials act as a gauge of what future action will be forthcoming on that subject matter.

Taxotere Regulatory History

1996 – Taxotere approved for U.S. sales by the FDA.

2003 – FDA sends warning letter to Sanofi/Aventis for suggesting in direct mail marketing to patients that Taxotere is more effective than other chemotherapy treatments.

2005 – Sanofi/Aventis warns European Union doctors of potential for alopecia universalis (permanent hair loss) due to use of the product

2009 – FDA warns Sanofi/Aventis a second time to stop misleading consumers about Taxotere’s effectiveness compared to other chemo treatments

2010 – Taxotere sales in 2010 were $3.1 billion. Sanofi’s patent expired, and the FDA approved generic versions of the drug in 2011.

2012 – Sanofi/Aventis warns Canadian doctors of potential for alopecia universalis (permanent hair loss) due to use of the product

2015 – FDA issues Safety Information Bulletin and requires Sanofi/Aventis to add warning of potential permanent hair loss from use of the drug, to product’s labeling.

Richard Harris Law Firm Represents Those Injured by Taxotere

Taxotere is one of many chemotherapy treatments approved by the FDA. It has never been shown in any clinical test to be more effective than other chemotherapy treatment. It does have the distinction of being one that causes permanent hair loss. It was sold in the U.S. for almost two decades before warning labels were updated to warn of this potential condition, in spite of the company warning doctors throughout the European Union and Canada of the potential. Failure to warn of potentially known side effects is an obligation required of any supplier of medications or equipment.

If you suffered from breast cancer and received chemotherapy treatments with the product Taxotere, and later suffered permanent hair loss, you may qualify for compensation. Call our lawyers today to discuss your potential case at (702) 444-4444.

Nevada law firm, Law firm Las Vegas

Filed under: Drug Injury

September 1, 2016

Breast Cancer Chemotherapy Drug Taxotere Linked to Permanent Hair Loss

Hair loss is not uncommon as a side effect of chemotherapy. Most patients, however, can expect their hair will grow back after the therapy is complete. Complete and permanent hair loss, also known as alopecia…

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Taxotere

Hair loss is not uncommon as a side effect of chemotherapy. Most patients, however, can expect their hair will grow back after the therapy is complete. Complete and permanent hair loss, also known as alopecia universalis, however, is uncommon as a result of chemotherapy.

It has become apparent that use of the chemotherapy treatment, Taxotere, manufactured by the French pharmaceutical manufacturer, Sanofi SA, also known as Aventis, dramatically increases the risk of permanent hair loss, not just of head hair, but all body hair including eyebrows, eyelashes, underarm and pubic hair. One study, the GEICAM9805 analysis, concluded nearly 1 out of 10 users of the drug will lose all body hair permanently.

For its part, Sanofi-Aventis has allegedly engaged in a willful pattern of deception and negligence, by not informing patients and medical providers of the known risks of using the drug, while attempting to market the drug as a superior treatment. The U.S. Food and Drug Administration (FDA) has found no support for such claims of superiority and has, over a number of years, warned the company to cease such claims. Sales of the drug has generated billions of dollars of revenue for Sanofi-Aventis, topping sales of $3 billion worldwide in 2010.

As a result, patients who have used the drug and suffered permanent hair loss are now bringing suit against the company, alleging that, as a result of the company’s long-standing pattern of deceptive marketing, they were unable to make an informed choice regarding their use of the drug and now are suffering from this emotionally and psychologically debilitating side effect for the rest of their lives.

Regulatory History of Taxotere

The drug was first approved by the FDA for use in the United States in 1996 for chemotherapy treatment after breast cancer. It subsequently won approval for other cancer treatments, and Sanofi-Aventis began touting the drug as superior to other chemotherapy products.

In 2003, the FDA sent a warning letter to Sanofi-Aventis regarding three direct-to-consumer print advertisements because “they suggested that Taxotere is more effective than has been demonstrated by substantial evidence or substantial clinical experience.” This warning letter also mentioned that it had previously requested that a “Dear Doctor” letter be destroyed because it made misleading effectiveness claims overstating the drug’s survival benefits.

