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Wright Hip Replacement Named in Lawsuit

The Wright Profemur hip implant system has been named in another lawsuit after an Arizona woman had to undergo revision surgery just three years after being implanted with the defective medical device.

The lawsuit, filed on behalf of Virginia M. Welch of Mesa, Arizona, is pending in the United States District Court for the District of Arizona, said Digital Journal. The complaint alleges that Welch received her Wright Profemur Z implant in February 2006. Intense pain led to medical evaluations that confirmed the device’s acetabular cup loosed and rotated about 90 degrees from its original implant position, explained Digital Journal. The complaint alleges defective design and manufacture and that the device maker never warned of the device’s potential defects and risks, said Digital Journal. (more…)

Pradaxa Maker Says Patients Need Kidney Checks

The maker of Pradaxa, Boehringer Ingelheim, just announced that in Europe, patients need kidney checks before taking the anti-clotting medication. The announcement is not doing much for Pradaxa’s safety profile.

According to Reuters, Pradaxa, a thrombin inhibitor, is the first of a new class of anti-clotting medications on which high hopes were placed. Unlisted Boehringer, the second-largest drugmaker in Germany, agreed with the European Medicines Agency’s (EMA) that updated information be provided to European healthcare professionals, Reuters noted. (more…)

Chinese Firms at Center of Tainted Heparin Disaster Still Importing to U.S.

The 2008 Baxter heparin disaster made headlines for months over contaminated ingredients that led to massive recalls and resulted in serious, some fatal, allergic reactions worldwide.

Now, three years later, two companies in China that had supplied the deadly ingredients to Baxter International Inc. are still sending their product to the United States, according to Republican lawmakers, said Bloomberg Businessweek. (more…)

Xigris Withdrawn After Study Finds No Improvement in Survival

Sepsis drug Xigris (Drotrecogin alfa) has been withdrawn from the market by drug maker, Eli Lilly and Company; this, following poor outcomes in a recent clinical trial. According to Reuters, Xigris did not improve survival in the PROWESS-SHOCK trial. NewsInferno previously wrote that Eli Lilly’s intravenous sepsis treatment was the subject of a U.S. Food and Drug Administration (FDA) safety review prompted by a prior study that revealed Xigris increased risks for dangerous internal bleeding when used by patients with a recent hemorrhage history. Similar to a natural protein produced in the body, Xigris decreases inflammation and blood clot formation in blood vessels and increases blood clot breakdown. (more…)

Tough New York Drilling Rules Could Rein in Frackers

Although the natural gas drilling ban has been lifted in New York, tough rules are reining in frackers—those companies seeking to hydraulically fracture shale formations to release the gas within.

Fracking is a controversial process in which a cocktail of water, chemicals, and sand are injected at high pressures into shale rock to shatter the formations and allow access to the gas. (more…)

Cell Phone Study Finds No Link To Tumors, But May Be Flawed

An new cell phone study claiming radiation from the devices is not linked to tumors, might be riddled with flaws, say a group of global experts. The study researching the link between cancer and cell phones touts that no proof exists that increased incidences of brain tumors or any cancer

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are linked to cell phones. Experts roundly disagree. The study reviewed cell phone links to brain tumors and cancer over an 18-year period; however, experts say that the study “seriously flawed” and should be “condemned as a misleading spin,” wrote MedScape. The study appears online in the October 20 issue of BMJ; the ElectromagneticHealth.org issued the stern rebuttal. (more…)

EPA Plans to Set Standards for Fracking Wastewater

This week, the U.S. Environmental Protection Agency (EPA) indicated that it wants increased oversight of the hydraulic fracturing (fracturing) industry by setting national standards for fracking wastewater, the polluted wastewater that results from natural gas extraction.

Fracking activities are on the rise in recent years and involve a process by which a combination of water, chemicals, and sand are injected deep into shale formations to unlock gas. Environmental advocates and experts have criticized the process, arguing that fracking leads to earthquakes and increased seismic activity; devastates the environment and human, aquatic, and wildlife health; pollutes water supplies; and ravages infrastructures, to name just a few. (more…)

CareFusion Issues New Recall for Ventilators

CareFusion has issued its second recall for ventilators, saying this is an urgent recall that involves problems that could lead to serious injury or death. According to CareFusion, it has recalled 29 of its EnVe ventilators over problems that could lead to delayed starts or shut down.

The recalled machines were manufactured between December 2010 and May 2011, said SignOn San Diego, noting that the U.S. Food and Drug Administration (FDA) assigned its most serious designation—Class I—to this recall. The FDA describes Class I recalls as involving situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death. (more…)

Australian Yeshiva Youth Worker Charged With Sexual Abuse

Another child sexual abuse scandal in the Orthodox Jewish Community is making headlines. This time, an Australian Yeshiva youth worker has been charged with sexual abuse in an alleged scandal that involves indecency charges. The former Chabad Youth leader, Aron Ezriel “Ezzy” Kestecher, 26, was charged on four counts of indecent acts on a child who was under 16 years of age, said The Age. Kestecher was recently employed as a substitute teacher at Yeshivah College, the East St Kilda boys’ school. The

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school is the focus of a pedophilia investigation by police there, said The Age. Kestecher was released on bail and is scheduled to appear in the Moorabbin Magistrates Court on November 29. (more…)

Albany, New York City Council Approves Fracking Ban

In Albany, New York, the city council approved a fracking ban, apparently unconcerned with industry retaliation. The narrowly approved ban prohibits gas drilling within city limits, a move that Times Union said is meant to ensure that hydraulic fracturing—fracking—does not occur there. The ban unites the Albany Common Council to Buffalo, Cooperstown, and about 50 more cities, towns, and counties in New York State that have ensured fracking limits are in place even before New York environmental regulators are able to issue fracking permits to gas companies, Times Union noted. The fact that Albany is critical to New York government and is also where the Department of Environmental Conservation (DEC) is located, is seen by some as adding more significance to an already highly controversial practice. (more…)

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