Wednesday, May 28, 2014

Pradaxa Settlement Announced

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.

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:




Blog Archive