Posted On: October 29, 2010

New Diet Drug Rejected by FDA

With Meridia tossed to the trash heap of history, there is a void in the market for a new diet drug. That void apparently will not be filled by Arena Pharmaceuticals' new drug lorcaserin. The FDA rejected the drug last week. The problem with lorcaserin was a big one: it caused the formation of cancer in rats, albeit in high doses.

There is obviously big demand for a diet drug that works and has limited side effects. Eventually, modern science is going to produce such a drug and extreme obesity will be a thing of the past. Arena Pharmaceuticals probably would tell you that while not a panacea, we are getting closer with lorcaserin and they will be able to prove it is both safe and effective. History gives us doubts.

Posted On: October 20, 2010

Vaginal Mesh Lawsuits Consolidated

Lawsuits involving C.R. Bard and Johnson & Johnson subsidiary Ethicon vaginal mesh cases have been consolidated in New Jersey state court. These vaginal mesh devices were implanted to treat pelvic organ prolapse but they may also put women at risk for internal injuries and urinary problems.

These vaginal mesh cases will be separate for the purposes of trial but they are treated as a class action lawsuit for discovery purposes because there are issues of fact that are common to both Ethicon/Gynecare vaginal mesh cases and C.R. Bard mesh claims.

You can find the court's order here.

If you think you may have a potential Ethicon or Bard Avaulta vaginal mesh lawsuit, call 800-553-8082 or get a free online defective vaginal sling case evaluation.

Posted On: October 20, 2010

Preemption is Dumb: Reason #11,493

The Menaflex Collagen Scaffold orthopedic knee device received fast track approval from the FDA to repair and reinforce the meniscus, a C-shaped disk in the knee that acts as a cushion and helps lubricate the joint. Last week, the FDA said approving this device was a mistake. The Food and Drug Administration has taken the unusual step of admitting that it made a mistake when it approved a device used to repair damaged knees.

The "bravo to the FDA for admitting a mistake" is somewhat lessened by the fact that they can point to President Bush's FDA for the mistake. Still, the rank and file FDA folks are largely the same, at least those who have not jumped on the revolving "FDA to Industry Shuttle Bus."

Now, patients with this device are looking at surgery to have the device removed because it has been absorbed and replaced with new tissue.

This is not going to be the next big class action lawsuit. This knee device to date has been implanted in approximately 50 people in this county. But what this underscores is that the FDA is not the watchdog the pharmaceutical industry claims. The "FDA approved" stamp does not mean the product is safe and could not and should not have been made safer.

Posted On: October 19, 2010

DePuy Class Action Lawsuit, Part 2

History tells us that it is not the crime but the cover-up that often causes the most damage. In drug and medical device cases, there is usually a Nixonian leitmotif: what did you know and when did you know it with respect to the potential harm caused by the drug.

Last month, another DePuy class action lawsuit was filed. The claim is an interesting cover-up allegation. The class action claims that after the DePuy ASR recall, the company deceived patients by agreeing to make things right and in exchange, getting access to hip recall victims' medical records. Of course, making things right is relative. DePuy has essentially promised victims nothing in exchange for something, which is the essence of this class action lawsuit.

This byproduct DePuy hip recall lawsuit is probably a sideshow to the core of these hip implant lawsuits. Rummaging through plaintiffs' medical records while pretending to promise them something in exchange is awful. It is a clear end run artifice designed to fool plaintiffs into believing they don't need a lawyer. But the compensation for this inappropriate conduct pales in comparison to the real injuries that stem from the DePuy ASR hip recall. But this class action lawsuit underscores that people are mad and DePuy is not making things any better by not playing it straight with victims.

If you have a potential DePuy hip implant lawsuit, call 800-553-8082 or get a free online consultation.

Posted On: October 18, 2010

Pick a Fight with Me and Pick a Fight with My Brother?

Last month, I took exception to a Drug and Device Law Blog post and wrote a semi snarly retort on the topic of the confidentiality of discovery documents.

Bad move. The Drug and Device Law Blog fired back a response pretty much took my post and beat me over the head with it. Adding insult to injury, they did it with good writing and good humor. I hate it when the bad guys are good and funny. It makes them seem almost human, an idea that fits in poorly with my world view.

