Articles Posted in Product Liability

The FDA have added new safety warnings to the heart rhythm drug Multaq, (dronedarone) after Sanofi company study linked the medication to higher rates of heart attack, stroke and death in a subset of patients. The FDA completed a safety review of dronedarone, which showed that the heart drug increased the risk for serious CV events, including death, when used by patients with permanent atrial fibrillation.

The review was based on data from the PALLAS and ATHENA trials. As a result of the review, the FDA has provided new information and recommendations for use of dronedarone to manage the potential serious CV events associated with the drug, according to a statement from the agency.

The boxed warning highlights the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation. The revised label indicates that Multaq is only approved for the short-term form of atrial fibrillation and atrial flutter. Doctors routinely prescribe drugs for conditions not listed on the labeling approved by the FDA, a process called “off label prescribing.”

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has rejected calls for all federal Plavix lawsuits to be consolidated in one court for coordinated handling during pre-trial litigation. This means that the litigation will proceed as individual cases in various district courts throughout the United States.

Last week, the JPML denied a motion by Bristol-Myers Squibb and Sanofi-Aventis to centralize the federal Plavix litigation in the U.S. District Court for the District of New Jersey. According to the panel, the centralization would not help move the cases through the system faster and would provide no benefit to the parties involved.

There are currently only 12 lawsuits filed against Plavix pending in the federal court system, with 10 of them pending in the U.S. District Court for the District of New Jersey.

According to plaintiffs’ lawyers, Knauf Plasterboard Tianjin Co., (KPT) a Chinese drywall maker, agreed to pay at least $800 million to settle homeowner claims that defective building materials contaminated their homes with corrosive sulfur fumes.

Knauf agreed to settle claims involving about 4,500 properties that contain the defective drywall. Homeowners said the faulty wallboard emits noxious sulphur gases that corrodes copper coils and electrical and plumbing equipment.

The accord was announced before U.S. District Judge Eldon Fallon in New Orleans, who is overseeing about 12,000 suits filed over the contaminated drywall that have been consolidated for pretrial evidence gathering.

As public awareness of problems with artificial hips and other medical implants increase, legislation was introduced in the Senate that would force manufacturers to track the performance of such products after they were approved for sale.

The bill would allow the Food and Drug Administration (FDA) to compel companies to track medical implants.

The bill is to address the controversial 510(k) process that the FDA uses to clear the sale of certain implants like artificial joints. To sell a new product under 510(k) process, a producer need only show that it is “substantially similar” to a product already on the market.

A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate and centralize all federal Wright Conserve hip replacement lawsuits. These lawsuits have been brought in courts throughout the United States by individuals who experienced injury problems after receiving the metal-on-metal artificial hip system.

Several lawsuits have been filed against Wright Medical in different federal district courts through the nation by individuals who complain that their metal-on-metal Wright Conserve Plus hip system failed within a few years of implant, often resulting in the need for revision surgery.

Since the FDA approved the Wright metal-on-metal hip replacement system under their controversial 510(k) approval system, more than 200 adverse event reports have been submitted by patients or physicians, which likely only represents a small percentage of the total number of problems with Wright Conserve hip replacements.

Transvaginal mesh plaintiffs are petitioning for the vaginal mesh litigation pending against 4 different companies to be centralized before one judge in the U.S. District Court for the Southern District of West Virginia.

As described in previous blogs, thousands women throughout the United States are bringing product liability lawsuits against the 4 main medical device manufacturers as a result of injuries with transvaginal bladder mesh systems, which have been associated with reports of infection, vaginal erosion and pelvic pain.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) in November received motions for many Boston Scientific pelvic mesh lawsuits, American Medical Systems (AMS) mesh lawsuits and Ethicon/Gynecare mesh lawsuits to be centralized before Chief Judge Joseph R. Goodwin, who is already presiding over all federal Bard Avaulta mesh lawsuits that were consolidated for pretrial proceedings.

A panel of federal drug experts has recommended that the FDA require newer warnings for side effects of the Ortho Evra birth control patch. These patches may increase the risk of venous thrombosis embolism (VTE) when compared to using some older oral contraceptives. The panel did not recommend that the FDA issue an Ortho Evra recall due to the potential dangers.

The FDA recently held the advisory committee to review the risk of VTE with the Ortho Evra patch, as well other newer forms of contraceptives, such as Yaz and Yasmin birth control pills and the NuvaRing birth control ring.

The panel voted 19-5 that the benefits of the Ortho Evra outweighed its health risks, and they voted 20 to 3, to recommend that the birth control patch’s blood clot warnings be rewritten.

Another example of a corporation being caught with its hand in the cookie jar. Medtronic has agreed to pay the U.S. Justice Department $23.5 million to settle allegations that the company paid doctors to implant its pacemakers and defibrillators.

The Justice Department investigation alleged that Medtronic paid doctors between $1,000 and $2,000 per patient implanted with a Medtronic pacemaker or defibrillator as part of four post-marking studies.

According to a press release from the Justice Department, the payments were to promote doctors to use a Medtronic device over other competing devices, and to persuade them to be loyal to Medtronic for future cardiac procedures.

This week the FDA held a 2 day meeting evaluating the newer oral, patch and ring contraceptives. This was a long overdue and highly anticipated hearing.

The FDA advisory panel voted 19-5 that the benefits of the Ortho Evra norelgestromin/ethinyl estradiol transdermal patch outweigh the blood clot risks, but panel members think those risks should be more clearly stated on the label.

The FDA’s Advisory Committee for Reproductive Health Drugs and a drug safety committee voted Friday to recommend that the FDA should allow the patch to remain a contraceptive option.

After a much publicized hearing, federal health experts said that drug labeling for Yaz and other drospirenone containing birth control pills should be updated to highlight recent data suggesting a higher risk of blood clots with these drugs than older contraceptive pills.

Expectations were heightened and many experts felt that the FDA may put a restriction on the sale of these drugs, but according to many, the FDA’s findings was very disappointing.

The FDA’s panel of experts voted 21-5 Thursday that labeling on the popular drugs made by Bayer is inadequate and needs more information about the potential risk of blood clots in the legs and lungs, known as deep vein thrombosis and pulmonary embolism.