Tvm Jury Verdict: What Does It Mean?

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Posted by Kim Truongle

February 27, 2013 – Yesterday, a jury in New Jersey found in favor of a mesh implant Plaintiff, awarding her a $3.35 million verdict. What does this mean for your mesh implant case?

This does NOT mean that all mesh cases will gross millions, nor that they will resolve for anywhere near that much. It is important to remember that trials involve specific facts; some of them may be applicable to you, and some may not. Also keep in mind that despite this verdict, the odds of this Plaintiff receiving her funds any time soon are quite low. The likelihood that this case will be appealed by the Defendants to therefore keep the case tangled in further litigation is high. Furthermore, case expenses are usually borne by the client, meaning that the costs of bringing this Plaintiff’s case to trial will most likely come out of the funds she ultimately receives – trying a case against Johnson & Johnson or any pharmaceutical company is not cheap.

The jury in the New Jersey case unanimously found that there was no design defect and instead put the blame on the Defendants for other failures. Defective design is one key cause of action in these cases, so this shows that juries may not always side with the Plaintiffs regarding every issue alleged. In other words, despite some seemingly large dollar verdicts, in no way are mesh cases “slam dunk cases”.

This does NOT mean the cases are close to resolution or settlement. There is still more work to do before we can sit across the table from Defendants and negotiate a settlement that is fair. Valuation of a case involves both personal and legal facts, as we take into account what each client has and will go through, as well as the facts that help shape the legal framework. The latter may involve things like additional development of the science, finding out more about what the companies did or should have done, etc.

We are optimistic about the verdict out of New Jersey, but there is still a road ahead. Sometimes, that road will run smoothly, but there may also be a few bumps we will have to navigate around as we move ahead. As a national pharmaceutical litigation firm, we use our experience to stay the course towards a resolution that is fair for our clients. If you have any questions, please phone our office at (800) 269-3050.

Affymax and Takeda Institute a Recall of OMONTYS

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Posted by Buck Daniel

February 25, 2013 – On February 23rd, Affymax and Takeda instituted a recall of OMONTYS following serious adverse reactions, including life threatening and fatal events. Omontys is used to treat anemia associated with chronic kidney disease for patients on dialysis. Anemia, in which the body is unable to produce enough red blood cells to deliver oxygen to the body’s organs, is often found in kidney dialysis patients. The condition causes fatigue and sometimes heart attacks.

Omontys was produced as an alternative to Epogen, which has been a staple of kidney-dialysis treatment since 1989. However, despite having knowledge that the safety endpoint of cardiovascular events and death was worse for Omontys than for its alternative Affymax kept Omontys on the market. It was further proven, through two randomized controlled trials published in 2013, that Omontys was no more effective than its alternative despite having far greater risks.

About five patients were reported to have died after receiving Omontys, according to the figures provided by Affymax, and around 17 had severe allergic reactions requiring immediate medical help and, in some cases, hospitalization. The reactions could occur within 30 minutes of the first dose.

Read the FDA report here: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340895.htm

Another Recall by DePuy

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By Cindy Nations

February 22, 2013 - A Class I recall has been issued by DePuy Orthopaedics.  This time the product involved is a device used in conjunction with the LPS System, an end-stage revision knee product.  Reportedly, the defectively-designed device can malfunction, which may lead to possible loss of function, loss of limb, soft tissue damage, infection, or even death.  This is not the first time DePuy has been in hot water. The Johnson & Johnson-owned company is defending lawsuits around the country for their defective hip implants, the ASR and PINNACLE models.  For more information about these and other defective drugs and devices, contact The Nations Law Firm for a free case evaluation.

Two Trials Scheduled to Proceed for Actos

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By Buck Daniel

February 20, 2013 – On February 19, 2013 Judge Rebecca Doherty issued a scheduling order to proceed with two potential bellwether trials in the Actos MDL. These trials are tentatively scheduled for January 27, 2014 and April 14, 2014. Both Plaintiff and Defense counsel will submit a pool of candidates to be possible participants in these trials, and the cases will be chosen shortly thereafter submission of these candidates. A bellwether trial is a trial to indicate future trends in a specific type of case. At a bellwether trial, both sides get to see what evidence the other side has, how the cases are decided and, if they are finding for the plaintiffs, what level of compensation is given. Losing a bellwether case does not necessarily mean the defendants won’t pay anything or offer to settle. Based on the evidence against them, they may still decide to settle rather than facing the cost of litigation and future potential losses at trial. But the bellwether trials give both sides in a lawsuit an idea of how future litigation might go.

Hip Implants a Bit More Likely to Fail in Women

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From ABC13 KTRK News

February 19, 2013 – Hip replacements are slightly more likely to fail in women than in men, according to one of the largest studies of its kind in U.S. patients. The risk of the implants failing is low, but women were 29 percent more likely than men to need a repeat surgery within the first three years.

The message for women considering hip replacement surgery remains unclear. It’s not known which models of hip implants perform best in women, even though women make up the majority of the more than 400,000 Americans who have full or partial hip replacements each year to ease the pain and loss of mobility caused by arthritis or injuries.

“This is the first step in what has to be a much longer-term research strategy to figure out why women have worse experiences,” said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families. “Research in this area could save billions of dollars” and prevent patients from experiencing the pain and inconvenience of surgeries to fix hip implants that go wrong.

Researchers looked at more than 35,000 surgeries at 46 hospitals in the Kaiser Permanente health system. The research, published Monday in JAMA Internal Medicine, was funded by the U.S. Food and Drug Administration.

After an average of three years, 2.3 percent of the women and 1.9 percent of the men had undergone revision surgery to fix a problem with the original hip replacement. Problems included instability, infection, broken bones and loosening.

