Posted on February 18, 2013 in Birth Defects

The firm is currently undergoing an investigation of Zoloft birth defect lawsuits for the families who had a child born with congenital abnormality that is allegedly associated with their mother's use of Zoloft during her pregnancy.

Federal Zoloft lawsuits are continuing to move forward in the multidistrict litigation that is underway in the U.S. District Court, in the Eastern District of Pennsylvania, according to Bernstein Liebhard LLP. Dated Jan. 17, the Pretrial Order states that the Court has established a protocol to select Zoloft suits for the early Bellwether trials. The Order also directs the Plaintiffs' Steering Committee to select 12 Zoloft birth defect claims from the total to include in the Early Discovery Group, no later than Feb. 15. The attorneys for Pfizer, Inc. as well, have been instructed to select a total of 13 cases for the Group no later than Feb. 25.

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 Posted on February 15, 2013 in Defective Medical Devices

The new lead free implantable heart defibrillator, invented by Boston Scientific Corp, should not be used on a regular basis until more data is available, according to a story in the Chicago Tribune. Defibrillator leads have often caused problems for device makers. Boston Scientific bought the new technology, known as a subcutaneous implantable cardioverter-defibrillator, or S-ICD, last year. “The S-ICD has not yet been shown to be safe and effective in a diverse patient population,” said Robert Hauser of the Minneapolis Heart Institute. He also pointed out that the lead free defibrillator is not even as good as the traditional ICDs that have leads.

According to Hauser, the new technology shows a lot of promise and could fill important gaps, especially in countries where facilities to implant traditional devices do not exist. However, it is necessary to obtain more data first in order to ensure the safety of the device. “Unless critical questions with regard to safety and efficacy in primary and secondary prevention are addressed, the S-ICD should be confined to certain subgroups,” Hauser said.

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 Posted on February 12, 2013 in Drugs

The FDA is now requiring sleep aids such as Ambien, Ambien CR, Edluar and Zolpimist to lower their dosage. Zolpidem, an ingredient in these brands, may remain in the blood the next morning in high enough levels to impair certain activities that require alertness.

Zolpidem is eliminated slower from women's bloodstreams, so the FDA is notifying manufacturers to lower the recommended dose for women—and they suggest lowering it for men as well. Especially in the extended-release form, zolpidem can cause problems the following morning for some activities, such as driving.

The FDA says in this article from January 10 that dosage for women should be cut in half (from 10mg to 5mg in immediate release pills, and 12.5mg to 6.25mg in extended-release) and the lowest possible dosage should always be used, regardless of sex. In addition, any patient that has complex tasks in the morning should talk to their health care professional to see if a sleep aid is the best choice for their lifestyle.

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 Posted on February 08, 2013 in Birth Control

Yahoo! Finance is reporting that the scheduled May 2013 trial date in the multidistrict NuvaRing litigation, which is currently pending before the U.S. District Court, Eastern District of Missouri, has been postponed. This latest continuance of the trial proceedings has resulted in rumors that Merck, the manufacturer of the vaginal ring contraceptive, is preparing to enter into settlement negotiations. Not only does this development raise the potential for much-needed financial relief for women injured by using NuvaRing, but it also leaves open the possibility that even more lawsuits will be added to the more than 1,000 NuvaRing lawsuits that already are pending.

NuvaRing was the first vaginal hormonal contraceptive device approved by the U.S. Food & Drug Administration (FDA) in 2001. The ring works by releasing a low dose of synthetic progestin and estrogen over a period of three weeks. Starting in May, 2007, consumers began to file complaints in jurisdictions nationwide claiming dangerous side effects from using the medical device. Studies in 2009 and 2011 reveal that using NuvaRing considerably increases the risk of serious blood clots, including a 56% increased risk of deep vein thrombosis and pulmonary embolism over those women who use regular birth control pills. To date, the FDA has received almost 5,000 adverse event reports from users of NuvaRing. Nonetheless, NuvaRing has not been recalled from U.S. markets, and 1.5 million women worldwide continue to use NuvaRing.

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 Posted on February 04, 2013 in Defective Medical Devices

Bloomberg Businessweek is reporting that Minnesota-based St. Jude Medical has received a warning letter from the U.S. Food & Drug Administration (FDA) regarding its implantable heart defibrillators, which it manufactures at a plant in Sylmar, California. These heart defibrillators are medical devices that can be implanted in a person's chest in order to correct abnormal or dangerous heart rhythms.

FDA's concerns arose when inspectors visited the plant in October, 2012, and allegedly found inconsistencies in the defibrillator manufacturing process and quality-control procedures. St. Jude claims that it is working to fix the problems identified by the FDA. In the meantime, the FDA will not approve any new product lines to be manufactured at the California plant until the problems are completely resolved. However, neither the heart defibrillators nor any other St. Jude product has been recalled by the FDA.

Unfortunately, these are not the first problems that St. Jude has encountered in recent years. In late 2011, St. Jude recalled its Rialta wires, which are used to attach the defibrillator to the heart, due to concerns about the insulation of the wires. In 2012, the medical device company recalled two other defibrillator wires, QuickSite and QuickFlex, amidst similar quality concerns. Currently, about 79,000 Rialta wires are implanted in U.S. patients. The FDA previously ordered St. Jude to conduct a three-year study of the wires in order to determine the risk of insulation failure.

