Archive for January, 2012

U.K. Issues Warning On Metal Hip Implants

Warnings have been issued in the United Kingdom over metal-on-metal hip implant devices. The move followed an investigation there and adds to the growing concern about metal-on-metal medical device appliances and their adverse impact on human health.

According to research, said The Telegraph, medical regulators in the U.K. issued new advice for the more than 40,000 Britons implanted with the devices amid concerns that metal-on-metal devices are more dangerous than first believed. (more…)

Cruise Line Makes Offer To Costa Concordia Survivors

The cruise line behind this month’s historic crash has made financial offers to Costa Concordia cruise ship survivors to compensate for lost luggage and psychological trauma.

Friday, January 13, the Costa Concordia luxury liner struck the rocks off the Italian island of Giglio, tearing a 160-foot gash in its hull and causing the vessel to capsize. The Costa Concordia, owned by the Italian company Costa Crociere SpA, a subsidiary of Miami-based Carnival Corporation, was carrying 4,200 passengers and crew at the time of the crash that left 16 dead and at least 22 passengers and crew missing, including an American couple. (more…)

Costa Concordia Owner Had Early Word Of Accident

The owner of the doomed Costa Concordia cruise ship had early word of the historic accident, according to emerging reports. The liner, owned by the Italian company, Costa Crociere SpA, is operated by Costa Cruises, a unit of U.S.-based Carnival Corporation.

Testimony presented by Costa Crociere to the Italian Senate revealed that it was aware—within minutes and, shockingly, more than one hour before the 4,200 passengers were told to evacuate—that the ship was flooding as a result of a crash off the Tuscan coast, wrote The Wall Street Journal. The testimony delivered by Pier Luigi Foschi, chief executive of Costa Crociere was, said The Journal, the first time the company publicly acknowledged that Captain Francesco Schettino had been keeping the company advised on crisis events. (more…)

Plaintiffs From Around The U.S. File Plavix Injury Lawsuit

Plaintiffs from across the nation just filed a Plavix lawsuit alleging that the so-called “super aspirin” caused them to suffer strokes, heart attacks, and other adverse reactions.

In all, 72 plaintiffs allege reactions that also include internal bleeding, blood disorders, and death after taking the drug manufactured and marketed by Bristol-Myers Squibb Company and Sanofi Aventis, The Madison-St. Clair Record wrote. (more…)

MetLife, Prudential Sued Over Handling Of Unclaimed Life Insurance Benefits

MetLife and Prudential are facing whistleblower lawsuits over how they handled unclaimed life insurance benefits. The lawsuit seeks over $1 billion in damages on behalf of Illinois State and was filed January 2011.

The lawsuit alleges that the insurance giants did not hand unclaimed life insurance policies to Illinois’ abandoned property department, said The Wall Street Journal. The lawsuit was just unsealed by a Cook County, Illinois state-court judge. (more…)

Democratic Lawmakers Seek Hearings On Transvaginal Mesh, Lap-Band

House Democratic lawmakers are seeking Congressional hearings on transvaginal mesh and Allergan Lap-Band medical device products. The group says the devices post hazards to patients.

Representative Henry Waxman (Democrat-California) and three fellow lawmakers have asked key Republicans in the House Energy and Commerce Committee to hold the hearing and order involved device makers to provide documentation, said Bloomberg News. The timing of the request is significant given that Congress is considering a U.S. Food and Drug Administration (FDA) overhaul of medical device rules, said Democratic lawmakers in a statement. (more…)

Yaz, Yasmin Judge Asked To Allow Evidence Of FDA Conflicts

The judge overseeing the Yaz and Yasmin multidistrict litigation has been asked to allow evidence concerning a U.S. Food and Drug Administration (FDA) conflict of interest. Women suing Yaz, Yasmin maker, Bayer, for injuries they alleged to have suffered from the controversial birth control pills, have urged U.S. District Judge, David Herndon, to review evidence pointing to conflicts of interest at the agency, wrote The Madison Record.

The Plaintiffs’ Steering Committee has opposed a January 17 motion by the defense to exclude former FDA commissioner, David Kessler’s, opinions about the current FDA. Kessler, an expert witness for the plaintiffs, noted panel conflicts in an expert opinion in which he stated, after reviewing internal Bayer documents, that Bayer wrongfully withheld safety information from the agency, said Pharmalot. (more…)

Covidien Recalls Duet TRS For Thoracic Surgery, Device Linked To Three Deaths

Covidien has issued a recall for its Duet TRS single use cartridges after the devices were linked to three deaths among patients undergoing thoracic surgery, the U.S. Food and Drug Administration (FDA) just announced. The Covidien Duet TRS is a product used in surgery in conjunction with a surgerical stapler.

The recall involves all production lots for the Duet TRS Universal Straight and Articulating Single Use Loading Units that involve use of this product family in the thoracic cavity. To date, Covidien has received 13 reports of serious injuries and 3 reports of patient deaths following the application of Duet TRS in the thoracic cavity. (more…)

Costa Concordia Captain Ordered To House Arrest

The shamed Costa Concordia captain who abandoned ship in Friday’s deadly luxury liner crash has been ordered to house arrest.

Captain Francesco Schettino claims his abandoning the doomed Costa Concordia cruise ship was accidental, that he slipped and fell onto a lifeboat while helping passengers exit the ship that went aground late Friday on the rocks of Giglio Island, an island off Italy’s Italian coast. While the liner continued to sink into the Tyrrhenian Sea, off northern Italy’s coast, and rescue crews frantically worked to recover the dozens missing and collect the dead, Schettino maintained he was faultless during a three-hour hearing yesterday, said La Repubblica, wrote The Guardian. (more…)

Asthma Drugs in Pregnancy Linked To Three Birth Defects

A new, 10-state study spanning from 1997 links asthma drugs to three serious birth defects. The study appears in the January 16th online issue of the journal, Pediatrics.

The study authors wrote that babies of women who took asthma drugs when pregnant suffered increased risks for isolated esophageal atresia (closed area of the esophagus), isolated anorectal atresia (closed area of the rectum and/or anus), and omphalocele (out-pouching of the intestines), said The Examiner. The risk was specifically seen in pregnant woman who took asthma medications in the month prior to becoming pregnant or in the first three months of being pregnant. (more…)