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Maker of Ancure Pleads Guilty to
Hiding Significant Product Problems from FDA;
Guidant's Admission Bolsters Hersh & Hersh's
Civil Suits Against Manufacturer
Guidant, maker of the Ancure Endograft System, pled
guilty yesterday to 10 felonies in federal court for
hiding evidence of significant problems with the
Ancure product from the FDA. Although the company knew
of problems with over 36% of the 7,632 Ancure devices
sold, the it reported only 172 of these to the
government.
The U.S. attorney charged that Guidant allowed sales
and marketing personnel to influence scientific
decisions, even when this put patient health at risk.
This complaint echoes those included in the civil
suits that Hersh & Hersh filed against the company
earlier this year.
Hersh & Hersh's civil suits allege that Guidant
gave inadequate warnings about its Ancure system. The
company marketed its product as a "safer"
and less-invasive method for fixing abdominal aortic
aneurysms. Abdominal aortic aneurysms are weakened
places in the aorta that can, if they burst, cause
death in a matter of minutes.
These aneurysms have traditionally been successfully
repaired through an open surgical procedure. However,
after approving the device in 1999, the FDA
subsequently received reports of device malfunctions
and severe adverse events related to Ancure. These
included cases of severe blood vessel damage with the
Ancure system.
Finally, the civil suits also allege that Guidant,
maker of the Ancure Endograft System, did not warn
patients that they would need lifetime monitoring to
ensure that their endovascular implants don't move,
leak, or cause other adverse effects. This level of
monitoring substantially raises the lifetime cost of
the procedure, and is not necessary with a traditional
open surgical repair..
Related Newspaper Articles:
Related Television and Radio Coverage:
- CNN, News Night with Aaron Brown, 7PM PST, 6/13/03
Hersh
& Hersh Aims to Enforce Prominent Cautionary Labeling
on Eli Lilly's Most Profitable Anti-Psychotic Drug
February 27, 2003
Hersh & Hersh of San Francisco today announced
that it has already filed several complaints on behalf
of plaintiffs across the U.S. against Indianapolis-based
Eli Lilly & Co. Attorneys are in the process of
filing numerous other complaints and plan to prove
that as a result of taking Zyprexa, a drug
prescribed for the treatment of schizophrenia and
bipolar mania, their clients have sustained life-threatening
or fatal injuries, including diabetes mellitus, hyperglycemia
and pancreatitis.
In some cases patients have died after long-term use
of Zyprexa, even though it has been FDA-approved only
as a short-term treatment, and their families have
hired Hersh & Hersh to represent them in wrongful
death suits against the giant drug manufacturer. Cases
are being filed individually, in both Federal and
State courts.
According to Hersh & Hersh partner Nancy Hersh,
"Eli Lilly's profits are skyrocketing from these
'atypical' anti-psychotic drugs, while patients are
being kept in the dark about their damaging side effects.
We believe Eli Lilly is culpable in heavily promoting
Zyprexa as a safe and effective drug for psychotic
disorders, yet virtually concealing the risks to doctors
and their patients."
Evidence of Fatal Side Effects Exposed.
Since 1996 Eli Lilly has widely promoted Zyprexa as
the most effective medication on the market for bipolar
disorder, with fewer adverse side effects than any
other methods of treatment. It is also the company's
top-selling drug, with reported sales of $3 billion
in 2001. However in 2002, author of Mad In America
and medical journalist Robert Whitaker exposed clinical
trial data about Zyprexa that was not made available
to most doctors prescribing the drug. According to
Whitaker, "Of the 2,500 patients in the trials
who received Zyprexa, 20 died; 20 committed suicide;
and 22% suffered a 'serious' adverse event. Two-thirds
of the Zyprexa patients did not successfully complete
the trials..."
In July 2002, a team of medical researchers
at Duke University discovered the link between the
new generation of anti-psychotic drugs like Zyprexa
and early onset diabetes. They identified 289
cases of diabetes in patients who had been prescribed
Zyprexa, stating, "Of the 289 cases of diabetes
linked to the use of Zyprexa, 225 were newly diagnosed
cases; 100 patients developed ketosis (a serious complication
of diabetes); 22 people developed inflammation of
the pancreas, a life-threatening condition; and 23
people died. Over 70% of these cases occurred within
six months of starting the drug treatment."
