ANOTHER SPECIALTY PHARMACY RECALL DUE TO STERILIZATION CONCERNS

May 16, 2013,

sterile drug.jpgA recent inspection of The Compounding Shop, a Florida specialty pharmacy located in St. Petersburg, uncovered numerous safety problems. On Wednesday, the United States Food and Drug Administration (FDA) publicly warned health care providers, hospital supply managers, and pharmacists to avoid drugs made by the specialty pharmacy. The Compounding Shop is cooperating with the FDA to recall all of its sterile drugs and is in the process of launching an informational campaign to notify its customers.

The Compounding Shop is a specialty pharmacy that mixes custom formulations of drugs to meet doctor's specifications. The nationwide fungal meningitis outbreak that occurred last year that was tied to contaminated drugs produced in a Massachusetts pharmacy; the outbreak killed more than 50 Americans and made over 700 ill. The outbreak created an increase in the inspection of pharmacies similar to and including The Compounding Shop, which previously were only inspected if a hazard report was filed. Compounding pharmacies have recently been the FDA's focus, targeting pharmacies across the country and resulting in several national recalls.

The FDA inspection of The Compounding Shop uncovered concerns about sterility problems with company drugs produced and distributed from the site that created the potential for causing bacterial contamination. The FDA advised health care professionals to remove all drugs from the company and not administer them to patients. The director of the FDA's drug center, Janet Woodcock, stated, "If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients."

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FAMILY SEEKS $20 MILLION IN DAMAGES OVER RESEARCHER'S WRONGFUL DEATH

May 14, 2013,

tubes.jpgLast year, a researcher of the Northern California Institute for Research and Education died after being exposed to bacteria. His family is seeking damages in excess of $20 million.

25-year-old Richard Din contracted the rare Neisseria meningitidis in April 2012 while working to develop a vaccine for the strand of the disease. He was working at the San Francisco Veterans Memorial Hospital when he was exposed to the bacteria.

The hospital has been found to have made three serious violations this past February that have been related with the incident. One violation found by the U.S. Department of Labor's Occupational Safety and Health Administration was that Din and other employees were not required to work in enclosed ventilation spaces. In addition to this violation, the hospital did not train employees to notice the signs and symptoms of the diseases they were conducting research on, and also were not provided with vaccines.

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MANY WORKERS FACE UNSAFE CONDITIONS AS THEY WORK TOGETHER IN THE POST-SANDY CLEANUP

May 10, 2013,

HURRICANE.jpgThousands have come to help clean up the devastating conditions after Hurricane Sandy hit earlier this spring. Hurricane Sandy caused over $75 billion in damages this past October. Thousands of people worked to clean up the devastating repercussions of the Category 3 storm. In their efforts, the workers have experienced dangerous conditions that have caused injuries and even death.

A Daily News investigation found that injuries were caused by shocks from exposed wires falling from roofs, and exposure to chemicals. According to Occupational Safety and Heath Administration (OSHA) records, a federal inspection found over 3,000 examples of unsafe conditions when they searched areas in New York City, Long Island and New Jersey. The inspectors took about 8,000 workers from hazardous conditions. Some of the unsafe conditions involved contractors who failed to abide by rules, or ignored warnings, even attempting to interfere with the investigation.

Even though there were 3,100 instances of unsafe situations, OSHA only issued violations in 32 cases. In each case the fines were minimal, between $1,000 and $11,600.

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$11.5 MILLION AWARDED IN HELMET LAWSUIT, FOLLOWING TEENAGE FOOTBALL PLAYER'S TRAUMATIC BRAIN INJURY

May 8, 2013,

foot.jpgA Colorado family has been awarded $11.5 million in a helmet lawsuit. The case was brought against Riddell, a helmet manufacturer, and high school administrators and football coaches. The lawsuit was filed after a teenager, Rhett Ridolfi, experienced brain injuries in 2008.

Ridolfi suffered a concussion during football practice at Trinidad High School. The concussion resulted in severe brain damage, and Ridolfi's left-side became paralyzed because he wasn't taken to the hospital right away. As a result, his family sued Riddell and his coaches.

The company said they were happy the jury denied complaints against design defects. In a statement, Riddell said, "While disappointed in the jury's decision not to fully exonerate Riddell, we are pleased the jury determined that Riddell's helmet was not defective in any way. The company stands by their products, and said that they think their headwear is the most protective for football players, compared to their competition.

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FIRST LAWSUIT FILED AGAINST CARDINAL COACH LINES, INC. AFTER FATAL CRASH

May 6, 2013,

buses2.jpgA charter bus crashed in Irving, Texas resulting in 2 dead and 41 injured. The Texas Department of Safety reported that the bus flipped after it crashed into a concrete barrier on President George Bush Turnpike near Dallas. The bus, carrying 45 elderly passengers, was heading to Choctaw Casino Resort, located in Durant, Oklahoma for a one-day gambling trip.

