October 2010

Google is famous for its motto of “Don’t be evil.”  I’m beginning to wonder if GSK has adopted a motto of “Be evil.”  In addition to selling Paxil without adequately warning women that it causes birth defects, GSK also knowingly sold Paxil that it knew wouldn’t do anything to help patients:

In one of the largest False Claims Act cases to date, a subsidiary of the pharmaceutical giant GlaxoSmithKline will plead guilty to charges related to the manufacture and distribution of contaminated drugs at a plant in Puerto Rico and pay $750 million in civil and criminal penalties, the Department of Justice announced on Tuesday in Boston.

* * * *

The DOJ said SB Pharmco failed to ensure that Kytril and Bactroban were free of contamination from micro-organisms and that the manufacturing process caused Paxil CR tablets to split, raising the possibility that some tablets were useless as therapy. The Avandamet tablets did not always have the mix of ingredients approved by the Food and Drug Administration, according to the DOJ, and the Cidra plant was plagued by production problems that sometimes caused different kinds of tablets to be packages in the same bottles.

Source: GlaxoSmithKline Settles with DOJ for $750 Million for Faulty Drugs | Main Justice

Avandamet is another version of Avandia, the drug that has basically been pulled off the market in the U.S. because it is so strongly associated with heart attacks.  One wonders whether any heart attacks were caused because of a wrong formulation in batches of Avandamet.

The reason I wrote this post and used the word evil, though, has to do with Paxil.  I recently read through the trial transcripts of a Paxil birth defect lawsuit.  During the trial, GSK repeatedly argued that people who need Paxil need Paxil and that Paxil is a “miracle drug.”  If Paxil really is so critically important to patients, then it’s evil to knowingly sell those patients a bottle of Paxil pills that are useless.

Between the Avandia settlement, the Paxil birth defect settlement, and this new settlement, 2010 is proving to be an expensive year for GSK.  Let’s hope that doing  evil eventually becomes so expensive that GSK decides it isn’t profitable.

Pharmaceutical companies use cheesy marketing gimmicks to help train their sales people.  Rhymes and limericks are perennial favorites.

Someone sent me a few of the ones used for Ortho Evra.  Get a load of these:

The patch contains hormones you knew;
E and NGMN are impregnated in glue.
It blocks eggs from a poppin;
Changes mucus for sperm blockin.
After one try, women will ask to renew!

Ortho-Evra – it works like a charm,
whether it’s placed on the butt or the arm.
It works largely by stoppin
those eggies from poppin,
Whether you live where it’s cold or it’s warm!

Move over pill, ring, and injectable.
Introducing a patch quite delectable.
The woman decides
On which cheek it resides.
It’s discreet and not too detectable!

If I were unethical, I’d go on about how limericks like these show that the company disregarded safety and focused only on sales, made jest of risks, etc.  But I’m sure that the science and safety guys weren’t spending their days writing limericks. 

Instead, I look at these and try to figure out who wrote them.  I figure it was either the most vapid airhead you’ve ever met in your life, or an English major whose life did not turn out the way he or she planned.

I also wonder if there was some lame training class in which all the reps had to sing these out loud.  If so, I imagine that all of the sales reps but one just gritted their teeth and went through it, but there was one rep who was really into it.  I also imagine that no one else liked that rep.

Anyway, I thought I’d share these because I know I’m not the only one who enjoys glimpses into big pharma.  If you’ve got any other limericks or gimmicks to share, shoot them my way.

Here’s a hypothetical for you: A patient goes to see a doctor about chronic heartburn.  The doctor thinks Reglan might be a good choice, so the doctor goes to the Physicians’ Desk Reference and reads the label for Reglan.  That label was written by Wyeth, which was the brand-name manufacturer of Reglan.  Based upon what was in the PDR, the doctor prescribes Reglan.  The patient gets the prescription filled, but the pharmacist substitutes a generic version of Reglan.  Eventually, the patient develops tardive dyskinesia and learns that the label for Reglan was filled with falsehoods.  Had the label been truthful, the doctor would not have prescribed Reglan to the patient, and the patient would not have a movement disorder.  Who should be liable, Wyeth or the generic manufacturer?