In 2009, the FDA again warned the company against unsubstantiated superiority claims in marketing the product. The FDA stated that the company’s marketing materials “misleadingly suggest that Taxotere is superior to paclitaxel in the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and overstate the efficacy of Taxotere. FDA is unaware of substantial evidence to support these claims.”

Finally, in 2015, the FDA issued a Safety Information bulletin which included reports of patients suffering permanent hair loss. However, Sanofi-Aventis had knowledge of this side effect and were warning doctors and patients outside of the U.S much earlier.

Recent Legal Action

In March 2016, a woman filed suit (Dodson v. Sanofi SA, et. al.) in California court claiming that the company failed to disclose that Taxotere has this side effect in a large portion of its users, and additionally conspired to keep this problem from the public in order to maintain sales volume of the drug. This lawsuit suggests that the company “obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to a normal life.”

Also in March 2016, a suit was filed by an Ohio woman (Carson v. Sanofi SA, et. al.) which alleged that Sanofi had warned doctors in Europe as early as 2005, and had warned Canadian doctors in 2012 of the possible alopecia side effect.

In a suit filed in Illinois on July 7, 2016 (Wysocki v. Sanofi SA, et. al.), plaintiff Theresa Wysocki contends that she suffered permanent alopecia as a result of her prescribed and proper use of Taxotere. Ms. Wysocki underwent a lumpectomy in August 2014 and under the supervision of her oncologist, began chemotherapy which included Taxotere from September 2014 to January 2015, and has suffered permanent hair loss.

The suit contends that there were other treatments available which were at least as effective as Taxotere without the side effect of permanent alopecia, which could have been used as part of Ms. Wysocki’s treatment, but because of Sanofi-Aventis’s deceptive marketing practices, neither she nor her medical providers could make an informed choice of treatments.

The suit also indicates that Sanofi-Aventis knew of and had warned of permanent alopecia in other countries, such as Canada and the European Union, but had failed to warn of the side effects in the United States, their largest Taxotere market, until December 2015.

Nevada Taxotere Attorneys

If you have received treatment for breast cancer with the chemotherapy drug Taxotere, and have suffered permanent hair loss, you may have a case against the manufacturer, Sanofi-Aventis. The Richard Harris Law Firm, Nevada’s largest personal injury law firm, is interested in helping you obtain due compensation for this debilitating side effect which was known by the manufacturer and withheld from the medical community and patients in the U.S. in order to maintain sales volume of this defective drug. Call us today to discuss your potential case with our representatives at (702) 444-4444.

Nevada law firm, Law firm Las Vegas

Filed under: Blog, Drug Injury

August 17, 2016

NEXIUM, PRILOSEC AND PREVACID LINKED TO SERIOUS SIDE EFFECTS

Some of the most commonly taken medications in the United States are treatments for acid reflux or heartburn and Gastroesophageal Reflux Disease (GERD). These include a class of drugs called Proton Pump Inhibitors (PPI). Nexium,…

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Prilosec Nexium and Prevacid LawsuitSome of the most commonly taken medications in the United States are treatments for acid reflux or heartburn and Gastroesophageal Reflux Disease (GERD). These include a class of drugs called Proton Pump Inhibitors (PPI). Nexium, Prilosec, and Prevacid are perhaps the best known PPIs and are available as both over-the-counter and prescription treatments.

Experts acknowledge that PPI use should be limited. Harvard Medical School Associate Professor and co-author of a study that linked PPI use to bone fracture, Dr. Andrew Chan M.D., says: “You really want to encourage patients to take the lowest effective dose that manages symptoms effectively, for the shortest possible duration.”

Prolonged use of PPI’s has been linked to several serious negative side effects ranging from bone fracture to dementia to kidney failure. It appears that the dangers are heightened by prolonged use of the drugs, and the Food and Drug Administration (FDA) has issued warnings about taking PPIs for longer than a year.

HEARTBURN OR ACID REFLUX AND GERD

Stomach acid is an important ingredient which allows the human body to digest food. Heartburn occurs when stomach acid backs up into the esophagus through the muscle valve where the esophagus and the stomach meet. This valve, called the Lower Esophageal Sphincter (LES), allows food to pass into the stomach and then closes.

