The Business of Law – Marketing and Business for Enterprising Attorneys

No of course, Dora the Explorer is not made with asbestos, but based on the news of Mattel’s recent settlement, the defects and subsequent recalls of the toy giant’s products are certainly hitting Mattel’s wallet in an asbestos-like way.

News hit last week that out of Federal Court in California that Mattel has reached an agreement to settle 22 separate class actions over millions of toys that were made in China and found to contain excessive levels of lead. The reported settlement could reach into the “tens of millions” according to reports.

According to Law 360 (subscription required):

“Mattel recalled over 14 million toys in the U.S. alone in 2006 and 2007. The toys were found to have lead levels that exceeded legal limits or to have small magnets that could become loose and harm children if ingested, according to a statement from Mattel.

More than 95 different types of children’s toys were affected, including some of the companies’ most popular items, like some Sesame Street toys, Dora the Explorer and Diego toys made by Fisher-Price, and Mattel toys such as Batman, Polly Pocket, Barbie accessories and Sarge cars, according to the company.”

There’s a lesson to be learned in the Mattel tragedy, and that is that too many manufacturers are still willing to cut corners and put consumers at risk.  When they do, civil litigators act as an appropriate safety net to compensate victims.

But civil litigation also makes products safer and changes policies.  Consider the following as has been reported publicly:

•    As part of the settlement, Mattel will donate $275,000 to the National Association of Children’s Hospitals and Related Institutions, a not-for-profit group of 150 children’s hospitals and pediatric units.
•    The six Mattel-related recalls in 2007 triggered recalls by dozens of other companies resulting in 21 million potentially toys being recalled.
•    The recalls drove Congress to pass a new law that sets strict limits for lead, lead paint and other chemicals.
•    Last year, Mattel and Fisher-Price agreed to pay $12 million to 39 states to end a lengthy investigation into the lead-tainted toys.
•     In June, Mattel also agreed to pay a $2.3 million civil penalty for violating the lead paint ban.

At Sokolove Law, we are actively marketing legal services in a number of categories related to product liability. If you’re interested in partnering with us, please get in touch with my colleague Marc Stern.

We are currently investigating claims of women who have experienced serious complications arising out of the implantation of a Bard Avaulta transvaginal surgical mesh device.  Manufactured by C.R. Bard, Inc., the Avaulta Solo Support and Avaulta Plus Biosynthetic Support Systems are surgically implanted devices which are designed to help increase bladder control and provide relief from the pain caused by Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).  However, there have been numerous reports of mesh-related complications including mesh erosion, extrusion, perforation of the bowel, bladder and blood vessels, infection, vaginal scarring, and recurrence of prolapse or incontinence.

In October 2008, the FDA warned healthcare professionals of the side effects associated with vaginal mesh devices after receiving over one thousand reports over three years from nine surgical mesh manufacturers of complications associated with surgical mesh devices used to repair POP and SUI. In some cases, the pain and discomfort is so severe as to require additional surgery to repair any damage caused by implantation of the device or to remove it altogether.

We will be continuing to monitor concerns about this device.  If you’re interested in learning more about these types of cases, drop me a note.

We’ve been following reported side effects from Januvia (sitagliptin) and Janumet, which is combination of sitagliptin and metformin manufactured by pharma giant Merck for over two years now, and there’s been mounting evidence to cause concern.  Just last week, the FDA finally weighed in and issued a safety alert warning of possible health risks. Read the FDA announcement here.

Specifically, FDA made revisions to the prescribing information for Januvia and Janumet to include information on reported cases of acute pancreatitis in patients using these products.

But the latest alert is not the first of the problems for the once-daily prescription tablet used to treat Type II diabetes.  In fact, concerns have been expressed linking the drug to Stevens-Johnson Syndrome and other skin reactions.  In clinical studies, patients given Januvia experienced an increase in creatine levels in the blood which is an early indicator of kidney problems.  It has also been linked to serious allergic reactions.

The pancreatitis issue first surfaced in April, when researchers at UCLA linked Januvia to low-grade pancreatitis in some patients and a greater risk of pancreatic cancer in long-term users. All told from the drugs approval in 2006 to February of 2009 88 post-marketing cases of acute pancreatitis, including 2 cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to FDA between October 16, 2006 and February 9, 2009.

In the safety report, FDA said it is working with the mfg to revise the prescribing information to include:

1)    Information regarding post-marketing reports of acute pancreatitis, including the severe forms, hemorrhagic or necrotizing pancreatitis;

2)    Recommendations that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of Januvia or Janumet and to discontinue either drug if pancreatitis is suspected while using these products;

3)    Information noting that sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis while using Januvia or Janumet.

The number of cases that we have taken on continues to increase and as always we are exploring ways to reach out to patients who may have suffered side effects associated with these pharmaceuticals if you are interested in working with us, drop me a note.

