Today, a settlement agreement was announced in the Pradaxa mass torts MDL litigation. Terms of the agreement are not readily available but initial reports have the settlement at $650 million. There are approximately 4,000 claimants in the MDL.
Pradaxa is a blood thinner marketed to compete with warfarin, or coumadin. Side effects claimed in the lawsuits are bleeding events and death.
Wednesday, May 28, 2014
Tuesday, May 20, 2014
New Mesh Studies Release and Update on Mesh Cases
A pair of new studies with mixed results suggests that removal
of vaginal mesh -- a device implanted to help support a woman's pelvic organs –
may not improve side effects such as pain and incontinence related to the
device.
The findings, reported Monday
at the American Urological Association's annual meeting, come at a time of
growing safety concerns over vaginal mesh devices. Last month, the U.S. Food
and Drug Administration (FDA) said it will require stricter oversight of the
products -- specifically, as they are used to treat pelvic organ prolapse. The
FDA now classifies these devices as "high-risk."
Unbelievably, the implants are
still in use, and the recent FDA action applies only to vaginal mesh used for
pelvic organ prolapse -- and not the other uses for mesh implants. Manufacturers
will have to provide extensive safety data to the agency before it will approve
future mesh devices for sale, unlike those that injured thousands of women,
which were approved based on their similarity to mesh that has been used for
decades to repair abdominal hernias.
In pelvic organ prolapse, the
structures supporting the bladder, uterus and rectum weaken and stretch. The
organs may drop from their normal position and protrude into the vagina, which
can cause pelvic pain, discomfort during sex, and problems with urination and bowl
movements.
Some women with pelvic organ
prolapse eventually need surgery to reposition and secure the pelvic organs. Vaginal
mesh implants were marketed to give extra support to the organs after
corrective surgery.
However, the FDA began
receiving reports of problems linked to the devices. There were cases where the
mesh eroded, and women suffered infections, bleeding or pain.
The study followed 123 women who had surgery to remove
either a mesh device or another synthetic device called suburethral tape. The
results from this study was mostly good. Most of the women -- including 67
percent of those with the mesh device -- became pain-free after surgery. And on
average, patients' pain ratings were much lower two to three years after
surgery versus before the surgery.
The second study, by researchers at the University of
California, Los Angeles, had less-positive results. It surveyed 214 women roughly
three years after their mesh implants were surgically removed. Post-surgery,
many women continued to have problems, the study found. Although two-thirds of
the women said they had no pain or only mild symptoms, the rest had moderate to
severe pain. Twenty-eight percent said they suffered from incontinence at least
once a day, and half had pain during sex, according to the study.
There are a multitude of manufacturers of these products.
As such, litigation over the various types of mesh implants have been going on
for a few years. The results of trials that have occurred have been mixed. Last
year, a major victory was achieved for the victims with a huge punitive damage
judgment. See my previous blog post on that story.
Earlier this year however, U.S. District Judge Joseph
Goodwin in Charleston, West Virginia, granted judgment for Johnson & Johnson
on Carolyn Lewis’s claims that a TVT Retropubic sling implanted to treat
incontinence was improperly designed, according to court records.
J&J is facing more than
12,000 federal-court claims that the TVT Retropubic slings and its other
vaginal-mesh inserts degraded over time, causing pain and injuries. The cases
have been consolidated before Goodwin for pretrial information exchanges.
Lewis’s case was the first sling suit to go to trial. More than a million women
have had the slings inserted since the device was approved in 1998.
Another
manufacturer, American Medical Systems (AMS) and its parent company, Endo
International Plc, announced an $830
million offer to settle approximately 20,000 pending vaginal mesh lawsuits.
News of the settlement was reported on May 1, 2014.
The
AMS settlement will resolve most of the lawsuits filed by women who allege they
have suffered injuries after being implanted with the company’s Apogee,
Perigee, and Elevate mesh devices that were meant to alleviate symptoms of
pelvic organ prolapse and stress urinary incontinence. Each claimant will
receive approximately $40,000, based on the total amount of the settlement.
