Drug Recall Lawyer Blog

This from Abnormal Use:

The sinister suggestion that major corporations have conspired to use the Stella Liebeck McDonald’s hot coffee case as a tool to promote tort reform is odd, although film maker Susan Saladoff and her pals at The Pop Tort seem to believe that business interests have spent millions in an effort to make the Plaintiff Stella Liebeck the poster plaintiff for tort reform. That’s one of the themes of Saladoff’s Hot Coffee documentary, which we reviewed yesterday. However, there really isn’t any evidence to prove such a corporate scheme, although as always, the absence of evidence of a conspiracy serves to confirm its existence in some eyes.

Sigh.

Well, I see your sigh and I raise you three sighs. I don't know exactly what Abnormal Use is doing here. It is a relative of making up a strawman. But it is not exactly OliverStoneLand to suggest that the tort reform movement funded by corporate America (who else would pay for it?) used a verdict that upset people to their advantage. Why would they engage in such a conspiracy? Because they would be idiots if they didn't. There is nothing "sinister" about it. It would be "tort reform malpractice" not to do so.

I remember a hospital in Rhode Island performed brain surgery on the wrong side of the brain three times in one year a while back (here, I Googled it). If a bunch of trial lawyer lobbyists were not sitting in a dark room somewhere drinking cognac trying to figure out how to exploit that, they should all be fired.

Everyone tries to use facts that support their argument to their advantage. You do this on tort reform, politics, and when arguing if Mays as better than Mantle. It is the way of things, the way of humans.

Continue reading " Abnormal Use and Stella Liebeck " »

Drug companies love to hid behind the FDA's skirt. I don't think the FDA is a bad organization. And it is getting better (I think). But we get almost weekly evidence that the FDA is not the lock down gatekeeper that pharmaceutical companies pretend that it is.

This week's evidence is revealed in the New York Times. In an audit of 17 FDA food recalls, the FDA often failed to follow its own rules in removing dangerous imported foods from the market. Keep in mind the level of screw up here: failure to follow your own rules after you know there is a problem. This audit concluded that government food officials are often sloppy and inattentive in their efforts to ensure that bad food is taken out of our mouths quickly.

The FDA is not a joke or a laughing stock. When it is sticking its chest out, the FDA implicitly but seductively suggests it can protect us. But its reach exceeds its grasp. It can't deliver. Even under the best case scenario with the greatest government regulation in the history of the world, it still can't deliver.

Who can protect us? Product manufacturers and food and drug companies need to be the gatekeeper for safety, not the FDA. When they fail to assume that role for their own product, there should be ramifications. Yes, that means lawsuits, folks.

Like every plaintiff''s lawyer and their mother, we have been trying to attract potential Yaz lawsuit clients. I think the Yaz cases are going to be good and I think when all is said and done, Yaz/Yasmin is going to come off the market and Bayer is going to reach a global settlement in these cases.

The FDA may indirectly push that ball along. The FDA now says it will take another look at the risks that accompany Yaz/Yasmin. The big risk that Yaz lawsuits allege that are going to make up most of the larger Yaz settlements should these cases resolve are the deep vein thrombosis (DVT)/ pulmonary embolism (PE).

Continue reading " Yaz Lawsuits: FDA Will Look More Closely " »

Johnson & Johnson, recall and odor. These words just flow together. J&J will recall of 16,000 bottles of the antipsychotic drug Risperdal because of - wait for it - an unnatural odor.

The culprit? You guess it. Wooden pallets. Unbelievable.

Some folks I'd rather not mess with - the Chinese government - has ordered Glaxo to a recall of an antibiotic medication that contained trace levels of a plasticiser. China's version of the FDA found small amounts of Di-isodecyl phthalate, an additive used in plastics that may cause liver problems. The medication, a combination of amoxicillin and clavulanate potassium, is used to numerous infections.

Health Canada, the Canadian version of the FDA, said it is taking a long look at the association between the diabetes drug Actos (pioglitazone) and bladder cancer. France and Germany have already ceased Actos sales after more information is coming to light about the connection between Actos and bladder cancer.

The Health Canada press release said that:

Health Canada has been closely monitoring this potential risk, and has been reviewing all relevant studies on an ongoing basis. We are taking these studies, including their strengths and limitations, into account as we continue to monitor pioglitazone safety.

• Actos recall/withdraw speculation by us
• Overview of potential Actos lawsuits

Is there an Actos recall in the future? No one knows. But the opinion that patients on Actos face a higher risk of developing bladder cancer is gaining currency.

Actos treats diabetes, an indisputably serious condition. So it is certainly acceptable that diabetes drugs - from a cost benefit perspective - come with risk. But the question is whether there are unnecessary risks.

That might be where we are with Actos. Studies are piling up to suggest that Actos patients have a disproportionate risk of bladder cancer when compared to patients on other diabetes medications.

There are tea leaves for an Actos recall in the U.S. In Europe, Actos has been pulled from the market in France and Germany. So is it a fair question to ask: if Actos is too risky for European patients, why is it okay for U.S.? The logic of this question underscores that, one way or the other, Actos' days are likely numbered. If there is not a recall, I think doctors will eventually stop prescribing the drug.

Tell us about your experiences - good or bad - with Actos.

FDA is poised to limit the sale and distribution of “Research Use Only” (RUO) and “Investigational Use Only” (IUO) products, issuing a draft guidance to that effect on Tuesday.

RUO products are usually in the laboratory research phase of development or are used as basic scientific research. But some companies sell these products when they know or should know that they are being misused diagnostically. Now, the FDA will require companies sales of its RUO or IUO products if the company knows or has reason to know that the product is actually being used diagnostically. In other words, no more turning a blind eye to what you know or assume the company's purpose for a product. The "hey, we make no diagnostic claims are being made" skirt is off.