Articles Posted in Pharmaceutical Drugs

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One drug that has attracted the attention of plaintiffs’ lawyers in massive numbers is Pradaxa. There are not a lot of cases – you can call it a mini mass tort. But they are very strong cases that I think are going to have a lot of value.

Pradaxa is an anticoagulant or blood thinner used to prevent strokes in patients with atrial fibrillation and others at risk for developing potentially life threatening clots. Plaintiffs’ lawyers, then prescription drug safety advocates, and now everyone else under sun, have realized that Pradaxa may substantially increase the risk of contracting viral infections. Continue reading →

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If you are on dialysis, you are vulnerable. Obviously. The last thing you need is someone who pretends to provide a product that helps while actually knowing that the product is going to create a risk to dialysis patients. That appears to be what we have in these Fresenius NaturaLyte and GranuFlo cases.

Continue reading →

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I get so many emails from so many marketing companies. Just today I got an offer to write a guest post on this blog (no), an email telling me that I rank poorly in Salisbury, Maryland on the search engines (he’s wrong), and two more random emails from companies telling me they are the best in the world at getting me to the top of the search engines (unlikely since, you know, you are spamming me).

But I found one of these emails really interesting. This one was from New York City and it offered to provide leads for Actos, Yaz, Yazmin, and Ocella cases. These emails are always flying in, but this one actually provided the prices for the leads:

  • Actos: $450
  • Yaz: $400
  • Yazmin: $400
  • Ocella $425

You can call them and ask them the cost per lead if you follow up on their emails, of course, but this is the first email I have gotten that comes right out and tells you. I just never really stopped and gave much thought to the the selling of potential personal injury cases. What’s a cerebral palsy or a wrongful death truck accident case lead worth? Can you sell those, too? Are people selling those? Should people be buying and selling these things like commodities on eBay? I’m not posing these questions in a judgmental “This is so wrong!” kinda way. I really don’t know.

So, what do I expect you to do with this information? I don’t know. I just found it interesting and thought I would pass it along.

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An MDL Panel ruled this week that any Actos lawsuits filed in federal court in Maryland will be consolidated in Louisiana.

Actos is another drug for type 2 diabetes that has helped treat the diabetes, but can get the patient into problems that they did not anticipate (Avandia has also had its share of problems). With Actos, studies have shown that people who take Actos for more than a year are 40 percent more likely to develop bladder cancer than those never exposed to Actos.

Actos does an effective job of treating diabetes. Actos improves blood sugar levels by increasing the body’s sensitivity to insulin in patients who have been diagnosed with type 2 Diabetes. Clearly, diabetes is a serious disease and the medications to treat diabetes come with – as most medications do – risk. Certainly, if you have life threatening diabetes and Actos is the only drug that works for you, maybe you take on otherwise unacceptable risks. I get that. But Actos users did not sign up for this risk of bladder cancer. There are too many patients over the years that would not have used Actos if they knew it caused bladder cancer. Continue reading →

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The FDA is currently investigating a possible association between the diabetes drug Actos (pioglitazone) and an increased risk of bladder cancer.

Actos is commonly prescribed to treat type 2 diabetes and works by increasing the body’s sensitivity to insulin. It is usually taken once a day by mouth. By all accounts, Actos helps treat type 2 diabetes, which is undoubtedly an awful disease. But there are other diabetes options where there is no suggestion of a link to cancer. The questions that doctors are going to have to answer are whether Actos is worth the risk of cancer and whether there are other less risky options available. Ultimately, juries are also going to be asked these questions, too. They will also have to dig into the other question: what did the manufacturer of Actos know or should it have known about the association between cancer and Actos and should they have issued a recall for Actos or at least provided a warning of the risk?

The bubbling concerns about Actos culminated in a safety announcement dated June 15, 2011, wherein the FDA warned the public that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” Information about the potential risk will be added to the Warnings and Precautions label for medicines that contain Actos, and the corresponding patient Medication Guides will also be updated to reflect information on bladder cancer. In response to the FDA’s actions, the drug’s manufacturer (Takeda) has undertaken a 10-year observational study to assess the long-term risk of bladder cancer associated with the use of Actos. Continue reading →

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The Drug and Device Law Blog writes whines about inadequate fact sheets in the Yaz Yasmin MDL.

Plaintiff Fact Sheets are basically questionnaires that serve as interrogatories in mass tort cases. In the Yaz/Yasmin cases and other MDLs, they are really agreed upon case specific interrogatories. If nothing else, fact sheets cut through the bickering of what defendants may legitimately ask. They could call them “agreed upon interrogatories” and it would mean the same thing.

Echoing this otherwise excellent Drug and Device Law Blog’s trite and tired leitmotif – those lazy, greedy plaintiffs’ lawyers! — the post gripes:

    The goal for the other side in MDL litigation is to file as many complaints as possible and after that do as little work as possible – while waiting around for the almost inevitable settlement, be it large or small. Thus, MDL plaintiffs want only one-way discovery. Their side gets to discover the living daylights out of our clients, and drive up our expenses to the maximum extent possible. But our side doesn’t get anything more than pieces of paper called “questionnaires” or “fact sheets.”