“There is an increased risk of failure in women compared to men,” said lead author Maria Inacio, an epidemiologist at Southern California Permanente Medical Group in San Diego. “This is still a very small number of failures.”

Women tend to have smaller joints and bones than men, and so they tend to need smaller artificial hips. Devices with smaller femoral heads — the ball-shaped part of the ball-and-socket joint in an artificial hip — are more likely to dislocate and require a surgical repair.

That explained some, but not all, of the difference between women and men in the study. It’s not clear what else may have contributed to the gap. Co-author Dr. Monti Khatod, an orthopedic surgeon in Los Angeles, speculated that one factor may be a greater loss of bone density in women.

The failure of metal-on-metal hips was almost twice as high for women than in men. The once-popular models were promoted by manufacturers as being more durable than standard plastic or ceramic joints, but several high-profile recalls have led to a decrease in their use in recent years.

“Don’t be fooled by hype about a new hip product,” said Zuckerman, who wrote an accompanying commentary in the medical journal. “I would not choose the latest, greatest hip implant if I were a woman patient. … At least if it’s been for sale for a few years, there’s more evidence for how well it’s working.”

STCL Animal Law Clinic Silent Auction

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Dean and Mrs Guter with the Caribbean Owl by Grant Manier

Dean and Mrs Guter with the Caribbean Owl by Grant Manier

By Andrea Schmauss

February 13, 2013 — The Nations Law Firm is proud to support the work of the Animal Law Clinic at South Texas College of Law by donating The Caribbean Owl a “Paint by Paper” canvas print by Grant Manier, one of Houston up-and-coming young artists, for their annual silent auction to raise funds for animal-related charities and organizations. The print was presented to STCL Dean Donald J. Guter and Patricia Guter by Andrea Schmauss, the firms IT Administrator.

More information on Grant Manier and the Caribbean Owl may be found at http://www.youtube.com/watch?v=srS1HIHCFlo&list=PLdToaZ0L1wIYP4dznHlnONZ-A7e2uEnp_  and  www.grantsecoart.com

The STCL Animal Law Clinic is the first in the State of Texas. This dynamic group allows law students the opportunity to assist in cases ranging from animal cruelty and regulation, to assisting local non-profit animal shelters and rescues within Harris County. More information about the Animal Law Clinic at South Texas College of Law can be found at http://www.stcl.edu/lawclinics/animal_law_clinic.html

This year’s silent auction is scheduled to begin February 20th, 2013. Funds raised will go to The Animal Law Clinic at South Texas College of Law, Caring Critters, Inc., and SNAP (Spay-Neuter Assistance Program Houston).

Caring Critters, Inc. is a Houston area all-volunteer organization that aims to enhance the lives of people through their Animal-Assisted Therapy program. http://www.caringcritters.org

SNAP is a non-profit agency that strives to prevent the suffering and death of cats and dogs due to overpopulation and preventable diseases, especially in low-income areas. http://www.snapus.org

ASR UPDATE

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Posted by Kim Truongle

January 18, 2013 – Today, it was reported in the media that settlement discussions are occurring with regard to ASR cases.  This information is speculative and unconfirmed.  Instead, Plaintiffs’ counsel nationwide are focusing on trial preparation, with the first case set to begin in Los Angeles on Tuesday.  Next month, another trial is set to start in Illinois.  Plaintiffs’ counsel for these two state trial cases are cooperating and working in conjunction with counsel in the Ohio MDL, whose first two cases are set for start in May and July.  Again, any “news” about settlements or settlement discussions is, at this point, purely speculative.  We believe there is still a lot of work and progress to be made before fruitful settlement discussions can occur.

The Nations Law Firm

AN UPDATE ON THE TRANSVAGINAL MESH CASES

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By Kim Truongle

December 6, 2012 - There are transvaginal mesh cases against many manufacturers moving forward across the country.

Johnson & Johnson pulled some of its mesh products off the market earlier this year. State-court cases against Johnson & Johnson are set to begin in New Jersey early next year.

The first MDL trial against the Bard Defendants is currently set for Spring of 2013. Earlier this year, there was a substantial amount of buzz surrounding a California Bard trial. It is important to be cautious of information on the internet and in the press regarding that trial. There were specific and unusual facts in that case that led to the outcome. Although there will be some indirect effect on our cases from that California trial, it is important to not assume that that the outcome there is an indicator of how any particular case may end up.

A new MDL was created in recent months in the Southern District of West Virginia, adding to the four other mesh MDLs already established in this court. The new MDL governs federal cases relating to the manufacturer Coloplast. We have filed cases in the Southern District of West Virginia and are active in this court system.

The Southern District of West Virginia Judge overseeing all mesh MDL cases has set forth strict Orders regarding requirements and deadlines that must be met. We are contacting our clients if any of those deadlines happen to apply to her individual case. It is important to note that there are key statements regarding what must be provided to the Defendants in these cases, and one of the most interesting items relates to the internet and social media. Anything a Plaintiff posts online, including onto social media sites such as Facebook or Twitter, and which relates to her experience with her mesh, must be saved and provided to the Defendants. Therefore, it is important that anyone involved in these cases be mindful before making any online post.

Meanwhile, we are diligently working on behalf of our transvaginal mesh clients, and we are handling each case on an individual basis. This process can take time, and it is normal for there to be seeming lulls in the individual case process as we investigate additional developments in the general cases. Clients and potential clients are always welcome to phone our office directly at (800) 269-3050 for more information. Our national pharmaceutical litigation firm has a dedicated team of attorneys, paralegals, and case managers actively working on the transvaginal mesh cases.