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U.S. Lacks Warning System on Artificial Joints

Excpert:

Last week, Zimmer, based in Warsaw, Indiana, announced it was suspending
marking and distribution of the Durom Cup. Surgeons are receiving letters
from the company advising them to stop implanting the medical device.

Zimmer admits that some U.S. surgeons may need better training and the label
on the product needs to be updated.

The company in a withdrawal announcement, says it plans to "provide more
detailed surgical technique instructions to surgeons and implements its
surgical training program in the U.S. The Durom Cup will continue to be
marketed outside of the U.S. where Europeans have enjoyed "excellent
clinical outcomes since the product launched in 2003."

Patients are being given an 800-number to report any concerns and problems,
though the company believes that a "low" percentage of the 13,000 who've
received the socket will need replacement.

Zimmer hopes to remarket the device by 2009.

The move has cost the company about $20 to $30 million and could open the
company to defective product litigation. Not that it hasn't faced that
before.

While Zimmer representatives would not talk to IB News about this topic,
Zimmer has successfully argued a blanket immunity defense used by many
medical device makers.

It's called federal pre-emption. Since the FDA oversees and conducts
pre-market review of a devices design and label and okays the device for the
market, the manufacturer is protected from lawsuits filed in state courts.

Stephen Sheller, of Sheller P.C., a Philadelphia lawyer who handles
defective drug and medical device cases (and an IB member), predicts if
litigation results from the Durom Cup withdrawal, Zimmer's admission may
preclude a pre-emption argument.

"The company says the fact is that the reason the problem is occurring is
that doctors are not adequately trained by the Zimmer people on how to use
product," he tells IB News. "The complaint could be negligent training and
a failure to train doctors properly, not the medical device per se. The
doctor is not necessarily at fault. It takes it out of pre-emption."

Litigation or not, how is a consumer to know if an artificial hip or knee is
causing problems and has to be replaced in patients?

If you live in countries such as Australia, Britain, Norway and Sweden,
Zimmer may have had to pull the controversial hip socket before 13,000 were
implanted, and consumers and doctors would have access to that information.

Those countries track problems with artificial joints in a national data
registry, called a joint registry. Not so in the U.S.

While this country tracks automobiles, trademarks, voters, refrigerators,
domain names, clinical trials, and even, occasionally - sex offenders -
the U.S. lacks a federal registry to monitor artificial joints.

Elsewhere, a registry works like this - a patient number is matched with
information on the device, including the manufacturer, the surgeon who
implanted it and the outcome of the procedure.

A registry could potentially police poor performing artificial hips and
knees. Their manufacturers would have to justify their continuation on the
market.

As it stands now - for the roughly one million U.S. patients who need
artificial hips or knees - the lack of oversight that ultimately shields
manufacturers at the expense of consumers, means patients have roughly
double the risk of a problematic replacement procedure, whether with the
device or the surgical technique, Dr. Henrik Malchau of Massachusetts
General Hospital tells the New York Times.

Who would oversee the registry?

The Food and Drug Administration (FDA) could oversee such a federal registry
but - as the recent search for the elusive salmonella tomato highlighted-
the agency has its plate full trying to regulate 80 percent of the food
Americans eat and all of the prescription drugs we take.

Medicare has the incentive to oversee a federal registry, saving billions in
procedures that need to be repeated. And patients would be saved from
enduring the pain and suffering associated with having an artificial hip or
knee removed and replaced.

In Sweden, where a federal registry exists, doctors knew there was a problem
with the Sulzer Orthopedics artificial hip after 30 patients experienced
complications. In the U.S., Sulzer took six months to withdraw the device
after Dr. Dorr's patients began experiencing problems, but not before 3,000
patients had the procedure.

Earlier this year when Zimmer began investigating complaints about the Durom
Cup failures, because there is no federal registry the company had to go
through 1,300 patient records.

Meanwhile 1,300 new patients had the procedure.

At an estimated $5 to $10 million annually, the cost of a federal registry
is far less than the cost of settling lawsuits.

Last year, Zimmer was among five medical device companies that agreed to pay
$310 million to avoid criminal charges and to settle civil charges resulting
from a Department of Justice investigation into doctor kickbacks.

