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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 worldview.

I thought they got some 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 (link since deleted, unfortunately). Even better, actually.

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.

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The Drug and Device Law Blog has an articulate rant about plaintiffs’ lawyers jerking around defendants on whether certain documents produced should be deemed confidential. The core of their argument is that plaintiffs’ interests in the battle over confidential documents are either for (1) sport or (2) to shop documents obtained in discovery to the press.

There is some measure of truth to almost the entire post. But it is as if Tiger Woods told the following story: “I was looking forward to a nice Thanksgiving weekend with my family but on Sunday my wife just left. Didn’t say goodbye or anything.” That’s a true story.

Similarly, the Drug and Device Law Blog leaves out a little fact of the story: mass tort defense lawyers are the undisputed kings of making plaintiffs’ lawyers work for pure sport. Plaintiffs’ lawyers in drug and device cases largely just want to get from Point A to Point B as quickly as possible. I think this is a function both of the personality types attracted to these very different jobs (and I’ve done both) and fundamental economics: plaintiffs’ lawyers get paid for success while defense lawyers get paid for working, even if they are just creating work.

Lots going on in GlaxoSmithKline’s Avandia world. They’ve been wounded but avoided summary execution yesterday when twelve of 33 members voted to allow it to stay on the market, albeit with significant restrictions and black box warnings. See CNN’s article.

One expert cited in the article noted that:

“I don’t have any patients currently taking Avandia,” said Nathan. He stopped prescribing the drug because “it just didn’t make sense,” considering there are alternatives that didn’t carry the potential risk, he said.

The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks. Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”

Here are some “talking points” from the editorial:

• At a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance

Two prominent Chicago orthopedic surgeons are calling for the recall of Zimmer’s NexGen CR-Flex Knee replacement devices. There has already been a recall of related devices to a part of the knee.

The porous femoral component (that is, the part of the replacement that covers the head of the femur, the bone that goes from the pelvis to the knee) is associated with a high rate of failure. The two Chicago surgeons calling for the Zimmer recall, Richard Berger and Craig Della Valle from Rush University Medical Center, have observed after two years’ of use that 36% of the implants were loose, and 9.3% were revised or set to be revised because of looseness and associated pain.

The doctors stated that “This component is still commercially available but should not be used for any patient.” They also questioned the fact that the product was released for sale to the public without clinical testing. Dr. Berger described the failure rate as “horrific.”

The first federal Kugel Mesh hernia repair lawsuit began in the U.S. District Court for the District of Rhode Island, yesterday. Plaintiff John Whitfield claims that the mesh, manufactured by Davol, Inc., was defective and broke after it was implanted, causing bowel obstruction, abdominal pain, nausea, permanent bowel injuries, and necessitating additional surgery.

This is the first of four bellwether trials, designed to give lawyers on both sides a sampling of how jurors will deal with the information and trial strategies. This may assist the parties to reach settlements in remaining cases after they learn the strengths and weaknesses of each side.

There are 1,300 other hernia mesh cases that are consolidated in the Rhode Island federal court MDL. An additional 1,774 cases are in Rhode Island state court, with the first trial expected later in the summer. Many of the hernia patches were recalled since 2004.

The Avandia debacle heats up, this time in the medical journal community. The editor of the premier medical journal, The Journal of the American Medical Association (JAMA) has taken other journals to task for their methods of publishing articles. Using the Avandia RECORD study as the example of the conflicts of interest rampant in the medical publishing community, the editor explains “concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.” For the past ten years, JAMA has required:

…at least 1 author must show that she or he “had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Additionally, that author cannot be funded by any commercial funding source. The source for this criterion is the age-old Hippocratic Oath—that physicians, above all else, must do no harm. The JAMA editor understands that when industry pressures are brought to bear, physicians may be (and have been) influenced to in a manner inconsistent with good science. And the result is that people rely on bad studies, and patients take bad drugs with incomplete and faulty information. The editor further recommends that drug study data be freely available to academic researchers.

Not only will the editor’s suggestions (if enacted by other journals) provide a means to double-check data to ensure its quality, but it will provide an extra reason for scientists and researchers to do the right thing from the beginning, and to stay true to the scientific method.

If my Google Reader subscriptions are any indication, about 50% of the new blog posts across the web in the past couple of days have been about Avandia. This post is intended as a hub for basic information on Avandia and the status of the proposed Avandia recall.

Indications:
Avandia is used to treat type 2 diabetes mellitus. That type of diabetes, commonly called adult-onset diabetes or non-insulin-dependent diabetes mellitus, is reflected by high blood glucose and insulin deficiency/resistance. Avandia (rosiglitazone), as well as Avandamet and Avandaryl (two drugs combining rosiglitazone with either metformin or glimepiride), is intended to help the body use its natural insulin for better glucose control.

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Two contrasting Accutane lawsuit updates in the news today:

First, some background. Accutane is used to treat severe acne and has been associated with a host of problems: birth defects, inflammatory bowel disease, injuries to the liver, kidneys, nervous system, and pancreas, dermatological reactions, and even suicide. Roche stopped selling it last year after a 27-year run, citing competition from generics and the 5,000 pending Accutane lawsuits.

Plaintiff’s Verdict: $25.16 Million

In May 2007, Andrew McCarrell emerged victorious in a New Jersey Superior Court Accutane lawsuit against Roche Holding AG. Mr. McCarrell developed inflammatory bowel disease caused by Accutane. (View the full original trial on video, purchase required). That victory was short-lived, as the verdict was appealed and overturned because the trial judge should have allowed the defendants to present statistical evidence—that there were five million drug users.

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As you remember, Fosamax, Merck’s osteoporosis drug, is the subject of much litigation. The question presented is whether the drug causes osteonecrosis of the jaw, which is the death of jawbone tissue.

Judge Keenan, ruling over the federal Fosamax cases from his bench in the U.S. District Court for the Southern District of New York (Manhattan), decided that Merck was not entitled to dismissal of the Louise Maley case on the issue of specific causation (essentially, Merck argued that plaintiff could not prove that Fosamax caused her injury. This is different from general causation, which is the argument that Fosamax can cause injuries of this type). The plaintiff did not argue against the dismissal of her strict liability and warranty claims, however. Her case will proceed on a failure to warn claim. See the Order (hat tip: Shearlings Got Plowed). The Maley case will go to trial on April 19, 2010.

So, Plaintiff Maley survived where Bessie Flemings could not—Judge Keenan dismissed her case (set for trial this month) last November on specific causation grounds.