In some cases, the valve doesn’t close completely, allowing stomach acid to move into the esophagus. This causes a burning sensation in your abdomen which can move into your chest or even throat. If this happens more than twice in a week, it is considered to be Gastroesophageal Reflux Disease, or GERD.

Acid Reflux can be caused by eating large meals, lying down after a meal, snacking at bedtime, eating spicy or fatty foods, smoking, obesity, drinking alcoholic or carbonated beverages, and pregnancy, among others. It can also be caused by hiatal hernia, a condition where the stomach and LES move above the diaphragm.

HISTORY OF HEARTBURN TREATMENT

Some of the earliest treatments for acid reflux were antacids, such as Rolaids and TUMS, which contained calcium carbonate. These treatments did not affect the amount of acid produced by the stomach, but neutralized the acid in the stomach.

The next wave of treatments were called H2 receptor antagonists, or H2 blockers, such as Tagamet, Pepcid and Zantac. These medications actually reduced the amount of stomach acid produced by the lining of the stomach, which allowed the esophagus to heal from acid burns.

More recently, Proton Pump Inhibitors were introduced. PPIs alleviate symptoms of GERD and acid reflux by blocking the enzyme in the stomach wall responsible for the production of stomach acid. These medications include Nexium, Prilosec, and Prevacid.

SIDE EFFECTS BECOME APPARENT

PPIs have been available in the U.S. since 1996, and their use is so prevalent, side effects have manifested themselves over time. The manufacturers have generated billions of dollars in revenue from sales of medications which contain PPI’s. Nexium alone sold 18 million prescriptions in a one-year period from July 2013 to June 2014, generating $6.3 billion in revenue.

The widespread availability of PPIs, both as prescription strength and over-the-counter forms, has led to overuse. Negative side effects linked to PPIs can manifest when the medications are taken for longer than a year, taken more than once a day or both. Over the past several years the FDA and numerous medical journals have warned that overuse of PPI drugs can cause serious side effects ranging from muscle spasms, irregular heartbeat, bone fracture (particularly in women), and dementia, among several others.

Perhaps the most concerning, however, are the recently reported findings that prolonged use of PPI drugs causes chronic kidney disease and ultimately, kidney failure. In January 2016, the Journal of the American Medical Association (JAMA Internal Medicine) reported research that showed patients who take PPIs once a day had a 15 percent greater risk of chronic kidney disease and taking PPIs twice a day subjected patients to a 46 percent greater risk of chronic kidney disease.

This follows an April 2015 report from the Canadian Medical Journal, CMAJ Open, that warned that users of PPI drugs may be 2.5 times more likely of suffering acute interstitial nephritis, leading to inflammation and ultimately kidney failure.

PPI LAWSUITS

As a result of the recent study results, patients are now filing lawsuits against PPI manufacturers for failure to warn of the serious side effects, especially of the kidney problems which have been linked to overuse of PPI drugs. It is thought that hundreds and maybe thousands of lawsuits may be coming.

The Richard Harris Law Firm is interested in evaluating whether you may have a claim. If you have taken Nexium, Prilosec, or Prevacid, or other PPI medication, for longer than a year, and have suffered kidney disease, call us today to discuss your potential case with our representatives at (702) 444-4444.

Read More

Prolonged use of a proton pump inhibitor reduces microbial diversity: implications for Clostridium difficile susceptibility

Proton-Pump Inhibitor Therapy Induces Acid-Related Symptoms in Healthy Volunteers After Withdrawal of Therapy

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245275.htm

Use of proton pump inhibitors and risk of hip fracture in relation to dietary and lifestyle factors: a prospective cohort study

Proton Pump Inhibitors and Risk of Incident CKD and Progression to ESRD

Association of Proton Pump Inhibitors With Risk of Dementia

Proton pump inhibitors and the risk of acute kidney injury in older patients: a population-based cohort study

H2 Blockers (Acid Reducers) for Gastroesophageal Reflux Disease (GERD)

