Fosamax, one in a class of drugs known as bisphosphonates, is supposed to make bones stronger. But new research suggests staying on the drug for five or more years can increase the risk of hip fractures.

Two new studies show the bones of post-menopausal women who take bisphosphonates (Actonel, Boniva, Fosamax, Reclast) to treat osteoporosis can stop rejuvenating and become brittle after long-term use. Researchers urge limiting the length of time people take the drugs.

One study found, 111 postmenopausal women with osteoporosis, who had been taking bisphosphonates for four or more years had a raised risk for an unusual type of femur fracture. The findings were compared with 50 women who were taking calcium and vitamin D supplements but not bisphosphonates for bone health.

Researchers stress that these drugs are still useful in the early years of use and people should not stop using them. However, more research is needed, says Dr. Melvin Rosenwasser of chief of orthopedic trauma surgery at Columbia University Medical Center.

“These are good drugs. They strengthen bone and protect from fractures for a while,” says Dr. Rosenwasser. “But, in some people they can become harmful after a period of time.”

Findings from both studies were presented at the American Academy of Orthopaedic Surgeons‘ annual meeting in New Orleans.

An estimated 10 million Americans, mostly women, have osteoporosis.

Osteoporosis happens when the bone building process within our body reverses itself after the age of 35. Then we breakdown more bone than we build leading to overall decline in bone mass. The quality and quantity of bone in adults is established by diet and exercise by the age of 18 in girls and 20 in boys.

Bisphosphonates are a class of drugs that slow or stop reabsorption of bone. They can reduce the risk of bone fracture, and in some cases can increase bone mass in those with osteoporosis. In cancer patients, they slow bone turnover in people with cancer of the bones or multiple myeloma.

Fosamax and similar drugs have been linked to other medical conditions in the past including heart irregularity, osteonecrosis of the jaw and most recently esophageal Cancer.

Originally posted at Chrissie Cole

Suffocation Dangers

The suffocation of seven infants has the Consumer Product Safety Commission issuing a warning to parents about problems with a baby sling harness-like devices.

The sling allows a parent to carry the child in a prone position in a sack-like bag that is attached around the neck of an adult. But because of the potential dangers, the slings will be the subject of a warning to be issued by the agency later this week.

“We know of too many deaths in these slings and we now know the hazardous scenarios for very small babies,” said Inez Tenenbaum, chair of the CPSC.

She spoke at a meeting of the Juvenile Products Manufacturers Association, a certifying industry group. Tenenbaum did not cite any one manufacturer, but there have been complaints for years

Seven Babies Dead

Over the last 11 years, seven infant deaths have occurred allegedly in connection with baby slings.

The deaths have been ruled suffocation and some have been ruled as Sudden Infant Death Syndrome (SIDS), which generally means the death is unexplained. The problem may come when an infant’s head bends forward cutting off the supply of oxygen.

Consumer Reports has identified at least two infants who have suffocated in baby slings made by Infantino of San Diego, California.

Included among the dead, six-day-old Derrick Fowler of Oregon. He suffocated against his mother while had him in a sling as she shopped. A seven-week-old boy from Philadelphia also suffocated in a sling around both him and his mother.

The mothers had no idea that their child was in trouble until they looked down to check on them.

Consumer Reports lists five products not to buy for your baby, including the baby slings. Other devices include the bedside and co-sleeping devices; baby bath seats; sleep positioners; and crib bumper pads.

Head Injuries

And the consumer group reports that over the past ten years there have been at least 22 injuries associated with the popular sling-type of carriers including skull fractures and head injuries that occur when the child falls out of the sling.

In 2007, about 100,000 Infantino Infant Sing Carriers were recalled by the CPSC due to a fall hazard.

The agency said the plastic slider on the fabric strap had the potential to break causing the carrier to release the infant. At that time there had been 10 reports of plastic sliders breaking and injuring eight babies, including a fractured skull.

Many parents report they prefer a baby harness that allows the infant to sleep upright with their head and stomach resting on the adult. #

Originally posted at Jane Akre

In Florida, mistakes in a hospital emergency room are the third most-frequent reason the injured patient files a medical malpractice lawsuit, according to the Office of Insurance Regulation, following injuries in a hospital and physicians’ offices.

