Drug Recall Lawyer Blog

Johnson and Johnson has issued a voluntary recall of its 1-Day Acuvue TruEye contact lenses. This recall is only for contact lens that were made in Ireland and sold in Japan, other parts of Asia, and Europe and Asia.

On this recall, Americans do not need to be particularly concerned. But all of us use Johnson & Johnson products. You don't even know half of the products you use that are made by J&J. The are ubiquitous. So the number of recalls coming from J&J in recent years on problems J&J seemingly either should have caught before putting the product on the market or should have caught sooner after the problem was noticed, is disturbing.

• More on J&J Problems (CNN)
• Johnson & Johnson on the Drug Recall Lawyer Blog

U.S. District Court in Minnesota Judge John R. Tunnheim denied a motion for summary judgment in a suit filed by Johnson & Johnson in a Levaquin lawsuit set for trial.

J&J's argument was the classic "doctor would have prescribed it anyway even if he knew of the risks" defense. But, according to this LawyerUSA article, the Plaintiff's treating doctor did testify that he would have approached his patient's case differently if he had know that Levaquin had greater tendon toxicity.

Plaintiff's Levaquin lawsuit alleges - as most of the claims involving Levaquin do - that the drug causes tendonitis, tendinopathy and tendon ruptures.

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!

Yesterday, the FDA posted a page on their website instructing consumers that the January 15, 2010 Tylenol recall has expanded once again.

See the FDA's notice for the affected lot numbers, but the products at issue (if you want to avoid them entirely while J&J sorts things out) is:

• Benadryl Allergy Ultratab
• Children's Tylenol Meltaways
• Motrin IB
• Tylenol Extra Strength
• Tylenol PM

I don't know if anyone is buying Tylenol anymore in light of the recall (I'm sticking with generics), so maybe the expansion won't mean anything. Then again, it could mean it takes longer for J&J to woo their consumers back into the fold.

Yesterday, J&J reported yet another recall. This time, it’s four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 Count, and one product lot of EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS, 50 Count. This is an expansion of the recall related to the wood pallets and the musty smell associated with the medication.

J&J reports that they inadvertently omitted these products from that recall list. Oops.

Here are this week’s stories:

• Vioxx: See Shearlings Got Plowed for a quick summary of the Australian Vioxx trial. Good news.
• Defibrillator Battery Recall: 5,418 battery packs used in Lifeline AED and ReceiveR external defibrillators are recalled. See the FDA’s notice.
• Scientist-CEOs: Should pharmaceutical companies bring back the scientist-CEO business model?
• Kickbacks and Hip Implants: Read about a former umpire’s quest for justice when a hip implant fails, and he finds out about the moneyed relationship between his surgeon and the medical device manufacturer.
• Benicar: The Drug Injury Watch has a post on the possible dangers of Benicar.
• Motrin’s Phantom Recall: See Brian Nash’s blog for his take on the J&J recall.

Happy Monday!

The New York Times has a good article from yesterday about the standoff between J&J and the government. Apparently, they are both still accusing each other of not paying attention. Maybe it's miscommunication, but I don't think J&J is winning the public relations battle.

Johnson & Johnson was supposed to provide a slew of documents to the House Committee on Oversight and Reform by 4:00 p.m. on Monday. The Committee reported that J&J missed their deadline, J&J told reporters that they provided the documents. Are they relying on the mail rule (you get an extra 3 days to send stuff to Congress if you send by USPS)? Maybe they should be using e-mail. Or couriers. Or anything to make sure Congress gets these documents by the time they want them.

It just looks bad, even if it is a miscommunication. As a consumer, it somewhat substantiates the allegations regarding J&J's manufacturing process. If they can't get documents sent over in time, can they really make complicated medication in a sanitary way?

Here are the week’s top stories:

• Off-Label Marketing: Jack’s Posterous has a recount of recent off-label marketing fines paid by drug dealers (oops, I mean manufacturers). “As long as off-label promotion is more profitable than the fines for punishing off-label promotion, we will have off-label promotion.”
• Motrin Phantom Recall: Pogust, Braslow & Millrood’s Drug Injury Lawyer Blog has details of Johnson & Johnson’s McNeil Consumer Healthcare and their effort to avoid a Motrin recall.
• Zocor: FDA says it may cause muscle injury (rhabdomyolysis). See our prior Zocor posts.
• Pfizer and Free Samples: Pfizer spends the most doling out free samples--$2.7 billion in a year. Kinda makes you think about those paltry fines, huh?
• Off-Label Marketing, pt. II: Take the poll.
• Drugs and Porn: Can drugs cause porn and gambling addictions? Looks like there are lawsuits in Australia and here in the U.S. I’m highly skeptical of this one.
• Fosamax: Jury selection just ended in the retrial of the Boles case, yesterday.
• Januvia & Janumet: We've been getting a lot of questions about these diabetes drugs lately, so see our website.