The pharmaceutical industry says neither company should be liable.  Because the patient didn’t take a pill made by Wyeth, big pharma says Wyeth shouldn’t be liable even though it knowingly disseminated a false label.  And the generic shouldn’t be liable in big pharma’s opinion because the generic supposedly can’t fix the false information in the label.  (Yes, generics can, but that’s the subject of another post.)

Prior to 10/20/10, only one court in the country that I know of would hold Wyeth liable in that situation.  That Court happened to be a California state court, and the decision was Conte v. Wyeth, 168 Cal.App.4th 89 (2008). To say that the pharmaceutical defense bar hates the Conte case is an understatement.  Defense lawyers say “outlier” to describe Conte when they want to be kind, and “wacky California decision” when they express their true feelings. 

I can only imagine that the order denying Wyeth’s motion for summary judgment in Kellogg v. Wyeth, 2:07-cv-00082 (D. Vt. Oct. 10, 2010) will give defense firms the sort of heartburn that Reglan was intended to treat.  Here’s a very pertinent part of the order:

At issue is whether it is reasonably foreseeable that a doctor, in reliance upon false or misleading information disseminated by a brand name drug manufacturer, will write a prescription that will be filled by the bioequivalent generic form of the drug.

* * * *

Ultimately, although the decisions from other jurisdictions
may offer insight, this Court seeks to follow the common law as
it has developed in Vermont. There is no reason, under Vermont law, to limit Wyeth’s duty of care to physicians by the
pharmacist’s choice of a generic bioequivalent drug to fill the
physician’s prescription.

To save you the PACER hassle, here’s the order in its entirety.

Finally, let me offer my hearty congratulations to Ralph Pittle, the Reglan lawyer behind Conte and Kellogg.  Ralph is a good friend of mine, and I can honestly say he has the biggest heart of any lawyer I know. 

If you use a 25 mcg/hour fentanyl patch, you’ll want to check to see if it’s on this Actavis recall:

Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient faster than the approved specification in laboratory testing. An accelerated release of Fentanyl from a 25 mcg/hour patch can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). The patches are packaged individually and boxed in quantities of five patches per box.

Recalled Control/Lot #s

30041, Exp 12/2011
30258, Exp 03/2012

30049, Exp 12/2011
30349, Exp 03/2012

30066, Exp 12/2011
30350, Exp 03/2012

30096, Exp 01/2012
30391, Exp 03/2012

30097, Exp 02/2012
30392, Exp 04/2012

30123, Exp 01/2012
30429, Exp 04/2012

30241, Exp 02/2012
30430, Exp 04/2012

30256, Exp 02/2012
30431, Exp 04/2012

30257, Exp 03/2012
30517, Exp 04/2012

Source: Recalls, Market Withdrawals, & Safety Alerts > Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/h

I would also suspect that a defective fentanyl patch like this could lead to death from acute fentanyl intoxication.  If you have a recalled patch, definitely click the link above to the FDA and follow the directions on exchanging the patches.

I’ve had the opportunity to email Dr. Elliott several times since interviewing him and he’s just an all-around good guy.  That sentiment was amplified today when I saw this column on CNN:

(CNN) — If you want to understand the way prescription drugs are marketed today, have a look at the 1928 book, "Propaganda," by Edward Bernays, the father of public relations in America.

For Bernays, the public relations business was less about selling things than about creating the conditions for things to sell themselves. When Bernays was working as a salesman for Mozart pianos, for example, he did not simply place advertisements for pianos in newspapers. That would have been too obvious.

Source: How to brand a disease — and sell a cure – CNN.com

Just as some believe the worst thing that happened to the legal profession was lawyer advertising, I believe the worst thing that happened to the medical profession is pharmaceutical advertising.  While I don’t know if Dr. Elliott feels that way, you can tell by reading his post that he is not a fan of the way in which pharmaceutical companies hype diseases.

This is not a good year for Johnson & Johnson.

Johnson & Johnson lost a $257.7 million jury verdict in Louisiana for making misleading claims about the safety of the company’s Risperdal antipsychotic drug.

