Articles Posted in Product Liability

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. It is a proton pump Prilosecinhibitor (PPI) used in the treatment of heartburn and gastroesophageal reflux disease (GERD). Nexium is a big competitor with Prilosec

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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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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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.

Keeping a patient warm is particularly useful during knee and hip replacement surgery because the procedures tend to be 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.

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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Over the past couple of years, I have written about some of the problems involving Wright Profemur Hip Implants. A few cases have settled but nothing game changing that has an impact on thehipimplant settlement value of the Wright hip implant cases.  But a big verdict in California sends a huge message that impacts the settlement value of these claims.

$4.5 Million Verdict

Wright is currently defending around 1,200 metal hip implant cases throughout various courts across the United States. The first of such to go to trial netted a big verdict for the plaintiff, perhaps giving Wright a taste of what is to come if more go to trial.  If this case is any indication, they can expect financial pain.

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Multidistrict litigation, called an MDL, is a special legal procedure used in mass tort cases to streamline the handling of large and complex cases.  An MDL is a “sort of” class action lawsuit.  It is a courtroomclass action in that the cases are all brought together under one judge for pretrial discovery.  But typically after a few bellwether trials of individual plaintiffs, the cases are send back to their local jurisdiction for trial if a settlement if not reached.  The hope of the MDL process is that the parties can figure out the value of the claims so a global settlement can be reached with most of the plaintiffs.

The idea of an MDL was actually ‘ idea. The concept was born in 1968 when lawmakers created the MDL system as a way to speed up and coordinate complex litigation that was filed in multiple federal judicial districts. MDLs are utilized in scenarios where a single defendant or group of defendants commits a single tort or does a single act that affects a large group of people. When all of those individual people then go to sue the defendant, it makes more sense to consolidate their cases. This streamlines the process and avoids different rulings regarding similar aspects of the case.

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Frequent readers of this blog will be aware of the litigation against Bayer/Johnson & Johnson regarding their drug Xarelto. The cases are consolidated in federal court as Multidistrict Litigation xarelto(MDL), and the presiding judge is moving proceedings along.

  • This update is a little old now.  Get a recent update and some rampant speculation on the value of these cases here.

Summer 2015 Update

Over the past few years, product liability suits against the makers and marketers of the drug Xarelto, Bayer/Johnson & Johnson, have been cropping up across the country. The suits are mostly filed in federal court, meaning the parties consolidated them as an MDL. Judge Eldon Fallon is the sole judge presiding over the MDL, giving him the ability to make all pretrial rulings. This is the great thing about an MDL; when many different cases are consolidated, the parties can avoid doing the same discovery over and over again, while getting consistent rulings from a single judge.

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Around 22 complaints involving power morcellators are pending in 16 different U.S. federal courts around the country. Plaintiffs are now requesting a federal judge to centralize proceedings for Multidistrict Litigation (MDL). I touched on the issues surrounding power morcellators on more than one occasion, but let’s talk about where these cases are and where they are going.

Power Morcellator Lawsuits

morcellator-device

Power Morcellator Litigation Heating Up

Power morcellators are surgical devices that are used to cut portions of the uterus into small fragments so they can be easily extracted through a patient’s stomach. Morcellators are utilized in laparoscopic hysterectomies where patients want to avoid traditional surgical scarring. Although morcellators are a great way of avoiding just that, the nature of the device and procedure often means that fragments of tissue are left behind after a procedure. Doctors and patients really didn’t worry about this too much because they were under the impression that the risks associated with leaving trace amounts of tissue behind were low.

Starting in 2006, however, pathologists informed a manufacturer of power morcellators, Johnson & Johnson, that their use has the potential to cause cancerous cells in the uterus to spread. Typically, these cells would have been contained in the uterus, but using a morcellator could break up cancerous fibroids in the uterus, increasing the risk of cancer spreading throughout the body. Granted, it’s not like every patient who undergoes a hysterectomy is faced with this risk. Current estimates suggest that about 1 in 350 patients who undergo this procedure have cancer cells contained within the uterus. So the incidence of cancer may be low, but considering that around a half-million patients have undergone a laparoscopic hysterectomy, around 1,500 patients were wantonly exposed to the risk of cancer.

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