Happy Tuesday!

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.

Happy Wednesday!

For those who want a quick seven page read—here’s yesterday’s testimony of Johnson & Johnson. As far as apology letters go, it is a good one (someone needs to write a book on the apology--lots of public experience, from the tawdry (Tiger Woods, Jesse James) to the corporate (J&J, etc.)). Throughout the testimony, J&J pledges to “earn back” our confidence, accepts that the conditions leading to the recall are “unacceptable,” and that J&J takes “these issues seriously.” There are two focuses to the testimony:

First, J&J goes to great lengths to convince listeners that there is no known medical risk of the products—the metal contaminants are small and inert; and the bacteria found at the plant has not been identified in any sold batch of medicine. This is their “no harm, no foul” argument.

Second, J&J describes what they have done to correct their missteps, including the prompt recall, notifications to the press, wholesalers and retailers, and even their social media efforts. This is their “stuff happens, and we’ve been on the ball, so we’re really doing all that anyone can” argument.

Nevertheless, the issue has been referred to the FDA crime division. Part of the problem is that the FDA contends they put J&J on notice of their deficient manufacturing practices back in February. The recall then happened in April, indicating that proper attention may not have been given to the issue, despite J&J’s assurances to the contrary.

Nice comparison post by John Mack of the PharmaMarketing Blog: Parallels Between BP and J&J.

John also gets kudos for his Bizarro reference (I would have invoked the parallel universe, but I still have to give credit where credit is due).

A number of reports and calls have come in regarding injuries related to Johnson & Johnson’s Tylenol (and other brands, see here) recall. The FDA is examining about 775 reports of side effects, including 30 deaths, potentially linked to the products. As the investigation proceeds, it appears that most of the 30 deaths have been excluded as resulting from the Tylenol. See the CNN report. As I mentioned earlier, I'm skeptical that any serious injuries will result from the contamination. But, only time will tell.

Yesterday, Johnson & Johnson released a plan to deal with quality control issues like the ones surrounding the Tylenol recall. It looks like they are taking some good steps to prevent future problems. Of course, the big problem is that they are reacting to past problems, when a bit of proactivity could have prevented this whole thing. At any rate, the plan will certainly help Johnson & Johnson to deal with the upcoming congressional probe by showing that they are responding quickly. But, is it quick enough? Maybe they should trade notes with BP…

Good morning! Here are the week’s top stories:

• Topamax: Johnson & Johnson is going to pay over $81 million (articles here and here in criminal and civil fines for illegally promoting Topamax. That’s a mere 0.070% of 2009’s $1.15 billion in sales, and 0.039% of 2008’s 2.7 billion in sales (quite the deterrent, eh?). Nevertheless, this compounds J&J’s woes in light of the current Tylenol recall.
• Topamax Whistleblowers: Here’s an article about the courageous Michigan whistleblowers who made it all happen.
• Vaccines & Autism: Dr. Andrew Wakefield, the British physician who wrote the initial Lancet article linking autism to vaccines, has been disbarred from the practice of medicine. He did not offer evidence on his behalf, and he has about a month to appeal.
• BPA—now in cans?: USA Today and Dr. Gupta report on the presence of BPA in cans, and discuss whether pregnant women in particular should be concerned. For more on BPA, see our prior blog posts.
• St. Jude Medical: The FDA recently issued a warning letter to St. Jude Medical about overpromotion of its Epicor Ablation System, used to treat atrial fibrillation. See the Forbes article and the FDA’s warning letter.
• Las Vegas Hepatitis Punitives: See one reactionist and alarmist article, “Health Cost Hikes May Follow $500M Jury Award in Hepatitis C Case.”
• Neurontin: Last week, Pfizer settled a Neurontin wrongful death case for a confidential amount.

Have a great week!