The investigation, from 2002 to 2006, found that orthopedic surgeons were
paid "exorbitant" amounts (tens to hundreds of thousands of dollars) and
were given trips to be consultants and to use their products exclusively.

Zimmer paid more than $1 million to 21 consultants in 2007, according to
Bloomberg News. The company paid $169.5 million and was to be monitored (by
former U.S. Attorney General John Ashcroft).

Zimmer did not admit any wrongdoing.

Today, Zimmer and the other manufacturers are paying lawyers tens of
millions to ensure compliance.

"We could have used some of that money for a registry," Dr. Malchau tells
the New York Times.

The hip and knee replacement business generated about $9.7 billion worldwide
in 2007, according to one analyst speaking to Bloomberg News.

Zimmer's 2007 sales of orthopaedic, spinal and trauma devices, dental
implants, and orthopaedic surgical products in more than 25 companies
totaled approximately $3.9 billion, according to a company statement.

There were 220,000 total hip replacements performed in the United States in
2003 according to CDC statistics. 60% are performed on women and two-thirds
are older than age 65.

Replacement is done to relieve the pain and degeneration in the hip due to
arthritis or trauma. #

http://www.injuryboard.com/national-...oogleid=244690

Study Finds Surgical Errors Cost Nearly $1.5 Billion a Year

http://www.injuryboard.com/national-...al+Malpractice

Medical errors are costing us billions and leading to preventable deaths.
That from the fifth annual Patient Safety in American Hospitals study, by
HealthGrades, a leading hospital rating organization. It finds from 2004
through 2006 there were 238,337 preventable deaths among Medicare patients.
That cost the program and ultimately taxpayers $8.8 billion.

Drug Mix-ups Affect One in 15 Hospitalized U.S. Kids

The near-death experience of the newborn twins of actor Dennis Quaid along
with a new study are highlighting the frequency of medication related harm
to children in U.S. hospitals. Researchers find that hospital mix-ups
involving drugs affect about seven percent of hospitalized U.S. children.
That translates to one in 15 hospitalized children or 540,000 kids each
year.

Merck Busted For Ghostwriting Vioxx Studies

Drug maker, Merck & Co., has always characterized its conduct as above board
and ethically appropriate among pharmaceutical companies. "We employ
rigorous scientific methods to design, conduct, analyze, and report results
of clinical trials in the development of innovative drugs and vaccines, with
a focus on meeting unmet medical needs and with an ethic that puts the
interests of the patient first."

$4,600 For Celebrity Medical Records Brings Indictment
The first in what likely will be several indictments was unsealed Tuesday in
connection with UCLA Medical Center celebrity record-leaking. In this
indictment, a workers is alleged to have sold records for $4,600. She is
facing up to 10 years in prison for violating the HIPAA privacy act.

Las Vegas Hepatitis C Doc Blocked From Medicine

Two doctors who owned clinics where an outbreak of hepatitis C is linked to
unsafe medical practices, face temporary restraining orders that could lead
to a permanent lose of their medical licenses.

A New Low of Indifference- Hospital Staff Ignores Dying Woman
A new low in human behavior is observed in this surveillance videotaped
death of a woman in a Brooklyn, N.Y. psychiatric hospital. No one comes to
help. While the hospital is instituting changes, how many among us are
capable of showing indifference?

Baby Dies After Receiving Heparin Overdose at Texas Hospital

Fourteen babies in the neonatal intensive care unit of Christus Spohn
Hospital South were given overdoses of the pediatric version of the blood
thinner Heparin, according to hospital officials. And one baby has died.

Texas Hospital Heparin Error (Part Two)

The CEO of a Corpus Christi hospital is apologizing for a medication error
that may have caused the death of an infant. Another is in critical
condition. Meanwhile, caps on damages in Texas mean that many medical
malpractice lawsuits will never be filed.

You're Not In Good Hands When It's Time To Pay - Worst Insurers Report

The American Association for Justice names the Top Ten Worst Insurers who
try to avoid paying when you need them most. Tactics include using a "boxing
glove" strategy against policyholders while the industry enjoys record
profits.