Now a Florida senator has come up with a creative way to limit the liability of those who work in hospital emergency rooms.

Last week, the Senate Health Regulation Committee approved a bill, on 5-2 vote, that would offer “sovereign immunity” to Florida’s 205 hospital emergency rooms. Sovereign immunity usuallyprotects the governmentfrom liability lawsuits

The bill, introduced by Sen. John Thrasher, an influential Republicans, would limit recovery to $200,000 per incident for nurses, doctors, emergency workers, paramedics and anyone working in an ER. The degree of injury suffered would not be a factor.

Thrasher is also the chair of the Florida Republican Party and who gained his Senate seat in 2009 despite ads by trial lawyers depicting him as being a friend of the business community. Thrasher fired back with ads showing “trial attorneys” sitting around and laughing chomping on cigars in a smoke-filled room.

Hospital groups like the proposal and the Florida Medical Association and Florida Hospital Association have offered their backing. Thrasher was general counsel to the Florida Medical Association.

If approved the state government would assume liability for any jury award in excess of the $200,000 cap. An injured plaintiff, or their survivors, would have to file a “claims bill’ in the Legislature to get the money, reports the Sun-Sentinel, but those can take years to pass.

Thrasher reasons that hospitals will be able to retain high-risk specialties, such as neurosurgeons and orthopedic surgeons, if protections are offered in an ER setting.

Not everyone is onboardincluding Republican Sen. Durrell Peaden, a medical doctor who Health News Florida reports is a top lawmakers on health issues.

He says “You’ve got to be fair to everybody on that issue,” referring to the fact that mistakes are made in the ER every day.

Florida Already Protects ER Docs

In 2003, the legislature passed a law that included protection from liability for those working in an emergency room. An injured patient is limited to $150,000 or $300,000 for non-economic damages, also known as pain and suffering, even in the case of gross negligence. Public hospitals already have immunity protections.

Sovereign immunity proposals extending to emergency rooms in all hospitals have never passed in the Florida legislature, even though they’ve been proposed for the past three years.

If enacted, the Thrasher proposal would go much further for the first time inprotecting not just the doctors and hospitals, but also the paramedics and nurses. Senator Al Lawson, a Tallahassee Democrat voted against the bill calling its reach to non-physicians “just too broad.”

Florida Justice Association lobbyist, Debra Henley, says the bill would make the state liable to defend doctors, including all costs associated with going to trial.

“When accountability (for doctors) is removed, care gets worse, not better. The scope of this bill is massive,” she says. #

Originally posted at Jane Akre

Stopped With Help From CHP

The Street reports that a 2008 Prius sped out of control at 94 mph in San Diego on Monday.

61-year-old James Sikes tells AP that “I pushed the gas pedal to pass a car and it did something kind of funny.it jumped and it just stuck there.” “As it was going, I was trying the brakes.it wasn’t stopping, it wasn’t doing anything and it just kept speeding up.”

According to reports, Sikes was driving on Interstate 8 and called 911. A California Highway Patrol (CHP) officer gave him instruction to help bring the car down to 50 mph and eventually to a stop, reports the Los Angeles Times.

The Times says that the officer used a loudspeaker to tell the driver to apply both his emergency brake along with the brake pedal at the same time. At 50 mph, Sikes could turn off the engine and coast to a stop. The officer drove his car ahead of Sikes to block itfrom moving forward.

Toyota, which has recalled millions of vehicles over unintended acceleration, has dispatched a field representative to study the car.

The 2008 Prius was part of a November recall of 4 million cars. No word on whether he took his car into the dealer as recommended by the recall notice.

Toyota has recalled some 8.5 million vehicles, 6 million in the U.S. over braking issues in the Prius and acceleration problems in other models.

At least 34 deaths are blamed on the problematic automobiles, including the San Diego deaths last August of CHP officer Mark Saylor and three family members when their Lexus accelerator got stuck and slammed their vehicle into a SUV at 100 mph then down an embankment.

Billions in Losses

The Wall Street Journal reports this morning that Toyota could be facing a $5 billion loss from campaigns to lure customers back including zero percent interest for five years and free maintenance, lawsuits and its extensive new marketing advertisements.

