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The Biggest, Ongoing FDA Recalls & Lawsuits

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If there’s one thing that consumers, organizations, and investors detest is, recalls because they’re packed with the inconvenience. For consumers, recalled products pose adverse safety risks and are tied to a barrage of ailments and even fatalities. For manufacturers, recalls usually tarnish their brand reputations. This leads to a decline in profit margins.

Disgruntled consumers that are adversely affected by recalls, file lawsuits against the manufacturers. It’s a nightmare for everyone involved. To that end, let’s explore the biggest, ongoing FDA recalls and lawsuits. Read on!

Losartan Recall

Did you know that approximately 103 million Americans have high blood pressure? As a result, Losartan is one of the most popular drugs used to treat this condition and in turn, diminish the likelihood of strokes. It’s also used in the treatment of kidney disease for those diagnosed with diabetes.

medicine organizer

As an Angiotensin receptor, Losartan aids in the relaxation of the blood vessels. In turn, this makes it a breeze for the heart to pump blood to the body. However, things recently took a turn for the worse when this once-trusted drug was recalled by the FDA due to carcinogenic impurities found in it.

They’re higher than acceptable levels of N-Methylnitrosobutyric acid (NMBA), N-Nitrosodimethylamine (NDMA), and N-Nitrosodiethylamine (NDEA). While these substances are present in dairy products, water, and meats, as per the FDA, the acceptable consumption limits in medications are:

  • 96 NG per day of NDMA
  • 26.5 Ng per day of NDEA

However, Losartan was found to contain 300 to 20,000 Ng per tablet.

Mylan Alprazolam Recall

The FDA publicly stated that Mylan Pharmaceuticals is carrying out a voluntary recall of Alprazolam tablets that are usually sold under the brand name Xanax. While the medication is renowned for treating panic and anxiety disorders, the recall stems from the possible contamination by a foreign component.

mylan alprazolam

The recall encompasses a barrage of bottles, each containing 500, 0.5mg tablets that were dispensed in the U.S from July to August of this year. The affected batch has a distribution number of 8082708, with an expiration date of September 2020. The Mylan Alprazolam Recall is at a consumer level across the nation. While the clinical impact of the foreign substance is seemingly rare and no adverse outcomes have been reported, there is still the likelihood of consumers being infected. Mylan has also pulled the plug on any distribution of Alprazolam.

Juul Lawsuit

Siddharth Breja, a former executive of Juul, filed a lawsuit against the company that laid him off for complaining about its contaminated products. He claims that the organization was aware of the contaminated e-liquid that was used in roughly 1 million pods that were shipped to retailers earlier in the year.

juul e cigarette

The lawsuit came the same day that Juul publicly stated that 10-15% (approximately 500) of its employees would be retrenched. Juul is currently under the FDA’s watchful eye which claims that the company issued misleading statements about its e-liquid and targeting teens.

According to Breja, it was during a meeting on March 12th that he caught wind of a contaminated e-liquid batch that was used in 1 million pods (250,000 refill kits). The company shipped the pods to retailers and intentionally kept consumers in the dark.

He also alleges that the organization’s unwillingness to recall the defective products or issue a safety and health notice was fueled by the potential loss of $38 billion in sales. Nearly 1 week later, Breja claims that the company laid him off.

Opioid Lawsuit

Approximately 400,000 fatalities in the U.S have been tied to overdoses of opioids for nearly 3 decades (from 1990). The U.S Centers for Disease Control and Prevention (CDC) states that roughly 218,000 of these fatalities stem from opioid prescriptions. And, the rest were from illegal opioids such as heroin.

The problem is only just heating up. The CDC announced that the opioid-related fatalities were 6 times greater in 2017 than in 1999. And, roughly 2500 lawsuits over opioids are pending. The initial lawsuit that survived a motion to dismiss was filed by Chicago city in 2014.