Use of proton pump inhibitors and risk of hip fracture in relation to dietary and lifestyle factors: a prospective cohort study

The Purple Pill Problem: PPIs and Serious Side Effects

Proton pump inhibitors

Prilosec Side Effects

Nexium Side Effects

Prevacid Side Effects

Nevada law firm, Law firm Las Vegas

Filed under: Blog, Drug Injury

June 27, 2016

Onglyza Linked To Heart Failure And Pancreatic Cancer

Onglyza the oral diabetes treatment designed to control blood sugar in patients with Type 2 diabetes, otherwise known as adult onset diabetes, has been linked by studies and lawsuits to serious side effects, which can…

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Onglyza the oral diabetes treatment designed to control blood sugar in patients with Type 2 diabetes, otherwise known as adult onset diabetes, has been linked by studies and lawsuits to serious side effects, which can result in death. Once heralded as the biggest breakthrough in diabetes treatment since insulin, patients using the drug face higher than normal risks of developing heart failure, and/or pancreatic cancer.

What is Onglyza?

Onglyza, a pill taken by mouth containing the active ingredient, saxagliptin, was approved by the U.S. Food and Drug Administration (FDA) in 2009. This drug along with Kombiglyze XR were developed jointly, by AstraZenica and Bristol Meyers Squibb, to treat Type 2 Diabetes sufferers to control high blood sugar for those who did not also suffer from diabetic ketoacidosis.

These medications belong to a class of drugs called incretin mimetics. These DPP-4 inhibitors cause the pancreas to secrete more insulin, and stop the liver from making excess sugar. The intended effect is to control high levels of blood sugar without weight gain.

Side Effects of Onglyza

DDP-4 inhibitors have been widely prescribed since their approval, and dangerous side effects began to surface shortly after widespread use of the drug. As early as 2011, the consumer advocacy organization, Public Citizen, urged patients to not to use the drug until the side effects could be studied further.

Also in that year, the medical journal, “Gastroenterology,” reported that the risks of pancreatic cancer were as high as 2.7 times greater among users of Onglyza than other diabetes sufferers. That year, the FDA required warning labels placed on the drug, warning of pancreatitis.

In 2013, the Journal of the American Medical Association, JAMA, reported serious increased risks of pancreatic cancer, and a study was released showing users of the drug were more likely to be hospitalized for heart failure.

The New England Journal of Medicine published results of a study of over 16,000 patients, showing that patients using Onglyza were nearly 30% more likely to be hospitalized for heart failure, than diabetes patients not using the drug.

Onglyza Regulatory Warnings and Lawsuits

As a result of these studies, the FDA launched an investigation of the drug. The FDA investigation concluded in 2015 with the requirement that AstraZenica place a warning label of increased risk of heart failure on the drug in addition to the warning of pancreatitis that it had previously required.

In 2015, a lawsuit was filed by the daughter of a deceased patient who began using the drug in 2010, and died of complications from heart failure in 2013. The suit alleges that the company manufactured a dangerous medication that it knew was connected to dangerous side effects, but that it failed to warn the medical community and the public of potential dangers from use of the drug, while spending millions of dollars marketing the drug. Hundreds of additional suits have been filed since, with similar allegations.

Also in 2015, Express Scripts, a national prescription drug insurance provider, dropped Onglyza from its National Preferred Formulary, the most widely used formulary in the U.S. Express Scripts coverage guidelines affect which drugs are insured for over 25 million Americans.

Sales of Onglyza have reached nearly $800 million annually, with projections showing possible increases to over $2 billion by 2018.

Symptoms

Symptoms associated with Pancreatic Disease include:

  • Upper Abdominal Pain
  • Loss of Appetite
  • Weight Loss
  • Jaundice
  • Fatigue
  • Nausea/Vomiting

Symptoms of Heart Failure include:

  • Difficulty breathing especially when lying down
  • Swelling of the hands feet ankles
  • Irregular heart beat
  • Fatigue
  • Persistent Cough

Nevada Onglyza Legal Representation

If you, or a loved one have been prescribed the medication, Onglyza, and have suffered symptoms like those described above, we want to speak with you to determine your eligibility to file a lawsuit against the drug manufacturer, for intentionally marketing a drug it knew to be dangerous, without warning you or your doctor of the risks. Please call us at 702-444-4444 to speak with our representative further.

