Maryland Injury Lawyer Blog

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 "Maryland Pradaxa Lawsuits" »

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 "Baltimore Dialysis Injury Cases: What Happened?" »

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.

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 "Maryland Actos Lawsuits" »

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 "Actos and Cancer" »

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 "Yaz Lawsuits and Plaintiff Fact Sheets" »

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.

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.

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.

The Yaz lawsuits pending around the country in federal court were consolidated yesterday in MDL-2100, Yasmin and YAZ Marketing, Sales Practices and Products Liability Litigation. John Cord's Drug Recall Lawyer Blog provides all of the details of the transfer. You can find an explanation of what the Yaz MDL means to pending and future Yaz lawsuits here.

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.

The Yaz and Yasmin litigation is just now starting to take off, with at least 11 lawsuits around the country. Lawyers evaluating Yaz/Yasmin cases need to pay particular attention to (1) the injuries; (2) the defendants; and (3) viable claims.

Continue reading "Yaz Lawyer: Information for Attorneys Handling Yaz/Yasmin Lawsuits" »

CNN reports that an FDA government advisory panel voted yesterday to recommend eliminating prescription drugs that combine acetaminophen with narcotics -- such as Vicodin and Percocet -- because of their risk for overdose and for severe liver injury.

I'm glad to see the FDA is looking at the safety and efficacy of existing drugs. There is no question that Vicodin and Perocet are misused and overprescribed. My only fear with a recall or withdrawal of these drugs for what I'm guessing is the 5% of people on Perocet or Vicodin that really need the drug. They are in great pain, are not finding relief elsewhere, and the benefits of the drugs far exceed the risk of overdose or liver damage for that patient.

The Courier-Journal in Louisville, Kentucky has an article on an amazing lawsuit in Kentucky in yet another derivative claim of the fen-phen litigation. Plaintiff claims that her lawyers told her that her echocardiogram showed that her heart was "like a tire that might burst” as a result of the use of fen-phen.

The claim made by a former paralegal of the law firm handling the case is beyond stunning: medical tests were altered to show more heart damage than expected and destroyed test results that were not consistent with plaintiffs’ lawyers’ theory of the case.

The law firm did what a lot of plaintiffs’ law firms do in product liability cases where there is a chance of significant recovery: they offer plaintiff a medical test at no charge which is characterized as an independent medical exam. In this case, the test was an echocardiogram.

As many good stories do in 2009, this one also involves sex and (audio) tape. Plaintiff’s lawyer is accused of telling his client that she needed to “spend some time on [her] back” with him (later in the conversation he said he was kidding), that he wanted to touch her breasts, asking her how many people she had had sex with, and the like. Plaintiff taped the conversations because – get this – her husband did not believe her. The article gives the impression that Plaintiff never really voiced objection to these comments.

Who do you root for in a case like this? Not the lawyer who, on his best day, acted inappropriately in the case. Bar counsel in Kentucky has put on hold its evaluation until after the case, but eventually these claims are going to be heard. But it also hard to root for a Plaintiff who claims the lawyer and his law firm damaged her "mentally and emotionally" and "caused her a great deal of humiliation.” Exactly how much money are allegations like this worth? There is no question that the allegations are very serious. But there is an incredibly important difference between making allegations of serious misconduct and allegations of serious injury.

A hospital did not breach a duty of care as a matter of law to a police office who was injured responding to a traffic accident allegedly caused by a just-released colonoscopy patient, Massachusetts' highest court has ruled, affirming the trial court below.

The police officer responded to an emergency report of a pedestrian-automobile accident. On his way to the scene of the reported accident, Plaintiff's police car was hit by another car, causing what were apparently pretty serious injuries. The pedestrian involved in the accident to which the Plaintiff was responding had earlier that day undergone sedation after a colonoscopy at Brockton Hospital. Plaintiff's theory of the case was had the hospital provided an escort for the patient/pedestrian, he would not have had to respond and the accident would not have occurred.

Specifically, Plaintiff argued that a duty of care existed under two theories to back door the foreseeability problem: (1) a "special relationship" the hospital had with the patient and with Plaintiff, (2) a voluntary assumption of a duty of care by the hospital to protect third parties from harm caused by "impaired" patients.

The case generated some attention. Amicus briefs filed by the Massachusetts Academy of Trial Attorneys in support of Leavitt, and by the Massachusetts Defense Lawyers Association and the Professional Liability Foundation, Ltd., in support of the hospital.

