Today Reuters (2/14, Siebelt, Burger) reported that over 2,000 lawsuits in the US have been filed against the German pharmaceutical firm, Boehringer Ingelheim over its blood thinning medicine, Pradaxa (dabigatran etexilate). The claims allege that the medicine causes severe and fatal bleeding. In fact, studies have established that individuals using the blood thinner have roughly a 33 percent higher risk for fatal health …
Mesh Manufacturer Accused of Destroying Evidence
In a motion filed on December 2, Plaintiffs in the federal multi-district transvaginal mesh litigation asked the judge to impose “severe sanctions”against Johnson & Johnson’s Ethicon subsidiary for alleged mishandling and destruction of thousands of documents in the case. The litigation is pending in the United States District Court for the Southern District of West Virginia before the Honorable Joseph …
First Johnson & Johnson-Ethicon Vaginal Mesh Trial Set For August 2014
The first trial against the Johnson & Johnson-owned subsidiary Ethicon over its vaginal mesh implants has been set for August 2014. There are currently more than 10,000 Ethicon mesh lawsuits pending in federal courts. Recently, U.S. District Judge Joseph R. Goodwin ordered the date of the first Ethicon vaginal mesh trial for August 19, 2014. Lawsuits against the manufacturer have …
Judge Refuses to Vacate $2 Million Verdict in Bard Avaulta Pelvic Mesh Case
According to Lexis Nexis Company, on Oct. 18, Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia ruled plaintiffs submitted sufficient evidence to allow a reasonable jury to conclude the device contained design defects and that C.R. Bard Inc. failed to adequately warn physicians of the risks. The West Virginia federal judge has …
FDA Announces Medical Device Tracking System
According to Reuters, the US Food and Drug Administration (FDA) announced last month that it would be requiring companies to include tracking codes on medical devices, allowing the agency to monitor them for safety issues or recalls. According to the FDA, the tracking codes will be unique device identifier or UDI codes, which will be placed into a database that …
FDA Issues Safety Alert on Cancer Drug Iclusig Due to Adverse Events
As reported by Bloomberg News (10/11 Tirrell), Reuters (10/11, Siddiqui) and MedPage Today (10/11, Gever), the FDA issued a drug safety alert on Friday for Ariad’s cancer drug Iclusig (ponatinib) after one-fifth of patients in a postmarket clinical trial were found to have developed blood clots and narrowing of blood vessels that puts them at higher risk for heart attacks and strokes. …
Louisiana Judge Refuses to Dismiss Mirena Case
On Sept. 23, Judge Jay C. Zainey of the U.S. District Court for the Eastern District of Louisiana refused to dismiss a Mirena IUD case that was brought under the Louisiana Products Liability Act against Bayer Healthcare Pharmaceuticals Inc. (Thompson, et al. v. Bayer Healthcare Pharmaceuticals Inc., No. 13-3702 (E.D. La.) Mirena (levonorgestrel) is an intrauterine device placed in the uterus …
‘Fat-burning’ supplement, OxyElite Pro, linked to liver failure
As reported by the USA Today (10/8 Weise), Wall Street Journal (10/9 Burton) and Reuters (10/9 Clarke), the U.S. Food and Drug Administration is investigating 29 cases of hepatitis linked to the ‘fat-burning’ supplement, OxyElite Pro, that possibly led to two liver transplants and one death. At least eleven patients have been hospitalized. Health officials are advising consumers to stop using the product. OxyElite Pro …
Deadline set for fungal meningitis claims against NECC
As described in the Tennessean (9/30, Roche), last week in Massachusetts, US Bankruptcy Judge Henry Boroff set a Jan. 15, 2014, deadline for victims of the nationwide fungal meningitis outbreak to file claims in the bankruptcy case of the company blamed for the deaths of 64 patients. NECC is the manufacturer of contaminated steroid shots that were distributed to medical …
Vaginal-mesh manufacturers in settlement talks
According to Bloomberg News (9/30, Feeley, Voreacos), C.R. Bard Inc., Endo Health Solutions Inc., Boston Scientific Corp., along with two other manufacturers of vaginal-mesh implants accused of injuring thousands of women are in settlement talks. According to the report, U.S. District Judge Joseph Goodwin in Charleston, West Virginia, who is overseeing the federal lawsuits targeting the implants has been asked to appoint a settlement …
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