Articles Posted in Pharmaceutical Drugs


                Zostavax Trials Set for 2020

U.S. District Judge Harvey Bartle of the Eastern District of Pennsylvania has selected the initial “bellwether” cases in the Zostavax MDL. The bellwether Zostavax cases will be grouped into two categories and prepared for five proposed trial dates that will take place between fall 2020 and summer 2021.

You never know how mass tort cases are going to go.  But I do think the Zostavax cases might be ripe for settlement long before these cases ever go to trial.

June 2018 Update:  Abilify lawsuits may be very close to a settlement.  There were three cases set to go to trial in the federal MDL.  They are settled.  These cases may settle very soon.  If you have not already brought a claim, contact a lawyer as soon as possible.

What is Requip?

facepalm-199x300Ropinirole, marketed under the name Requip, is a dopamine agonist.  The drug stimulates dopamine receptors and mimics the action of dopamine in the brain.   In 1995, GSK sought to submitted get Requip approved to treat the symptoms of Parkinson’s disease.  The FDA approved ropinirole for marketing and distribution for treating symptoms of Parkinson’s disease in 1997.

xareltoAll Xarelto lawsuits, including lawsuits to be filed by Maryland residents, will be consolidated before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana.

This happened quickly.  Xarelto came on to the market three years ago.  Now there is a class action type MDL that has been created because there are too many lawsuits.  This does not speak well to this drug and it does not speak well to Johnson & Johnson and Bayer, who introduced Xarelto with so much pomp, circumstance and excitement that it might be a drug that could really change the quality of people’s lives.

What the MDL Means?

I always call an MDL a “sort of” class action.   All federally filed cases — which is the vast majority of these claim and virtually all of the Maryland claims — are consolidated under one federal judge in a single jurisdiction, Louisiana in this case.   When a lawsuit is filed, the lawyers have an opportunity to conduct discovery where both sides get a chance to learn about the case.  In the Xarelto lawsuits, there are some facts common to all of these claims.  The biggest issue is going to be what Bayer and J&J knew or should have known about the bleeding risks associated with Xarelto.

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One drug that has attracted the attention of plaintiffs’ lawyers in massive numbers is Pradaxa. There are not a lot of cases – you can call it a mini mass tort. But they are very strong cases that I think are going to have a lot of value.  (2019 Update: Most of the 2,500 claims against Boehringer-Ingelheim settled for $650 million.)

Pradaxa is an anticoagulant or blood thinner used to prevent strokes in patients with atrial fibrillation and others at risk for developing potentially life-threatening clots. Plaintiffs’ lawyers, then prescription drug safety advocates, and now everyone else under the sun, have realized that Pradaxa may substantially increase the risk of contracting viral infections. Continue reading

If you are on dialysis, you are vulnerable. Obviously. The last thing you need is someone who pretends to provide a product that helps while actually knowing that the product is going to create a risk to dialysis patients. That appears to be what we have in these Fresenius NaturaLyte and GranuFlo cases.

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I get so many emails from so many marketing companies. Just today I got an offer to write a guest post on this blog (no), an email telling me that I rank poorly in Salisbury, Maryland on the search engines (he’s wrong), and two more random emails from companies telling me they are the best in the world at getting me to the top of the search engines (unlikely since, you know, you are spamming me).

But I found one of these emails really interesting. This one was from New York City and it offered to provide leads for Actos, Yaz, Yazmin, and Ocella cases. These emails are always flying in, but this one actually provided the prices for the leads:

  • Actos: $450

An MDL Panel ruled this week that any Actos lawsuits filed in federal court in Maryland will be consolidated in Louisiana.

Actos is another drug for type 2 diabetes that has helped treat diabetes but can get the patient into problems that they did not anticipate (Avandia has also had its share of problems). With Actos, studies have shown that people who take Actos for more than a year are 40 percent more likely to develop bladder cancerActos2 than those never exposed to Actos.

Actos does an effective job of treating diabetes. Actos improves blood sugar levels by increasing the body’s sensitivity to insulin in patients who have been diagnosed with type 2 Diabetes. Clearly, diabetes is a serious disease and the medications to treat diabetes come with – as most medications do – risk. Certainly, if you have life-threatening diabetes and Actos is the only drug that works for you, maybe you take on otherwise unacceptable risks. I get that. But Actos users did not sign up for this risk of bladder cancer. There are too many patients over the years that would not have used Actos if they knew it caused bladder cancer. Continue reading

The FDA is currently investigating a possible association between the diabetes drug Actos (pioglitazone) and an increased risk of bladder cancer.

Actos is commonly prescribed to treat type 2 diabetes and works by increasing the body’s sensitivity to insulin. It is usually taken once a day by mouth. By all accounts, Actos helps treat type 2 diabetes, which is undoubtedly an awful disease. But there are other diabetes options where there is no suggestion of a link to cancer. The questions that doctors are going to have to answer are whether Actos is worth the risk of cancer and whether there are other less risky options Actos2available. Ultimately, juries are also going to be asked these questions, too. They will also have to dig into the other question: what did the manufacturer of Actos know or should it have known about the association between cancer and Actos and should they have issued a recall for Actos or at least provided a warning of the risk?

The bubbling concerns about Actos culminated in a safety announcement dated June 15, 2011, wherein the FDA warned the public that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” Information about the potential risk will be added to the Warnings and Precautions label for medicines that contain Actos, and the corresponding patient Medication Guides will also be updated to reflect information on bladder cancer. In response to the FDA’s actions, the drug’s manufacturer (Takeda) has undertaken a 10-year observational study to assess the long-term risk of bladder cancer associated with the use of Actos. Continue reading

The Drug and Device Law Blog writes whines about inadequate fact sheets in the Yaz Yasmin MDL.

Plaintiff Fact Sheets are basically questionnaires that serve as interrogatories in mass tort cases. In the Yaz/Yasmin cases and other MDLs, they are really agreed upon case specific interrogatories. If nothing else, fact sheets cut through the bickering of what defendants may legitimately ask. They could call them “agreed upon interrogatories” and it would mean the same thing.yaz

Echoing this otherwise excellent Drug and Device Law Blog’s trite and tired leitmotif – those lazy, greedy plaintiffs’ lawyers! — the post gripes:

The goal for the other side in MDL litigation is to file as many complaints as possible and after that do as little work as possible – while waiting around for the almost inevitable settlement, be it large or small. Thus, MDL plaintiffs want only one-way discovery. Their side gets to discover the living daylights out of our clients, and drive up our expenses to the maximum extent possible. But our side doesn’t get anything more than pieces of paper called “questionnaires” or “fact sheets.”

The reality is that when a plaintiff does provide meaningful responses, mass tort defendants applaud the effort by beating them down over every last detail. And, oh my, if plaintiff’s fact sheet triggers something like defendant has to provide shipping records or any other obligation, it will NEVER be good enough. “Dear Counsel, your Plaintiff’s Fact Sheet is incomplete because you did not tell us who your doctor was in the eighth grade when you broke your leg.” Continue reading

The first line in this editorial adequately summarizes the problem that leads to unsafe drugs and medical devices:

What would your reaction be if the results of a football match were reported as 5:0 by one of the teams and as 3:1 by the other team?

This editorial underscores a point that I think the “FDA approval is the gold standard” crew completely ignores: it is painfully easy to rig drug testing to get the desired results at any stage of the research and testing process. Most of the injuries were at the end of the study? Change the end point. Most of the adverse effects were in patients with blonde hair? Take them out of the study.shutterstock_69220570

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