According to Robert Hare, a passerby, "bodies and blood" covered the scene. Panicked and in shock, he heard shouts of "Help me, help!" He told NBC5 that he worked to take around 6 passengers off the bus, and that many were "screaming." Members of the rescue teams, and witnesses at the scene said that a lot of those affected were trapped underneath the bus, which flipped on its side.

The first lawsuit has been filed. Charlotte Reed, age 74 from Forth Worth, TX, is suing the bus company, Cardinal Coach Lines, Inc. from Mansfield. She sustained three broken ribs from the accident. Her suit holds Cardinal Coach and the bus driver, negligent. Loyd Rieve, the driver, is not listed as a defendant in the lawsuit.

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CLASS 1 RECALL FOR THE SHAPEMATCH CUTTING GUIDE

April 29, 2013,

surgeon.jpgThe FDA has notified healthcare professionals of a Class 1 Recall for the ShapeMatch Cutting Guide. The cutting guides are single use devices manufactured specifically for each patient based on volumetric data from CT or MRI scans.

The guides are intended to be used as surgical instrumentation to assist in the positioning of total knee replacement (arthroplasty) components intraoperatively. In addition, they are intended to assist in guiding the marking of bone before cutting.

The recall is due to a software detect that has resulted in wider cutting ranges, which may not meet the surgeon's pre-operative planning parameters entered via the web application. In addition to this defect, Stryker Orthopaedics determined that another software defect resulted in the displayed parameters (e.g. depth of resection, angle of cut) not matching the cutting guides produced.

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LAWSUIT FILED AGAINST TEXAS FERTILIZER PLANT OWNER AFTER DEADLY EXPLOSION KILLS 14 PEOPLE

April 26, 2013,

Thumbnail image for Thumbnail image for law.jpgAdair Grain, Inc, the parent company of West Fertilizer Co, has been accused of negligence according to copies of two lawsuit filings provided by the court on Tuesday.

The plant exploded last week, leaving 14 dead and destroying dozens of homes and an apartment complex in a small town in Texas. A single mom, along with several insurance companies, is suing the owner of the plant.

A lawsuit filed on Friday reports Adair Grain "was negligent in the operation of its facility, creating an unreasonably dangerous condition, which led to the fire and explosion." The suit was filed by insurance companies on behalf of individuals, two churches, and businesses including a Chevrolet car dealer and a bakery.

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UPPER BIG BRANCH MINE FOREMAN FAILED TO USE GAS DETECTOR BEFORE FATAL EXPLOSION

April 25, 2013,

danger.jpgFormer Upper Big Branch mine foreman Jeremy L. Burghduff surrendered his assistant underground foreman license for three years. The announcement came last week and settles the allegations against Burghduff that he did not turn on his methane gas detector while performing safety inspections.

Burghduff was employed as an assistant foreman in the former Massey Energy mine where an explosion occurred in April 2010. The disaster killed 28 Massey employees and one contract worker, marking it as the worst US coal mining accident in four decades. The blast was triggered by old and worn equipment and a buildup of methane gas and coal dust due to clogged water sprayers. The mine was sold to Alpha Natural Resources in Virginia and has since been closed.

The accident was the third to happen in West Virginia in the past four years. One of those accidents occured in another Massey subsidiary that happened two years prior to the UBB disaster, resulting in $4.2 million in criminal fines due to safety violations.

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JOHNSON & JOHNSON WINS SECOND OF OVER 10,000 CASES INVOLVING ALL METAL-HIP IMPLANTS

April 24, 2013,

jury.jpgLast week, a Chicago state jury ruled in favor of Johnson & Johnson in an all-metal hip implant trial. This is the second of over 10,000 cases regarding the company's now recalled all-metal hip implant, known as the Articular Surface Replacement, or ASR XL. The case was brought forth by Carol Strum of Illinois, who claimed that the product was defective and asked for an award of at least $5 million alongside punitive damages.

The plaintiff, age 54, had an ASR XL implanted in 2008, which was replaced three years later. The hip replacement is made of chromium and cobalt, and Strum's attorneys argued that metal was shed into the plaintiff's body, poisoning muscle tissue and contaminating her blood stream with metal ions. The defense refuted this claim, stating that Strum had a certain hypersensitivity to the implant and her pain remained after the ASR XL was replaced with another type of implant. J&J's attorneys were adamant that the design was not defective.

The 12-member jury deliberated for just over a day and returned with a verdict in favor of DePuy Orthopedics Inc, the manufacturer of the disputed hip implant. Lorie Gawreluk, a spokeswoman for the company, indicated that DePuy appropriately and responsibly addressed concerns with the implant and instituted a program to help patients with recall related medical costs.