The Massachusetts high court found that both theories were not distinctions from the duty and foreseeability problem in finding that a hospital owes a duty of care to a nonpatient third party to prevent a sedated patient from causing injury after the patient leaves the hospital.

Whether negligence extends to "an innocent third-party bystander" was recently decided in Maryland in Gourdine v. Crews. In that case, the family of a man killed in an auto accident brought a lawsuit against Eli Lily claiming that his death was caused by a diabetic who blacked out while under treatment with two insulin medications.

Continue reading "New Massachusetts Opinion on Duty and Foreseeability" »

We recently added a sixth lawyer, John Cord, to our team at Miller & Zois. You can read his biography here.

John has started his own blog, the Drug Recall Lawyer Blog. This blog is directed a product liability lawyers handling drug and medical device case in Maryland and around the country. If you find it useful, add it to your list of favorites (as well as the Maryland Injury Lawyer Blog, of course).

The Washington Post has an article providing more detail on Study 15, the Seroquel study that saw the same fate as many pharmaceutical company drug trials do that the companies don't like: they stick them in their glove compartment - even deeper than I would stick my parking tickets in college. The chickens came home to roost on my parking tickets about 9 months later. AstraZeneca has had this study stuffed away for 12 years.

For the folks that made a ton of money off Seroquel and have since left AstraZeneca, it all worked out just fine, didn't it? Is it that same warm fuzzy feeling I got when I learned that many of the guys that caused the AIG debacle got huge bonuses? No, the feeling is different for two reasons.

Continue reading "Seroquel Study 15" »

Wyeth v .Levine!!!! Plaintiffs' lawyers have seen drug (and medical device) injury victims take punch after punch. But in a huge win for patient safety, the Supreme Court upheld in a 6-3 ruling today that in a Vermont woman's verdict against Wyeth for injuries she suffered after taking one of the drug maker's medicines. Justice John Paul Stevens, writing for the majority, said FDA oversight of drug labeling doesn't prevent the filing of state tort claims.

It is a little bit pathetic that this is a huge win. Gee, the law for the last 90 years is not going to be completely uprooted. Yippy! But the Drug and Device Law Blog predicted victory and those guys have been on the winning side of most everything lately. (A guest Drug and Device Law blogger also broke down the justices individually and predicted victory but I cannot find the post to link to it.) So I'll admit I was more than a little scared. Now, I'm thrilled that even this conservative Supreme Court found decisively in favor of the Plaintiff.

The one downside: a loss may have mobilized Congress to act. This win in Wyeth v. Levine could ironically slow progress on a bill to overturn Medtronic v. Riegel.

You can find an article on the verdict here and comments on Justice Alito's dissent here. You can find the Supreme Court opinion in Wyeth v. Levine here.

Last Wednesday, I reported on the Seroquel summary judgment in Florida in the much awaited first Seroquel MDL. The opinion appeared to give AstraZeneca Pharmaceuticals a boost (although there are a thousand variables that are involved in the 1% rise in the stock price – the Seroquel lawsuits are a small piece of the large mosaic that is a major pharmaceutical company) and depress not only Seroquel litigants and their lawyers, but also plaintiffs’ lawyers in drug and medical device litigation, who have had a tough year.

But after reading the order granting the summary judgment in this Seroquel case, the reports of the demise of the Seroquel litigation were greatly exaggerated. This case was decided on its particular facts, and the fact pattern in this case was not advantageous for Seroquel lawyers.

Continue reading "Seroquel Lawsuits: Followup to Summary Judgment Ruling in Florida" »

Unfortunate setback today in the AstraZeneca Seroquel lawsuits pending in federal court: two lawsuits set for trial in Orlando next week have been dismissed. This was the first MDL class action trial in federal court, where most of the Seroquel lawsuits have been filed.

The judge’s reasoning for throwing out these Seroquel cases was that the scientific evidence does not “meet the standards" to go to trial. I cannot figure out whether this is a general or specific causation opinion with respect to the link between Seroquel and diabetes. I assume it is the latter because I do not think there is dispute of the link between Seroquel and diabetes.

The Bloomberg article on the ruling mentioned something from one of the plaintiffs' Seroquel lawyers I found particularly odd:

This ruling basically means that there were some glitches in how these two cases were prepared for trial.

I'm sorry? Come again? What glitches? Can we get a little further explanation? Someone needs to clue in reporters in these kinds of cases: it is okay to ask follow-up questions.

I will report more when I learn the exact basis for the ruling. Not much good news for plaintiffs in the drug and medical device world of late.