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

Congress is now looking to give FDA the authority that most people thought they already had: to order food recalls.

The underhanded tactic, known as pay for delay, occurs when a generic drug company tries to bring its product to market by challenging the patents on a brand-name drug. Rather than engage in a costly and unpredictable court battle, the brand-name manufacturer sometimes pays the challenger substantial compensation to delay marketing its drug, and the generic company often welcomes the easy, risk-free money.

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.

Drug companies, who are anti-lawsuits until they want to file one, are frequently parties in patent lawsuits involving one drug company accusing another of reverse engineering or copying of drugs.

This amounts to about $10,000 a plaintiff which is certainly a different value that had been expected. But it seems as though these are weak Seroquel cases. I have written before that of the over 10,000 lawsuits filed in the Seroquel cases, there were certainly some that could not make it past summary judgment. I suspect these 200 odd Seroquel lawsuits are these cases.

It is a smart move tactically for AstraZeneca because these settlements will lower the expectations of many Seroquel plaintiffs with lawsuits pending. But if AstraZeneca thinks bottom has dropped out on the remaining Seroquel cases because it has had a string of early victories, I think they are wrong.

• Seroquel Lawsuit Overview
• Seroquel Lawsuit Updates
• Video Explaining Plaintiffs' Case Against Seroquel
• February 22, 2010 Update
• Free Seroquel Lawsuit Consultation at 800-553-8082

Luflumomide has had strong warnings since 2003 but the FDA decided to turn up the warning even further after a review this year of adverse event reports associated with leflunomide. The FDA identified 49 cases of severe liver injury associated with the luflunomide, including 14 reports of fatal liver failure, between August 2002 and May 2009.

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.

Makes sense to me. Even if the FDA's vote wasn't the immediate death-knell, I think it was a mortal wound. Avandia will wither away, and die later so GSK can claim that it was pulled for non-safety reasons.

Bayer (you know them b/c they also make Gadolinium, the subject of other lawsuits) has just lost the fifth straight trial over long-grain rice crops. The Washington Post detailed the overwhelmingly successful efforts of farmers to prove to juries that Bayer's genetically engineered seeds were contaminated, causing U.S. crop exports to plunge, and hurting the business of domestic farmers. There are 500 more cases, and Bayer has already lost $52 million.

• 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!

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

This probably isn't a huge deal, and doesn't imply any particular defects. On the other hand, it's hard to know about defects if Medtronic isn't actively looking for them...

In the first trial, bifurcated on liability and damages, the jury held the drug company responsible to the tune of $2.7 million in compensatory damages, and then $19.4 million in punitive damages. Appeals predictably followed, and the U.S. Court of Appeals for the Eighth Circuit overturned the punitive damages award based on some evidence that should not have been permitted. That court then ordered a new trial on punitives, only.

The issue that some wanted the Supreme Court to decide was whether a new trial on punitives alone was okay, or whether the entire trial had to be redone.

On the one hand, it seems a little difficult for a jury to get the full scope of a defendant's malfeasance without redoing liability, as well. But, the lawyers trying these hormone therapy cases are a resourceful bunch, and I'm sure they can do it. It's just sad that a new jury won't have the benefit of the same amount of time detailing all of the drug company's missteps.

On the other hand, the plaintiff has already proven her case, at least on the fundamental level of liability and causation and (non-punitive) damages. To make her retry the whole thing would be cruel, and would certainly lack judicial economy. Furthermore, to take that away when the initial non-punitive process was without judicial error would be inappropriate even according to the rules of the playground.

One sidenote--the author of the blog stated that:

The case involves a woman who allegedly developed cancer after taking hormone therapy drugs. (The FDA continues to approve the drugs as safe and effective.)

• The Sixth Circuit and Preemption: As mentioned by Drug & Device Law Blog, the 6th Circuit wants the FDA's viewpoint on preemption by July 29.
• Testosterone Gel: The Drug Injury Lawyer Blog reports on the links between testosterone gel and heart attacks/strokes. We've blogged about Testim, one version of the drug, before.
• Fosamax: I'm really sorry to have missed reporting such a big event. Here's a bunch of stories on the $8 million plaintiff's victory in the Boles Fosamax trial: Drug Injury Watch; Shearlings Got Plowed (victory notice)(post-trial motions)(next trials)
• Vioxx: Can Louisiana sue Merck to recover for money spent on Vioxx?
• BPA: The National Resources Defense Council (NRDC) sued the FDA over the FDA's failure to ban BPA in selected products. We'll see how that goes.... Here's an update on BPA from the FDA.