Drug Recall Lawyer Blog

Two pharmaceutical manufacturers, Watson Pharmaceuticals and Sandoz/Geneva Pharmaceuticals, have settled drug pricing lawsuits for $145 million, according to a settlement agreement filed in federal court. Watson makes generic drugs; Sandoz is owned by Novartis' generic drug division (did you know they had one?).

By now, the allegations in these claims are commonplace. The lawsuits alleged that these drug companies charged government health care programs inflated prices for prescription drugs. This case spun out into an MDL in the District of Massachusetts.

Both lawsuits were filed under the U.S. False Claims Act - a whistleblower statute - by Ven-A-Care of the Florida Keys Inc., a specialty pharmacy. The law allows whistle-blowers to file on behalf of the government and share in any recovery. Their lawyers are pocketing some real cash, Ven-A-Care gets some found money (between the two, $8.3 million), and the states make out well, too. The big ones bring home the real bacon: Texas will receive $29.5 million, Florida $20.2 million, and New York $79 million.

Continue reading "More False Claim Act Settlements: Watson and Sandoz" »

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).

Bristol-Myers Squibb issued a recall yesterday for a single lot of its blood thinning drug Coumadin. The recall affects certain 5-milligram Coumadin tablets that expire September 30, 2012. The recall came after an oversized tablet.

My dad ended up in the hospital once for a Coumadin overdose. But it wasn't Bristol-Myers fault. My dad got the amount mixed up in his head and was taking like four times the recommended dose. So he started bleeding like crazy. (We still played tennis that weekend.)

With all due respect to Ted Frank, the Drug and Device Law Blog is making a mad run at the all time lead for snarky comments about plaintiffs. I'm a traditionalist; I would like to see a playoff.

Here's the latest open-ended, unexplained jab at plaintiffs made in a comment about a federal judge's ruling in the Kugel hernia mesh cases:

The court rejected defendants’ motion to strike plaintiffs’ experts, who were an assistant professor of surgery at Harvard Medical School and a long-time professor of bioengineering and orthopedic surgery research at the University of Pennsylvania. We don’t see many plaintiffs’ experts with those kinds of credentials, and their credentials and experience appear to have persuaded the court to overlook an otherwise shaky foundation for their testimony.

Really? Where is the evidence/argument you refer to that this federal judge was overwhelmed by the experts' credentials? I'm fine with anyone taking this position - who knows, maybe they are right - but how about offering a fact or two to support your position. If you are unabashedly committed to taking the defense position on every issue, it is a little hard to jump all in based on unsupported analysis.

Continue reading "Funny Line from Drug and Device Law Blog" »

Zicam lawsuits? The ones where people get hurt? I support them. Zicam lawsuits where the investors are complaining they got the shaft? Less so.

Of course, the Supreme Court has my back on all pro-plaintiff lawsuits that I really didn't care about in the first place. The Court unanimously ruled yesterday that investors suing Zicam's manufacturer can rely upon the failure to disclose reports of adverse affects about Zicam.

I own stock both for investment and for the sport of it (it is like playing craps with the wind to your back). But I'm not a huge fan of these shareholder lawsuits.

If your sole source of information about drug and medical device companies was the Drug Recall Lawyer Blog, you would have a pretty low opinion of drug and medical device companies. We all agree that drug companies are doing great things and awful things. We just disagree with the balance.

On the very positive side of the ledger sheet for drug companies is Bristol-Myers Squibb's incredibly exciting news that its new drug Yervoy prolonged survival in advanced skin cancer patients.

Because many skin cancers are extremely minor - my wife was diagnosed with incredibly minor skin cancer last year - skin cancer does not get as bad of a rap as it should. Some skin cancers - particularly, obviously, advanced skin cancers - are tough to combat.

Bristol would have gotten an even bigger on line hug from me if they had actually released the test results. Why not? But let's not cut it too thin. I take them at their word that Yervoy is testing great. And I don't mean that in the Mitch McConnell "I take President Obama at his word that he is a Christian" sense of the phrase.

Not so fast: Why the FDA might now approve Yeroy

President Obama does not really hate drug companies. The title of this blog post probably made you look. Sorry. I just fell into the same trap as this Motley Fool article entitled "Obama Hates Your Drug Company."

Actually, the article could also be titled "President Obama Loves Your Generic Drug Company." His new budget proposal includes new law that would allow generics to get on the market sooner rather than later, by reducing the 12-year exclusivity period that biologic drugs have now down to seven years. (I'm oversimplifying the President's plan a little bit here but that is the gist of it.)

