Thornton Law Firm Blog

More medical evidence of the long-term consequences of the use of transvaginal mesh was presented during the American Urological Association’s annual meeting this month. While several studies showed that the majority of women who undergo surgery to alleviate pain from transvaginal mesh implants are pain free after excision surgery, there is still a significant percentage of women whose pain continues after surgical removal of the mesh.

Fresenius Medical Care North America(FMCNA), a Massachusetts based company, will voluntarily recall 56 lots of NaturaLyte® Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines). The products were recalled because they could develop harmful levels of bacteria during their shelf life. The bacteria in the solution has been identified as Halomonas (species 1, 2, 3), a Gram Negative bacteria.

The Food and Drug Administration (FDA) has proposed that surgical mesh used vaginally for Pelvic Organ Prolapse (POP) be classified as a “high-risk” device and that manufacturers accordingly must submit scientific evidence that their transvaginal mesh is safe and effective.

Posted by David C. Strouss on Apr 23, 2014 4:22:00 PM UPDATE: This verdict was overturned by the Fifth Circuit Court of Appeals in 2017. The Fifth Circuit ruled that the verdict was based on insufficient evidence. The plaintiffs opted not to appeal. On Tuesday, April...

Posted by Michael A. Lesser, Esq. on Apr 23, 2014 10:35:00 AM Congratulations to all the runners, spectators, race officials, medical and security personnel who made this year's Boston Marathon a great success! Boston came out in force to reclaim our Marathon after...

Posted by Marilyn McGoldrick on Apr 11, 2014 10:49:00 AM NOTE: The trial judge on this case later reduced the award to $36.8 million, by lowering the plaintiffs’ $6 billion award for punitive damages against Takeda to roughly $27.7 million and the $3 billion dollar...

On Tuesday, the Food and Drug Administration (FDA) announced it is investigating a possible increased risk for heart failure associated with the diabetes drug Saxagliptin, manufactured by Bristol-Myers Squibb and AstraZeneca and marketed as Onglyza and Kombiglyze XR. The FDA has requested full data from the results of a recent clinical trial assessing the cardiovascular safety and efficacy of many current medications used to treat type 2 diabetes, including Saxagliptin (SAVOR trial). The FDA intends to further investigate the 27% increased risk of hospitalization for heart failure among patients taking the Saxagliptin reported in the study. The findings were first reported in August of 2013 at the European Society of Cardiology meeting and subsequently published in the New England Journal of Medicine.

Posted by Marilyn McGoldrick on Feb 3, 2014 3:32:00 PM On Friday, the federal judge overseeing the Ethicon transvaginal mesh (TVM) litigation ruled that Johnson & Johnson (J&J) and its subsidiary, Ethicon, will not be allowed to introduce evidence that...

The first federal MDL Bellwether trial in the Actos litigation (MDL 2299) began yesterday in Lafayette, Louisiana before the Honorable Rebecca Doherty. The plaintiff is Terrance Allen, a New York man who was prescribed the diabetes drug Actos from 2004 until 2011 when he was diagnosed with bladder cancer. Allen’s opening statement asserts that the evidence will show that Takeda had information about Actos causing bladder cancer for over 10 years and withheld this information from doctors and patients. Actos also raises the risk of heart disease, although that is not at issue in this trial.

A new study of children born near fracking operations in populated areas of Colorado has found that natural gas development within a 10-mile radius of the residences of pregnant women is positively associated with having a child with a congenital heart defect, and possibly associated with having a child born with a neural tube birth defect.