Our friends at the Pharma Marketing Blog discuss Johnson & Johnson's recent social media efforts in light of their children's Tylenol recall. Johnson & Johnson Director of Corporate Communications Marc Monseau responded in the comments. Nice, but there is a lot more Johnson & Johnson could be doing, social media-wise. This is a good opportunity to earn points with the public through full disclosure, links to media critical of J&J, videos of J&J's corporate talking heads reassuring the public, etc... It's a brave new world, but only if you embrace the technology.

After the recall of Johnson & Johnson’s Tylenol (including Motrin and other) products, Congress has gotten involved and is launching an investigation. They are seeking all sorts of documents, and presumably trying to determine whether the recall should have happened sooner in light of the 46 customer complaints.

I suspect the big uproar is caused by the subject of the recall—children’s Tylenol. If this was adult medication, it probably wouldn’t be as big of a deal (which isn’t to say that it shouldn’t be a big deal). But, we are hard-wired to protect our children, so anything that potentially harms their health gets center-stage attention. There are a lot of other products out there that could use Congressional investigation, in particular, drugs and medical devices that have actually been traced to injury. Right now, there is no evidence that the contaminated Tylenol products can cause any ill effects. Of course, lots of parents are on pins and needles after giving their children medication that they thought was safe.

Here’s a link to a recent CNN article, and links to our prior Tylenol Drug Recall Lawyer Blog posts.

Here are some stories to follow this week:

• Tylenol Recall: Johnson & Johnson’s statement about the recall is here, and they have a blog post here (with some interaction with consumers via comments).
• Vyvanase and Off-label Marketing: John Mack has an interesting post analyzing an ad that might be promoting off-label use through subtle imagery. Is it off-label, or is just a picture? You be the judge!
• Maalox: The FDA posted a statement (scroll to the bottom) under Patient Safety News regarding the problems with confusing various types of Maalox, which can have disastrous results.
• April 510k Clearances: viewable here.
• Topomax: After the $81 million settlement with the DOJ over its drug Topomax, Johnson & Johnson sales reps are going to be randomly observed during sales pitches (HT: FiercePharma).
• Preemption and Generic Drugs: post by the For the Defense.
• Fosamax: I’ve been trying to get a post on this important decision, but it’s been a busy couple of days. Tom Lamb has a description.

Happy Monday!

CNN reports on the Tylenol recall and the FDA's investigation into the quality control issues and security lapses at Johnson & Johnson's Pennsylvania manufacturing facility.

An FDA representative has stated "This is yet another example of when a company has to take full accountability for the quality of its drugs [with] severe consequences for not doing so." As new evidence comes to light, it appears that Johnson & Johnson has not timely addressed customer complaints since June 2009 about foreign substances in the medicine.

Here's a link to the FDA's press release, and a link to the 17-page FDA plant inspection report.

Here are this week’s stories:

• FDA: The FDA is changing the medical device approval process. See the FDA announcement (HT: Eye on FDA).
• FDA II: Little progress on more FDA independence and power in drug safety reviews (An appropriate lament by Tom Lamb).
• Heparin: Congressional examination into the contaminated Heparin debacle (HT: FiercePharma).
• Tylenol Recall: Seems we just went through this. Here’s another one, affecting infant/children Tylenol, Motrin, Zyrtec and Benadryl. See the recall notice.
• Pain Pumps: Drug and Device Law Blog’s view of the recent MDL denial.

Happy Monday!

Here are the stories we’re following this week:

• Fosamax and Statute of Limitations: Recent Fosamax case and application of American Pipe mass tort/class action tolling (HT: Drug and Device Law Blog)
• Drug Pushers: Are sales reps who promote their companies drugs with direct-to-consumer (DTC) advertising “pushers?” (HT: Pharma Marketing Blog)
• Anemia Drugs: Anemia drugs by Johnson & Johnson and Amgen may exacerbate heart problems and survival in kidney patients (HT: FiercePharma)
• Price-fixing: According to a Bloomberg report, Germany cuts costs of drugs by precluding manufacturers from setting their own prices.
• Neurontin: Reuters reports that Pfizer loses a RICO trial to the tune of $141 million.
• Boston Scientific Defibrillators: Another perspective here. You can see our previous blog post here.
• CT Scan Radiation: New York Times article about whether FDA ignored warnings about radiation problems.

Happy Monday!