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MONTLICK & ASSOCIATES, Attorneys at Law
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Atlanta, GA 30329
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Kidney failure might be caused by drug used in heart surgery


A drug called Trasylol that is used during open-heart surgery is the subject of a growing number of lawsuits claiming that it causes kidney failure and other ailments.

Because Trasylol is used in surgery and not prescribed, many patients have no idea whether it was administered to them – unless they ask.

A recent "60 Minutes" report estimated that 4.5 million patients worldwide have been given Trasylol, including 1.5 million in the U.S.

Since last year, about 150 Trasylol lawsuits have been filed against Bayer, its manufacturer.

Trasylol, the brand name for aprotinin, reduces blood loss during surgery and thereby decreases the amount of blood needed for transfusion.

In 1993, it was approved for use in high-risk cardiac surgeries, and was widely used in all types of cardiac surgeries after that.

But in January 2006, a study in the New England Journal of Medicine concluded that the drug more than doubled the risk of kidney failure.

In September 2006, the FDA met with

 

Bayer and decided to keep Trasylol on the market. The following week, Bayer disclosed its own study confirming the New England Journal of Medicine results, and the FDA issued a public health advisory.

In December 2006, the drug's label was changed to warn of potential kidney dysfunction.

After a Canadian research trial was halted in October 2007 because patients were dying within 30 days of being given aprotinin, the FDA suspended sales of Trasylol.

The final results of that study were published in May 2008, and Bayer pulled the remaining stock of Trasylol from the market.


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Lawsuits claim the Yamaha Rhino ATV is unsafe


Scott Smith, a 42-year-old from California, was a passenger in a Yamaha Rhino ATV when it flipped over, crushing his right leg and causing severe injuries.

A hiker and skier, Smith was confined to bed for a year while he underwent seven surgeries.

He sued Yamaha, claiming the design of the Rhino ATV – a four-wheeler that looks like a souped-up golf cart – is particularly unsafe and prone to rollovers.

Smith’s lawsuit is one of about 300 across the country that claim the Yamaha Rhino is unsafe at any speed.

Introduced in 2003, the Rhino, which seats two people and can reach 40 miles an hour, has been blamed for crushed and broken arms and legs, head injuries and deaths.

The lawsuits claim that even at low speeds, the Rhino is prone to rollovers because of its top-heavy narrow design, small tires and side-by-side seating.

In addition, the suits claim, the vehicle's steel roll cage is unsafe and can cause severe or fatal injuries if the rider is pinned between the ground and the roll cage or ejected from the Rhino.

Yamaha has offered to retrofit older

 

models with free half-doors and a passenger handhold. And it has installed half-doors and a handhold on its 2008 model.

The company has put a warning label on the dashboard of new models stating that the Rhino is not intended for drivers under 16, and that "abrupt maneuvers and aggressive driving" have caused rollovers, even on level ground.

A Consumer Product Safety Commission report found that in 2005, more than 136,700 injuries that required hospitalization were caused by four-wheel ATV accidents, including rollovers. Some 30 percent of those accidents involved children under 16.

In 2005 alone, 57 children were killed in accidents involving all types of ATVs.


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General contractor sued for death of unlicensed workman


A general contractor may have to pay in court for the death of an independent contractor who was killed while performing a dangerous job he wasn't licensed to do, the New Mexico Supreme Court ruled in a recent case.

A general contractor renovating a garage into an apartment was told by the city that he needed to connect the apartment's sewer line directly into the town's main line.

The work required a licensed excavator and a licensed plumber, and it would have cost at least $10,000 to

 

comply with all of the federal and state licensing and safety requirements.

Instead, the general contractor hired an unlicensed contractor to do the work for $3,800. The contractor violated several safety standards and died while digging the trench for the sewer line.

His widow sued the general contractor, arguing that he was responsible for the death because he knew her husband was unlicensed and wasn't qualified to do the work for which he was hired.


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Nine out of 10 nursing homes are deficient, U.S. study finds


More than 91 percent of nursing homes were deficient in quality of care and other services in each of the past three years, according to a new government report.

Overall, for-profit nursing homes were more likely to be deficient than non-profit nursing homes, the report found.

The study, which was conducted by the U.S. Department of Health and Human Services, found that the most common problems involved quality of care, resident assessment and quality of life.

Some 73 percent of the nursing homes in the survey were cited for quality-of-care deficiencies in 2007. Accident hazards were one of the most common issues.

About 58 percent of nursing homes were cited for resident assessment problems involving professional standards and the qualifications of service personnel.

And more than 43 percent of facilities were cited for quality-of-life deficiencies,

 

such as loss of dignity.

In addition, almost 43 percent of homes were cited for dietary service violations.

