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Zoloft Birth Defect MDL Conference Scheduled

Last month, the U.S. Judicial Panel on Multidistrict Litigation centralized all federally filed Zoloft birth defect lawsuits before Judge Cynthia M. Rufe in U.S. District Court for the Eastern District of Pennsylvania. At that time, nearly 100 lawsuits were centralized to the court on behalf of children who were born with birth defects from Zoloft prescribed to their mother’s during pregnancy, and the number is expected to grow.

Earlier this month, Judge Rufe issued a pretrial order scheduling the initial status conference of the MDL for July 12, at which time, attorneys for each side will “suggest procedures that will facilitate the expeditious, economical and just resolution of this litigation,” the order said. More Zoloft Birth Defect MDL Conference Scheduled

Federal Judge Expedites Actos Lawsuit Filing Procedures

U.S. District Judge Rebecca Doherty, who is overseeing the Actos Products Liability multidistrict litigation in U.S. District Court for the Western District of Louisiana ,has issued a direct filing order for all new Actos lawsuits, which will allow new plaintiffs to join the MDL directly instead of filing Actos lawsuits in local courts and having to wait for it to be transferred to the Lafayette federal court.

As many as 10,000 lawsuits could be filed against Takeda Pharmaceuticals over allegations that the type 2 diabetes drug Actos has patients to develop bladder cancer, Bloomberg reported. Last year, the U.S. Food and Drug Administration issued a warning that long-term or high dose Actos users face a 40 percent increase in developing bladder cancer. Health Canada has also issued a warning concerning the drug, and the drug is currently banned in Germany and France. More Federal Judge Expedites Actos Lawsuit Filing Procedures

PA Judges Hear Appeals in Risperdal Dismissal

Seven Pennsylvania Commonwealth Court judges heard arguments on Wednesday to reverse a dismissal by two Common Pleas Court judges of a lawsuit filed against Johnson & Johnson over allegations that it inappropriately profited from the antipsychotic drug Risperdal, the Philadelphia Inquirer reports.

Previously, Judge Howland Abramson dismissed a count made by the state that it could sue J&J subsidiary, and Risperdal maker Janssen Pharmaceuticals, as a “provider” under the fraud laws of Medicaid. Then, Judge Frederica Massiah-Jackson dismissed the lawsuit after a week of testimony ruling that PA did not have enough evidence for the case to continue. More PA Judges Hear Appeals in Risperdal Dismissal

Actos Whistleblower Lawsuit Implicates Cleveland Clinic Researcher

The 2011 whistleblower lawsuit filed by former Takeda medical reviewer Helen Ge against the pharmaceutical company, which alleges that Takeda downplayed the number negative events associated with the type 2 diabetes drug Actos, including bladder cancer and heart failure, that it reported to the FDA.

The whistleblower lawsuit, which was unsealed earlier this year, further alleges a financial connection between Takeda and Cleveland Clinic’s Dr. Steven Nissen, who authored a meta-analysis that showed Avandia, also a type 2 diabetes drug, was more dangerous than Actos. The lawsuit also alleges that Nissen was the principal investigator for the Actos phase 2 PERISCOPE trial, and that the trial used technologies invented by Nissen as part of the trial. For this, the suit claims, “payment Nissen received from Takeda through Cleveland Clinic Foundation was estimated to be $8 million to $10 million” for this participation in PERISCOPE, while Cleveland Clinic garnered over $13 million in revenue from Takeda for the Nissen invented imaging technologies. More Actos Whistleblower Lawsuit Implicates Cleveland Clinic Researcher

Appeals Court Upholds Sulindac Drug Liability

The First Circuit Court of Appeals has upheld a products liability verdict that awarded Karen Bartlett of Plaistow, New Hampshire $21.6 million after finding the generic, non-steroid, anti-inflammatory drug Sulindac was unreasonably dangerous.

