Drug Recall Lawyer Blog

We’ve been getting a lot of questions over the past few days about Seroquel. That usually means I need to put up a new post, especially in light of recent events.

Earlier this week, AstraZeneca (the manufacturer of Seroquel) agreed to pay $520 million to settle a federal inquiry into Seroquel marketing practices. As we have stated before, Seroquel is approved to treat schizophrenia and bipolar disorder. However, investigators and plaintiffs believe that AstraZeneca marketed the drug for myriad other unapproved uses, including depression, obsessive-compulsive disorder, dementia, and post-traumatic stress disorder.

There are no criminal charges associated with the deal. Giving credence to plaintiffs’ claims (aside from the credibility arising from the mere fact of a whopping large settlement), is that federal investigators got much of their information from AstraZeneca whistleblowers, drug sales rep, James Wetta (who had some involvement in the whistleblowing at Eli Lilly around 2003).

The deal comes at a time when such deals seem to be simply the cost of doing business. As just one example, Boston Scientific is in the midst of trying to settle with investigators for $296 million over the actions of a company it acquired, Guidant. Seroquel’s settlement pales in light of the fact that in 2009 alone, they made $4.9 billion in Seroquel sales. Isn’t that criminal?

Anyway—civil lawsuits are still continuing, but Plaintiffs are having a hard time of it. For more information, visit our Seroquel website and past Drug Recall Lawyer Blog posts on Seroquel.

This is something every blog must struggle with. What voice should the blog have? First-person (or the blogger variant--the royal first-person, where everything is about "we" and "us," though the blog is written by one person), or third-person?

Corporations frequently choose a corporate voice, making everything about the corporation. The voice of the blog is often the "voice" of the corporation (corporations are legal entities with rights, of course). But, this can be tough to read sometimes, and still manages to lose the personal flair of a first-person narrative.

So, when my Google Reader blog-feed listed AstraZeneca's recent post, "Connections for Cardiovascular Health," I was interested to see that they are gravitating toward a first-person voice. The side panel shows that the main contributor and "voice" is Earl Whipple, the blog editor and senior director in the AZ corporate communications group. The sidebar mentioned that others would contribute (the CEO had a post on March 23), but perusing the posts, it looks like Earl is the only contributor except for occasional guests.

I think first-person is the way to go, but only if you can actually convey a sense of the personality behind it--I suspect that AstraZeneca will not let loose the reigns, and we will not find out anything interesting about Earl. That's too bad, because personality is probably the largest reason people read blogs (except in my case, where if you spend any time reading my blog, knowing my intense love for all things sci-fi might actually turn you off--comments to the contrary appreciated!).

So how about it, Earl? Tell us about yourself. Maybe even give us some personal viewpoints that deviate from AZ's corporate perspective...

The Seroquel cases are not going well for plaintiffs.

On April 6, the Eleventh Circuit Court of Appeals affirmed the summary judgment ruling of the Massachusetts federal trial court in a Seroquel case. The plaintiff alleged that Seroquel caused her to gain weight and develop diabetes, but at the trial level (and affirmed on appeal), she lost her specific causation expert on a Daubert ruling. The trial record showed that the excluded expert did not have sufficient medical history upon which to base her conclusions—at deposition, she lost points by not knowing the full history of plaintiff’s weight gain and loss. The Court stated:

In fact, Guinn's weight fluctuated before, during, and after her use of Seroquel, with her highest recorded weight during each period being roughly equivalent. Guinn also had a sedentary lifestyle, a poor diet, a significant family history of diabetes, hypertension, hyperlipidemia, schizophrenia, and prediabetes, all of which, in addition to her age of 61, put her at an increased risk for developing diabetes.

Tellingly, the plaintiff’s expert commented that the plaintiff would have likely developed diabetes, even absent taking Seroquel.

Experts must be given full access to information well before litigation commences. This highlights the need for plaintiffs’ attorneys to work with experts, to make sure they have everything they need, and to thoroughly examine their opinions and conclusions prior to naming them as experts. In mass torts this is especially important, and in bellwether cases this is crucial—to some degree, these cases set the precedent for following cases.

The scorecard brings that to seven grants of summary judgment (one affirmed on appeal), and one defense verdict. AstraZeneca, the manufacturer of Seroquel, has settled with the government to the tune of $520 million regarding improper Seroquel marketing. There are about 25,000 cases left to go.

For more information on Seroquel, see our prior blog posts.

Drug Recall Lawyer Blog Round-Up (03-22-10)

Here are this week’s stories:

• Avandia: The MayoClinic investigated who authored articles supporting Avandia in medical journals, and discovered that 90% had ties to the manufacturer, GlaxoSmithKline (HT: FiercePharma).
• Seroquel: Trial number one is won by AstraZeneca (see blogs here and here).
• Zocor: FDA issues a new warning for Merck’s cholesterol drug Zocor (HT: Tom Lamb’s Drug Injury Watch).
• Sanofi-Aventis: More on their lessons from the botched Facebook experiment (HT: Pharma Marketing Blog).

Happy Monday!

To follow up on our March 2, 2010 post BigPharma Goes All “Social Media” is a website that features all comments submitted to the FDA on the social networking question. A somewhat more readable version (though, less complete) is at www.fdasm.com. Here are links to some of the heavy hitters (including law firms and internet providers) who have commented. The papers are downloadable directly from the website.

• Abbott
• AstraZeneca
• Bayer Healthcare
• Covidien
• Eli Lilly
• Google
• Hogan & Hartson
• Johnson & Johnson
• Medtronic
• Merck
• Novartis
• Pfizer

The New Jersey Superior Court Case (Middlesex County) of Baker v. AstraZeneca Pharmaceuticals LP is now focusing on the drug manufacturer’s advertising strategy. The plaintiff in that case is alleging that he should have been better warned about the risks for weight gain and developing diabetes.