Another medical device case type that we’ve been watching has to do with Calaxo Osteonconductive Interference Screws, also known simply as the Calaxo Screw. These devices are used to repair knee ligaments and promote bone growth most often after ACL repair or reconstruction. ACL injuries are common in many athletics including football, soccer, ice hockey and downhill skiing.

The Calaxo Screw was supposed to be an innovative product because it’s made of a bioabsorbably polymer, so that unlike conventional screws used to reattach ligaments, it could be reabsorbed by the body 12 months after surgery.

The problem is that the Calaxo Screw has been linked to graft failure and premature material degeneration. Symptoms include swelling, fluid build-up around the knee redness around the joint, loss of flexibility in the knee area, screw fragmentation, and localized joint pain. These side effects often require additional surgery to remove dead or infected tissue.

From 2006 to 2009, more than 300 adverse effects related to Calaxo Screws were reported to the FDA, and in August 2007, the manufacturer Smith & Nephew voluntarily recalled 68,000 units implanted worldwide. Some of the product was also recalled in October 2007 in the U.K.

There have been several suits filed alleging failure to warn patients about possible side effects. We’ll be monitoring the case, and may engage in a marketing effort targeting potential litigants who may have been given one of these screwed up screws as part of their surgery.

I’m catching up on some of the news that broke over the summer, and one of the interesting stories was about bioengineered proteins usined during spinal fusion procedures to correct neck pain. These substances sold by either Medtronic or Stryker are not technically approved for neck procedures, but Doctor’s are not prevented from using them for that. A new study however suggests that patients whose treatment included the proteins had more complications than patients who didn’t.

According to a study in the Journal of the American Medical Association, (subscription required) researchers at Boston’s Brigham and Women’s Hospital found that patients who received the proteins during treatment for lower or middle back pain had increased complications after the procedures, and in some cases those complications may have been underreported because they did not occur until after patients left the hospital. Check out a very good New York Times story on the subject here.

While the study is fairly new, we at Sokolove have been following the complications associated with off-label use of these proteins going back more than a year. In fact, the FDA has received dozens of complaints over the past four years of neck swelling and breathing problems in patients given the product for neck pain.

Last July the problem became so accute that the FDA issued a Public Health Notificiation indicating the life-threatening complications associated with the proteins. In December and January, the first lawsuits were filed.

As ever, we’re monitoring the situation and looking for affiliates who are interested in potential leads in this area. If you’re interested in partnering with us on marketing efforts, shoot me a note.

Today Erin Marie-Daly, over at Law 360 (Subscription required, but it’s well worth it!) had a great piece on Top product Liability Motions and How to Win Them.

In it, a group of top product liability defense attorneys, including  Mark Miller, a partner at Wildman Harrold Allen & Dixon LLP, who typically represents medical device, pharmaceutical, heavy equipment and consumer products manufacturers, George Soule, a managing partner at Bowman and Brooke LLP who does defense work in commercial, personal injury and product liability litigation, and James W. Huston, a partner at Morrison & Foerster LLP who represents product manufacturers, all talk trial strategy in product liability cases, with specific recommendations for how the defense can win key motions.

The piece details defense trial strategies around Motions for Summary Judgment, Motions to Strike Cause of Action, Motions to Require Re-Enactment, Motions to Exclude ‘Other Accident’ Evidence Motions to Strike Punitive Damages, Motions in Limine, Daubert Motions, Motion to Bifurcate Trial and Jury Instructions.

For plaintiffs’ attorneys, reading the piece is not quite like being handed the other side’s playbook, but it’s close.

To plaintiffs’ lawyers, the claim is all too familiar.  Major drug manufacturer gets FDA approval for a new treatment, but the marketing campaign for the new drug allegedly overstates the benefits and downplays the risks.

Today, that claim is being levied at Bayer HealthCare Pharmaceuticals with respect to popular birth control pills Yaz and Yasmin.

The National Law Journal has the story here (free registration required).

In 2008, the pharma giant reached an agreement with FDA to run a $20 million corrective ad on the benefits and risks of Yaz.  The FDA had previously issued a warning letter to Bayer about its marketing activities.

This month, we’re seeing the first lawsuits being filed on this issue. According to the NLJ, the lawsuits allege: “that Bayer failed to warn women and their doctors of the pills’ increased risk of injury — most notably blood clots — while over promoting the benefits of the drugs.”

Janey Abaray, an attorney with Burg Simpson Eldredge Hersh & Jardine (A Sokolove Law affiliate) said there may be additional risks.  Here’s what she said in the NLJ story:

“ (our) firm has amassed evidence that shows that there are many more adverse events reported to the FDA for Yaz and Yasmin than for other birth control pills that have been around longer… We expect to be filing consistently over the next several weeks and months. We have many cases. It’s just a matter of getting all of the medical records”.

A spokesman for Bayer offered the typical “it’s perfectly safe if used as directed” response, which of course completely ignores the question of whether the advertising was fair and accurate, or whether the company adequately warned patients.

As always, stay tuned as we’re likely to see many more cases in this area.