Articles Posted in Multidistrict Litigation

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A few weeks ago I wrote about an Androgel testosterone case being tried in Illinois. We now have the verdict, and the result is, well, a mixed bag. Still, on balance, it must be viewed as a win for plaintiffs, and a major rebuke for companies like AbbVie, Inc. who aggressively market their prescription drugs for off-label uses. After all, at the end of trial the jury awarded the plaintiffs $150 million in punitive damages for fraudulent misrepresentation.

Androgel testosterone trial
Just to recap, Androgel is a roll-on testosterone product. Jesse Mitchell began taking Androgel in 2007 after doctors ran blood tests and found that Mitchell’s testosterone levels were quite low. In 2012, at the age of 49, Jesse Mitchell had a massive heart attack. From what I’ve read, the heart attack almost killed him.

Mitchell and his wife sued AbbVie in 2014, claiming the company marketed and sold Androgel without properly warning men about the increased risk for heart attacks. During the trial an expert for the Mitchells testified that in his opinion there was a connection between Mitchell’s 2012 heart attack and his extended use of Androgel.

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An important trial is taking place over testosterone in Illinois. As part of the testosterone prescription multidistrict litigation, manufacturer AbbVie, Inc. is defending itself against claims that Androgel, a roll-on testosterone product, caused the heart attack of Jesse Mitchell in 2012 after years of taking the prescription medication. Let’s take a look at that case:

Mitchell v. AbbVie Inc. (1:14-cv-09178) 

AbbVie's Androgel TestosteroneIn 2007 Jesse Mitchell visited his doctor complaining of a constellation of symptoms, including fatigue and depression. He was 44. The doctor ran tests and discovered Mr. Mitchell’s testosterone levels were quite low, and prescribed Androgel, an easy-to-use roll-on testosterone product manufactured and (aggressively) marketed by AbbVie, Inc. Mitchell applied the roll-on testosterone to his upper body for several years. In 2012, at the age of 49, he had a massive heart attack. From trial and media reports, the heart attack permanently damaged his heart and almost killed him.

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SGLT2 Inhibitor Diabetes Drugs
Originally touted as a wonder drug, a new class of medications based on SGLT2 inhibitors promised to help those suffering from Type 2 diabetes by increasing their ability to lower and control their blood sugar, while also lowering body weight and blood pressure. Pharmaceutical companies were hoping that these new products could potentially become blockbuster drugs. Invokana and Farxiga are two examples of SGLT2 inhibitors.

But just a few years after the release of these drugs in the United States, the drug companies started facing stiff competition among themselves. Additionally, the public learned of the serious risks of taking SGLT2 inhibitors. The purpose of this blog post is to provide a quick overview of SGLT2 inhibitor drugs and the status of their litigation.

What Is a SGLT2 Inhibitor?

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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?