In October 2018, settlements in the AbbVies AndroGel lawsuits FINALLY appear ready to resolve.  The drug company and plaintiffs lawyers are dotting the i’s and crossing the t’s on a settlement agreement that would resolve thousands of testosterone cases.

Lawsuits had been filed claiming that the makers of Androgel, AbbVie, failed to warn thousands of men about the potential side-effects of the drug. These side-effects include heart attacks, blood clots, stroke, and even sudden death in extraordinary cases. As the litigation wheels are starting to turn here, AbbVie is trying to gum them up with objections to slow down the process.  You could say everything is going according to plan….

Androgel Lawsuits

If you are reading this you probably already know this but let’s recap where were are. Currently, there are about 7,000 lawsuits against AbbVie percolating around the federal court system. The various suits allege that the makers of Androgel, AbbVie, neglected to warn thousands of men about the serious side effects of the “Low-T” treatment drug. This drug has certainly been a big hit, understandably so considering that it promises men physical enhancement to counteract the forces of aging. But thousands of lawsuits -allege that low-T drugs can lead to heart attack, stroke, pulmonary embolism, deep vein thrombosis, or other injuries, prompting men across the U.S. to sue AbbVie and the other manufacturers for not being adequately warned of the risks.

That really is what this is about.  No one — at least not many people — are calling for a low-T recall.  The risk might outweigh the benefit for some although probably not many of us.  It is about giving patients and doctors a choice. Tell us what can happen and let us make the call.  They are giving this warning now.  They should have given it to us before.  That is what these lawsuits are about.

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1. What is Zostavax?

Zostavax is a single shot vaccine that helps prevent herpes zoster, also known as the shingles. It is a weakened live form of the virus, meant to train the immune system to fight it off. Zostavax is primarily meant for individuals 50 years and older. Developed by the pharmaceutical company Merck & Company, the FDA approved it in 2006. It is a stronger version of Varivax, another shingles’ vaccine also developed by Merck.

2. What are the shingles?

According to a new study recently published in the Journal of the American College of Cardiology, exposure to drugs found in the family fluoroquinolone increased the risk of aortic aneurysms and dissections. Fluoroquinolone drugs include Levaquin and Cipro.

What are fluoroquinolones?

Fluoroquinolones are a family of antibacterial agents that are used primarily for respiratory and urinary tract infections. Drugs found in this family include Levaquin, Cipro, and Avelox.

Bayer announced today that after thousands of reports of injuries from women and repeated safety restrictions by regulators said Friday that it will stop selling the device in the U.S.

What is the deal with these medical devices and what is happening with the lawsuits in these cases?

The Essure Permanent Birth Control System was to provide women a safer, less involved (and painful) tubal ligation alternative. This medical device was triumphantly marketed as the “[only] FDA-approved permanent form of birth control with a procedure that can be performed in an office setting without general anesthesia.” Unfortunately for the 750,000 women who have used this system since the Food & Drug Administration (FDA) approved it in 2002, both new scientific research and anecdotal evidence suggest that Essure has caused substantial injuries to thousands of patients, motivating calls among consumer advocates for the drug’s recall and spurring legal action.

How Essure Works and Why the System Appeals to Women

The Essure system consists of two flexible coils that are inserted into the Fallopian tubes in order to produce permanent sterilization. Both patients and doctors have liked Essure, at least conceptually, because the system offers a less-invasive solution than tubal ligation and other birth control surgeries, ostensibly with shorter healing time and fewer side effects. Premarket studies tracked women’s pregnancies before and after Essure implantation, leading Bayer to assert that the device is 99.83 percent effective at preventing pregnancy and that “mild to moderate pain” and “spotting” are the most common side effects.

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Some 3T heater-cooler devices manufactured by LivaNova, PLC may have caused dangerous and deadly Nontuberculous Mycobacteria (NTM) infections in many patients. 3T heater-cooler devices are used in cardiothoracic surgeries, which usually involve the heart, lungs, or esophagus. The common nature of these surgeries means that more than 500,000 patients may have a cause for concern.

As a result, a 3-T Heater-Cooler class action lawsuit has been filed.  Our law firm is talking to potential victims about joining the class action lawsuit (technically an MDL).

What Is Going On?

