Drug Recall Lawyer Blog

Here's all the news that's fit to print:

• Tylenol Recall Lawsuit: According to Bloomberg, consumers are striking back against Johnson & Johnson over the recalled Tylenol (and other) drugs. Basically, the federal class action suit seeks to force J&J to pay money for returned products instead of offering coupons for the same products. That is a logical position--who wants to buy Tylenol, now? Would you use it if they gave it to for free? However, J&J's website says they offer refunds or coupons, and it seems like the customer's choice.
• Avandia: The FDA's advisory committee on Avandia is set to meet this week to go over the risk/benefit profile.
• Fosamax Trial: See here for Merck's complaint about plaintiff's trial counsel in the Boles case, and here for the other side of the story (HT: Shearlings Got Plowed).
• Free Speech: Can doctors criticize pharmaceuticals online? (HT: Pharma Marketing Blog)
• Preventing Children Medication Errors by Parents: Just because it's important (scroll down halfway)
• Thimerosal: Another one bites the dust.
• FDA Facebook Page: Good idea or bad idea?
• History of Prescription Drug Recalls: HT Tom Lamb.
• Rapamune: Off-label marketing allegations (HT: Drug Injury Lawyer Blog).

Happy Monday!

Here are this week’s stories:

• Medtronic: Medtronic reported that it paid $15.7 million to U.S. doctors in the first 3 months of 2010. Payments were for consulting fees and royalties. This report comes well in advance of the new law requiring disclosure beginning in 2013. See Medtronic’s searchable database of payments.
• Digitek: A request for a class certification was recently denied in the Digitek MDL. The MassTortDefense Blog has an update.
• PediaCare Recall: over 100,000 bottles of PediaCare, formerly manufactured by Johnson & Johnson (and, still being manufactured in their facility), have been recalled. This is a precautionary recall, based on the known problems with the J&J manufacturing facility.
• AstraZeneca and Social Media: Here is AstraZeneca’s take on the transparency/social media issue.
• Generic Drugs: The Supreme Court asks Obama’s administration for an opinion as to whether generic drug manufacturers can be sued for inadequate labeling that matches labeling of brand-name drugs. Here is the Eighth Circuit’s opinion, deciding that generic drug manufacturers can be held liable.
• Celebrities in the News: Dennis Quaid is bringing public awareness to injuries caused by pharmaceutical companies. He settled with the hospital on the heparin overdose of his children, but now he’s going after the pharmaceutical company, Baxter Healthcare Corp.
• More on Whistleblowing: Wyeth (through Pfizer) is accused of illegally promoting its kidney transplant drug for other organs and specifically among African-Americans, who have greater risks associated wit the drug.

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...

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!

Interesting developments in online social media and drug companies, in the past week. As you know, the FDA has been soliciting requests about how to manage online social media for drug and device manufacturers. This is clearly a lot for drug companies to deal with, and here are some things they should wrap their minds around:

1. Sanofi-Aventis VOICES Facebook Page: This drug company, maker of the cancer drug Taxotere, learned first-hand the downside of having a Facebook site that allows interaction with customers. That downside is that customers interact. One Taxotere user posted complaints to the FB page about the drug, only to have her post removed. Undeterred, she sent more posts, opened other Facebook accounts, sent more posts, had friends send posts, and just generally assaulted the Sanofi-Aventis stronghold. Finally, Sanofi-Aventis changed their information and stated on the FB page:

   This page is not intended as a forum for discussing sanofi-aventis’ or other companies’ products. As such, Postings that contain product discussions will be removed by sanofi-aventis.

   See John Mack’s Pharma Marketing Blog, which examines whether the complainant’s posts constitute a reportable adverse event that Sanofi-Aventis must share with the FDA.

   This exemplifies some of the problems drug companies will face in creating online social media—how much customer interaction is too much? The value of social media is that it is open to comments and questions and interaction. Otherwise, it becomes simply another mouthpiece for the company, and is bereft of actual benefits (though, to be fair, it would also limit possible damages). But, Sanofi-Aventis now just looks bad for canceling the conversation.

2. Use of hashtags for online social media: Again, John Mack’s blog has a good analysis of this as a possible partial solution to the problem of presenting consumers with a full and balanced view of drug risks and benefits. You can find Novartis’ comments regarding space-saving measures on Twitter here.

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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

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.

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