Numerous other medical studies have reported that
Zyprexa can result in serious - and oft-fatal -- diabetic
diseases, caused by severe insulin deficiency.
In one Hersh & Hersh case, the North Carolina
plaintiff suffered a diabetic coma after taking Zyprexa
for eight months, and had to have his left leg and
right foot amputated. In spite of these dangerous
side effects there is no warning in Zyprexa's product
information to monitor blood glucose levels, or discontinue
use if high blood sugar is noted or if the patient
develops diabetes. Currently, the literature accompanying
Zyprexa only alludes to diabetes and acidosis as part
of a list of side effects that are purported to be
very rare.
In the early 1980s Hersh & Hersh began working
on DES cases and was the first law firm in the Bay
Area to successfully beat Eli Lilly on behalf of DES
children. Today Hersh & Hersh is suing Eli Lilly
for failing to adequately disclose the serious side
effects of Zyprexa, and for not ameliorating the cause
of these injuries even though they were "scientifically
knowable" at the time of distribution.
Off-Label Drug Use is Growing Problem
Among the numerous cases to be filed by Hersh &
Hersh attorneys, several individuals were prescribed
Zyprexa for the treatment for "off label"
symptoms, including anxiety and depression, even though
it is FDA-approved exclusively for schizophrenia and
bipolar disorder. At least one client so far has
developed an irreversible neurological disorder known
as Tardive Dyskinesia and is subjected to a life of
repetitive, rhythmic involuntary movements such as
tongue thrusting, lip smacking, chewing movements,
rocking of the trunk, marching in place and repetitive
sounds such as humming or grunting.
Zyprexa is among a host of anti-psychogic drugs
that doctors are encouraged to prescribe for off-label
uses by manufacturers. According to an article
published last summer in The Globe & Mail (August
13, 2002), medical ethics professor Miriam Shuchman,
MD, stated that the biggest difference between the
approved and unapproved use of a drug is the evidence
that backs it up. To get a medical condition approved
or "on-label," drug companies must convince
the FDA that high-quality studies show that the drug
makes a real difference for people with that condition.
Off-label uses of a drug typically have not been subjected
to that level of scrutiny.
"To boost sales and circumvent the FDA approval
process drug manufacturers like Eli Lilly are actually
encouraging their sales reps to push secondary uses
of these anti-psychotic drugs and regularly review
reports of the frequency of doctors prescribing these
meds for off-label uses," added Hersh. "In
many cases, off-label sales account for the bulk of
revenues generated by these drugs. Our intention in
the case against Eli Lilly is to also shine a light
on the severe damage caused by this kind of dubious
sales and marketing practice."
Related Newspaper Articles:
Hersh & Hersh
Represents Employees in Toxic Mold Claim Against
Landlord of San Benito County Government Office Building
February 27, 2003
San Benito County Takes Steps to Remediate Toxic
Mold
On Friday, February 28, employees of the San Benito
County Department of Child Support Services, located
at 220 San Felipe Road in Hollister, CA, will be temporarily
relocated to a new facility while the building undergoes
extensive toxic mold remediation.
The building's landlord will begin remediation immediately
to address the severe mold problem in order to make
the building safe for the workers. The repairs are
expected to take eight to ten months. Child Support
Services Workers will be temporarily re-located to
2320 Technology Way, Hollister while the remediation
takes place.
January 17, 2003
Hersh & Hersh Files New Complaints, Takes on
Majority of Workers
San Francisco plaintiff rights law firm Hersh &
Hersh filed six additional complaints on behalf of
employees at the San Benito County Department of Child
Support Services, located at 220 San Felipe Road in
Hollister, Calif. This brings the total number of
individual complaints filed to twenty-four, or 96%
of the buildingís workers.
Test Results Confirm Presence of Mold in Building
Test results issued by Air Quality Sciences Building
Consulting, Inc. confirm the presence of harmful mold
spores in the conference room and bathroom, which
require remediation. The landlord has responded by
cordoning off the conference room.