Many of the lawsuits have been consolidated into the MDL in front of Judge Goodwin.
However, Endo is facing a number of lawsuits filed in various state courts
throughout the country.
Wednesday, May 14, 2014
O'Bannon Case Looks Like It Is Still Going To Trial In June
The 9th U.S. Circuit
Court of Appeals on Tuesday rejected the NCAA's request that it consider an
appeal that likely would have delayed — and potentially changed the complexion
of — a lawsuit relating to the use of college athletes' names and likenesses and
the association's limits on what major-college football and men's basketball
players can receive for playing sports.
For more on the story, click on the link below:
Monday, May 12, 2014
Alabama Supreme Court Opinion On Service By Publication
Volcano
Enterprises, Inc. v. Rush, No. 1121185, provides a cautionary
tale about serving a defendant by publication.
Plaintiffs
sued an allegedly intoxicated driver for causing an accident and Volcano
Enterprises, a bar licensee, under the Dram Shop Act. Initially, the plaintiffs sought to serve
Volcano Enterprises’ designated registered agent for service by certified
mail. When the certified mail was
returned, the plaintiffs engaged a private process server. The server discovered that the agent’s listed
address had been destroyed by a tornado.
(Unfortunately, it turned out that the agent was still receiving mail at
that address; additionally, there was no indication that the process server
investigated where the agent was living.)
On three or four occasions, the process server went to the bar looking
for the agent/operator. (Unfortunately,
the Supreme Court found that the process server’s efforts were quite
minimal.)
The
trial court granted the plaintiffs’ request to serve Volcano Enterprises by
publication; the plaintiffs complied with the formalities of service by
publication. Volcano Enterprises filed
no answer. A trial resulted in the
entries of a $3.25 judgment against the driver, despite his defense, and a $37
million judgment against Volcano Enterprises.
Within 30 days of the entry of the judgment, Volcano Enterprises filed a
Rule 59(e) motion in which it contended that the judgment should be vacated
because it was not properly served with process. (Volcano Enterprises alternatively requested
a remittuter of the judgment.)
The
Supreme Court held that the plaintiffs failed to meet their burden of
demonstrating that Volcano Enterprises’ registered agent had avoided service, a
requirement for being permitted to serve by publication. The process server’s efforts were extremely
minimal and did not show that the agent was actively hiding or endeavoring to
avoid being served. The Supreme Court
discounted that there was some indication that Volcano Enterprises may have
received some of the pleadings filed prior to the trial.
The
lesson is clear that, before requesting to serve a defendant by publication, a
plaintiff must exhaust all reasonable attempts at perfecting “normal” service,
including searching for new addresses for the defendant, and must be able to
proffer sufficient evidence that the defendant is actively avoiding service, as
opposed to, just being difficult to track down.
Monday, May 5, 2014
Government Releases Study Linking Health Defects to Chinese Drywall Exposure
A study released last week by the U.S.
Agency for Toxic Substances & Disease Registry (ATSDR), found a causal link
between exposure to tainted Chinese drywall and health issues. The most common
reported problems were headaches, nosebleeds and sinus issues. Advocates of
Chinese drywall victims have been saying for years that the toxic and corrosive
drywall was responsible for victims' ailments. This study confirms what many
have thought all along.
The latest report also disputes the
results of a "study" conducted by the Consumer Product Safety
Commission (CPSC) released a few years ago that claimed there was no causal
linkage, or more specifically, that the levels of toxins were not of a level allowable
for a good test.
Sadly, many homeowners with Chinese
drywall will probably never be made right as one of the major manufacturers of
the corrosive board has thumbed their noses at the U.S. Justice System. Those
victims will be lucky if they receive pennies on the dollar to remediate their
homes. Also, the settlement money set aside for bodily injury claims is
minuscule when compared to the monies set aside for other categories of
damages.
For more on the story, clink on the links
below:
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