Nevada law firm, Law firm Las Vegas

Filed under: Drug Injury

September 10, 2014

New Xarelto Lawsuit Filed

On August 29, 2014, Shirley Boynton filed a lawsuit in the U.S. District Court for Eastern New York alleging that her use of Xarelto caused permanent and debilitating injuries.  She alleges that the manufacturer, Johnson…

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On August 29, 2014, Shirley Boynton filed a lawsuit in the U.S. District Court for Eastern New York alleging that her use of Xarelto caused permanent and debilitating injuries.  She alleges that the manufacturer, Johnson & Johnson, Janssen Pharmaceutica subsidiary, provided inadequate warnings of the potential dangers of using the drug.

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Filed under: Drug Injury

November 22, 2013

Pradaxa Case Filings Increase

The number of lawsuits filed against the manufacturer of the blood thinning agent Pradaxa has increased dramatically over the last month.  According to the Food and Drug Administration (FDA), Pradaxa is an anticoagulant (blood thinner)…

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The number of lawsuits filed against the manufacturer of the blood thinning agent Pradaxa has increased dramatically over the last month.  According to the Food and Drug Administration (FDA), Pradaxa is an anticoagulant (blood thinner) medication prescribed specifically to reduce the risk of strokes and blood clots in patients who suffer from atrial fibrillation (AF), not caused by a heart valve problem.  AF is the most common type of heart rhythm abnormality.

Based on reports available from the Judicial Panel on Multi-District Litigation (JPML), the number of lawsuits increased 6%, from 1,643 suits in October 2013, to the current 1,748 as of November 18, 2013.

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Filed under: Drug Injury

November 14, 2013

FDA Declares Oxyelite Pro and Versa-1 Adulterated Products

The Food and Drug Administration (FDA) working with the Centers for Disease Control and Prevention (CDC) have deemed the dietary supplements OxyElite Pro and VERSA-1 to be adulterated products and ordered that they be removed…

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The Food and Drug Administration (FDA) working with the Centers for Disease Control and Prevention (CDC) have deemed the dietary supplements OxyElite Pro and VERSA-1 to be adulterated products and ordered that they be removed from store shelves and that warehouse stock be destroyed.  This comes after 56 cases of non-viral hepatitis were identified in the U.S. from users of these products, resulting in at least 1 liver transplant, with others waiting, and one death.

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Filed under: Defective Products, Drug Injury

April 23, 2013

Fungal Meningitis: Still Spreading and Still Killing

The Centers For Disease Control and Prevention(CDC), and the Food and Drug Administration (FDA)continue to monitor and update results on the fungal meningitis outbreak, which began when the now defunct New England Compounding Center (NECC)…

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The Centers For Disease Control and Prevention(CDC), and the Food and Drug Administration (FDA)continue to monitor and update results on the fungal meningitis outbreak, which began when the now defunct New England Compounding Center (NECC) shipped non-sterile injectable steroid doses of Methylprednisolone Acetate, to locations throughout the United States in 2012.

This non-contagious form of meningitis was spread when patients had the mold-tainted NECC steroid preparation injected into their spines.

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Filed under: Drug Injury

April 16, 2013

Granuflo and Naturalyte Recalled by the FDA

The products Granuflo® and Naturalyte®, used in dialysis treatment for acute renal (kidney) failure, has had a Class I recall issued by the Food and Drug Administration (FDA) as of March 29, 2012.  A class…

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The products Granuflo® and Naturalyte®, used in dialysis treatment for acute renal (kidney) failure, has had a Class I recall issued by the Food and Drug Administration (FDA) as of March 29, 2012.  A class I recall, the most serious type of recall, is used for products with a high probability of serious adverse consequences or death.

Both of these products are manufactured by Fresenius Medical Care (FMC) and distributed through their subsidiary, Fresenius Medical Care North America.