It is unlikely to pass Congress, according to this article. Maybe strangely coming from a plaintiffs' lawyer, I have some concern about not giving drug and medical device companies enough time to enjoy the exclusive fruits of their discoveries. I don't know what the optimal period is to balance the competing interests between lower cost drugs and innovation but I just fear there is temptation to tinker with it in the short term to reduce costs (read: Medicare costs) at the expense of innovation.

The Baltimore Sun is reporting that the Maryland General Assembly is considering legislation to bar gifts from drug and medical device companies to doctors as another backlash from the St. Joe's stent debacle in which a doctor is accused of performing unnecessary stent procedures.

How does this tie in to gifts for doctors? Good question. I'm not entirely sure. Maryland doctors are commonly paid by drug and medical device companies to promote products to other doctors. So the thinking is maybe Abbott's incentives helped push stents?

If they enact this law, they will be making a good law for all the wrong reasons. Which I guess is okay. But, let's be realistic. It is never going to happen. Doctor and hospital lobbyists plus drug company lobbyists plus no real public inertia for change equals no change. You can bank on that equation.

• Hospitals to put doctors' relationships with pharmaceutical companies under the microscope (The Denver Post). Of course, they have been saying this for years. But I never see anyone actually pull out this microscope. Five years from now, I will link to a similar article suggesting the dawn of a new era. Hopefully, they will be efficient with their time and just cut and paste this article.
• Aggressive drug marketing and resultant prescribing causes harm to patients (Emax health). Aggressive drug marketing is not good for patients. Another "haven't we seen this before?" study.
• Research and Markets: Allergan - SWOT Framework Analysis (Business Wire)
• Ask Not For Whom the Drug Tolls (Intermex Financial). “If Huckleberry Finn and Tom Sawyer were in a school in Massachusetts today, they’d be drugged with Ritalin, according to many psychiatrists and other experts.” I guess the question is whether that would be a bad thing. I'm not sure one way or the other. (Using the word "drugged" certainly baits the answer.) I could probably offer more insight if I had read Huck Finn instead of the Cliff Notes. They should have put a warning about this in ALL CAPS.

Continue reading "Today's Stories and Links" »

The Oregon Attorney General John Kroger announced today that a lawsuit has been filed claiming that Johnson & Johnson should not have left its defective Motrin on the market.

The allegations are problematic for J&J. The lawsuit claims that instead of coming clean, J&J planned a "phantom recall" by quietly pulling the defective product.

Again, I appreciate Oregon's view. But the real end game is stopping and punishing drug and medical device companies when they are putting the public in real danger as opposed to selling a product that smells bad. I think there may be a forest for the trees problem.

Too often, drug companies choose profits over people. I'm sure this statement is true. But the cousin of this argument, drug companies make too much money, I think is flawed.

A story I just read underscores why drug companies can charge $200 for a pill that costs $.05 to make and still be charging a fair price. Inspire Pharmaceuticals suffered an awful setback for both the company and for cystic fibrosis patients when its experimental treatment for cystic fibrosis failed to improve patients' health in a critical study of the treatment's safety and efficacy. Their stock fell, good people will probably lose their jobs, and cystic fibrosis patients continue to look to the next horizon for better treatment options. There are a lot of losers for every drug that is not a hit and not just the pharmaceutical company that will have no profits from which to draw for their next experimental treatment.

Why make this point on the Drug Recall Lawyer Blog? Because I think it is important to identify the real problem. When we say these drug companies just make too much money, the fallacy of this argument bleeds into the real truth: businesses in general have a tendency to put profits ahead of people and we need effective watchdogs of personal injury lawsuits and government regulation to level off the tendency. This does not mean most businesses do this. Most businesses and most drug companies do the right thing. But too many do the wrong thing and those folks need to be watched like hawks. A big company like Johnson & Johnson has divisions that are like companies. Some are great and some are not so good.

But railing against pharmaceutical companies profits is general as opposed to specific examples of individual companies putting profits ahead of safety is not productive and is just plain wrong. I think I can prove this. If you think drug companies are too profitable, go buy some pharmaceutical stocks on the NYSE. If you don't, they are not too profitable.

Last month, I took exception to a Drug and Device Law Blog post and wrote a semi snarly retort on the topic of the confidentiality of discovery documents.

Bad move. The Drug and Device Law Blog fired back a response pretty much took my post and beat me over the head with it. Adding insult to injury, they did it with good writing and good humor. I hate it when the bad guys are good and funny. It makes them seem almost human, an idea that fits in poorly with my world view.