Union Rep Follows Suit, Requests Worker Relocation
On Thursday, January 16, 2003 the union representative
for the workers sent a letter to the County requesting
that employees be relocated to a different facility.
Under advisement of the union rep, employees are considering
all allowable collective actions next week if the
situation is not remedied.
January 14, 2003
San Francisco plaintiff rights law firm Hersh &
Hersh today announced that it has filed 18 individual
complaints so far on behalf of employees of the San
Benito County Department of Child Support Services,
based in Hollister. Each complaint, filed in San Benito
County Superior Court, states that the one-story
office building, located at 220 San Felipe Road, has
been a breeding ground for dangerous toxic mold due
to chronic water intrusion and leakage. Because
of neglect and faulty building maintenance, air quality
inside the premises -- and the health and well being
of Hersh & Hersh plaintiffs -- have been adversely
affected.
"California law requires landlords to maintain
their premises in a safe and sanitary condition and
to remedy known health hazards," said Charles
Kelly II, Hersh & Hersh attorney representing
San Benito County plaintiffs. "We believe this
is a case in which the landlord is being negligent
and not looking out for the health and welfare of
its tenants."
Hersh & Hersh attorneys contend that county
employees had notified the building owner and landlord,
Lawrence Family LLC on numerous occasions complaining
that the hazardous fungal growth was causing a range
of health problems including respiratory, sinus, gastro-intestinal,
and skin rashes -- even neurological damage -- prior
to filing the complaints. But despite employees'
persistent efforts Lawrence Family has failed to perform
the necessary repairs even though they promised to
do so. Moreover, attorneys argue, employees have
suffered the loss of earnings and will continue to
incur medical expenses precipitated by the harmful
exposure.
According to the World Health Organization, countless
cases have been reported. It now estimates that one
out of three employees is working in a place that
is making them sick and it is costing businesses billions
each year in lost productivity. Locally, the California
Legislature has addressed the "sick building"
problem in the last 12 months by appointing a taskforce
to identify standards and ultimately provide guidelines
to building owners, landlords and contractors.
Hersh & Hersh has identified a particular fungus
in the Hollister building as stachybotrys, which is
becoming more common in homes and buildings within
the United States and Canada. Stachybotrys is a greenish
black mold that typically grows on building materials
such as wood, ceiling tile, drywall, insulation backing,
cardboard boxes, paper files, etc. when these items
become water damaged. The fungus tends to proliferate
in very wet or high humid conditions due to plumbing
leaks or water leaking through foundations. Many experts
agree, in fact, that once a building has been contaminated
with this fungus, it is extremely difficult to remediate
it.
Lawrence Family LLC has until February 8 to respond
to complaints filed by Hersh & Hersh.
Related Newspaper Articles:
Hersh &
Hersh Files Complaint Against Bay Area Pro Wrestling
School;
Exposes Danger and Deceit of All Pro Wrestling
Student Dies of Injuries Suffered in Wrestling
"Boot Camp"
When Pitted Against Goliath Sparring Partner
The San Francisco law firm of Hersh & Hersh (www.hershlaw.com)
filed a complaint at the Superior Court of California
in Alameda County against Roland Alexander, founder
of All Pro Wrestling (www.allprowrestling.com)
and Pacific Coast Sports Promotion companies. The
complaint was made on behalf of the parents of Brian
Ong of Berkeley, California who died as a result of
injuries suffered during All Pro Wrestlingís "Boot
Camp" training. Headquartered in Hayward, California,
Alexanderís company bills itself as the number one
wrestling school in America and markets wrestling
"Boot Camps" to amateurs as a chance to
"Live Your Dream" as a professional wrestler
by providing wrestling training camps, career counseling
and talent agency services to wrestling amateurs at
fees of $6,000 or more.
Mr. Ong, age 24, enrolled in All Pro Wrestlingís Hayward,
CA Boot Camp and was fatally injured as a result of
being thrown to the ground in a practice wrestling
maneuver. According to the complaint, Mr. Ong suffered
a concussion during a practice session and instead
of being advised to seek medical attention and take
time off from his training to fully recover, he was
given a lower evaluation for not avoiding injuries
and was told to continue practicing and performing.