Since then, a barrage of individuals (thousands) from different cities and states has filed lawsuits against opioids. Approximately 2000 of these pending litigations are under the watchful eye of a federal judge in Cleveland, Ohio. The judge will have the responsibility of keeping everyone on the same page and leading pretrial motions.

Purdue Pharma Lawsuit

Purdue Pharma, the manufacturer of OxyContin that is sold under the brand name Oxycodone, is facing more than 2000 lawsuits ranging from $10 billion to $12 billion. The Sackler family (the owners) is facing litigations for starting and maintaining the opioid crisis.

purdue logo

According to the CDC, Purdue’s sales were deceptive and partially responsible for the crisis that claimed more than 400,000 lives between 1999 and 2017. Some of the litigations allege that since 2007, the Sackler family drained the company’s funds to enrich themselves. And, they established a multi-billion dollar empire based on Oxycodone addiction that’s popularly used to treat adverse pain.

Zantac Recall

Sanofi voluntary recalled its over-the-counter (OTC) medication Zantac, in Canada and the U.S due to possible contamination of N-Nitrosodimethylamine (NDMA), that’s a carcinogenic substance. The company’s decision to recall the drug was fueled by discrepancies in the test results conducted.

sanofi logo

Sanofi announced its dedication to transparency and keeping health authorities in the loop about the outcome of ongoing tests. They have agreed to continue co-operation with authorities to permit informed decisions based on the available evidence and data from the tests.

Sanofi also stated that they’ll decide on the extent and level of the recall after conferring with the FDA and Canada Health. The two health authorities are diligently investigating the source of the contamination.

Amlodipine Recall

The FDA has recalled an array of blood pressure medications including Amlodipine that’s used to lower high blood pressure. So, the drug curbs cardiac arrests, strokes, and kidney problems.

high blood pressure

Amlodipine is part of a class of drugs called calcium channel blockers that function by relaxing the blood vessels, thereby facilitating easy blood flow. The recall stems from the presence of carcinogenic (cancer-causing) contaminants, N-Nitrosodimethylamine (NDMA), or N-Nitrosodiethylamine (NDEA).

Nonetheless, the FDA urges patients not to stop taking the prescribed medication without consulting their respective healthcare providers. Abrupt discontinuation of Amlodipine can have adverse repercussions. So, healthcare providers can propose alternative drugs that effectively manage high blood pressure.

Roundup Lawsuit

Renowned weed killers such as Roundup depend on herbicide known as glyphosate as the active ingredient. However, a connection between this ingredient and adverse health issues such as cancer was found. In turn, this has fueled a plethora of toxic torts by gardeners, landscapers, and farmers against the manufacturer, Monsanto.

In August 2018, a California jury reached a verdict in favor of a 46-year-old groundskeeper for various schools in the jurisdiction. The plaintiff’s lawyer argued that his client developed non-Hodgkin’s lymphoma from using Roundup on the job. And, there’s a scientific link between the illness and the product. The jury agreed that Monsanto failed to give consumers a heads up on the cancer risks associated with the product. As a result, the plaintiff received a hefty settlement of $78.5 million.

Hernia Mesh Lawsuit

It’s no secret that a hernia won’t fix itself. So, one of the main treatments is to implant a hernia mesh. This requires surgery that involves a small piece of netting that provides extra support to the damaged or weakened area. The most publicized litigations encompass synthetic hernia mesh.

There’s a barrage of such lawsuits across the U.S revolving around the use of defective hernia mesh in the surgeries. As a result of numerous reports to the FDA, the manufacturers have withdrawn an array of hernia mesh products from the market.

According to the litigations, the manufacturers were aware of their defective products but chose to keep the patients and their doctors in the dark.

Mesothelioma Lawsuit

As fate would have it, Asbestos exposure leads to Mesothelioma. And while this exposure could’ve been prevented, a Mesothelioma lawsuit allows the victims to take action. The two essential components in this lawsuit are the defendant (the asbestos company) and the plaintiff (the Mesothelioma victim).

