Dangerous Product Update: Trans-vaginal Mesh Trial Begins in West Virginia Federal Court

Trans-vaginal mesh (TVM) products, produced by several companies and used in surgical repairs in tens of thousands of female patients, has been found to degrade and shrink, requiring replacement and causing other medical problems. The FDA alerted the public in 2008 and further in 2011 of serious complications associated with TVM used to repair pelvic organ prolapse.

On Monday, February 10, the first federal trial against Johnson & Johnson, makers of the “TVT Retropubic” and “Gynecare Prolift” pelvic mesh products, began. Johnson & Johnson will face answering charges that the TVM products are defective and have injured tens of thousands of women.  Over 10,000 lawsuits filed against Johnson and Johnson (and about 50,000 against all manufacturers) have been collected into a federal “multi district litigation” (MDL).  The federal judge in charge has selected several cases to be “bellwether” test cases. Lewis v Ethicon is the first suit against Johnson and Johnson to proceed in Charleston, WV, according to the Gazette-Mail newspaper.

In August 2013, a Charleston jury told another TVM manufacturer, C.R. Bard Inc., to pay $2,000,000  to a woman who suffered serious injuries due to the faulty mesh.  The award included $250,000 in compensatory damages and $1.75 million in punitive damages, the latter because Bard officials put profits ahead of safety by ignoring warnings about defects in its “Avaulta” mesh implant.

Our firm, Schroeter, Goldmark & Bender, is handling several of these TVM cases and will be closely monitoring the national results.

Dangerous Drug Report: Makers of Pradaxa May Have Suppressed Health Study

Pradaxa has been linked to over 1,000 deaths and is the subject of thousands of lawsuits.   The lawsuits are overseen in federal court by a “Multi-District Litigation” (or “MDL”) in Illinois.  According to a recent New York Times article, e-mails and memos revealed by those lawsuits discussed whether an internal report on scientific research would undercut the manufacturer’s claim that using the drug does not require regular blood tests.  The manufacturer of Pradaxa, Boehringer Ingelheim, has been in a race to capture market share from warafin, which requires frequent blood testing, do Pradaxa’s “no blood testing” claim is a big selling point.  Pradaxa has garnered more than $2 billion in sales in the U.S. since 2010.  So it should come as little surprise that the manufacturers “were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether, according to newly unsealed legal documents.”

Our system of justice may not be perfect, but here is one more example where trial lawyers standing up for the rights of consumers forced a company to reveal what was really going on.  Little did we know that the doctors in charge of drug safety have a vested financial interest in the outcome of their research and would consider suppressing their findings just to turn a buck… or a billion bucks.

Victory for Cyclists: Washington Supreme Court Decision

We all celebrate a victory today for  cyclists. In the matter of  Camicia v. Howard S. Wright Const. Co. and The City of Mercer Island, the Washington State Supreme Court found for a seriously injured cyclist, Ms. Camicia.  The Court held that recreational use immunity could not be determined as a matter of law on account of the trier of fact needing to determine disputed facts. The disputed facts concern whether the trail served a recreational purpose as opposed to a transportation purpose.

The case entails the I-90 bike trial.  Sound Transit had retained Howard S. Wright Construction Company as the general contractor for a project at the South Transit Mercer Island Park and Ride Facility.  To prevent public access during this construction, Wright Construction installed a chain link fence around the perimeter of the site; however, some of the fence footing at the site protruded onto the bicycle trail. Along came Ms. Camicia, who veered left to avoid the fence footing. Her swerve veered her right into a wood post, which threw her from her bike. The accident rendered her paralyzed.

Ms. Camicia brought suit against the City of Mercer Island and the construction company.  The King County Superior Court initially rejected the City’s argument that it should be granted recreational use immunity because Ms. Camica was on a recreational use trail. But the Superior Court later adopted the City’s argument.  Ms. Camicia appealed and prevailed at the Court of Appeals.  Today she has prevailed again at the Supreme Court.