The complaint goes on to state that Mr. Ong, at 5
feet, 7 inches and 185 pounds, was subsequently pitted
against a sparring partner more than twice his size
and that the enormous disparity in size between
Mr. Ong and his opponent, a massive 7 feet, 3 inches
and weighing 400 pounds, increased the risk of harm
to Mr. Ong. He was thrown twice off his sparring partnerís
shoulders, lost consciousness when his head hit the
floor and died in the ambulance on the way to the
hospital. All Pro Wrestling did not provide Mr. Ong
with any protective gear or any supervision by APW
staff, and the floor mats provided were not adequate
to cushion the impact of such maneuvers.
"All Pro Wrestling lures wrestling wanna be's
with the promise of fame and fortune on the exhibition
wrestling circuit," stated Nancy Hersh, partner
of Hersh & Hersh. "Legitimate wrestling organizations
would never pair-up sparring partners from weight
classes at such opposite ends of the spectrum. Tragically
for Mr. Ongís family, they lost their son as a result
of All Pro Wrestlingís negligence and deceit."
The complaint, seeking damages and requesting a jury
trial for injuries causing death and for fraudulent
contract charges, will proceed to trial within the
near future.
Related Newspaper Articles:
Related Television and Radio Coverage:
- Connie Chung Tonight, 8PM PST, CNN National,
8/27/02
- NBC11 News, KNTV 11/NBC3, San Jose & San
Francisco, 8/27/02
- ABC 7 Morning News, KGO-TV (ABC) San Francisco,
9/18/02
- ABC 7 News at 11:00, KGO-TV (ABC) San Francisco,
9/17/02
- KGO-AM 810 Radio (ABC) San Francisco, 9/17/02
- KCBS-AM 740 Radio (CBS) San Francisco, 9/17/02
Hersh
& Hersh Represents "Jane Doe" in Landmark Embryo
Mix-up Case,
Files Suit Against San Francisco Fertility Clinic
Hersh & Hersh filed suit against Fertility Medical
Associates of the Bay Area, a fertility clinic that
implanted an embryo belonging to another couple during
Jane Doe's in vitro fertilization procedure in June
2000.
The suit alleges that the clinic scientist and the
doctor knew before Jane Doe left their offices on
the day of the implantation that they had implanted
the wrong embryo in her. But the clinic did not inform
Ms. Doe and the couple of the mix-up until a year
and a half later, and then only after the California
Medical Board began investigating the switch. According
to Nancy Hersh, "they were keeping the information
secret and never intended to tell. The only reason
they did is because the medical board was nosing around.
That's very bad. Aren't they morally and ethically
obligated to tell?"
Related Newspaper Articles:
- "Embryo mix-up at S.F. clinic prompts lawsuits."
Contra Costa Times, 8/4/02
- "Suit filed over mix-up of embryos at S.F.
clinic." San Jose Mercury News, 8/2/02
Related Television and Radio Coverage:
- CBS Early Show, National, 8/23/02
- KCTV5 News at 4:30 & 6, KCTV-TV CH 5 (CBS)
Kansas City, 8/23/02
- CBS 4 News at 5:00, WFOR-TV CH 4 (CBS) Miami/Ft.
Lauderdale, 8/23/02
- CNN Live Today, National, 8/08/02
- Connie Chung Tonight, CNN National, 8/07/02
- Barbara Simpson Show, KGO-AM 810 Radio San Francisco,
8/03/02
- Channel 5 Eyewitness News, KPIX-TV 5 (CBS) San
Francisco, 8/2/02
- NBC2 News at 5, KNTV-TV CH 11 (NBC) San Jose,
8/2/02
San Francisco
Chronicle: "All in the Family;
These Kids Went to Work
with their Mom or Dad - and Stayed There" (4/24/03)
Seeing how much their father, LeRoy Hersh, enjoyed
practicing law inspired both Nancy Hersh and her sister Jill to
follow him into the legal profession. Read more
in the San Francisco Chronicle story.
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