Sales for Toyotas are down 12.7% in February, an improvement over the previous months 14%.

Litigation and Class-Actions

Class-action status is being sought in at least a dozen lawsuits. The latest is brought on behalf of the Pena family of Texas who owned a runaway Avalon, made by Toyota.

Robert Hilliard, (IB Partner) of Hilliard Munoz Guerra LLP, believes the lawsuit, filed in federal court in Corpus Christi, will include owners of all types of Toyotas from all over Texas.

And Beasley Allen (IB Partner,) an Alabama law firm, announced last week it is filing suit in Florida on behalf of more than 5 million Toyota owners affected by the recall.

Toyota is facing lawsuits from individuals as well including the Houston plaintiff who alleges his wife was killed in when her 2009 Toyota accelerated and crashed. #

Originally posted at Jane Akre

Riegel Decision Still Reverberates Today

Two years after a Supreme Court decision that favored medical device makers over those patients injured from them, and thousands of patients still have no legal recourse.

The Riegel decision gave immunity to manufacturers of Class III medical devices that undergo pre-market approval by the Food and Drug Administration (FDA).

That means patients such as Katie Meyer had no recourse. Katie had cancer, which she eventually beat, but she did not survive the three shocks from a malfunctioning Medtronic Sprint Fidelis lead attached to her defibrillator.

She died three days before her 31^st birthday.

The Riegel Decision

As a result of the Riegel decision, issued by the U.S. Supreme Court on February 20, 2008, consumers injured by FDA approved medical devices cannot hold the device maker accountable, reports AAJ.

The case law was established by Donna and Charles Riegel who brought a lawsuit against medical device maker, Medtronic, when its Evergreen Balloon Catheter ruptured in Charles Riegel’s coronary artery during heart surgery.

A Class III medical device, the catheter had received FDA premarket approval, but the Riegels argued that it was defective in its design and label and violated New York law.

In losing their decision to the high court, it was established that federal safety oversight for medical devices, established by the Medical Device Amendment of 1976, trumped state authority.

Consumers injured by a defective device would be pre-empted from filing a lawsuit against a manufacturer of a medical device approved by the FDA.

Judge Antonin Scalia noted the FDA spends about 1,200 hours reviewing each application for a medical device and will grant approval if there is a “reasonable assurance” or its safety and effectiveness.

As a result, the Riegel decision largely leaves consumers unprotected, while medical device makers, even if their device is later found to be defective and removed from the market, enjoy protection from pre-market surveillance and costly litigation.

In fact, several lawsuits on behalf of thousands of patients with the Medtronic heart-defibrillator wires were dismissed by a federal judge last year.

The Riegel ruling applies to medical devices that receive FDA premarket approval.

The majority do not.

510K System – No Pre-Market Approval

Americans may not be aware that someClass III devices, those considered to carry the highest risk, do not even undergo pre-market approval or PMA.

Most Class I and Class II devices, considered less risky, are approved for marketing only under a little known clause in the FDA known as the 510 (k) that allows manufacturers to obtain approval to market the device, bypassing the more stringent PMA review. In an exchange of paperwork, the manufacturer must claim their device is substantially equivalent to one already on the market, known as a predicate device.

Even some Class III devices are approved under 510 (k).

Under 510 (k), about 8 % to 10% of device makers include clinical data required for high-risk device approval. The rest do not.

The FDA’s own Web site says “Only a small percentage of 510 (k) s require clinical data to support a marketing clearance by the Food and Drug Administration.”

Last year, IB News reported on the synthetic surgical mesh, a Class II device that is approved under 510 (k) for marketing, yet is causing problems for thousands of patients who had the devices implanted to correct hernias and urinary incontinence.

In January, the GAO concludes the FDA inadequately tests many Class III medical devices. The American Association for Justice reports that in a five-year period, the FDA approved 228 high-risk medical devices with minimal testing. Some of the devices are implanted in patients.

Remedy

Congress has introduced the Medical Device Safety Act to allow injured patients injured by medical devices to seek a remedy in court. Consumers may want to inquire whether the medical device they are slated to receive has undergone premarket approval by the FDA or was approved for marketing under 510 (k). #

Originally posted at Jane Akre