Articles Posted in Drugs

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Asia’s biggest drugmarker, Takeda Pharmaceutical Co., is facing its first trial of lawsuits involving Actos. Alleged to have caused cancer in some patients, Actos was once the world’s biggest-selling diabetes drug. Like many diabetes drugs that were pushed on the market as the drug companies chased a gold rush of profits, lawsuits ensued. Now Takeda faces more than 3,000 lawsuits alleging Actos caused bladder cancer or other ailments among patients.

More than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. The first federal case is set for trial in November 2014. In the meantime, Takeda faces its first case today in state court in Los Angeles. Plaintiff is a 69 year old man who took Actos for more than two years. Diagnosed with bladder cancer in November 2011, he is “gravely ill” according to the Judge that granted an expedited trial of his claim.

This trial comes one month after Japanese-based Takeda won U.S. regulatory approval for Nesina, a new diabetes drug to replace Actos.

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I wrote last week about how nothing is going right in the Fosamax cases. Now something did go right. A jury in New York yesterday awarded $285,000 to a plaintiff for Novartis on the defective design case. Which is fine, really. You only need one reason to win.

Is $285,000 a huge victory in a piece of litigation where some of the injuries are so utterly awful? No. But after a string of losses, a win is a win. Could this be the turning of the tide in these cases? I think Novartis is probably going to bet no and keep on trying these cases. We will see.

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In a blow to all Fosamax plaintiffs, but one in particular, the 2nd Circuit Court of Appeals upheld a defense verdict for Merck on Wednesday, finding no errors in the lower court’s rulings.

At particular issue was the trial court’s exclusion of plaintff’s key experts. The 2nd Circuit said that one of the experts offered irrelevant testimony that was properly excluded, and that the trial court correctly ruled that the expert could not give testimony about the competency of the FDA because the expert lacked the qualifications to do so. As for another expert (awkward writing because I hate using names when I don’t have to, sorry), the court found that the expert’s causation opinion was properly excluded because it was offered in his capacity as a treating doctor.

How does this make sense? Well, Florida law requires plaintiff to show that the treating doctor would have recommended that she stop taking Fosamax if they had known about the risks. Here, the treating doctor did not know she was taking Fosamax during the relevant time period.

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Bellwether trials in the first state and federal NuvaRing cases have been scheduled.

The first “test” trial in state court is scheduled to begin on May 6, 2013, and will be held in the New Jersey state court. The first trial will be picked from a group of nine eligible bellwether cases. Seven will be pulmonary embolism cases, one of which resulted in death, and two stroke cases.

The first federal court bellwether trial has been scheduled to begin on July 8, 2013. This will also consist of both pulmonary embolism cases and stroke cases.

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Last month brought changes to fifty-eight (58) medical product labels(down slightly from 60 changes in September), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

Published on:

Last month brought changes to fifty-eight (58) medical product labels(down slightly from 60 changes in September), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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The 11th Circuit affirmed summary judgment in a lawsuit where the plaintiff claimed he went blind from the use of Genetech’s macular degeneration drug.

Plaintiff acted as his own lawyer in this case. His argument was “C’mon, look at the temporal relationship here” instead of bringing an expert who could testify – as Georgia law requires – that the drug at issue, Lucentis, caused his vision loss.

Putting together a drug injury case that can get past summary judgment is difficult. Most practicing attorneys in the country could not do it, much less a pro se plaintiff. This is true even if the facts are on your side.

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Last month brought changes to sixty (60) medical product labels(up from 53 changes in August), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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The FDA said yesterday that Mirapex, a drug used to treat Parkinson’s disease and restless leg syndrome, may cause heart failure.

I don’t think anything is conclusive, but results of recent studies indicate a potential risk of heart failure. More studies are necessary to confirm these findings but if you are taking Mirapex, you have to be concerned. This was not just a single study that could have gone awry. Instead, the study looked at pooled analysis of multiple randomized clinical trials. Researchers found that heart failure occurred more frequently in patients taking Mirapex than in patients taking a placebo.

Should you stop taking Mirapex because of this risk to your heart? Well, one good rule of thumb is don’t make medical decisions based on what you read on a legal blog. Really, you should be talking to your doctor about the potential risks and your options. The FDA agrees, saying that patients taking Mirapex should continue to do so and consult their doctors.

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Last month brought changes to fifty-three (53) medical product labels (way up from 41 changes in July), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected: