Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Twitter: @JjrkCh
Showing posts with label President Barack Obama. Show all posts
Showing posts with label President Barack Obama. Show all posts
Alex Neil has been pressed into action to help women whose lives have been ruined
by the painful side-effects of plastic vaginal mesh implants.
The health secretary
yesterday said he would seek an urgent meeting with the United Kingdom
regulatory body for medical devices after a group of women told Holyrood of
their suffering due to the controversial treatment.
Members of
pressure group Scottish
Mesh Survivors – Hear Our Voice have presented a petition to the
Scottish Parliament urging treatment be suspended.
Polypropylene
mesh medical devices are implanted in women who experience bladder and prolapse
problems, typically after pregnancy.
Appearing in
front of Holyrood’s petitions committee, sufferers told MSPs (Ministers of
Scottish Parliament) their lives had been blighted after having the implant.
Some were in tears as they spoke of severe mobility restrictions, immune system problems and damage to
internal organs caused by the mesh or tape implanted in the pelvis.
There were reports of the mesh becoming infected and
contracting – cutting through organs “like cheesewire” – and the extreme
difficulty in removing the material safely.
Despite a
campaign to have the procedures suspended until a full investigation is carried
out, sufferers say
government ministers are passing the buck.
Elaine Holmes,
49, from Newton Mearns, East Renfrewshire, had an implant to treat a leaky
bladder in February 2011. Since then she has had four operations to remove the
mesh.
“Too many women
in Scotland are being hurt on a daily basis while we wait on the slow-moving
wheels of Westminster to turn,” she said. “We already have the legal powers
needed to make a difference in Scotland, today. The rest of the UK can follow
suit, but let us lead the way.
“We have been
told that regulation and safety is an issue for the European Commission. But we
would contend that the current EU system is not working and if our First Minister shows
political willingness to intercede over fishing quotas, he can surely show
political willingness to intercede over something which is having such a
detrimental effect on human life.”
MSPs requested
that the health secretary and deputy Michael Matheson, the public health minister,
appear before the petitions committee to give evidence on the Scottish
Government’s position.
Yesterday, Mr
Neil wrote to the Medicines
and Healthcare Products Regulatory Agency (MHRA). He called on the MHRA
to reach a swift conclusion to ensure that no further women suffered
complications as a result of having the implant.
He said: “I met
with some of the women affected and I am clear that no-one else should have to go through the suffering
they have experienced.”
The
Scottish Government has written to all GPs to ensure they make patients who may
be considering this treatment aware of the potential side-effects.
Labour’s health
spokesman, Neil Findlay, said: “The ball is firmly in the court of the
government and I hope they finally take note of the evidence presented by the
women.”
An MHRA
spokesperson said the body would be happy to meet Mr Neil: “We listened to and
understand the concerns many women have about vaginal tapes and meshes.
“The evidence currently available
indicates that the benefits continue to outweigh the risks and can help in
dealing with upsetting conditions such as urinary stress incontinence and
pelvic organ prolapse.”
MASSDEVICE ON CALL — Medical device tax repeal efforts have made friends
across party lines and in both houses of Congress, but Senate Health Committee chairman Tom Harkin
isn't one of them.
In harsh comments made yesterday Harkin characterized the debate over
the medical device tax as a fabricated controversy, saying that the industry
can afford to pay its share to help fund healthcare reform, Minnesota Public Radio
reported.
"That medical device tax
issue is one of the phoniest issues I have seen in my years here," Harkin
said. "It is absolutely, totally fraudulent and phony. That small amount
of tax won't hurt them one bit, and they make a lot of money on medical
devices."
Harkin promised to fight any efforts to repeal the tax, MPR wrote.
The sentiment is one long shared
by the White House.
The Obama administration has on several
occasions said that medical device
tax repeal is a non-starter, maintaining that the levy represents the medtech industry's
fair burden in helping to fund healthcare reforms that will bring them more
customers. The so-called "windfall"
rhetoric has been a staple of the battle over the medical
device tax, with proponents of the tax arguing that medtech companies will
offset much of their costs through their new customers and the industry
insisting that the newly insured aren't the kind that end up needing medical
devices.
The White House
said for the 1st time this month that it would consider repeal of
the levy, as long as lawmakers could come to terms on some means of making up
for the lost revenue. The issue of a so-called "pay-for" to make up
for the lost revenue the medical device tax is projected to generate has been a
sticking point for many Democrats.
Vaginal Mesh Effectiveness Target of New Boston Scientific Study
By: Austin Kirk | Published: June 10th, 2013 (FiDA highlight)
Boston Scientific announced last week that it is
working with the Pelvic Floor Disorders Network (PFDN) to study the effectiveness
of treating uterine prolapse with vaginal mesh compared to traditional surgery.
The company is contributing more than $1 million
to the study, which will look at one form of pelvic organ prolapse (POP) and
the available treatment options.
The announcement
comes two years after the FDA found that there was no evidence that
transvaginal mesh provides any additional benefits when compared to traditional
surgery, yet it appears to carry a risk of serious complications.
Concerns about the safety of surgical mesh for
treatment of pelvic organ prolapse and female stress urinary incontinence
gained widespread attention in July 2011, when the FDA indicated that nearly 3,000 reports of problems with
vaginal mesh were received by the agency between January 2008
and December 2010, including cases where the mesh eroded through the vagina,
caused infections and other debilitating injuries.
In early 2012, the FDA sent a letter to several
manufacturers of these products, ordering that they conduct additional studies and trials
to evaluate the safety of transvaginal mesh products, looking
for additional information to establish whether they pose an unreasonable risk
of injury for women.
Concerns Over Safety and
Effectiveness of Vaginal Mesh
The main
manufacturers of vaginal mesh products sold in the United States are Boston
Scientific, American Medical Systems (AMS), C.R. Bard, Johnson & Johnson’s
Ethicon and Gynecare subsidiaries, Coloplast Corp. and Cook Medical.
Many of
these products were approved through the FDA’s controversial 510(k) system,
which allowed the manufacturers to begin selling the devices without conducting
rigorous pre-market studies. Products were approved by the agency as long as
the manufacturer could indicate that it was “substantially equivalent” to other
products on the market.
As concerns have surfaced over the safety and
effectiveness of vaginal mesh, many of the manufacturers have elected to cease marketing
their products in an effort to avoid conducting the required
studies.
The new study announced last week by Boston
Scientific, the SUPeR clinical trial, is expected to enroll 180 women considering surgery
to treat uterine prolapse who do not plan to have any more children. The women
will either be implanted with the Boston Scientific Uphold LITE Vaginal Support
System or they will be treated with more traditional surgery, including a
vaginal hysterectomy.
The test
subjects will be evaluated every six months for up to five years. Researchers
will look at the safety, success, cost-effectiveness and other factors
resulting from the surgery. The final results are expected in 2018.
Vaginal Mesh Lawsuits
About
20,000 women throughout the U.S. are currently pursuing a vaginal mesh lawsuit against
the makers of these products, alleging that transvaginal surgical mesh is
unreasonably dangerous and defective, carrying a severe risk of painful and
debilitating health problems for women that outweighs any potential benefits.
The U.S. Judicial Panel on Multidistrict
Litigation (JPML) has established separate consolidated proceedings in the
federal court system for cases involving different manufacturers, with five
Multidistrict Litigations (MDLs) centralized before U.S. District Judge Joseph
Goodwin in the Southern
District of West Virginia.
Several cases pending in state courts throughout
the country have already gone to trial, with a California court awarding $5.5 million in damages to a
woman who experienced complications
with a Bard Avaulta mesh in July 2012, and a New Jersey
state court jury awarded $11.1
million in damages in February, including both compensatory and punitive
damages for problems with
Ethicon’s Gynecare Prolift mesh.
In the federal court system, the first vaginal
mesh trials are scheduled to begin next month, with a series of
lawsuits involving the Bard Avaulta mesh set to begin on July 6. Later this
year and early next year, a series of at least three additional trials will be
held involving AMS mesh, Boston Scientific mesh and Ethicon mesh.
These early trial dates are designed to help the
parties gauge how juries are likely to respond to certain evidence and
testimony that may be offered throughout the vaginal mesh litigation. The
preparation and any outcomes may help facilitate negotiations to reach vaginal mesh
settlements in other cases.
A new study finds that long-term benefits are limited for many women who undergo an
operation to treat a common condition called pelvic organ prolapse, which can lead to urinary
problems and discomfort.
The surgery, called abdominal sacrocolpopexy, has been the standard
treatment for the gynecological condition for more than three decades, but its outcomes rarely have been
studied systematically beyond two years. In addition, there isn't
agreement among doctors about what constitutes success for the procedure.
In pelvic organ prolapse, the uterus or vaginal walls "drop"
after childbirth and sometimes protrude into or out of the vaginal opening.
Most women who have had children vaginally have some degree of prolapse but may
not notice symptoms, which can include feeling a bulge in the vagina, a delay in
urinary stream and difficulty with defecation.
For some 225,000 women a year in
the U.S., the symptoms become so problematic that they get surgery.
Two procedures, abdominal sacrocolpopexy and a type of vaginal surgery,
are used to prop up or anchor the organs to keep them in place, sometimes with the use of
synthetic mesh. A third operation, used only rarely for older women,
closes up the vagina.
The new study, published Tuesday in JAMA, the Journal of the American Medical Association,
followed the outcome of more than 200 women for an average of seven years
after sacrocolpopexy surgery. It is one of the longest follow-ups to date of
such patients.
The study showed that many women receive short-term relief from symptoms
and most don't need repeat surgery, but a substantial portion—some 25%—see some symptoms recur
over time, and more than 60% develop urinary incontinence, sometimes as a
result of the surgery itself.
"Surgery for pelvic organ prolapse isn't perfect," said Ingrid
Nygaard, first author on the study and a professor of obstetrics and gynecology
at the University of Utah School of Medicine. "It is very good at
alleviating symptoms and improving quality of life, but the results may not
last forever."
For those who had mesh implanted as part of the procedure, some 10%
experienced movement of the mesh from its original location, which "may
cause problems for years down the road," said Dr. Nygaard.
The use of synthetic mesh in a related pelvic organ prolapse procedure,
in which the mesh is inserted through the vagina rather than through the
abdomen, is the subject of
hundreds of product-liability lawsuits against mesh makers. The suits
allege the women were injured when the mesh failed.
Mesh contraction can occur in the vaginal procedure and cause pain, but
mesh movement with the abdominal surgery is unlikely to be painful, according
to Dr. Nygaard, who has no ties with mesh makers.
Strategies to prevent pelvic organ prolapse center on pelvic-muscle
exercises and childbirth through cesarean section. Some studies have shown such
exercises to be effective, and one large epidemiological study in Sweden
suggested a link between C-sections and lower risk of the condition. But the
preventive effect of C-sections hasn't been studied in a randomized trial. Further reading: Jane Akre: Mesh Device News Desk http://meshmedicaldevicenewsdesk.com/featured-articles/mesh-fails-25-percent-of-time-in-vaginal-prolapse-repair/
Q. Is it important to the public to know that Dick Smothers may be conflicted by his personal bankruptcy?
Q. Is it important to the TV watching public to know that the need for Covidien's product is limited to 1-2% of the people who have Barrett's Esophagus and only 10-15% of the people who have acid reflux have Barretts Esophagus? This is rare, rare, rare!!!!
Q. Where is the FDA in providing guidance to the public on providing truth in DTC ads? Patient harm comes from interventions that are intrusive, costly and potentially dangerous.
Q. Is this one?
Barrett's esophagus is a serious complication of GERD, which stands for gastroesophageal reflux disease. In Barrett's esophagus, normal tissue lining the esophagus -- the tube that carries food from the mouth to the stomach -- changes to tissue that resembles the lining of the intestine. About 10%-15% of people with chronic symptoms of GERD develop Barrett's esophagus.
Barrett's esophagus does not have any specific symptoms. Patients with Barrett's esophagus may have symptoms related to GERD. It does, though, increase the risk of developing esophageal adenocarcinoma, which is a serious, potentially fatal cancer of the esophagus.
Although the risk of this cancer is higher in people with Barrett's esophagus, the disease is still rare. Less than 1% of the people with Barrett's esophagus develop this particular cancer. Nevertheless, if you've been diagnosed with Barrett's esophagus, it's important to have routine examinations of your esophagus. With routine examination, your doctor can discover precancerous and cancer cells early, before they spread and when the disease is easier to treat.
SARASOTA - Dick Smothers may be renowned for his humor, but there is nothing funny about his current financial situation.
The 71-year-old comedic actor filed for Chapter 11 bankruptcy protection in Tampa earlier this month, listing $2 million in assets and $2.8 million in debts on homes he and his ex-wife, Denby Smothers, own on Bird Key and Golden Gate Point.
Smothers is the younger brother in a two-man comedy team. The brothers hosted the "Smothers Brothers Comedy Hour" on CBS in the 1960s, and still perform together in concert halls across the country.
Dick Smothers could not be reached for comment. His bankruptcy attorney, John Cole, said he is on the road.
"Like a lot of people, he got tied up in property that went south," Cole said.
Court records show that Smothers and his ex-wife, a luxury real estate agent with Michael Saunders & Co., borrowed heavily against their two homes during the boom years. But Denby Smothers said there is no reason why her ex-husband should have stopped making interest payments.
"Dick still works and has money to pay his mortgages," she said. "He just chooses not to."
An income statement included in his bankruptcy filing shows that Smothers made $45,300 per month from performances he and his brother have given across the country.
A look at the Smothers Brothers Web site shows that they are booked for 21 concerts this year from Escondido, Calif., to Chatauqua, N.Y., and are to appear in Plant City on March 12.
But a second income statement included in the court filing projects that Smothers will make only about $7,400 per month going forward.
The larger number of $45,300 represents the past and the smaller number represents the future, Cole said.
Denby Smothers, 60, declined to comment further about her husband's financial situation.
The couple got married in Las Vegas in 1997 and filed for divorce in late 2005. That was shortly after Denby Smothers complained in court documents that her husband had pushed her into her car, poked his finger into her chest and told her she had no rights to her house and that their marriage was over.
In their divorce settlement, signed in March 2007, Smothers agreed to provide his ex-wife with $10,000 per month for 36 months to cover mortgage, tax and insurance payments on her 2,000-square-foot, first-floor condo unit with views of Sarasota Bay.
That agreement was set to expire next month.
Both Denby Smothers' condo at 226 Golden Gate Point and Dick Smothers' canal-front house at 460 Meadowlark Drive on Bird Key are listed for sale.
His bankruptcy filing says a short sale contract is pending on the Bird Key house.
Smothers has been coming to Sarasota for more than 20 years and initially stayed at the Colony Beach & Tennis Club.
But in June 2001, he and his ex-wife paid $485,000 for a house in eastern Manatee County.
Two years later, they sold the house for $124,000 more than they paid, and then paid $1.15 million for their Bird Key abode, financing it with $1.2 million in loans from Sarasota Bank.
In 2004 and 2005, they refinanced, increasing their indebtedness on the property to $1.9 million.
A January 2006 article in Herald-Tribune said the property had a low-key beach-house feel with "his" and "hers" kitchens. The article said the couple were trying to sell the house because of their pending divorce.
A few months earlier, they bought the Golden Gate condo unit for $780,000 and eventually borrowed $834,000 against it.
Court records show that Smothers defaulted on his home loan in October 2007, but the loan on the condo unit has remained current.
When called by the Herald-Tribune, Denby Smothers said her ex-husband had not informed her of his intention to file for bankruptcy.
News Research Manager Cindy Allegretto contributed to this report.
Radiofrequency ablation has been shown to be a safe and effective treatment for Barrett's esophagus. While the patient is sedated, a catheter is inserted into the esophagus and radiofrequency energy is delivered to the diseased tissue. This outpatient procedure typically lasts from fifteen to thirty minutes. Two months after the procedure, the physician performs an upper endoscopic examination to assess the esophagus for residual Barrett's esophagus. If any Barrett's esophagus is found, the disease can be treated with a focal RFA device. Between 80-90% or greater of patients in numerous clinical trials have shown complete eradication of Barrett's esophagus in approximately two to three treatments with a favorable safety profile. The treatment of Barrett's esophagus by RFA is durable for up to 5 years.[14][15][16][17] Q. Is this man responsible for the birth of U.S. direct-to-consumer drug/device advertising?
Daniel B. Burke, Leading Media Executive, Dies at
82
Daniel B. Burke, who helped engineer the
acquisition of the American
Broadcasting Company by Capital Cities, one of the boldest corporate
takeovers of the 1980s, and went on to become chief executive of the merged company, died on
Wednesday at his home in Rye, N.Y. He was 82.
The cause was complications of Type 1 diabetes,
according to a statement by the family, which has been powerful in American
business and mass communications. His older
brother, James, ran Johnson & Johnson, and two of his sons have held
top posts at NBC Universal, Disney, TBS, Comcast and the Weather Channel.
Mr. Burke worked for most of his career alongside
Thomas S. Murphy, whom he served as a trusted
lieutenant and partner. Mr. Murphy had been a Harvard Business School classmate
of Mr. Burke’s brother, James.
Daniel Burke and Mr. Murphy were a formidable
pair. Together they built Capital Cities through a series of acquisitions and
orchestrated the merger with ABC in 1986. While Mr. Murphy was the outside man,
happy to be the public face of the company, Mr. Burke thrived as the inside
man, the cost-conscious manager much less eager for publicity.
“He was really a partner,” said Mr. Murphy, who
described their relationship as a collaboration of equals, even though Mr.
Murphy was always a notch higher on the organizational diagram. “It was not a
one or a two,” he said of their working relationship.
“As far as running the business and, particularly
when we took over ABC, the details of putting that ship in order so we maximized our financial
opportunities, a great deal of that was him,” Mr. Murphy said.
Mr. Burke’s son Bill said that Mr. Murphy and Mr.
Burke were a “phenomenal team” and became close friends. “They worked together
all week,” he said, “and then played golf and tennis all weekend.”
The acquisition of ABC, a much bigger company
than Capital Cities, for $3.5 billion stunned the business world. At the time
it was the biggest
corporate acquisition outside the oil industry.
Despite the surprise, Wall Street reacted
positively, not least because Capital Cities brought in Warren E. Buffett to
help finance the purchase.
Mr. Burke became president and chief operating
officer of the merged company, while Mr. Murphy was chairman and chief
executive.
Capital Cities was a highly profitable company
that owned television and radio stations, newspapers and trade magazines. ABC
was the third-largest network, but still a vast operation that ran television
and radio stations and produced programming.
ABC insiders were skeptical about the acquisition
at first, but Mr. Murphy and Mr. Burke turned the new company into a
well-managed and profitable media conglomerate. Known as cost-cutters, they
sought to replace a celebrity-oriented culture at ABC with a less profligate
one that emphasized management teamwork.
Mr. Burke could be a tough taskmaster, Mr. Murphy
said, but he also had a deft way with people.
Daniel Barnett Burke was born in Albany on Feb.
4, 1929, a son of James and Mary Barnett Burke. His father was an insurance
salesman. He grew up in Slingerlands, N.Y., outside Albany, and Dorset, Vt. He
graduated from the University of Vermont in 1950, served as an infantry
lieutenant in the Korean War in 1951 and 1952, and received an M.B.A. from
Harvard in 1955.
After leaving Harvard, he worked for the Jell-O
division of General Foods. In 1961, Mr. Murphy hired him to manage an Albany
television station owned by Capital Cities. Mr. Burke became chief executive of
Capital Cities/ABC in 1990, when Mr. Murphy retired from that position but
stayed on as chairman. Mr. Burke retired in 1994.
In 1995
Mr. Murphy pulled off one more mega-deal: negotiating the sale of the company
to the Walt Disney Company for $19 billion.
In retirement, Mr. Burke lived in Maine and ran a
minor league baseball team, the Portland Sea Dogs.
He was a director of Conrail, the federally
operated freight railroad, from 1981 to 1986. He was also a director of the
Partnership for a Drug-Free America, and he was a chairman emeritus of New York
Presbyterian Hospital in New York City.
Two of his three sons also made careers in media.
His oldest son, Stephen, held top posts at Comcast and Disney and in January
was named chief executive of NBC Universal. His
son Bill was president of TBS and the Weather Channel.
