Articles Posted in Pharmaceutical Drugs

I get so many emails from so many marketing companies. Just today I got an offer to write a guest post on this blog (no), an email telling me I rank poorly in Salisbury, Maryland on the search engines (he’s wrong), and two more random emails from companies telling me they are the best in the world at getting me to the top of the search engines (unlikely since, you know, you are spamming me).

But I found one of these emails interesting. This one was from New York City and it offered to provide leads for Actos, Yaz, Yazmin, and Ocella cases. These emails are always flying in, but this one provided the prices for the leads:

  • Actos: $450

The Wall Street Journal has an editorial with an anti products liability lawyer spin. No surprise. But what is surprising is that I agree with it.

Considering Enron and other business collapses that left stockholders holding the bag with no actual picture of the company’s financial condition, the Financial Accounting Standards Board wants to tighten standards. One requirement would make companies account for the potential cost of ongoing litigation not just regarding attorneys’ fees but regarding the actual value of the claims. The Wall Street Journal editorial says product liability lawyers will use the information to extort settlements and influence jury verdicts.

I’m not worried about either of those outcomes no matter how many times the editorial uses the phrase “extort settlements.” But I think there is a risk of forcing a defendant to publicly estimate settlement and verdict values because I think it tips off product liability lawyers and creates a floor for the value of any mass tort claim. I also think the editorial is correct, that predicting the trajectory of long and complex litigation is inherently unscientific. Mass tort cases are like the stock market in that their values are always changing. A good trial outcome or even a good expert deposition in an MDL can increase or decrease the value of a case. I’ve been involved with mass torts from both sides and believe knowledge of the true value is rarely known even to the insiders until the advanced stages of the settlement process.

The Wall Street Journal has a good article online about the preemption battle that is being waged the FDA’s bureaucrats in the courts and in Congress.

The last line of the article says that “Some drug companies are telling plaintiffs’ lawyers that if they settle their cases now, they won’t pay as much to the plaintiffs as they would have six months ago, before the Supreme Court announced that it would hear the Wyeth case. A lawyer negotiating a settlement with one drug maker said company executives told him it wants the ‘Wyeth discount.'”

I don’t think many cases will settle for a “Wyeth discount” because both sides seem to think they will win. I cannot imagine how the court could find that there is a conflict between state and federal law in drug cases because I think federal labeling requirements create a floor for state tort claims, not a ceiling.

Since the Supreme Court’s disaster in Riegel v. Medtronic, I have been hoping and expecting Congress would step in to fix the Supreme Court’s ruling, because it was clear from the amicus briefs submitted in Riegel, from history, and from common sense, that Congress did not intend to prevent medical device tort claims. Yesterday, California Congressmen Henry Waxman and New Jersey Congressman Frank Pallone, along with 62 bipartisan supporters, introduced HR 6381, the Medical Device Safety Act. This bill would undo the wrong the Riegel does to medical device victims. We expect the Senate to offer a similar bill next month.

As the Wolf said in Pulp Fiction, we can’t start congratulating ourselves yet (I’m paraphrasing). This bill has not even made it out of a committee yet. But at least something is happening.

The FDA said yesterday it is looking into an association between Merck’s allergy and asthma drug Singulair and suicide. The FDA has received reports of mood changes, suicidal ideation, and suicide in patients who have taken Singulair. Trying to get out on the front of the curve with its package insert, Merck has previously updated Singular’s drug labeling four times to include potential risks of tremors, anxiousness, depression, and suicidal behavior reported in some users of Singulair.

To call Singulair a popular drug is an understatement. Singulair is Merck’s biggest selling drug and one of the world’s top-selling medicines with $4.3 billion in sales. Singulair is also a leukotriene receptor antagonist. These types of drugs have been linked to suicidal ideation and suicide. Two similar drugs, AstraZeneca’s Accolate and Critical Therapeutics’s Zyflo, will also be reviewed by the FDA. Neither of these drugs’ labels include suicide warnings.

Singulair/suicide litigation just might be the next big mass tort. But I doubt it. Unfortunately, 40,000 people a year commit suicide and when you have a drug like Singulair that millions use, some of those people will take Singulair and commit suicide. Some will even take Singulair and commit suicide in a close temporal relationship with the initiation of the drug which really leads people to assume that it must be the drug. But it does not automatically follow that Singulair causes suicide. That remains to be seen and my guess is that Singulair does not cause suicidal behavior. Either way, it is nice to see the FDA is trying to get out in front of potential risk (for once). This is probably a byproduct of the errors that the FDA made with Chantix, where the FDA rushed Chantix – a drug that alters mood – onto the market without fully assessing the suicide risk.

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