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 Posted on February 01, 2013 in Drugs

The Zoloft lawsuit currently has 250 claims that are now pending for the Zoloft Litigation that is underway in the Pennsylvania Federal Court.

In the Easter District of Pennsylvania, the Zoloft lawsuits continue to move forward in the multidistrict litigation that is currently underway in the U.S. District Court. There have been at least 250 cases filed in the Pennsylvania litigation by plaintiffs whose alleged use of Pfizer's antidepressants during pregnancy has caused birth defects in their children. Overseeing the federal Zoloft litigation is U.S. District Judge Cynthia Rufe, who issued Pretrial Order No. 15 on November 25, 2012. This order set forth a joint discovery of scheduling a plan for the proceedings.

The nationwide law firm that is representing these victims of defective drugs and medical devices said, “We are pleased to see the federal litigation moving forward, and expect more complaints to be filed in the coming months.” The firm is also offering help to those victims of birth defects that may be associated with Zoloft.

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 Posted on January 29, 2013 in Drugs

In a new Yaz lawsuit filing, five plaintiffs will join the multidistrict litigation (MDL) against Bayer Healthcare Pharmaceuticals, Inc. for their birth control pills Yaz, Yasmin, and the generic form of the drug, Ocella. For the Southern District of Illinois, the MDL is located in the U.S. District Court. On December 11, 2012, plaintiffs Crystal Elias, Monica Mack, Angela Thorton, Shanda Thomas, and Casey Maguire filed for compensation for the side effects from the birth control medication. These side effects included deep vein thrombosis (DVT) and pulmonary embolism (PE). The plaintiffs are seeking damages, punitive and exemplary damages, compensatory damages, and reimbursement for their legal fees.

MDL consolidates complaints against Bayer

The MDL against Bayer consolidates complaints nationwide of women who supposedly suffered from side effects of the medication ranging from blood clots, PE, DVT, and other problems. The main ingredient in Yaz, Yasmin, and Ocella is the newly developed fourth generation progestin drospirenone. This lawsuit claims breach of express and implied warranties, negligence, failure to adequately test, nonconformance with representations, inadequate warning, design defect, and defective manufacturing from the five participating plaintiffs.

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 Posted on January 26, 2013 in Drugs

Doyle Swafford ended up filing a lawsuit against the manufacturer of his type 2 diabetes medication called Actos after he suffered from severe side effects. Swafford took the case to Cook County Circuit Court, saying that there is a link between the use of Actos medication and the development of baldder cancer, which is one of the side effects recognized for the medication. A story on the case can be found at injurylawyer-news.com.

Doyle Swafford filed a lawsuit against drug manufacturer Takeda Pharmaceuticals, saying their diabetes drug was the cause for bladder cancer. The suit named Takeda Pharmaceuticals, et. al. And Eli lilly & Company as defendants the suit.

Swafford's lawsuit claims that Takeda and Eli Lilly knew about the linkg between Actos and an increased risk of cancer before the drug was ever released. In Swafford's opinion, patients were not adequately warned about the risks involved in taking the drug.

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 Posted on January 23, 2013 in Defective Medical Devices

It's not just the people using defective medical devices that suffer from them, according to the Huffington Post. “Faulty medical devices are costing taxpayers billions of dollars that should be paid by the manufacturer,” the HuffPost reports, because of a Supreme Court decision that grants immunity to the manufacturer of a faulty device. The first bombshell case like this to ricochet through the medical community was the one involving Medtronic's Sprint Fidelis defibrillator lead, a wire that connecting the defibrillator to the heart and which faced fire in 2007 for causing electrical shocks to reverberate through the body of the user. It was in 2008 that the Supreme Court decided, in Riegel v. Medtronic, that “FDA-approved medical devices have complete immunity from product liability cases, even in instances when the devices have proven to be unsafe or defective,” according to the HuffPost.

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 Posted on January 20, 2013 in Defective Medical Devices

In 2012, the Food and Drug Administration (FDA) passed a new act, the Medical Device User Fee Amendments, which went into effect on October 1. The new act, according to the FDA, “includes performance goals and user fees paid to the FDA by medical device companies when they register and list with the FDA and when they submit an application to market a medical device in the U.S.” In the long run, the new act will help to shape with way that the FDA approves products, clinical trials, and also shorten timelines for scheduling appeals of meetings or decisions. It also will change the process for the reclassification of devices.

The provision that medical device manufacturers pay fees to the FDA when they register their establishment and list their devices first went into effect in 2002. They must pay fees whenever they submit an application or a notification to market a new medical device. The Medical Device User Fee Amendments (MDUFA III) that were passed in 2012, a decade after the fee schedule first went into effect, were meant to further regulate the approval and medical devices, despite fees that were being paid to the FDA. According to the FDA, MDUFA III “is the result of more than a year of public input, negotiations with industry representatives, and discussions with patient and consumer representatives.”

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