Drug Recall Lawyer Blog

There have not been any medical device recalls announced by the FDA since early June. This is a good thing. But there are a lot of silent recalls when a product is taken off the market because sales are crashing in response to all of the reasons why there should be a recall in the first place.

From a plaintiffs' lawyers' standpoint, the best cases to try are those cases where a bad product was given a soft recall but the product is left on the market until the shelves clear. Defense lawyers are not racing to the courthouse steps to try these cases and they usually settle in the highest value range of a mass tort settlement (or the plaintiff opts out of the settlement and gets a higher offer later).

Bayer is facing over 6,000 lawsuits involving Yaz/Yasmin. Yaz sales are plummeting. Bayer is in trouble. Lawsuits are all that matter to these drug companies and it's time to stop pretending otherwise.

Oh wait. Not at all. The German pharmaceuticals giant shrugs off these minor nuisances. Sales rose 5.4 percent in the second quarter. Profits keep flowing.

Lawsuits seem like the whole universe to product liability lawyers and to the in-house lawyers. But they are really a just a drop in the bucket to big drug companies.

The FDA put out a proposed new rule to to withdraw 21 CFR § 203.50(a) to deal with court orders striking it down. The courts' problem with the rule was a regulation that requires that certain information be included in a pedigree, which documents the custody of certain prescription drugs in the drug supply chain.

The FDA has defended its rule while noting the courts' objections to it. This new rule hopes to reconcile the courts' concerns.

The rule was struck down in 2006. The FDA gets around to solving it five years later. Maybe "FDA approved" should not be a "get out of jail free" card for drug companies.

Speaking of efforts to sneak out of the MDL, this effort failed in the Yaz litigation.

The vast majority of DePuy hip replacement lawsuits will - if they go to trial - be tried in the states where the surgeries occurred (excluding bellwether trials and state court cases). But the discovery of these DePuy cases is consolidated in Ohio. That means for now, every federal court case sits in what is called an MDL in Ohio.

Some DePuy plaintiffs' lawyers, for various reasons, do not want to wait on the slow pace of the MDL in Ohio. A number of cases that were transferred from Alabama have named a sales representative from DePuy/Johnson & Johnson as a defendant. Plaintiffs' lawyers claim because there is diversity of citizenship - an Alabama resident on both sides of the "v" - that the cases should be remanded to Alabama.

Let's be honest. Plaintiffs' lawyers would not have named this sales rep if he was not an Alabama resident. The DePuy lawsuits are clearly not about a sales rep. Still, that is not the litmus test as to whether the joinder is fraudulent. In fact, the burden for the defendants is quite high. To keep these Alabama cases in the MDL, DePuy was required to meet the difficult burden of showing either “(1) there is no possibility the plaintiff can establish a cause of action against the resident defendant; or (2) the plaintiff has fraudulently pled jurisdictional facts to bring the resident defendant into state court; or (3) there is no real connection between the claims against a diverse defendant and those against a non-diverse defendant.

Continue reading " Where Are DePuy Hip Implant Cases? New Opinions from MDL Judge in Ohio " »

• Some calcium gluconate injections, used to treat a variety of conditions, are being recalled because they may contain silicone particles.
• Two consumers allege that the drug Humira causes nerve damage.
• Litigation over the Arkansas attorney general's claims that AstraZeneca concealed the risks associated with Seroquel use from Arkansas Medicaid participants will go to trial next September. The state claims the company knew before it started marketing the anti-psychotic drug that it could lead to weight gain and diabetes. The FDA is also adding a heart health warning to Seroquel.
• An Indian news outfit reports that Rite Aid is suing Indian drug company Ranbaxy over the company's generic version of the anti-nausea drug Reglan. The drugstore chain alleges that Ranbaxy breached its agreement to defend Rite Aid in litigation over the medication, which some consumers allege causes movement disorders.
• What happens when the plaintiff in a drug wrongful-death case doesn't know which company manufactured the medication that allegedly killed the decedent?

• Europe's look at Actos

Our attorneys are investigating potential lawsuits involving Crestor and its possible side effects. There are two types of Crestor cases in particular that have gained the interest of many mass tort lawyers: Crestor induced cardiomyopathy and Crestor induced diabetes.

