Articles Posted in Multidistrict Litigation

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On June 12, 2017, a jury in New Orleans reached a verdict in favor of defendants in the second Xarelto bellwether trial. This verdict follows a defense verdict in the first bellwether trial. Let’s take a closer look.

The Second Xarelto Bellwether Trial  

Neoplastin PT Blood Test for Xarelto PatientsTo recap briefly, Xarelto (rivaroxaban) was first approved by the FDA for sale in 2011. As an anticoagulant, it was supposed to prevent pulmonary embolism (PE), deep vein thrombosis (DVT), strokes, and other serious conditions. And it was easier to take than warfarin. In studies, however, Xarelto caused a higher rate of complications from internal bleeding; but unlike other anticoagulant drugs, there is no “antidote” for stopping internal bleeding in patients. People bleed and often can’t stop bleeding.

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Diabetes Drug InvokanaDiabetes is an awful disease. It is a chronic condition that affects the way the body metabolizes sugar. Diabetes is also a growing health problem in the United States, with over 29 million Americans currently suffering from the disease. Of the newly diagnosed cases of diabetes in adults, approximately 95% are for Type 2 diabetes (sometimes referred to as adult onset). It’s also expected that one out of every three people will develop diabetes in their lifetimes.

Type 1 diabetes occurs when the human body doesn’t produce enough insulin, a hormone used to help the body absorb glucose. Type 2 diabetes occurs when the human body produces enough insulin, but cannot use insulin properly. Both types of diabetes result in high blood sugar levels which can cause long-term health problems.

What does all this mean? From the perspective of pharmaceutical companies, it means there is a huge market for Type 2 diabetes drugs.

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Pregnant Woman Taking Zofran for NauseaZofran is an anti-nausea drug. It works to prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that triggers nausea and vomiting. The drug was designed to help cancer patients dealing with the side effects of chemotherapy but it was also approved by the FDA for those suffering nausea due to radiation therapy, anesthesia and surgery. Nevertheless, GlaxoSmithKline (GSK) eventually pushed to market and sell Zofran to pregnant women. Women who are pregnant are often plagued by morning sickness, and some can suffer from extreme nausea. The problem is, the FDA never approved the use of Zofran for pregnant women; it’s an “unapproved” use of the drug. Unfortunately, “off-label drug use” is very common. I wrote about off-label drug use and its potential dangers here.

By 2013, 110,000 monthly prescriptions of Zofran were issued to pregnant women. If this were an approved use, we could rest easier, as an approved use means the drug has been thoroughly tested and evaluated, with the determination backed up by “strong scientific data.” For unapproved uses there is none of that. If a drug is approved for any use, a doctor can then use his best judgment to prescribe the drug for any other purpose.

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Jury Verdict in First Xarelto Bellwether Trial

More than 18,000 lawsuits have been filed against the drug manufacturers of Xarelto over internal bleeding injuries. Two weeks ago the first bellwether case in the Xarelto multidistrict litigation was tried to a jury in Louisiana. On May 3, 2017, that jury rendered a verdict in favor of Bayer Healthcare Pharmaceuticals, Janssen Pharmaceuticals, and parent company Johnson & Johnson. After a seven day trial, the jury found in favor of defendants on one narrow issue: that the plaintiff did not prove his claim that the drug makers failed to give adequate instructions to the physician on the safe use of Xarelto; specifically, the plaintiff argued that drug makers failed to give instructions to doctors about the need to perform a blood-clotting test on Xarelto patients before prescribing the drug.

Although a setback for the plaintiffs, this narrow decision makes me confident there is “plenty of game left” in the overall Xarelto litigation. I do not believe the Boudreaux case adequately represents so many of the remaining claims against Bayer, Janssen, and J&J.

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Depuy ASR Settlement Agreement ExtensionWe are getting more clarity on the recent extension of the Settlement Agreement in the Depuy ASR artificial hip litigation. As I wrote about in a previous post, the ASR Settlement has now been extended to cover people implanted with the Depuy ASR hip who received a revision surgery between January 31, 2015 and February 15, 2017. This is an important development because up to this point the Settlement did not include any injured people who had undergone revision surgery after January 31, 2015. And this represented a lot of people.

Last week the Depuy ASR MDL executive committees sent correspondence with more clarification of the extension agreement. To make things easy, I am going to refer to this Depuy ASR extension agreement as the “Third Settlement” (because it follows two prior Settlement Agreements which had clearly defined terms and clearly defined deadlines).

Third Settlement Enrollment Deadlines

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Internal Bleeding on XareltoNext week the first bellwether trial begins in the Xarelto multidistrict litigation. Bellwether trials are important events in the life-cycle of MDLs. Both sides select several representative cases and submit those cases to the MDL judge, who then makes the final selection for a list of bellwether cases to try. From there, these cases are tried one after another. Along the way, the plaintiffs and defendants get a real sense of what juries think of the common issues raised in the MDL. This can lead to global settlements and ultimately to the resolution of hundreds or thousands of cases.