On the plaintiff’s side is Dr. Wayne Geller, a former AstraZeneca employee—a global safety officer—who testified that the company rebuffed his efforts to strengthen internal documents describing the weight gain issue. He testified that “I found out there were people from the commercial side” who opposed the changes. This is another indication of marketing trumping. AstraZeneca is defending the case, noting that it adequately warned about the risk of diabetes, and that Seroquel doesn’t cause diabetes, anyway. They rely on several studies that showed favorable data, but other reports show average weight gain for users on Seroquel is 27 pounds.

Continue reading "Seroquel Trial Update" »

Up until now, online social networking has been treated mostly as a plaything for some pharmaceutical manufacturers. They will post a few updates on Twitter, maybe start a Facebook page or post a YouTube video or two, but I have not seen much indication that the companies have really bought in, much less that they “get it” (though, some like AstraZeneca may be playing it safe while the FDA works out the regulation aspect).

Eye on FDA has a good summary of what’s happened to get us to this point. Initially, the FDA was more concerned with the content of pharmaceutical and medical device manufacturers’ messages. However, last year the FDA realized that there is only so many contraindications you can fit in 140 characters. So, in September 2009, they took the proactive step of setting a meeting (which BigPharma interestingly did not attend), and encouraging comments (open through last month). The hope is that they will be able to draft some sort of guidelines, so everyone knows where the line is.

Continue reading "BigPharma Goes All “Social Media”" »

Here are this week’s stories:

• 2009 Adverse Event Reports: Avandia (GlaxoSmithKline) and Seroquel (AstraZeneca) topped the charts for most adverse events for the third quarter of 2009, with 1,218 reports and 977 reports, respectively. See The Institute for Safe Medicine Practices (HT: FiercePharma).
• Avandia: “Glaxo Strikes Back at Drug Critics, But It’s a Big Swing and a Miss.” ‘Nuff said.
• $13 Million Zyprexa Settlement: Lilly settled a suit brought by the state of Montana over off-label marketing of Zyprexa, used to treat bi-polar disorder and schizophrenia. Most of the funds will be used to pay for mental health services in the state. See BusinessWeek.
• BPA: Maryland is considering legislation to ban or limit the use of BPA in plastics used by children. See the Baltimore Sun.
• Seroquel Trial: The Seroquel trial (New Jersey), alleging the drug causes diabetes, is in full force. The parties are arguing over whether marketing took precedence over safety research. See Bloomberg.

Happy March!

Here’s what we’re looking at, this week:

• AstraZeneca sets up a website devoted to its social networking efforts: Twitter, Facebook, YouTube and blogging
• Judge Keenan denies Merck’s motion to dismiss 24 Fosamax lawsuits because a jury may be able to conclude that the drug can cause jaw damage in under 3 years of use
• Increasing use of antipsychotics by pediatric patients
• The Pharma Marketing Blog reports on Big Pharma’s direct to consumer (DTC) advertising trends
• Informative post by Tom Lamb and the Drug Injury Watch on detecting adverse drug reactions and pulmonary embolism

Happy Monday!

Some items of interest while you eat turkey sandwiches for lunch, today:

• Class-1 recall of Stryker’s Navigation System II: 23 of these units are potentially faulty. The device is a computer-aided surgery platform that performs hip, spine, knee, neuro and ENT surgeries. The computer may not work properly, which could lead to serious injury or death. Stryker is also a manufacturer of shoulder pain pumps.
• Second bellwether Fosamax case dismissed:
  Judge Keenan (S.D. New York) dismissed the second of three Fosamax bellwether cases last week because of lack of specific causation (proof that Fosamax caused her injury, which is different from general causation—proof that Fosamax can cause these types of injuries). The third case is set for an April 2010 trial.
• Making drug safety information more accessible to patients: discusses the labeling of drugs, and whether those labels are sufficient for detailing drug efficacy and safety issues (hat tip to Tom Lamb at www.DrugInjuryWatch.com).
• AstraZeneca performs its own Seroquel study—surprised at what they found? Dr. Paul Woolf, a paid consultant who has received more than $216,000 from AstraZeneca, intends to testify that he reviewed AstraZeneca’s 2004 study on Seroquel, and that it shows the drug does not significantly affect blood-sugar levels. See our other blog posts on Seroquel and the findings of other studies (including AstraZeneca’s own covered-up research).

Happy Monday!

Tons of press on AstraZeneca and their antipsychotic drug Seroquel, lately, much of it dealing with one Dr. Michael Reinstein, a physician who, by all reports, is going to have to answer a lot of questions about his patients.

Here’s the Cliffs Notes:

Continue reading "Who Do The Drug Companies Cater To?" »

An e-mail from the Seroquel litigation, dated May 14, 2001, contains some talking points for Seroquel’s Product Managers and Marketing Managers. AstraZeneca understood that they had a big problem with the weight-gain issue. The e-mail reflects their approach:

• “The global strategy is to demonstrate to customers that Seroquel has a weight neutral profile in the long term
• Seroquel is not associated with diabetes nor its exacerbation

Attached to the e-mail was a “weight objection handler,” more talking points to counter objections to Seroquel by health care providers who questioned the weight gain issue.

Does this make any sense at all? Are they trying to say that, with Seroquel, patients gained weight rapidly in the short-term, but then lost that weight over the time they were on the drug? And, what is the short-term, anyway? This is far-fetched, and is another example of a desperate company trying to fiddle with studies and data that leave one inescapable conclusion—they should warn people about dangers associated with their drug.