Crestor is a statin that treats dyslipidemia. Crestor is intended - and probably does - reduce “bad” cholesterol while increasing “good” cholesterol. But Crestor lawsuits allege that Crestor can cause cardiovascular injuries leading to cardiomyopathy and diabetes.

As if that was not problem enough, rhabdomyolysis has also been linked to Crestor which may lead Crestor patients to suffer kidney injuries.

Do you want more information on Crestor lawsuits to help you decide whether (1) you qualify, and/or (2) you are interested in bringing a Crestor injury claim? Tell us about your case and we will give you our thoughts.

Speaking of GlaxoSmithKline, the pharmaceutical giant was told by the Hong Kong government to recall its antibiotic Augmentin because it contained detectable levels of plasticizers. The level of plasticisers is unlikely to be harmful in usual dosages of Augmentin, which is easy to say unless you are the one taking the Augmentin.

Plasticisers are beating down Glaxo in Hong Kong a bit of late. Last month, Glaxo issued a recall for a pediatric antibiotic because of plasticisers in the product.

James Murdock was elected to the GlaxoSmithKline board of directors in 2009. He was re-elected to the Glaxo board in May, making Stalin proud by winning 97 percent of the votes cast. Glaxo's love for Murdock is understandable. Anytime you can get a billionaire's son whose only business accomplishment is working for his dad, you have to jump on that opportunity. "Should we recall Actos? Let's get Murdock in here to figure it out." Inside sources tell me Glaxo turned to Murdock when their first choice, Ivanka Trump, wasn't available. I think they actually meant to get Matlock.

I'm taking a shot a James Murdock because it's funny. Is James Murdock an idiot? Corrupt? I don't know, of course. But I doubt it. He's probably a very smart guy. Maybe he was born on third base but what does that ultimately have to do with anything?

But still. Why is he on the board at Glaxo? I'm a smart guy ,too. But I'm not qualified to be on the board at Glaxo either. I think shareholders of Glaxo should be looking at exactly how the sausage is being made at Glaxo and whether they really want some.

In the middle of a not so good stock market Friday after the jobs report, Amylin Pharmaceuticals went up 5% after a new study of its diabetes drug Bydureon took a step forward towards reaching the market.

Rezulin, Actos, Byetta, Avandia... it seems there are a few diabetes drugs that have come on to the market with controversy and, yes, lawsuits. Is Bydureon different? I guess we are going to find out.

Our firm is now reviewing potential Bydureon lawsuits. Call us today for a free consultation. (I'm just kidding, by the way. Hopefully, Bydureon is a safe and efficacious drug that just helps people like the vast majority of drugs and medical devices.)

• SCOTUS says that drug-labeling laws that require generic drugs to use the same labels as their name-brand equivalents mean patients taking the generic version of Reglan can't sue over failure to warn.
• Abnormal Use writes about the possible preemption fallout from the FDA's Avastin decision.
• Vitamins recalled for failure to meet standards for child-resistant caps.
• How dangerous is Chantix to the heart?
• This is not exactly a drug, but the FTC has now made sure Nivea can no longer imply in advertisements that one of its skin lotion products will make you skinnier. (HT:Legal Blog Watch.)
• Autism and Zoloft.

USA Today writes an article that I thought was going to have the false premise of "Does the Tylenol recall pose a risk for consumers?" There is no evidence this latest and greatest Tylenol recall puts consumers in harm's way. But then it asks the larger question: are Johnson & Johnson's products safe? Here's the argument:

"Clearly if a company has one recall, I could say 'Well, that's sort of an accident, just something that was very unfortunate.' But I think Johnson & Johnson has had it happen over and over and over again. They don't have their act together," says Curt Furberg, a professor of public health sciences at Wake Forest Baptist Medical Center in Winston-Salem, N.C. "I would be worried and try to go with other drugs, other pain relievers." Furberg has served on the Food and Drug Administration's Committee on Drug Safety and Risk Management.

That's the key point, well phrased. Does Johnson & Johnson have its act together and, if it doesn't, does that make all of its products - or a least products where there appears to be the theoretical possibility that a defect could cause injury - a riskier bet for consumers?