Drug Recall Lawyer Blog

According to the Maryland Intellectual Property Law Blog, Maryland has seen only 10 patent lawsuit in 2010. Incredibly, there have already been 265 patent lawsuits in Texas. There are not more patents in Texas. Maryland inventors received almost as many patents in the first half of 2010.

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.

AstraZeneca will pay $2 million to settle more than 200 Seroquel lawsuits. These are the first Seroquel settlements.

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

The FDA reports that leflunomide received a boxed warning last week about the risk for severe liver injury, the US Food and Drug Administration (FDA) announced today. Luflumomide is a rheumatoid arthritis drug.

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.

Lots going on in GlaxoSmithKline's Avandia world. They've been wounded, but avoided summary execution yesterday when twelve of 33 members voted to allow it to stay on the market, albeit with significant restrictions and black box warnings. See CNN's article.

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.

Okay, it's a bad play on words.

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.

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.

We're just hearing about a May 7, 2010 FDA warning letter to Medtronic over Medtronic's failure to establish protocols to review customer complaints and to validate device designs. The letter relates to image-guided surgical systems for spinal, cranial, and ENT applications.

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...

MassTortDefense Blog posted about the U.S. Supreme's Court decision to not hear a punitive damages case, Wyeth v. Scroggin.

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.)

Actually, the case involves a woman who has proven that she developed cancer because of hormone therapy drugs. And, to say that the FDA continues to approve the drugs as safe and effective is a gross oversimplification. Sure, they are safe when used properly. Doctors didn't have the right warnings at the time, and now they are used more frequently with the "lowest effective dose." After all of the studies that have been done, you can't deny that hormone therapy drugs causes breast cancer. Well, you could, but if you are, you are probably a drug company executive...

Last week was a busy one--our firm had two trials (one continuing on this week with closing arguments tomorrow), and one that concluded very favorably with a plaintiff's verdict. But, now that I'm back, here's this week's edition of the Round-Up:

• 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.

Hope you had a happy 4th!