* * * *

The jury found 35,542 violations of the state’s Medical Assistance Programs Integrity Law and imposed a penalty of $7,250 for each. The total $257.7 million verdict is the fifth- largest in the U.S. so far in 2010, according to data compiled by Bloomberg.

Source: J&J Must Pay Louisiana $257.7 Million Over Risperdal Marketing Practices – Bloomberg

Is $7,250 per violation a lot of money?  Maybe.  But keep in mind that another jury assessed over $9,000 per violation for each MP3 song a consumer illegally downloaded. 

It seems to me that ripping off the government should carry a higher penalty than downloading a song.  Especially since taxpayers don’t get billed for every song you download.

 If you're taking one of these, consult with your doctor before you decide to stop taking the drug. 

Food and Drug Administration officials said all bisphosphonates used for osteoporosis will carry a new warning about rare but serious fractures of the thigh bone, even though it remains unclear if the medicines caused the fractures.

Source: FDA warns of thigh fractures with bone drugs | Reuters

I know that some lawyers are handling fracture lawsuits.  If you'd like me to put you in touch with one of those lawyers, just drop me a line.

This is promising:

Drugmaker executives whose companies promote unauthorized uses of their medicines may be targeted by U.S. regulators for misdemeanor prosecutions, Food and Drug Administration Deputy Chief for Litigation Eric Blumberg said.

* * * *

‘“It’s clear we’re not getting the job done with large, monetary settlements,” Blumberg said. “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.”

Source: Drugmaker CEOs May Be Targets for U.S. FDA in Off-Label Cases, Lawyer Says – Bloomberg

However, I would go one step further.  As a matter of public policy, I would prevent pharmaceuticals from paying for the legal defense of anyone who is charged with criminal off-label promotion.  Let’s face it – the DOJ doesn’t have the best track record in the world in complicated prosecutions.  And the reason the DOJ isn’t winning more cases is because multibillion-dollar companies are able to provide the best defense money can buy.

If pharma executives had to pay the cost of their own defense, two things would happen.  First, executives would be less likely to engage in conduct that might get them criminally prosecuted.  Second, the DOJ wouldn’t be outgunned by multimillion-dollar dream teams.

That sounds crazy, I know.  But here’s my logic.

The vast majority of pharmaceutical lawsuits are brought under what’s called a failure to warn theory of liability.  Failure-to-warn lawsuits allege that a manufacturer of a drug didn’t accurately inform a plaintiff about the risks associated with taking a specific drug.  If the manufacturer does give an adequate warning about the risks of a drug, you basically can’t sue the manufacturer if you’re hurt.

The way in which manufacturers warn the public is through the drug’s label. The label includes the very lengthy package insert that describes the risks of the drug.  The pharmaceutical companies write that label in cooperation with the FDA.  In other words, they don’t get to just put whatever they want there.  Whatever they put in the label has to be supported by evidence and approved by the FDA.

So, the solution is simple: pharmaceutical companies could fully disclose all of the known risks of taking a drug on the drug’s label.  If they did that, there wouldn’t be anymore failure to warn litigation.  Case in point: Ortho-Evra.  If someone uses the patch today and suffers from a pulmonary embolism tomorrow, no lawyer will take the case because the label FINALLY has a strong warning about the risks of a pulmonary embolism.

So why don’t the pharmaceutical companies disclose all the risks of a drug in the first version of a label?  Because stronger warnings lead to lower sales.  In other words, the drug companies would rather sell more drugs and get sued than sell less drugs and not get sued.  So clearly it must be more profitable not to warn consumers and to get sued than it would be to virtually eliminate all lawsuits.

There’s even a safety valve built into the system that prevents a pharmaceutical company from writing a ridiculously overbroad warning label: The FDA.  As I mentioned, there must be evidence to support everything in a label.  Any warnings that aren’t justified will be rejected by the FDA.  And if by some chance, the FDA rejects a warning that it shouldn’t have, the pharmaceutical company is still safe: It’s tough to win a failure to warn lawsuit if the warning was specifically rejected by the FDA.

The pharmaceutical companies therefore have it within their power to get rid of nearly all tort lawsuits against them.  But they choose not to.  I believe that they choose not to because it is more profitable to sell additional drugs and use the profits to pay the people who are injured and do sue.

Am I wrong?