He is also survived by his wife of 54 years,
Harriet; another son, Frank; a daughter, Sally McNamara; his brother, James; a
sister, Phyllis B. Davis; and 14 grandchildren.
Mr. Burke’s son Bill said he was often asked how
the family came to produce so many top corporate executives, across two
generations. He said it may have had something to do with Daniel Burke’s
parents, a father who was a war hero and a football coach at the University of
Vermont and a mother whom he described as highly intelligent and an early
feminist. When his father was young, he said, the children were asked to read
articles from the newspaper and discuss them at dinner.
But he said it was hard to pinpoint what drove
the Burke children to excel in business. “There was something in him and my
uncle and my aunts as well,” Bill Burke said. “It was just in their makeup.”
By BARRY MEIER April 16, 2013 The New York Times FiDA highlight
A jury in
Chicago rejected claims on Tuesday that the orthopedics unit of Johnson & Johnson inappropriately marketed
an artificial hip, which the company recalled in 2010.
The verdict came in the second trial of some 10,000 pending lawsuits
involving the all-metal device, which was known as the Articular Surface
Replacement, or A.S.R. In March, a jury in Los Angeles awarded $8.3 million in the first trial of an
A.S.R.-related case.
The DePuy Orthopaedics unit of Johnson &
Johnson said in a statement that all its actions related to the sale, marketing
and recall of the device had been appropriate.
Internal
DePuy documents introduced at the trials indicated that company officials knew
that the design of the A.S.R. was flawed long before they recalled the device
and even considered redesigning the implant. They never shared that information
with doctors and patients, those documents show.
It was not
immediately clear why the two juries returned such differing verdicts.
Some lawyers and industry analysts have estimated
that the suits ultimately would cost Johnson & Johnson billions of dollars
to resolve. Thousands of the individual cases have been consolidated into a
large proceeding in a Federal District Court in Ohio and a resolution of that
action could provide a framework for settling the bulk of the cases and
determining awards to patients.
The A.S.R. belonged to a class of once widely
used hip replacements whose cup and ball components were both made of metal.
It was first sold by DePuy in 2003 outside the United States for use in
an alternative hip replacement procedure called resurfacing. Two years later,
DePuy started selling another version of the A.S.R. for use in the United
States in standard hip replacements that used the same cup component as the
resurfacing device.
A raft of lawsuits filed Thursday against St. Jude Medical Inc. STJ -0.99%
over an implanted heart device could challenge the broad liability protection
that medical-device makers have enjoyed since a key Supreme Court ruling in
2008.
The lawsuits, filed both in Los Angeles Superior Court and federal court
in the Central District of California, claim
that problems with the manufacturing and oversight of Riata defibrillator
"leads" injured or killed more than 30 patients. Faulty leads,
which connect the heart to defibrillators that zap irregular heart rhythms back
to normal, caused the devices to fail or
needlessly deliver blasts of electricity, the suits allege.
One plaintiff, Rebecca Clawson, said in an interview that she was
shocked several times over 25 minutes while in bed at her Orange County,
Calif., home last November. Her lead was surgically removed and doctors said it
displayed faulty wiring, said Ms. Clawson, who is 55 years old.
"As a matter of policy, we generally don't comment on pending
litigation," a St. Jude spokeswoman said.
If the new cases succeed, they could help reopen a closed-off corner of the law that has left people who believe they were
injured by medical devices with little recourse—and tempered the
business of both plaintiff and defense lawyers who once earned hefty fees from
device cases.
In recent years, the legal landscape has shifted against would-be
plaintiffs injured by devices that go through the Food and Drug
Administration's premarket approval process, lawyers specializing in device
cases say.
The 2008 Supreme Court ruling, Riegel v. Medtronic, MDT -1.78%
shielded makers of such devices from most product-liability claims, which are
governed by state law, so long as the companies had complied with the federal
standards of the FDA, including those for manufacturing, labeling and device
monitoring. That meant that even if such
devices were later found to be defective, companies are protected from
many suits.
