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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 Posted on January 14,2013 in Defective Medical Devices

Back in 2010, the FDA sent an open warning letter to DePuy Orthopaedics Inc., because the company had started producing and marketing their metal-to-metal joint replacement device Trumatch without an FDA approval. The company was also marketing a hip replacement device in cases where it had no approval for doing so.

In case of the metal-to-metal joint device, it was possible for people to get the device installed, because the company started offering the device for sale. However, since there was no FDA approval, this should have never happened. The warning letter to the company clearly explains that they had no approval, and thus they broke the law by offering the product for sale.

A product released to the public without FDA approval is a perfect example of a device that can cause serious problems patients who purchase such a product as part of their treatment. If a person were to suffer from serious problems with a medical device that was not FDA approved, this would certainly mean the victim would be a candidate eligible for compensation.

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 Posted on January 11,2013 in Drugs

Parents who had a baby with a serious heart defect sued a drug manufacturer and a number of others, saying medication prescribed to the mother caused the defect. Among others named as defendants are the local pharmacy and the mother's physician. The Montana Standard reported a story on this court case.

Lisa Rodney and Wayne Halvorsen are seeking compensation in the case where they allege that their daughter suffered serious birth defects as a result of the mother's Effexor XR medication. Effexor is an anti-depressant that the mother was ingesting before the child's birth.

The lawsuit names a number of defendants: Wyeth Pharmaceuticals Inc., Pfizer Inc., CVS Pharmacy, and a few others. The couple are also suing the physicians involved.

The filed lawsuit alleges that Wyeth failed to alert doctors, pharmacists, and the public on possible birth defects on babies if the mothers are ingesting Effexor before or during their pregnancy.

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 Posted on January 08,2013 in FDA

On December 3, 2012 the U.S. Food and Drug Administration announced that the agency has become a part of a nonprofit group that consists of representatives from across the medical device industry, nonprofit associations, and the government. The FDA chose to become a part of the organization to fulfill its aspiration to further patient access to new and safe medical devices.

The new Medical Devices Innovation Consortium, ideally, will help to improve the government's methodologies with which they assess the safety, quality, effectiveness, and performance of new medical devices. With these new changes, the panel could “not only aim to improve how products are developed and evaluated, but also could reduce the cost and time it takes for a promising device to come to market,” according to an FDA statement.

An example of an innovation that the nonprofit consortium may attempt is a computer model that can “test an implant on a virtual patient before a manufacturer spends the time and budget to study that product in a clinical trial.”

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 Posted on January 05,2013 in Defective Medical Devices

Metal on metal hip replacements are called that because the two parts are both made of metal, the ball and the socket. When these two are put together they recreate the movement of a hip. Hip replacements are surgically implanted on deteriorated hip joints to combat pain and stiffness. This can be accomplished in one of two ways, either a hip resurfacing which reinforces the existing joint or full replacement. After being used for years, the FDA has researched claims that metal on metal hip implants are causing a variety of physical ailments.

Their research was initiated by a study conducted by British researchers at the National Joint Registry of England and Wales. Surveys uncovered that metal on metal hips require more maintenance than other types of hip replacements, be that ceramic or plastic. After being in use for five years, 6 percent of the over 30,000 metal on metal hips needed to be replaced or repaired. This is startling because only around 2 percent of the over 350,000 other types needed the same care after 5 years.

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