Articles Posted in Product Liability

According to a new public warning from the FDA, certain leadless pacemakers made by Medtronic have a defect that may cause them to poke holes in the heart resulting in life-threatening complications.

The Food and Drug Administration (FDA) recently posted a new warning regarding a potentially fatal defect in the Medtronic Micra leadless pacemaker devices. The November 17 warning advises doctors about new findings which show that patients with the Medtronic leadless pacemaker implanted have displayed a significantly higher risk of cardiac perforation and potentially deadly complications.

Transvenous vs. Leadless Pacemakers

It’s the peak of the summer beach season, but if you drop by your local retailer to pick up some sunscreen, you will likely see a lot of empty shelf space. Why? Because independent consumer product testing recently discovered that a number of major sunscreen products contained hazardous levels of benzene. Benzene is a notorious and well-known human carcinogen that is very harmful to the human body.

In response to this discovery, manufacturers and major retailers have started pulling sunscreen spray, lotion, and other products from their shelves. Now plaintiffs’ lawyers around the country are evaluating whether contaminated sunscreen lawsuits could be the next big mass tort.

Valisure Finds Dangerous Levels of Benzene in Sunscreen Products

Medical device manufacturer Boston Scientific has issued an emergency safety recall of its Vici Venous stent devices because a defect in the stents causes them to migrate once inside the body.

If you had a Vici Venous stent surgically implanted and it subsequently migrated inside your body, you may be entitled to financial compensation. Our medical device lawyers are currently new Vici Venous stent cases against Boston Scientific.

hernia mesh lawsuitsTo date, thousands of lawsuits related to defective hernia mesh implants have been filed in courts across the country. These suits claim that defective surgical implant devices were the cause of chronic pain, serious infections, obstructed bowels, perforated abdomen lining, and the development of adhesions. Some plaintiffs’ injuries were severe enough that they needed further surgeries to correct these issues.

In June 2019, AbbVie’s AndroGel testosterone lawsuits settled for $775 million. (Our lawyers are still taking testosterone lawsuits in 2022.  Just no longer involving this testosterone supplement.)

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 litigationabbvie androgel lawsuits wheels start turning here, AbbVie is trying to gum them up with objections to slow down the process.  You could say everything is going according to plan…

What Is AndroGel?

Androgel is a form of testosterone replacement therapy (TRT). The purpose of testosterone is to increase levels of testosterone in the blood of humans.  So TRT is a process to supplement our naturally occurring levels of testosterone. Why?  Because some men have low testosterone production (and some just want more).

AndroGel is a synthetic testosterone gel formulation.   The gel formulation was developed to give transdermal delivery of testosterone continuously for 24 hours.

Androgel Lawsuits

If you are reading this you probably already know this. But let’s recap.  There were about 7,000 lawsuits against AbbVie percolating around the federal court system.

The various suits alleged 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 — was 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 were about.

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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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3t cooler ntm infectionSome 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?

The Food and Drug Administration (FDA) started receiving reports about NTM infections caused by heater-cooler devices in 2010. “Between January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. Twenty-five of these MDRs were reported to the FDA in 2015.”

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

3M and one of its subsidiaries, Arizant Healthcare, are facing some heat over their Bair Hugger warming blanket. Lawsuits are starting to be filed, suggesting that the company knew that the use of the Bair Hugger could expose surgical patients to the risk of infection. Patients who underwent surgery for hip or knee replacements are at the greatest risk of infection.

The Bair Huggerbair hugger lawsuits

The Bair Hugger is a fairly interesting and ingenious device. When under anesthesia, the core body temperature drops a few degrees. While only a minor fluctuation, this drop in body temperature causes bleeding to increase in addition to longer recovery times. To address this, an anesthesiologist developed the Bair Hugger back in the 1980s. The device is a blanket of sorts that wraps around the patient on the operating table, blowing warm air to regulate their body temperature. As a result, a surgical patient’s core temperature can be maintained at exactly 98.6, ensuring minimal bleeding and recovery time.

The device is incredibly popular considering that it sees use in around 90% of all major surgeries. It is estimated that there are around 50,000 Bair Huggers in use around the country, meaning they are somewhat of a mainstay in the modern operating room.

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