Articles Posted in Product Liability

In August 2018, the FDA warned that sodium-glucosecotransporter-2 (SLGT2) inhibitors such as Invokana can cause a rare but serious infection that could cause an amputation of the genital area.

This is a big deal because Invokana is a commonly used diabetes medication. The list of diabetes drugs that have let patients down is long.  The money in these drugs is unreal.  To make the most money, you need to rush your product on the market without fully testing the drug.  That is the biggest problem.

Long before the FDA got involved, I have been looking at potential Invokana lawsuits.  These are the 11 questions victims have about Invokana and the Invokana litigation.

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 with 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.

This page was written many moons ago (2018 actually) but we do provide a 2023 Essure litigation update at the bottom of this page.

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 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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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 harm than help.

• In late-2022, hair relaxer lawsuits are being brought for uterine cancer, uterine fibroids, breast cancer, and other injuries

Nearly 2,000 HeartWare Ventricular Assist Systems (VAS) are being recalled because of potentially faulty power supply connectors. The defect could lead to serious injury or death in the event that power failure causes the entire system to stop working.

The Recall

The FDA issued a Class I recall for certain VAS devices after receiving numerous reports of malfunctions. Luckily, most of the failures did not result in any damage, but there was at least one serious injury reported due to a power failure. A “Class I” recall means that the FDA thinks that there is a “reasonable probability” that the continued use of the product will lead to serious health consequences or even death. Obviously, this is a recall to take very seriously should you use VAS. Mechanically, the main issue is that power connector ports tend to wear down over time. Should they become worn down enough, the power supply would lose its connection to the system, effectively rendering the VAS useless. Patients have reported that the power supply connectors have become twisted or bent, which prevents them from connecting the device control unit to the VAS itself. You know how when you’re vacuuming and you round a corner too quickly, ripping the cord out of the wall and bending up the power cord prongs? That’s what is going on here. The stakes are just a little higher.

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I recently heard that if we all keep taking antibiotics we will be responsible for creating the “superbug.” The theory is that since the advent of antibiotics nearly a century ago, we have caused bacteria to become so resilient that normal antibiotics will be ineffective in the not so far future. Incurable infection and bacteria will purportedly run rampant through the streets, and I can only assume that our society and landscape will be a barren wasteland similar to that of Mad Max. Ok, maybe not that last part, but there’s no denying that there has been a serious proliferation of antibiotics. While these have revolutionized medicine and generally increased health on the whole, there are complications that can arise unrelated to the infections that antibiotics are prescribed to treat.

Recently, a group of antibiotics referred to as “fluoroquinolones” has been linked to permanent nerve damage. The risk is real, and the side effect is referred to as peripheral neuropathy.

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If you want an erection, Viagra seems to work. Over 23 million men a year can’t be wrong.  It is easy to joke about, but it is obviously a great thing for many men.  But for the last 16 years since Viagra received FDA approval in 1998, we have been trying to figure out what side effects Viagra has.  Because people have a right to balance their desire to keep an erection – and also consider the other drugs they might use – and the medication’s side effects.   We have heard lots of discussion of vision-threatening complications and hearing loss.  Now there is a new deadly concern:  melanoma.

Sildenafil citratre, more commonly known as Viagra, is used to treat erectile dysfunction (ED) by relaxing muscles and increasing blood flow to particular areas of the body.  Now, in a study recently published online in JAMA Medicine, it has been reported that men who have used Viagra for ED had a significantly elevated risk of melanoma.  Melanoma, the most dangerous type of skin cancer, is the leading cause of death from skin disease.  While melanoma accounts for less than 2% of skin cancer cases each year, it makes up the majority of skin cancer fatalities.  

The study, involving researchers from Harvard and Brown Universities, compared the medical charts of 26,000 men to see if cancer rates differed among those who took Viagra and those who did not.  The study revealed that men who had taken Viagra for erectile dysfunction had double the risk of developing melanoma than men who had not taken the drug.

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The concerns over the anti-seizure drug Potiga were given new weight by a new black box warning.  The problem is concerns of possible vision loss and blue discoloration of the skin that can be permanent.  The FDA says that anyone who considers this drug should get an eye examination both before initiating treatment and every six months during the course of the treatment.

Just as importantly, the FDA underscores the limits of this medication by essentially saying that this medication should only be used by those who have not done well with other options.  Why?  The risks of taking the drug are pretty high.  So it makes sense to make sure every other option has been fully explored with your doctor.  So this drug has its place, but only in those situations where Protiga’s benefits outweigh the risk.  Of course, this is true with every drug, but particularly so when the risks are what they are here.
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Plaintiffs’ counsel in the Aredia/Zometa MDL are asking the judge overseeing the coordinated litigation to remand the over 300 consolidated cases.

Why?  Discovery is not over.

Some people may not live to get their day in court

Vaginal prolapse is incredibly common, with approximately 30-50% of women having some sort of prolapse during their lives. Our lawyers are investigating vaginal mesh lawsuits involving Cook Medical, in addition to other manufacturers of vaginal mesh systems.

Cook Medical Transvaginal Mesh Cases

Cook Medical held its products out as breakthrough technology

Pelvic organ prolapse is a condition in which structures such as the uterus, rectum, bladder, urethra, small bowel, or the vagina itself may begin to fall or “prolapse” out of their normal positions. These structures may eventually prolapse farther and farther into the vagina, or even through the vaginal opening, without medical treatment or surgery. Enter synthetic mesh devices. No doubt a great idea.

According to the FDA, between January 2008 and December 2010, there were nearly 3,000 adverse event reports involving transvaginal mesh devices. Side effects reported with vaginal mesh can include:

• Infections
• Internal bleeding
• Vaginal scar tissue
• Vaginal wall narrowing
• Painful urination
• Fistulas
• Mesh shrinkage
• Mesh migration
• Urinary problems
• Punctures to the bladder, blood vessels, bowels, or other organs in the lower abdomen
• Mesh erosion into the vagina, bladder, intestines, and uterus
• Pain
• Painful sexual intercourse for both partners
• Recurrence of incontinence
• Recurrence of both pelvic organ prolapse or stress urinary incontinence, or both

Cook Medical held its product out as breakthrough technology, resistant to infection, and “unlike synthetic mesh, nothing is left permanently in the body to cause problems down the road.” On the contrary, Cook Medical transvaginal mesh products have had more than their fair share of problems. (In fairness, they have all put out awful products. Cook Medical is no exception.).

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