I thought they got some of the substance just dead wrong and there was lots of room for a good counterattack. But to find the time to write a cogent, witty response to rival theirs? They spit that response out in an hour, I bet. It would take me all day to come up with something and it still would not have been as well written.

Thankfully, my brother jumped in to stand up for me. My brother? Yes, for our purposes here, my brother. Justinian Lane stepped up and wrote the response I wanted to write. Even better, actually. It is really worth reading.

So instead of beating this topic any further, I'll comment off-topic to the core issues in this debate and address another fascinating point Justinian makes about the economic disparity between plaintiffs' lawyers and defense lawyers:

In DDL’s first post, they made a quip about plaintiffs’ lawyers buying Maybachs, and now they’re complaining that “plenty” of plaintiffs’ lawyers have private jets. While I don’t think that the authors of DDL are green with envy over the financial success of a few plaintiffs’ lawyers, plenty of their readership is. By and large, defense lawyers go to better schools than plaintiffs’ lawyers, earn better grades, write better briefs, and I’ll say it – are better lawyers. And they know it. It therefore irritates them to no end that lawyers who they perceive as being inferior to them are more financially successful than they are.

I don't know that defense lawyers are better trial lawyers than plaintiffs' lawyers in mass tort cases. Plaintiffs' lawyers get more reps because, typically, plaintiffs' lawyers have more trial experience. A lot of great mass tort defense lawyers can go a career without trying a case. I'm not saying they can't do it effectively when called upon but, like with most things, experience counts. Pharmaceutical companies hire great trial lawyers but if cases are remanded all over the country, they don't have as deep of a bench as plaintiffs' lawyers.

Continue reading "Pick a Fight with Me and Pick a Fight with My Brother?" »

Too often, we look to lawsuits as our first resource to settle disputes. People need to stop bundling all of their problems at the doorstep of someone else and take responsibility for their own mistake (illness, condition, etc.).

This is the Drug Company Manifesto, page 1. Fair enough. But these drug companies are like those who believe that driving 55 mph is for everyone but them.

Lately, when doing research on claims against various drug and medical device companies, it has taken me an inordinate amount of time to find what I am looking for because I have to weed through so many patent lawsuits between these drug companies. The wars between these companies remind me of the ongoing wars in George Orwell's 1984 where the enemy was always changing. In some ways, they should be thanking plaintiffs' drug injury lawyers because we create a common enemy they can rally behind.

Drug companies disdain all lawsuits except for the ones they file.

I have a great dentist. My wife has been going to him since she was a teenager, and when I moved to Maryland I signed on, too. He’s personable, understands a little about out-of-the box marketing (he’s the only one of my health care providers who actually sends e-mails), and does a great job. However, my wife and I have an inside joke that his office is really a front for the mob.

How do I know? Before any appointment, I get crazy calls to confirm the appointment. By crazy, I mean they will start calling a week before, and if I don’t return the call within 30 minutes, they call again. And again. And again. I know—they lose money if I don’t show up, because that’s time they could reserve for another patient. But, their practice of repeated (I won’t say harassing, but it feels that way) calls makes me wonder if it isn’t a matter of time before they come out with wood baseball bats and thumb screws if I were to ever miss an appointment.

The Red Cross is the same way.

Continue reading "What Do The Mob and Drug Companies Have In Common?" »

A really nice Bloomberg article on whistleblowers "hit the stands" today. The authors, David Voreacos and Margaret Cronin Fisk did an excellent job of tracing the payouts and controversy surrounding corporate employees of drug companies who alert the DOJ to bad pharmaceutical practices. Essentially, the act of telling the DOJ gives the federal government the ability to recoup millions of dollars, a portion of which is given to the whistleblowers as an incentive payment. Without that payment, few whistleblowers would risk their jobs and peer ostracization to bring these bad practices to light. Some think the payments to whistleblowers are too high. I don't have any problem with it--it may encourage others to report bad practices (and remember--not all whistleblowing cases are accepted, or result in multi-million dollar settlements).

See our prior Seroquel/Whistleblowing blog post.

I saw a link the other day to CNBC's "Pharma's Market" by Mike Huckman titled The Funny Business of Selling Drugs. Unsure if it was truly funny or more simply "funny" in the sense of "something funny is going on, here," I clicked the link.

Turns out it's a little of both. It's a brief article about an HBO Comedy, "The Life and Times of Tim" (which, admittedly, I've never seen nor heard of).

According to the article, one episode has the following premise:

The show is a bawdy, hilarious send-up of doctors' offices that are overrun by so-called "Meals on Heels." That's industry slang for the stereotypical short-skirted, wheely-bag toting, lunch-catering drug sales reps.