I find this outcome to be gratifying on so many fronts.  As someone who has and does represent the severely injured, I am, of course, gratified to see an avenue of recourse not getting tossed on account of a technicality.  As a cyclist, I know how scary it is out there.   Some drivers don’t understand why, for example, cyclists take to the middle of a country road when riding down hill, as opposed to hovering on the shoulder. Ms. Camicia’s accident drives home the point: one unexpected obstacle in your path and you could  be in some serious trouble; when you are on the shoulder, your choices can be to hit the obstacle, crash off the road, or swerve into the path of cars passing you. Being in the middle when going downhill resolves this safety dilemma and the little patience, if any, it calls for from drivers shouldn’t pose a problem.  Lastly, it wasn’t too long ago when the dirty little secret among lawyers was that for a time our State Supreme Court was an inferior bench to certain of our appellate courts. That can be said no more. We have an excellent Superior Court bench, excellent appellate courts and we certainly have an outstanding Supreme Court bench we can all be proud of.  This decision is well-written, well-reasoned, and, last but not least,  because it culminates in a just result, is well-done.

 http://www.courts.wa.gov/opinions/pdf/855838.pdf

NFL Mass Settlement Update

U.S. District Court Judge Anita Brody denied preliminary approval of a $765 million settlement of NFL concussion claims. 

 http://espn.go.com/nfl/story/_/id/10292549/judge-rejects-preliminary-approval-765-million-nfl-settlement-concussion-case

Judge Brody fears that the settlement may not be enough to cover 20,000 retired players. This is a refreshing amount of skepticism being exhibited by the Court. The Court will no doubt want to also take a close look at how the figures were calculated, including the claim for $100 million in attorney fees.  

Many former NFL players had expressed concern that the settlement wasn't enough: to that end, more transparency can be nothing but beneficial. This is a step closer to ensuring that there's fair compensation for these injured former professional athletes.

So why are we discussing this news item here on the Washington Product Liability Blog?  Well, it's important for us to discuss this timely topic for a number of reasons. First, this is a mass injury litigation, something we cover on this blog and something that our law firm Schroeter Goldmark and Bender handles. Second, although the lawsuit here is between the NFL and former players, there's a product element at play here: Are football helmets sufficient to protect players from the types of violent hits the game allows today? The answer is that they are obviously not. Football is a sport near and dear to my heart - I played it in high school and college.  But it's going to have to change - the rules will need to be changed, the equipment may need to evolve, and the culture will need to change.

We'll be turning at a later date to the Frontline program that has recently come out, League of Denial.  

http://espn.go.com/nfl/story/_/id/10292549/judge-rejects-preliminary-approval-765-million-nfl-settlement-concussion-case

For now, we should all celebrate the good caution that the Court is taking here to make sure that this settlement is sufficient, is transparent, and is appropriate.  

Dangerous Product Alert: E-Cigarettes May Be Poisonous, Dangerous to Children, and a Fire Hazard

Want to quit smoking? Well, it looks like those electronic cigarettes—or e-cigarettes—are not safer than regular smokes. According to a recent investigation, poison control centers across the U.S. have witnessed a 161 percent increase in e-cigarette complaints. 30% of e-cigarettes investigated had as much formaldehyde and acrolein, which are known carcinogens, as regular cigarettes.

What is worse, the investigation found that more than half of the poison control calls were about children who got their hands on e-cigarettes and exposed our found the liquid cartridge inside.  Kids have reportedly been injured by ingestion or skin exposure to the liquid.  Another report concerned a bedroom fire when an e-cigarette overheated while in the charger, causing a home to burn down.

The FDA and the American Cancer Society both say that there is no evidence that e-cigarettes are safe.  The FDA website states:

As the safety and efficacy of e-cigarettes have not been fully studied, consumers of e-cigarette products currently have no way of knowing:

• whether e-cigarettes are safe for their intended use;
• how much nicotine or other potentially harmful chemicals are being inhaled during use; or
• if there are any benefits associated with using these products.

Additionally, it is not known if e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death

 In initial tests, the FDA found carcinogens and toxic chemicals.  The FDA is now in the process of promulgating regulations to oversee the nearly $2 billion global industry, a move that the industry is fighting.