Just for Men pitchmen like Keith Hernandez may promise we will “Go from Grey to Great” but some are finding an unpleasant catch to the inexpensive hair and beard dye. Specifically, customers are complaining of painful reactions after using the product to clean up their patches of grey.

Just for Men’s manufacturer, Combe Incorporated hasn’t issued a recall of any of their hair dye products and most negative reactions to the products are usually temporary. But for many middle-aged men hoping to hold onto that youthful look a little longer, Just for Men’s potential for skin irritation and other issues may do more to harm than help.

Consumer Complaints Old and New

A Philadelphia jury crushed Bayer and Johnson and Johnson earlier this month with a $27.8 million verdict.  The jury awarded $1.8 million in compensatory damages and $26 million in punitive damages.

The punitive damage award is key because Bayer had to be thinking they could win these cases after winning three in a row in federal court.  This resounding victory changes the game.

While $28 million is chump change to these companies.  But these cases could be worth billions.  This gets the attention of corporate.  The value the Xarelto is a big question mark on their balance sheets right now. Moreover, the fear of loss of revenue from these drugs.  Meaningful settlement talks a global class action settlement may not be far away.

In 2000, Bayer Healthcare introduced the Mirena IUD, which is a flexible T-shaped RUD implant that is placed in the uterus for up to five years as a form of birth control.   It has been a relatively effective birth control device. It is even more effective in preventing pregnancy than even female sterilization.  But while effective for its intended purpose, a lot of problems have been reported with the Mirena IUD.  Since 2004, the FDA has received over 77,000 adverse event reports relating to Mirena.

Mirena IUD’s have been linked to perforating uteri, and the IUD’s have been known to move out of position on occasion, causing internal injuries, with over 4,000 lawsuits pending from women.  The reality is these cases have either failing or have already failed.  It is unfair but our justice system is not always fair. Recently, however, a new type of lawsuit has started to arise regarding Mirena IUD’s and Bayer Healthcare Pharmaceuticals.

Pseudotumor Cerebri(PTC)

PTC is called many different things: idiopathic intracranial hypertension, pseudotumor cerebri, benign intracranial hypertension are the most common.  This serious condition is characterized by a buildup of fluid pressure on the brain. This fluid buildup results in severe headaches, vision loss, and possibly other problems.

PTC is most commonly in obese females of reproductive age.  The biggest symptom of PTC is papilledema.  Early symptoms include headaches and visual disturbances. Patients with these symptoms, particularly obese patients or those with recent weight gain, should be screened for papilledema and, if present, the patient should be referred to a neurologist for further diagnosis and care.  Continue reading

The Bard Recovery IVC filter and its ostensibly new and improved cousin, the Bard G2 IVC filter, have been linked to an increased risk of fracture which can cause serious injury or death.

A New Verdict in 2018 That Means Something to You

The big news in these IVC filter cases came in April 2018 when plaintiff scored their first big win.  An Arizona jury awarded a Georgia woman $3.6 million, including $2 million in punitive damages.

Things That Could Hurt You: Prilosec

What is it?

Made by AstraZeneca, Prilosec is the brand name for a generic drug, omeprazole, used in combating acid reflux by reducing the amount of acid produced in the stomach.

Prilosec was the first of a class of drugs known as proton pump inhibitors (“PPIs”), which are prescribed to treat chronic heart burn, acid reflux, and other gastrointestinal maladies. The reason Prilosec works is its active ingredient, omeprazole. Nexium, another drug that has been the subject of a great number of lawsuits, is a big competitor with Prilosec.  There is so much money in PPIs.  The manufacturers of these drugs have been in litigation with each other for a very long time, battling over patents and profits.

How popular is it?

Following its introduction in 1989. Prilosec rocketed to widespread popularity. In 2013, Prilosec sales were $358.8 million – making the drug the second-highest-selling over-the-counter digestive remedy. Prilosec belongs to a class of acid-reducing medicines on which the public spends over $14 billion a year.

The active ingredient in Prilosec, Omeprazole, is a racemic mixture containing S- and R-enantiomers. Enantiomers are molecules that have two Non-superimposable mirror image forms Racemic mixtures, such as omeprazole, contain equal proportions of the two enantiomers. Continue reading