Usually, asbestos companies opt for out of court settlements to evade the high likelihood of the judgment being in favor of the victim. This ensures the best outcome for both parties involved.

However, if the case goes to trial, then it’s up to the victim’s lawyer to have overwhelming proof of asbestos exposure. And, more evidence could mean a larger settlement.

Xarelto Lawsuit

There are thousands of litigations against Janssen Pharmaceutical, the manufactures of Xarelto. Under the brand name rivaroxaban, this drug is a prescribed blood thinner for victims of deep vein thrombosis (DVT), strokes, and pulmonary embolisms.

Owned by Johnson and Johnson, Janssen Pharmaceutical has partnered with Bayer Healthcare to advertise the drug. The litigations brought against the companies allege that Xarelto is the root cause of irreversible damage that leads to fatal internal bleeding issues.

They also state that other blood thinners are just as effective minus the endangerment of the lives of patients. The lawsuits further state that Bayer and Janssen failed to give healthcare experts proper guidelines for the type of patients who are eligible for treatment via Xarelto. The companies also fail to offer ideal screening and warnings for adverse side effects of the drug.

These lawsuits are packed with essential arguments:

  • The drug is arguably defective and dangerous
  • Janssen failed to take proper precautions in manufacturing the drug
  • Xarelto didn’t undergo rigorous testing by the manufacturer
  • Bayer and Janssen didn’t give patients and healthcare providers a heads up of the likelihood of uncontrolled bleeding
  • Janssen and Bayer kept the evidence of these adverse side effects under wraps. So, health regulatory bodies like the FDA and the public were in the dark
  • Despite being aware that Xarelto is dangerous, Bayer and Janssen continued promoting it as being safe for human consumption

Invokana Lawsuit

Commonly known as Invokana, this drug penetrated the market in 2013. Under the medical term Canagliflozin, Invokana was approved by the FDA for the treatment of those diagnosed with Type 2 diabetes. However, in 2015 things took a turn for the worse when the FDA issued a warning that this drug may lead to excessive acid in the blood (diabetic ketoacidosis).

invokana logo

Patients were also warned to keep an eye out for any ketoacidosis-related symptoms and, if so, seek medical care immediately. The warnings were issued after 20 cases were reported.

Invokana lawsuits thereby stem from the manufacturer failing to issue warnings against the risks like diabetic ketoacidosis associated with consuming the drug. The litigations claim that Johnson and Johnson, along with its subsidiary (Janssen Pharmaceuticals) failed to warn prescribing doctors and their patients about the possible risks of the drug.

Baby Powder Lawsuit

Its distinctive fragrance is easily recognizable and has been a cornerstone of the brand’s reputation. It’s the smell of innocence. Johnson & Johnson has been touting its signature baby powder as being smooth enough for a baby’s bum for over a century.

But, in an unfortunate twist of events, this reputation, coupled with Johnson & Johnson’s stock price has been threatened by a swarm of lawsuits. They allege that the powder is contaminated with a carcinogen known as asbestos. The company has denied these allegations even though they are also corroborated by the FDA. The company claims that the plaintiffs’ tests of the product are packed with flaws and inaccurate results.

The litigations from more than 15,000 plaintiffs also claim that Johnson & Johnson knew about the asbestos for decades but chose not to disclose these concerns to consumers.

The Take-Home Message

Lawsuit payouts are usually bitter-sweet. While some plaintiffs get the settlements they deserve, there are inevitable setbacks before the lawsuits can kick-off. Nonetheless, armed with reputable attorneys, a multitude of people receives their deserved compensation.

Just as with any lawsuit, there are statutes of limitations, or time limits, to act if you’ve been injured. If you or someone you know has been injured by a drug or device recalled by the FDA, then consult with a lawyer today.

Need legal advice about your specific case? Our experts are here to help!

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