The reality is that when a plaintiff does provide meaningful responses, mass tort defendants applaud the effort by beating them down over every last detail. And, oh my, if plaintiff’s fact sheet triggers something like defendant has to provide shipping records or any other obligation, it will NEVER be good enough. “Dear Counsel, your Plaintiff’s Fact Sheet is incomplete because you did not tell us who your doctor was in the eighth grade when you broke your leg.” Continue reading →

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The first line in this editorial adequately summarizes the problem that leads to unsafe drugs and medical devices:

What would your reaction be if the results of a football match were reported as 5:0 by one of the teams and as 3:1 by the other team?

This editorial underscores a point that I think the “FDA approval is the gold standard” crew completely ignores: it is painfully easy to rig drug testing to get the desired results at any stage of the research and testing process. Most of the injuries were at the end of the study? Change the end point. Most of the adverse effects were in patients with blonde hair? Take them out of the study.

Okay, that is a little bit of hyperbole. But you get the point. No doubt there are a lot of good, decent people at the world’s largest pharmaceutical companies and most make the right decisions. There are also some pharmaceutical executives who would shoot their own parents in the head before not pushing what they believe will be a profitable drug to market. There is no doubt about this either. By the time the lawsuits that will, in the end, kill most of the profitability hit, that executive will have gotten a promotion out of that division (or off to another company). We can debate how often this happens, to be sure. But we really can’t debate that this does happen.

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Bayer, the manufacturer of Yasmin and Yaz birth control, is slowly moving in the right direction by strengthening its warning about blood clots. There is no plan to update the warning with respect to gallbladder injuries. Plaintiffs’ lawyers in the Yaz/Yasmin lawsuits contend that the progestin contained in the pills, drospirenone, is causing serious health problems in otherwise healthy women, including deep vein thrombosis (blood clots in the deep veins), strokes, heart attacks and gallbladder disease.

The FDA informed Bayer in a letter earlier this month that it is responsible for updating its warning on a key issue in the Yaz lawsuits: whether Yaz causes blood clots. Still, Bayer is not putting a warning on Yaz/Yasmin that is going to clear its duty-to-warn obligation in future blood clots cases (and, again, this warning has no impact on the Yaz gallbladder cases). The new Yaz/Yasmin labels make clear Bayer is not backing all the way down: “The serious side effects of the pill occur very infrequently, especially if you are in good health and are young.”

Bayer is in an interesting spot with Yaz/Yasmin. These birth control drugs combined were Bayer’s most profitable drug last year. Yaz and Yasmin are also Bayer’s biggest seller and the leading birth control pill in North America. I strongly suspect Bayer realizes a strong warning means less prescribing doctors which means less profits. But if Bayer ignores the growing evidence that Yaz and Yasmin are more dangerous than other comparable birth control pills, they are risking lawsuit payouts that exceed the generous profits they now enjoy. Nothing short of a Yaz recall is going to stop the flow of future lawsuits.

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Gauging the next “move” based solely upon how much the other side has budged- “tit for tat” negotiations with no bearing on one’s own case evaluation is another common mediation mistake. It is understandable that negotiators and mediation participants desire proportionality and reciprocity in adjusting demands and counteroffers. The problem is that many adjusters think that plaintiffs have no ceiling on the amount that they can demand, whereas defendants can never offer anything less than zero. For this reason, arguments that, “We’ve come down by $100,000 so you need to come up by $100,000” often fall on deaf (adjuster or defense lawyer) ears.

Defense lawyers often set up mediations better than personal injury lawyers. The defendant’s lawyer will call you and ask for a demand. You decide to be reasonable. So when you show up at the mediation, the range is between reasonable and zero. That is the wrong psychology to settle a case.

The best way to address this problem: if defendant puts you in this game, don’t be above the game with your reasonableness. Your opening demand under this dynamic should mirror the defendants’ maximum exposure. Most states now have caps on non-economic damages. Add up your economic damages: past and future medical expenses, past and future lost wages, loss of earning capacity, vocational training and/or rehabilitation. Add that number to the amount allowed under the applicable non-economic damages cap. This should be a good approximation of the maximum exposure on the claim. With any luck you will be right around the amount of the reserve the insurance carrier has set for the claim. This should help in estimating the settlement value of the case on the continuum between maximum value and zero. This will let you calibrate your demands to where you want to end up on a case, not necessarily to match the other side amount for amount.

This tactic only works in a case where it is possible a jury would give such an award. Not likely but “best day possible.” If you are demanding the cap in a soft tissue injury claim, you are also sending the wrong message. Similarly, when you demand $5 million in a case where your cap is $2 million, you are sending the same “I’m not exactly sure what I’m doing” message.

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Sean Wajert’s MassTortDefense blog reports that Bayer moved last week to dismiss the master complaint in the federal MDL involving combination aspirin products pending in New York.

Plaintiff’s’ lawyers in this MDL allege Bayer marketed combination aspirin and dietary supplement products without approval from the FDA and deceived the plaintiffs and putative class members with respect to the safety and efficacy of the products.

So the plaintiffs used these products and suffered serious injury which is why we are making a federal case out of this? Not really. Instead, plaintiffs claim damages because they say they would not have purchased these products if they had known that Bayer did not file a new NDA for each of these combination products, but instead relied on prior FDA review.

I’m sitting in the back row but I’m just not a huge fan of lawsuits against drug companies where no one has actually been injured. I also realize that complex litigation with what I’m sure are sophisticated issues cannot be reduced to a tag line like, “C’mon aspirin has been around for a zillion years.” That said, aspirin has been around for like a zillion years.