Articles Posted in Product Liability

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] sickwomanFDA-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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courtroomSome 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.

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 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.  Plaintiffs’ lawyers were high on these cases when we were losing because we always thought a jury would get angry at the fact in these cases.  It took us a while — which often happens in mass tort cases — but we were right.  Now the momentum is with the plaintiffs and the estimated settlement value of the IVC cases is on the rise.  Is the average settlement value of these cases going to be $3.6 million?   No way.  But the value of these cases is on the rise and other big verdicts will push the settlement value that much higher.

Things That Could Hurt You: Prilosec

What is it?

Prilosec-300x236Made 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

The antibiotic family of fluoroquinolones goes by many brand names, including Cipro, Levaquin, and Avelox. Every year, millions of Americans take fluoroquinolones to treat bacterial infections, including urinary tract infections, pneumonia, and bronchitis. Since the antibiotics work on a number of different conditions, they are popular among doctors.

Surprisingly Diverse Dangers

headache-300x199However, new studies indicate that these medications can also have serious side effects. These studies have linked fluoroquinolone use to risks like peripheral neuropathy. Peripheral neuropathy is a form of permanent nerve damage.  It can result in constant pain and often, limited mobility. In many cases, peripheral neuropathy is irreversible, which means that patients who develop it must live with pain and impairment for the rest of their lives.

Currently, several pharmaceutical companies are facing lawsuits filed by patients who have suffered irreversible peripheral neuropathy after taking fluoroquinolone. Evidence in court documents indicates that drug companies may have known about the nerve damage risks as early as 1996, but they did not remove these medications from the market or alert patients and doctors to the risks.

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Today, a U.S. Judicial on Multidistrict Litigation panel of federal judges will hear arguments on Plaintiffs’ request to consolidate all of the knee and hip infection lawsuits that have been filed in Bair Hugger MDL Coming Soon?federal court claims the infection was allegedly caused by a 3M Bair Hugger warming blanket.

What These Bair Hugger Cases Are About

A Bair Hugger device is a temperature management system that is used during surgery.  The purpose of the invention is to help the body regulate the appropriate temperature. The Bair Hugger pushed hot air through a hose into a blanket specially made to work with the device. The hot air produced by Bair Hugger accumulates under the surgical drape covering the patient.  This hot air escapes under the surgical drape below the level of the surgical table or over top of it

Bair Hugger Forced Air Warming Device is designed, manufactured, and marketed by Defendants 3M Company and Arizant Healthcare, Inc.
There are more than 50,000 Bair Hugger FAWs in the United States.

How does it work? The Bair Hugger is a portable heater/blower connected by a flexible hose to a blanket, typically positioned the patient getting surgery.

Keeping a patient warm is particularly useful during knee and hip replacement surgery because the procedures tend to be very long.   The body loses heat increasingly over the course of surgery.

Another thing about metal hip and knee replacement surgery is that your body is particularly prone to infection. Why?  The metal helps spread the infection.

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Bad news for Plaintiffs’ in the first liver damage lawsuit involving Tylenol.  A ten juror panel in New Jersey found for Johnson & Johnson (J&J) on all counts on Friday.  This is the first Tylenol liver damage lawsuit to go to trial.  It will not be the last. [See my 2017 update below.  [That “it will not be the last” statement is yet another thing I got wrong, as you will see in the 2018 update below.]

RisperdalclaimsThe lawsuit alleged that a 55-year-old woman suffered liver damage as the result of the use of Extra Strength Tylenol.  But the jury seemed to find that the injuries occurred before she took Tylenol.

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Big update in the pelvic mesh lawsuits and it is not a good one.  A Texas jury yesterday found for Johnson & Johnson’s (J&J) Ethicon division in a Gravel and Moneypelvic mesh claim.  Twelve Dallas jurors found that the Prosima pelvic mesh, given to women who suffer from pelvic organ prolapse, was not defective in its design, and that J&J did not fail to properly inform doctors of the risks and problems associated with this product.   It was no slam dunk.  Unlike a lot of states, Texas does not require an unanimous verdict in civil cases.  So a 10-2 vote was good enough for J&J to eke out a win.

It is just one case, but I’m not going to lie, this was one the Plaintiffs’ wanted to win.  I’ll be honest about something else.  I’m surprised J&J let this case go to trial.  They have been picking off cases to avoid a bellwether effect on settlement value that is going to wildly increase the expectations of Plaintiffs and make these cases that much harder to settle.  On this one, they gambled and won.

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