If you are one of thousands of people in the United States who depends on a hip implant to get around and maintain your routine, you need to take notice of the recent action taken by the US Food and Drug Administration (FDA), as the government is in effect cracking down hard on one
of the leading manufacturers of hip implants and hip and joint replacement parts.

The FDA recently sent the manufacturer of the hip implants in question, Stryker Corp. of Kalamazoo, Michigan, an extremely stern,six-page letter detailing the problems that have been discovered with the company’s manufacturing process and other issues that need to be corrected immediately. For an overview of the problems visit the Stryker Hip Implant Defect page.

A man was charged with drunk driving dui on a lawn mower in New Zealand Tuesday according to police. Richard Gunn, 52, was driving the lawn mower down a street in the northern New Zealand town of Dargaville late Monday evening when police stopped him, police spokeswoman Sarah Kennett said.

Gunn’s breath alcohol level was at more than twice the legal limit for drivers, police said, and he previously had lost his driver’s license. Gunn said he has been using the lawn mower to get around town since losing his license.

“I thought I was safe,” he told TV One News.

Even bicycles went faster than the lawn mower’s 5 mph, he said. “I’ve watched them go past me.”

Gunn was scheduled to appear in court later this week on charges of careless driving, driving while disqualified and driving with excess breath alcohol. He faces a potential prison term if convicted.

Police impounded the lawn mower for 28 days.

A similar incident was posted in this video last year that captured attention on the popular video site youtube.

Posted by: Miami Dui Lawyer

Authorities say 25 people have been hurt, several seriously, after a commuter bus accident and burned off a freeway near the Nevada-California state more… line. Investigators aren’t sure what caused the crash.

CARTER CO. - An eastern Kentucky school bus driver was charged with leaving the scene of a crash involving the bus and driving under the influence Monday, Kentucky State Police said.

Della Hoover, 38, of Olive Hill in Carter County, was driving the empty bus westbound on Kentucky 182 in the Grahn community, police said. She met an eastbound wrecker in a curve shortly before 3 p.m., and the rear driver’s side of the bus hit the wrecker, police said.

The wrecker was disabled, but police said Hoover left and was found shortly afterward at West Carter High School. She returned to the bus garage and was charged by police with leaving the scene of a collision, DUI and other traffic charges, police said.

One of the best selling all terrain vehicles (ATV) available today, the Yamaha Rhino is continually raising concern for its questionable safety. Made available to consumer for the first time in 2003, the Rhino is being blamed for several life threatening injuries, as well as fatalities. Though questions continue to be raised in regard to the safety of the Rhinos’ design, Yamaha has not admitted any fault pertaining to this ATV, and thus it is still available to consumers for purchase.

The height of the Rhino is disproportionate to its narrow wheel base making it top heavy and prone to rollover incidents. As a result of the growing number of cases being reported, Yamaha has offered to install small plastic door to the sides of the Rhino in order to prevent drivers and passengers from putting limbs outside the ATV in the event that it begins to roll. Also, they have offered additional plastic handles available for installation free of charge. Amendments have been made to the Yamaha Rhino Owner’s Manual since its original release including a section about how to steer an ATV that is believed to be rolling, as well as more specific information about the types of factors that may increase the likelihood of a rollover crash.

Legal action has been taken by several parties, including those who have been involved in accidents in addition to the families of those who have been severely debilitated or killed in a Yamaha Rhino rollover accident. Several consumers affected are speaking out against the questionable safety of the Rhino and asking that the manufacturers take responsibility for their faulty design.

When using an ATV safety precautions should always be taken, such as wearing protective gear and responsibly operating the vehicle. Nothing is more senseless than a preventable death.

More warnings for the drug Provigil Side Effects by the FDA today.

A Food and Drug Administration panel said Wednesday that sleep disorder drug Provigil should carry a stronger warning to discourage doctors from prescribing it to children.

The drug by Cephalon Inc., which is approved to treat certain sleep disorders in adults, already contains labeling stating the product is not approved for use in pediatric patients.

The drug’s label was recently updated to warn of the possibility of serious skin reactions and psychological problems such as hallucinations, anxiety and suicidal thoughts. Cephalon sent doctors a letter detailing the change and noted the drug is not approved for use in children.

The Food and Drug Administration has tallied at least 235 reports of deaths linked to the blood-clotting drug Trasylol.

More people are coming foward about their loved ones’ side effects from Trasylol.

If you or a loved one received Trasylol and suffered a severe side effect contact our office today and a professional, trained legal representative will listen to your Trasylol issues.

Call 1-866-242-0905

Or fill out the free case review form located Here

For information on Trasylol Side Effects and other defective drugs, defective medical devices and consumer resources visit:

www.resource4thepeople.com

In an earlier report, the FDA and Bayer announced the temporarily sales suspension of Trasylol. Bayer Temporarily Suspends Global Trasylol ® blood-clotting drug Marketing

Leverkusen, Germany and West Haven, CT, USA – November 5, 2007

Following consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the U.S. Food and Drug Administration (FDA), Health Canada, and other health authorities, Bayer announced today that it has elected to temporarily suspend worldwide marketing of Trasylol® (aprotinin injection) until final results from the Canadian BART trial can be compiled, received and evaluated. The company took this global action following direction from the German BfArM and requests from the FDA and other regulators that Bayer temporarily suspend Trasylol marketing in their respective countries until final BART data were available. The BART study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients.