As funny as it may (or may not) be, there is usually a little truth behind most jokes. The description of the episode seems to be an indictment of sorts against the way things are done in the Pharm industry--drug companies selling their wares by plying doctors with gifts--little things, like office supplies, stress balls, gadgets, and trips to Hawaii. Is there a better way to keep doctors informed about your products? Well, we're all human, and without a personal incentive, we may not have any interest in learning about these products (I routinely refuse to see vendors who "stop by" the office without an appointment, though some in my office love to spend 30 minutes chatting for some complimentary swag).

Bribery (and that's what it is) doesn't exactly send the right message. I'm sure the drug companies will defend the practice, saying that doctors use their independent judgment, and they are using the gifts as a means to get in the door so they can have a really serious sit-down, but what human wouldn't want to "earn" the free gifts, or at least repay the favor? Surely there is a better way...

To follow up on our March 2, 2010 post BigPharma Goes All “Social Media” is a website that features all comments submitted to the FDA on the social networking question. A somewhat more readable version (though, less complete) is at www.fdasm.com. Here are links to some of the heavy hitters (including law firms and internet providers) who have commented. The papers are downloadable directly from the website.

• Abbott
• AstraZeneca
• Bayer Healthcare
• Covidien
• Eli Lilly
• Google
• Hogan & Hartson
• Johnson & Johnson
• Medtronic
• Merck
• Novartis
• Pfizer

Here are the week’s stories:

• Adverse Events: Our friends at the US Recall News have a link to governmental agencies in charge of adverse event complaints and concerns.
• Avandia: Lots of concern recently about diabetes drug Avandia and heart problems (HT: Nursing Home Abuse Blog).
• Iqbal: The Lewis & Clark law review released its symposium “Pondering Iqbal.” There’s some good topics here—a must read (HT: PrawfsBlog).
• BPA: More on BPA research (HT: Nash & Associates).
• Fentora: This narcotic painkiller is the subject of possible off-label promotion (HT: Drug Injury Lawyer Blog).
• Pharmaceutical Marketing: The title says it all: “A Snarky Look at Sneaky Marketing Tactics Pharma hasn’t Avoided" (HT: Pharma Marketing Blog).
• Gadolinium/Omniscan: A settlement has been reached in the libel suit brought by General Electric (GE) against Danish researcher Henrik Thomsen.

Happy Monday!

In Foster Care Children and Off-Label Drug Use I discussed the use of drugs, particularly psychotropics, to medicate children. In Who Do The Drug Companies Cater To? I talked about doctors (one in particular) who, by all accounts, clearly overprescribed medications, including Seroquel and clozapine.

Now, an article from the Anchorage Daily News reports that the Law Project for Psychiatric Rights filed a federal lawsuit against over a dozen Alaskan psychiatrists, stating that the doctors “unnecessarily drugged children and committed Medicare fraud.”

The article points out that children on Medicare are four times as likely to be put on antipsychotic medication as children who have private insurance. 90% of children seeing psychiatrists are put on medication, while less than 10% of those medications are FDA approved for children.

Assuming these facts are true and that doctors are overmedicating children in Anchorage, some may think that the doctors are to blame. They have the ultimate responsibility, having intimate knowledge (hopefully) of their patients’ conditions, and being able to fully and fairly judge what medication, if any, they should be on. Others may point to the drug companies, who encourage doctors to prescribe drugs to patients, often for off-label uses which have not been safety-tested or FDA-approved. Those same drug companies may use subtle persuasion to enforce these practices—lunches, gifts, and vacations masquerading as medical education seminars.

But one thing is certain—if a drug company sees a physician or group prescribing an inordinate percentage of their drugs, they should spend some time with that physician/group to make sure that the doctor fully understands what the drug is approved for? The drug companies have track these statistics, but something tells me many of them happily look the other way and their profits climb…

Here are links to some stories we’re following:

• Hormone Therapy: New Philadelphia hormone therapy case proceeds to trial, and the plaintiff’s twin sister, who sits in the courtroom and took a different type of hormone therapy, did not have cancer. Both sides try to use it to their advantage
• Ortho Evra MDL: The judge addresses the issue of plaintiff ex parte communication with treating physicians (HT MassTortDefense Blog)
• Digitek: Bad news for some plaintiffs’ lawyers in the Digitek lawsuits (HT Overlawyered)
• Social Media and Drug Companies: Several drug companies have banded together to comment on the FDA’s proposed policies on promotion of medical products using the internet and social media (HT Pharma Marketing Blog)

Happy February!