The report found that 17 percent of nursing homes in 2007 were cited for causing actual harm or immediate jeopardy, and that there is a trend toward violations that are more severe and broader in scope than in the previous two years.

Today, almost 40 million Americans are 65 or older, so nursing home care will continue to be a major concern. By 2030, it's expected that the 65+ age group will represent 20 percent of the population.


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Substance used in MRIs might cause serious disease


Almost 400 lawsuits have been filed across the country claiming that a metal used in contrast solutions during magnetic imaging caused a devastating disease.

Gadolinium is used to enhance the images when a patient undergoes magnetic imaging, such as an MRI or MRA.

The lawsuits claim that gadolinium causes Nephrogenic Systemic Fibrosis, a debilitating disease with no cure.

NSF causes scarring or fibrosis of the skin and internal organs. Symptoms include red or dark patches of skin or thick, coarse and hard patches of skin; generalized muscle weakness; stiff joints; and burning, itching or swelling skin.

Symptoms may appear as early as two days after receiving an injection or up to 18 months after exposure.

The vast majority of NSF cases involve people whose kidney function was already compromised at the time they

 

received a gadolinium injection.

Four manufacturers of gadolinium agents have been sued – GE Healthcare, Bayer HealthCare Pharmaceuticals, Tyco/Mallinckrodt, and Bracco Diagnostics.

In June 2006, the FDA issued its first warning about the effects of gadolinium on people suffering from kidney problems.

The federal agency urged physicians to screen patients for kidney disease prior to using gadolinium in MRIs. In December 2006, the FDA announced that it had received 90 reports of patients with moderate to end-stage kidney disease who had developed NSF after being exposed to gadolinium-based contrast agents.

More recently, in May 2007, the FDA requested that the manufacturers of gadolinium agents include a warning on their product labels highlighting the risk to patients with kidney problems.


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NuvaRing birth control device may pose hazards


The NuvaRing contraceptive device is defectively designed and can cause serious side effects, according to more than 150 lawsuits filed across the country.

NuvaRing is a vaginal contraceptive that releases estrogen and synthetic progestin. Its main advantage is convenience, because women can leave it in place for three weeks instead of taking a pill every day.

NuvaRing delivers a constant flow of the hormones to the woman's body. But lawyers claim that the combination of

 

these hormones increases the risk of developing heart attacks, blood clots, strokes and pulmonary embolisms.

The suits name NuvaRing's manufacturer, Organon, as well as two parent companies, Schering-Plough Corp. and Akzo Nobel N.V.

Schering-Plough says that blood clots "have long been known as a rare risk associated with all combined hormonal contraceptives." The company says it has reported adverse effects to the FDA, and the FDA hasn't mandated any labeling changes based on this data.


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Emergency room wait costs hospital $10 million


A New York jury has awarded $10.7 million to a 66-year-old woman who lapsed into a coma after waiting two hours in an emergency room.

Candida Diego initially went to the ER after falling down stairs and hitting her head, but she left the hospital permanently paralyzed on the left side after emergency brain surgery.

Diego went by ambulance to the New York Hospital Medical Center of Queens after falling down a flight of stairs at the drugstore where she worked.

A physician's assistant examined her, noting that she had vomited once and was unable to recall the accident, but was otherwise alert. He ordered a CAT scan at 1:15 p.m. in order to rule out internal bleeding because of her age and

 

the fact that she had suffered a head injury.

But it was 3:30 p.m. when the attending physician finally saw Diego and immediately gave her the scan.

Once the scan was completed, Diego lapsed into a coma. She was stabilized and then operated on at 5:50 p.m.


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85-year-old wins personal injury lawsuit


An 85-year-old farmer has been awarded a very substantial verdict by a jury after an ambulance crashed into his car.

The case is part of a growing trend toward personal injury awards for the elderly. Both life expectancies and medical costs are increasing rapidly, and many juries are taking these facts into account in making their awards.

Louis Del Barba, a longtime farmer in the Sacramento area, was left paralyzed and has been on a ventilator since the April 2007 accident. His medical care could cost more than $20 million, according to his attorneys.

Del Barba was attempting to make a left turn onto a highway when an ambulance rammed him. The ambulance was on its way to an emergency, but had no patients inside.

 

Although the siren was on, the ambulance was speeding at 65 m.p.h. in a 35-m.p.h. zone. Experts testified that the excessive speed, in rush-hour conditions, was reckless and unsafe.

After a five-and-a-half-week trial, the jury ordered the ambulance company to pay $14.9 million in economic and $9 million in non-economic damages.



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The information in this newsletter is intended solely for your information. It does not constitute legal advice, and it should not be relied on without a discussion of your specific situation with an attorney.

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