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SURGICAL ROBOT PROMPTS MEDICAL MALPRACTICE SUITS

April 24, 2013,

dr.jpgThe technological wonder that has been used in just under 400,000 surgeries in the past year has had "freak episodes," leading to its scrutinization by the U.S. Food and Drug Administration (FDA). The surgical robot da Vinci is multi-armed and worth millions of dollars.

Recently, reports of problems associated with the robot have pushed da Vinci into the limelight. Reported incidents have even included some deaths that may be linked to the high-tech device. Using da Vinci has also resorted in some freak accidents, including a time the robotic arm hit a patient in the face while she was on the operating table and a time the hand would not release tissue grabbed during surgery.

The FDA has only approved one robotic system for soft-tissue surgery - da Vinci. Da Vinci is made by Intuitive Surgical Inc. of Sunnyvale, California.

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OSHA ISSUES OVER $38,000 IN PENALTIES IN RESPONSE TO HORRIFIC WORKPLACE ACCIDENT

April 23, 2013,

garage.jpgThe Occupational Safety and Health Administration (OSHA) issued over $38,000 in penalties split between five separate contracting companies on April 10 in response to the collapse of Miami Dade College's west campus parking garage. The collapse occurred on October 10 and killed 4 workers in one of the county's worst workplace accidents.

The collapse of the five-story, $20 million concrete garage was due to a series of oversights and careless errors committed by the contracting companies. After an investigation, OSHA discovered evidence of missing welds and grout in certain support columns, failure to secure columns and failure to follow through with the required inspection of 18 columns.

According to the OSHA citations, the garage was a workplace "free from recognized hazards that were causing or likely to cause death or serious physical harm to employees." After the collapse, the site was so unstable that one of the four worker's bodies was not recovered for more than a week.

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TENANTS PLAN TO SUE LANDLORD OVER ELEVATOR THAT REMAINS UNFIXED AFTER SUPERSTORM SANDY

April 22, 2013,

ELEVATOR.jpgResidents at 2770 W. 33rd St. plan to sue their corporate landlord Coney Island Site 4A-1 Houses Inc., contending that the landlord has left several residents, many of which are elderly and disabled, stranded in their apartments of a five story building after Superstorm Sandy.

The tenants have been living in a building with an elevator that broke during Sandy - a superstorm that occurred over five months ago. The residents claim to have been trapped in their apartments for more than five months.

The attorney representing the tenants, Brent Meltzer of South Brooklyn legal services, said, "It's just not right. They first had to live through Sandy and now they have to live trapped in their homes."

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DENTAL PATIENTS IN OKLAHOMA EXPOSED TO HIV AND HEPATITIS

April 17, 2013,

Image of Dentist.jpgOklahoma health inspectors launched an investigation last month of Dr. W. Scott Harrington's dentist office located in a suburb of Tulsa, after one of Harrington's patients contracted hepatitis C. Inspectors uncovered multiple sterilization, staffing, and other infractions noted as creating an environment that was a "perfect storm" for infections.

Harrington, 64, practiced oral surgery for 35 years prior to the surrender of his license on March 20 after inspectors found the health infractions. Some of the sterilization and cross-contamination offenses included "unauthorized, unlicensed" employees using IVs to sedate patients, as well as improper handling of needles during surgery. The executive director of the Oklahoma Board of Dentistry stated "basic universal precautions for blood-borne pathogens" were not followed.

Another source of the failed health inspection was the drug cabinet in Harrington's dentist office. It was reportedly unlocked and unattended, appearing to be unchecked for proper inventory. A drug was found by inspectors that expired in 1993, according to an official complaint filed before the state dental board. Also, records in the office show that up through 2012, morphine was used to treat patients, yet there was no record of the office receiving a morphine shipment after 2009.

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GREEN VALLEY DRUGS RECALLS ALL STERILE PRODUCTS

April 15, 2013,

LABS.jpgDue to quality control concerns, Green Valley Drugs is voluntarily recalling all lots of all sterile products compounded, repackaged, and distributed by the pharmacy. This recall is based on observations of clean room personnel and specific aseptic techniques.

A full list of the recalled products can be found at greenvalleymed.com.

Founded in 1984, Green Valley Drugs began as a family-run, basic retail pharmacy. The business quickly expanded in 1993, when it entered the arena of specialty compounding. Now, it serves as Southern Nevada's largest compounding pharmacy.

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TOUR BUS DRIVER CHARGED AFTER NEGLIGENT DRIVING ON SOLDIERS FIELD ROAD IN BOSTON, MA

April 12, 2013,

buses.jpgState police announced that a Philadelphia tour bus driver will be charged for crashing into an overpass on Soldiers Field Road on Feb. 2, 2013.

The driver is being summoned to court on a criminal charge of driving negligently as he injured several Pennsylvania teenagers and violated several civil traffic violations.

The group included high school students and chaperones from the Bristol, Pa. nonprofit Destined for a Dream Foundation. The bus was on its way back to the Philadelphia area following a trip to Harvard University.

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