Bartlett began taking the drug in December 2004 after her physician prescribed it for shoulder pain, and within a few weeks she began to experience problems that led to blindness and severe burning of her mucus membranes and skin. More Appeals Court Upholds Sulindac Drug Liability

Medtronic Facing Infuse Lawsuits

Martin Gavin has filed a lawsuit in the U.S. District for the Eastern District of Louisiana against Medtronic Inc., Medtronic USA Inc., and Medtronic Sofamor Danek USA Inc. over the Infuse bone graft, alleging the device caused abnormal bone growth in his spinal cord after having a lumbar fusion surgery.

According to the lawsuit, Gavin had a transforaminal lumber interbody fusion surgery in February 2011. Following that surgery, Gavin claims that he was unable to recover from the surgery, and suffered severe pain. He had to have epidural spinal injections, endure another surgery for the implantation of a transcutaneous electrical nerve stimulator, and have physical therapy. More Medtronic Facing Infuse Lawsuits

Abbott to Pay $1.5 Billion over Depakote

Abbott Laboratories has plead guilty to promoting the anti-seizure drug Depakote for uses that were not approved by the U.S. Food and Drug Administration. Abbott will pay over $1.5 billion including civil settlements with the various states and the federal government in the amount of $800 million, as well as criminal fines and forfeiture in the amount of $700 million.

The Associated Press reports that Deputy Attorney General James Cole said the settlement shows the that the government was determined to “hold accountable those who commit fraud.” More Abbott to Pay $1.5 Billion over Depakote

9 Lawsuits Filed Against Plavix over Life-Threatening Bleeding Events

Over the past week, the national law firm of Parker Waichman LLP has filed a total of nine new lawsuits in the Supreme Court of the State of New York, County of New York, on behalf of individuals who suffered life-threatening bleeding events linked to the use of the blood thinner Plavix.

According to the lawsuits, the plaintiffs have suffered serious Plavix side effects including gastrointestinal hemorrhage, cerebral hemorrhage and a blood condition called thrombotic thrombocytopenic purpura. The plaintiffs also allege that Plavix users are at a greatly increased risks of stroke, heart attack, and death. More 9 Lawsuits Filed Against Plavix over Life-Threatening Bleeding Events

Class Action Filed After DMAA Warning

Anthony Velasco has filed a class action lawsuit against SEI Pharmaceuticals alleging that the DMAA-containting product MethylHex 4,2 is “illegal and dangerous” and that millions of dollars have been taken from consumers because of the company’s fraudulent behavior, Natural Products Insider reports.

The class action lawsuit is one of several filed following a warning by the FDA regarding DMAA (dimethylamylamine). The U.S. Food and Drug Administration “issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA. Also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a “natural” stimulant,” the FDA website said. More Class Action Filed After DMAA Warning

First Bard Avaulta Transvaginal Mesh Trial Date Set

U.S. District Judge Joseph R. Goodwin has set a February 5, 2013 trial date for the first of nearly 600 federally filed lawsuits alleging that Avaulta vaginal mesh implants, made by C.R. Bard, and used to treat pelvic organ prolapse and stress urinary incontinence, causes injury, including organ damage.

In 2011, the FDA released a report finding that vaginal mesh products should be categorized as high-risk based on the reported side effects of the devices. This past January, the FDA ordered 31 vaginal mesh makers to conduct three-year studies on the devices and the rates of complications and organ damage, as well as the safety and efficacy of the mesh.

All federally filed vaginal mesh lawsuits against Boston Scientific Corp., the American Medical Systems unit of Endo Pharmaceutical Holdings Inc., and C.R. Bard, have been consolidated in multidistrict litigation be Judge Goodwin in Charleston, West Virginia. In his ruling, Judge Goodwin wrote that the trials for the first Avaulta cases “will be determined after completion” after pretrial “information exchanges between Bard and the plaintiffs,” Bloomberg reported.

Bard, as well as the other vaginal mesh manufacturers, face a number of lawsuits filed on the state level also.