Articles Tagged with Warning Labels

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Individual Opioid Lawsuits
Most of you have heard reports about the devastating effects of opioids. Millions of people have become addicted, and many of those people have overdosed and died while taking the addictive pain medication. Even in cases when death does not occur, addiction has caused job losses, ravaged families, and cost billions of dollars in treatment for victims.

Up to this point, most of the recent litigation involving opioids has involved lawsuits against the makers of opioids on behalf of states and local governments. The essential complaint is this: [Blank] State has incurred millions of dollars in losses because citizens in the state became addicted to opioids and required government assistance in the form of hospitalization, treatment programs, unemployment, welfare, and other governmental expenditures.

Oxycontin is an addictive opioid.
But what about individuals? It is plain to see how a state or county can articulate damages from the direct and indirect costs of widespread opioid addiction, but individuals have been injured as well. In 2018, do these individuals have valid claims? Increasingly, it appears the answer is yes. And if so, this litigation will eventually be massive.

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Earlier this month the judge in the most recent Xarelto trial voided a $27.8 million jury verdict. I wrote about that case here and here and here. On January 9, 2018, Judge Michael Erdos in Philadelphia state court held that the jury’s verdict on plaintiff’s inadequate warning claim was not supported by the evidence. Let’s take a look:

Treating Doctor’s (Very Unhelpful) Testimony

Xarelto-259x300One key issue in the case was whether Defendants Bayer AG, Janssen Pharmaceuticals and Johnson & Johnson failed to provide adequate warnings on the Xarelto label regarding the increased risk of internal bleeding. In an important study, bleeding rates for patients taking Xarelto in the United States were much higher than the bleeding rates of patients in other countries. This information was not added to the Xarelto label until September 2015. Plaintiff Lynn Hartman was prescribed and took Xarelto in 2013 and 2014.

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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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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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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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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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Transvaginal Mesh Warn LabelBetter late than never when it comes to warnings on potentially harmful medical devices, but the harm will only stop when the use of defective medical devices stops. Boston Scientific, a maker of transvaginal mesh and slings, is confronting the reality that its product can cause serious harm to patients. In June the company announced its products will carry a new warning label. Transvaginal mesh is used to treat common pelvic disorders in women, which you can read about here.

Boston Scientific is facing more than 36,000 product liability cases because of injuries the mesh has caused, including infections and erosion of surrounding tissue, according to the Minneapolis Star Tribune. Transvaginal slings are used as treatment for incontinence and surgical meshes are surgically implanted to strengthen tissue in women suffering from pelvic organ prolapse.

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