Once the complete BART dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol. At that time the temporary marketing suspension will be reevaluated. Additionally, the U.S. FDA, Health Canada and other health authorities have indicated their interest in working with Bayer to create a program for use during the temporary suspension under which physicians in these markets might request and receive Trasylol for treatment of certain surgical patients with an established medical need. Bayer will work with the FDA, Health Canada, and any other authorities who wish to institute similar programs, to outline appropriate patient profiles and the specific details.
This action follows notification to Bayer and regulatory authorities that the BART Executive Committee had halted the trial after a planned periodic data analysis indicated reduced bleeding but also an increase in all-cause mortality (that almost reached conventional statistical significance for 30-day mortality) for patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid. Bayer has been informed that data are now being collected from centers throughout Canada and a final data analysis will be undertaken by BART investigators — a process that is expected to take up to eight weeks, or perhaps longer.
On October 25, 2007, Bayer posted additional guidance to physicians and health care providers regarding the use of Trasylol and BfArM, the FDA and other regulatory authorities posted health alerts and other communications in their respective markets. In the time since, the agencies have continued to work with Bayer to evaluate appropriate next steps. Given the limited and preliminary nature of the information available to date from the BART study, these are challenging and complex decisions.
To reiterate, once more complete information is available from BART investigators and a thorough evaluation can be conducted by Bayer and global health authorities, the company will communicate publicly regarding any further actions that may be undertaken in response to the analysis of that information. Over the next days, information concerning the temporary market suspension will be communicated to physicians, health care providers and hospital pharmacists in each respective market.

About Trasylol®
Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.
Trasylol administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure and a history of any prior aprotinin exposure must be sought prior to Trasylol administration. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure. Trasylol should be administered only in operative settings where cardiopulmonary bypass (CPB) can be rapidly initiated. The benefit of Trasylol to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin.

Safety Considerations
Trasylol is contraindicated in patients with a known or suspected aprotinin exposure during the last 12 months. Aprotinin may also be a component of some fibrin sealant products.
Trasylol administration increases the risk for renal dysfunction and may increase the need for dialysis in the perioperative period.
 This risk may be especially increased for patients with pre-existing renal impairment or those who receive aminoglycoside antibiotics or drugs that alter renal function.
 The incidence of serum creatinine elevations >0.5 mg/dL above pre-treatment levels was statistically higher in the full-dose aprotinin group (9.0%) compared with placebo (6.6%).
 The incidence of serum creatinine elevations >2.0mg/dL above baseline was slightly higher in the full-dose aprotinin group (1.1% vs. 0.8%).
In clinical trials Trasylol® did not increase the risk of the following perioperative events: myocardial infarction, congestive heart failure, hepatic dysfunction and mortality.
For Trasylol contraindications, warnings and precautions see prescribing information.

Resource: http://www.trasylol.com/Trasylol_11_05_07.pdf

NEW YORK (Reuters) - Merck & Co has agreed to pay $4.85 billion to settle claims that its painkiller Vioxx caused heart attacks and strokes in thousands of users, the drugmaker said on Friday.

The agreement covers lawsuits filed against the company in U.S. courts, resolving a major legal battle that has dogged the drugmaker since it pulled Vioxx off the market three years ago. Merck recalled the popular painkiller, which had $2.5 billion in annual sales, in September 2004 after a study showed it doubled the risk of heart attack and stroke in patients taking it for more than 18 months.

In the settlement, reached with representatives of plaintiffs in federal and state courts, Merck did not admit Vioxx caused patient injury and did not admit fault. The drugmaker, whose shares rose nearly 2 percent in pre-market trade on news of the deal, said it would take a charge of $4.85 billion to cover costs of the agreement.

The settlement marks a shift in strategy for Merck, which previously said it intended to fight Vioxx litigation on a case-by-base basis rather than consider a broad settlement.

“The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding Vioxx product-liability claims in the United States for a fixed amount,” said Richard Clark, chairman, president and chief executive officer of Merck.

The drugmaker said it would still defend all claims not included in the settlement. Since the withdrawal of Vioxx, Merck has won 11 court cases over the drug and lost five. While it is appealing those cases that it lost, analysts said the settlement will solidify Merck’s future. Continued

Seattle - A worker died Monday after he fell 60 feet from a tower crane at a Belltown construction site, authorities said. The accident was reported about 10:30 a.m. at condominiums under construction at Third Avenue and Battery Street.

The man, in his 40s, was climbing a ladder to the crane’s cab when he slipped and fell, landing on concrete below, fire spokeswoman Helen Fitzpatrick said. The worker was taken to Haborview Medical Center, where he later died, spokeswoman Susan Gregg-Hanson said. Read more…

ORLANDO, Florida (Reuters) - A European study released on Tuesday has raised new concerns about the safety of women’s long-term use of the birth control pill, suggesting increased risk of heart attack or stroke.

Women who had used oral contraceptives were more likely than those who did not take the pill to have a buildup of plaque in their arteries, the researchers told an American Heart Association meeting.

“The main concern is if you have higher plaque levels that you might develop a clot on one of these plaques and have a stroke or a myocardial infarction (heart attack) or sudden cardiac death,” Dr. Ernst Rietzschel of Ghent University in Belgium, who led the research, told reporters. Read more…