I thought they got some of the substance just dead wrong and there was lots of room for a good counterattack. But to find the time to write a cogent, witty response to rival theirs? They spit that response out in an hour, I bet. It would take me all day to come up with something and it still would not have been as well written.

Thankfully, my brother jumped in to stand up for me. My brother? Yes, for our purposes here, my brother. Justinian Lane stepped up and wrote the response I wanted to write. Even better, actually. It is really worth reading.

So instead of beating this topic any further, I'll comment off-topic to the core issues in this debate and address another fascinating point Justinian makes about the economic disparity between plaintiffs' lawyers and defense lawyers:

In DDL’s first post, they made a quip about plaintiffs’ lawyers buying Maybachs, and now they’re complaining that “plenty” of plaintiffs’ lawyers have private jets. While I don’t think that the authors of DDL are green with envy over the financial success of a few plaintiffs’ lawyers, plenty of their readership is. By and large, defense lawyers go to better schools than plaintiffs’ lawyers, earn better grades, write better briefs, and I’ll say it – are better lawyers. And they know it. It therefore irritates them to no end that lawyers who they perceive as being inferior to them are more financially successful than they are.
I don't know that defense lawyers are better trial lawyers than plaintiffs' lawyers in mass tort cases. Plaintiffs' lawyers get more reps because, typically, plaintiffs' lawyers have more trial experience. A lot of great mass tort defense lawyers can go a career without trying a case. I'm not saying they can't do it effectively when called upon but, like with most things, experience counts. Pharmaceutical companies hire great trial lawyers but if cases are remanded all over the country, they don't have as deep of a bench as plaintiffs' lawyers.

Continue reading " Pick a Fight with Me and Pick a Fight with My Brother? " »

Posted On: October 18, 2010

Lawsuits Are Unnecessary.. Unless I'm Filing One

Too often, we look to lawsuits as our first resource to settle disputes. People need to stop bundling all of their problems at the doorstep of someone else and take responsibility for their own mistake (illness, condition, etc.).

This is the Drug Company Manifesto, page 1. Fair enough. But these drug companies are like those who believe that driving 55 mph is for everyone but them.

Lately, when doing research on claims against various drug and medical device companies, it has taken me an inordinate amount of time to find what I am looking for because I have to weed through so many patent lawsuits between these drug companies. The wars between these companies remind me of the ongoing wars in George Orwell's 1984 where the enemy was always changing. In some ways, they should be thanking plaintiffs' drug injury lawyers because we create a common enemy they can rally behind.

Drug companies disdain all lawsuits except for the ones they file.

Posted On: October 5, 2010

Fosamax Remittur and Sanctions

A Southern District of New York judge has granted defendant's remittur motion after an $8 million verdict in a Fosamax trial, leaving Plaintiff's attorneys with a tough choice: take the $1.5 million remittur or take a new trial. It is like kicking a field goal while there is a penalty on the defense, that gives the kicking team an automatic first down. Do you take the points off the board? For Plaintiff's lawyers, their advice depends on where Plaintiff is on the figurative field. The question is what is the settlement value of the case? If it is less than $1.5 million, it is a good 'settlement" that you have to take, even while grinding your teeth.

In an unrelated event, Plaintiff's lawyer was sanctioned by the court for referencing another Fosamax trial after the trial judge specifically warned him not to do so, which Plaintiff's attorney knew anyway as an experienced trial lawyer. He also said that what Fosamax manufacturer Merck did was "reprehensible" and "disgusting" in his closing argument.

Were these sanctions warranted? With respect to referencing other Fosamax lawsuits and trials, I think it really depends on the context and the intent which is hard to surmise unless you were actually there. But I don't thinking calling Merck "reprehensible" and "disgusting" in closing argument comes anywhere near a sanctionable offense. Plaintiff's lawyer is arguing that this is awful and that negligence is not even a close call. As a matter of trial tactics, I think this is a bad idea because the jury can figure out on their own if the conduct is reprehensible or disgusting. My thinking is, just lead the horses to the water and let them drink it themselves. But that is a trial tactic question. I don't see why this is worthy of sanctions.