A 1976 law governing medical devices generally prohibits states from
attempting to regulate devices, which are subject to federal rules, but Riegel
broadly interpreted those provisions in a way that plaintiffs' attorneys say
made it much harder to pursue claims.
To push cases through, lawyers generally must find state laws that
specifically address violations of the FDA's requirements.
"Riegel was basically a graveyard for"
device cases, said George Conk, a professor at Fordham Law School in New York and
former product-liability attorney. In 2010, an appeals court upheld the
dismissal of more than 8,000 cases alleging that a Medtronic Inc. defibrillator
lead had injured patients, after the firm argued Riegel protected it. The
company, though, had agreed to pay $268 million to settle the cases days
earlier.
Medtronic said that without such protections from state law, "there
would be no central standard for device safety, effectiveness, testing,
labeling and marketing, which would ultimately be detrimental to
patients."
Lawyers in the new Riata cases are
alleging that St. Jude violated both the FDA's requirements for the company to
report device flaws to the agency, along with state product-liability laws,
an emerging approach to clearing Riegel's hurdles that has been buttressed by
several recent appeals-court rulings.
They will also attempt to show St. Jude erred in manufacturing the
devices in accordance with FDA rules, the approach favored in most device cases
since Riegel.
The industry defends Riegel and its broad protections. "There is no
absolutely safe medical device," said Ralph Hall, a Minnesota lawyer who has
worked with device makers. "Making risk-benefit determinations in any
design is FDA's job," he said.
St. Jude's Riata problems led to a recall of the leads in late 2011, and
researchers have attributed at least 20 deaths to problems with the leads. Wires
inside the Riata leads can break through their insulation, becoming exposed and
potentially leading to electrical problems.
Some patients with the leads have seen their cases turned down by
lawyers. Greg Jessee, 51, the general manager of a hydraulics-repair firm in
Portsmouth, Va., was shocked three times before his heart briefly stopped
during his son's football game in late 2011. He consulted an attorney last year
to consider suing St. Jude, but the lawyer declined the case. "He studied
it and came back to me to say he has found no way around" the protections,
Mr. Jessee said.
The lawyer, Duncan Garnett, of Newport News, Va., didn't immediately
respond to a request for comment.
Since the ruling "we've had numerous clients—including clients who
have had Medtronic devices implanted in them—who have been reluctant to bring a
case," said Brian J. McCormick Jr., a partner with Sheller PC, a
Philadelphia law firm that specializes in cases involving defective products,
drugs and medical devices.
Attorneys at large law firms that once made a lucrative business of
defending the industry also say the Riegel ruling affected their businesses.
"It has narrowed the playing field by 75%," said one defense lawyer
specializing in devices who declined to be named because he still represents
the industry in some matters.
Appeals courts are now split on the breadth of claims that Riegel
blocks. A January ruling, for instance, in the Ninth U.S. Circuit Court of
Appeals, which includes California, found Medtronic wasn't protected from
liability related to a Medtronic pain-medicine pump malfunction, in part
because the plaintiff, a patient named Richard Stengel, alleged the company
failed to warn the FDA about known risks.
Medtronic said it disagreed with the January ruling.
The lawyers in the newly filed cases are hoping such rulings could
propel their cases.
"What the judges are recognizing now is that
there's no recourse for consumers, and that's changing," said
Reza Torkzadeh, a Los Angeles attorney representing the plaintiffs in the new
cases.
Write to Christopher Weaver at christopher.weaver@wsj.com
and Jennifer Smith at jennifer.smith@wsj.com Joleen ChambersThe
medical device industry actively obscures the cascade of harm (and cost) when
their products do not perform as advertised. Long-term post-market surveillance
that is available in other countries via national registries are proprietary
silos here in the U.S. Patients cannot access basic information prior to
surgery about which devices perform best. Purchasing a toaster oven is more
predictable. And when a device fails the debilitated patient is expected to go
to federal court to face a lawyered-up industry. The aviation industry stops
everything for a battery issue in a new airplane, Lulu-lemon gets national
attention for failed fabric in their yoga pants but vaginal surgical mesh, ICD
leads, joint replacement failures: silence! Why is the medical device industry
"special"? Follow the money and see the cost of the entitlements to
this small segment of our national economy! It is costly and immoral.