So as I said, the first Xarelto bellwether trial starts on Monday (April 24, 2017), unless the parties settle the case between now and then, which sometimes happens. If not, in a few weeks we will all get to see what the first jury thinks of the first Xarelto case.

I have written about Xarelto several times on this site, but to recap briefly, Xarelto (rivoroxaban) was supposed to be a game-changer as a blood thinning drug medication when it was first approved for sale in 2011. Blood thinning medications are important drugs to treat certain conditions in patients, as they can prevent pulmonary embolism, deep vein thrombosis, and even strokes. These serious conditions often arise after surgery, when blood clots are more likely to occur. Xarelto was later approved to treat people with atrial fibrillation (irregular heartbeat).

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Stryker LFIT V40 Artificial Hip MDL
We’ve previously blogged about Stryker LFIT V40 artificial hip problems, discussing a recall made back in August 2016 and how to tell if you have an artificial hip that’s part of that recall. Since those posts a lot has been going on in courthouses across the country, with dozens of lawsuits popping up from individuals who received affected artificial hips made by Striker Orthopaedics and its subsidiary, Howmedica Osteonics Corporation (HOC).

Just recently, approximately 33 pending lawsuits against HOC were consolidated into a multi-district litigation (MDL). In a way, you can think of this consolidation as a “things just got real” moment for HOC. But what’s the big deal about the Stryker LFIT V40 litigation now being in MDL status? Let’s begin by discussing the underlying lawsuits.

Why Are the Plaintiffs Suing?

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Fosamax user with broken femur
Osteoporosis is a disease where the human body’s bones become weaker. It is a common issue with women who have gone through menopause. The drug company Merck developed a drug called Fosamax (alendronate) hoping to prevent and treat osteoporosis in postmenopausal women.

As with all other drugs, Fosamax had side effects, one of which was actually increasing the risk of femoral (thigh) bone fractures. Thousands of users of Fosamax suffered this side effect and sued Merck.

Even though there were a lot of plaintiffs suing, many of their cases became consolidated into a multi-district litigation, or MDL, in New Jersey.

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ViagraThe Viagra litigation is ramping up. Last April the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation site in the Northern District of California for lawsuits alleging injury against Pfizer from the use of Viagra. Since then, the Viagra lawsuits have piled up in California federal court.

The U.S. Food and Drug Administration approved Viagra (sildenafil citrate) for sale in 1998. It set out to fix an intimate and unhappy problem: erectile dysfunction. One study indicated that thirty million men may suffer from erectile dysfunction. And it worked (I’ve heard). Millions of men standing on the sidelines were back in the game.

The reason I know it worked is because Viagra’s manufacturer, Pfizer, Inc., sold $1.8 billion dollars worth of the drug in 2013. Pfizer has self-reported that it has prescribed Viagra to 35 million men. All over the country and all over the world, those 30th wedding anniversary weekends were suddenly a lot more fun. And that’s a wonderful thing.

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Female contraception is common these days, with many medications, medical devices and methods available. One popular birth control method is the intrauterine device, or IUD.

There are many companies making different types of IUDs that work in different ways. Some use copper as the primary means of contraception while others use hormones. One of the most popular hormonal IUDs available goes by the brand name Mirena.

How Does the Mirena IUD Work?

Mirena is a hormonal IUD that is inserted into a woman’s uterus. Once inserted, the IUD continuously releases a small amount of the hormone levonorgesterel. The Mirena IUD is extremely effective and works primarily by preventing fertilization from occurring, rather than preventing implantation of the fertilized egg into the uterus.

Another advantage of the Mirena IUD is that it works for a long period of time (three to five years) without any intervention by the woman. And when the effective time period of Mirena passes or the woman decides she wants to try to get pregnant, the Mirena IUD can be removed and fertility restored. Because of these advantages, many women have chosen Mirena as their preferred form of birth control.

What’s Wrong with the Mirena IUD?

Woman with Mirena IUD Suffering from Intracranial HypertensionDespite its effectiveness as a contraceptive and its popularity, the Mirena IUD has caused some women to suffer from a variety of serious conditions, including the dangerous buildup of cerebrospinal fluid in the brain. This fluid buildup then causes an increase in intracranial pressure and can lead to severe headaches, ringing in the ears, nausea, blurred vision, neck pain, and blindness due to the swelling of the optic nerve.

Many women experience progressively worsening vision as the optic nerve swelling increases. Most of these symptoms are similar to those people suffering from a brain tumor. There are several names to describe this condition, including Pseudotumor Cerebri (PTC) and Intracranial Hypertension (IH).

Depending on the woman, the effects of PTC or IH can sometimes be reversed, but it often results in permanent damage to a woman’s vision. Even if the effects can be reversed, it usually takes years of maintaining normal intracranial pressure in the brain. As a result of these problems, many lawsuits against Bayer, the maker of Mirena, have recently emerged.

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