Category: News

IVC Filter Implants Decrease Nationwide

Tighe Wilhelmy with Velawcity here to review a recent study by Temple University that was published in the July 10th, 2017 issue of JAMA Internal Medicine.

Temple University conducted a nationwide study to identify what impact was made on implant rates, following the FDA’s 2010 safety communication recommending the removal of filters as soon as Pulmonary Embolism (PE) protection is no longer needed.

The professors (led by Riyaz Bashir) used the National Inpatient Sample database to identify all IVC Filter implant patients during January 2005 and December 2014. And here were their findings:

Approximately 1,131,274 patients underwent IVC Filter implant surgery over the 10-year study period. IVC Filter placements saw a 22.2% increase from 2005 to 2010. After the FDA safety communication in 2010, IVC Filters saw a 29% reduction in placement from 2010 to 2014.

For purposes of international comparison, the United States has an IVC Filter implant rate as high as 55 per 100,000 consumers, while the largest European countries have an implant rate of 3 per 100,000 consumers.

Not only did the FDA’s questionable approval process fail the American people, but an earlier safety communication regarding the dangers of IVC Filters could have helped thousands of more consumers.

For more information on pharmaceutical drug or medical device lawsuits, call (480) 508-0219.

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Essure® Ban Lifted by Brazil

Tighe Wilhelmy with Velawcity here to explain the decision on July 11th, 2017 by Brazil to lift the ban on Essure® device sales. This comes as a result of Bayer presenting documents that detailed test results sought by the Brazilian Health Regulatory Agency (Anvisa). Bayer® was initially unresponsive and thus, Brazil applied the ban.

In other international news for Essure®, 400 women are set to file a lawsuit in France during September against Bayer®. This is coupled with the discontinuation of Essure® device sales in Canada, Finland and The United Kingdom.

Essure has sold more than 1,000,000 devices worldwide.

Though according to Bayer’s® annual report, they face over 3,700 lawsuits and lost approximately $413 million dollars in revenue during 2016 because of the Essure® lawsuits. The birth control device’s side effects are said to include unwarranted pregnancies, chronic pain, uterus and fallopian tube perforations, device migration and more.

For more information on medical device and pharmaceutical drug lawsuits, call (480) 508-0219 to speak with a representative.

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JPML Approves Onglyza Consolidation

Tighe Wilhelmy with Velawcity here to discuss the recent consolidation of Onglyza® and Kombiglyze XR® claims by the JPML. The MDL was approved on February 2nd and will be overseen by Judge Karen K. Caldwell in the eastern district of Kentucky.

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Onglyza® and Kombiglyze® XR are both Type II diabetic prescription drugs. They are manufactured by industry giant, AstraZeneca®, and were released July 31st, 2009 and November 5th, 2010 respectively. Combined revenues generated for these drugs exceeds (1) billion dollars per year in the United States.

Currently, thousands of claimants allege various cardiovascular injuries were experienced as a result of taking these diabetic drugs. These injuries currently include, but may not be limited to, Heart Failure, Congestive Heart Failure, Cardiac Failure, and Death.

On April 14th, 2015 an FDA Advisory Committee Meeting concluded with a (14-1) recommendation to the FDA that Onglyza® and Kombiglyze® XR add warnings for heart failure. It should be noted the (1) opposing vote believed a warning was insufficient and the drugs should be withdrawn from the market.

These recommendations came as a result of the Saxagliptin Assessment of Vascular Outcomes Recorded study, also known as SAVOR study, which found a 27% increased risk of heart failure. SAVOR ultimately reported that 3.5% of Saxagliptin patients suffered their first recorded Heart Failure event and roughly 26% of these subjects deceased. On April 5th, 2016 heart failure warnings were added to Onglyza® and Kombiglyze’s® drug labels.

Hopefully you enjoyed this mass tort update. For more information regarding Onglyza®, including case acquisition, please contact us at (480) 508-0219.

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