September 2010

I frequently read Drug and Device Law, (DDL, hereafter) a blog written by attorneys who represent drug companies.  I read it not because I agree with their point of view, but because I acknowledge they’re smart fellows and offer the opposite perspective of what I do.  I also frequently read the Drug Recall Lawyer Blog, (DRLB, hereafter) a blog written by an attorney who represents people injured by defective drugs.  So when I saw these two blogs get into a brawl, I knew it would be something good. In fact, it was so good I just have to offer my own opinion.

The story begins a week ago when DDL wrote about a confidentiality agreement in the Aredia and Zometa cases.  The plaintiffs in the litigation have a great number of documents that are confidential that they would like to be made public.  DDL argues that the real reason the plaintiffs want the documents revealed is so that the press attention will “create additional pressure [on the defendant to settle] and cook the jury pools.”   DDL further argues that plaintiffs routinely try and use confidential documents for improper purposes.

Three days later, DRLB suggested that while there may be some truth in DDL’s allegations, the real problem with document designation is twofold.  First, defendants designate too many documents as confidential.  And second, the public benefits from dissemination of these documents because they reveal what pharmaceutical companies really think about the safety of the drugs they sell.

DDL apparently took umbrage with the criticism, because it offered a lengthy response.  I’m not sure if DRLB is planning on responding, but I couldn’t resist doing so.  And I’ll do it in my favorite style of point-by-point refutation that is sometimes known as Fisking.

We trust that you are familiar with the typical life-cycle of confidentiality protective orders in mass tort litigation. It is as predictable (and maudlin) as an ABC after-school special. It invariably begins with plaintiffs seeking discovery of millions of pages of internal company documents. Mind you, the plaintiffs will never use more than one percent of the documents, but the process is fun for them and enormously difficult and expensive for the defendant.

Source: DDL – Lack of Confidence

Sorry, but the process is not fun for us at all.  I can assure you I’d love nothing more than to send a request to Wyeth stating, “Please produce all documents that help our case.”  If I sent that request, among other objections that Wyeth would raise is that they don’t know what the word “help” means.  So we’re reduced to sending overly-broad requests that don’t contain words with any subjective meaning.  The drug companies still complain, but they eventually produce more documents than we can ever possibly hope to review manually.  No matter whether we use manual review, computerized review, or a combination thereof, it costs us both time and money.  And unlike defense lawyers, we don’t get paid by the hour to review these documents.  We only get paid if we win, and our pay isn’t dependent upon how many hours we worked. 

DDL continues:

To facilitate such discovery, the plaintiffs grudgingly agree to a protective order that permits the defendant to designate documents as confidential, usually on trade-secret or commercial sensitivity grounds. * * * * The plaintiffs eventually decide that the defendant designated too many documents as confidential. There’s usually some truth to this accusation, because it’s hard to analyze the confidentiality of millions of documents and get every call exactly right. If one errs on the side of underdesignation, some confidential documents will end up in the hands of competitors and that sort of damage can’t be undone. But if one errs on the side of overdesignation, the documents can be dedesignated and nobody is hurt.

Source: DDL – Lack of Confidence

“Nobody is hurt.”  Actually, people are hurt.  Our clients are hurt because getting these documents properly designated usually requires us to spend time and money.  Both of those resources are finite, and when we’re dedicating them to fixing errors made by defense lawyers, we’re not helping our clients. 

DDL next argues:

But the plaintiffs want to inflict pain. More out of sadism than any legitimate litigation concern, the plaintiffs start challenging confidentiality designations en masse, forcing the defendant to submit detailed, particularized justifications for hundreds, or even thousands, of documents.”

Source: DDL – Lack of Confidence

Wrong again.  We don’t want to inflict pain.  We want to force defendants to follow the law.  And the law is couldn’t be more pellucid that a defendant may only seal documents for which good cause exists to seal them.  Don’t believe me?  Then read Citizens First Nat. Bank of Princeton v. Cincinnati Ins. Co. 178 F.3d 943 C.A.7 (Ill.),1999.  In it, Judge Posner (no friend of plaintiffs’ lawyers) explains that courts may not grant “a virtual carte blanche to either party to seal whatever portions of the record the party wanted to seal,”  and that “[t]he judge is the primary representative of the public interest in the judicial process and is duty-bound therefore to review any request to seal the record (or part of it).”  In the Zometa litigation in question, the documents the plaintiffs’ lawyers want unsealed are part of a motion for summary judgment, and thus are part of the judicial record. 

DDL complains that the defendants are forced to “submit detailed, particularized justifications for hundreds, or even thousands, of documents.”  And what forces them to do so?  Nearly forty years of law:

“The burden of justifying the confidentiality of each and every document sought to be covered by a protective order remains on the party seeking the order.”  Pansy v. Borough of Stroudsburg 23 F.3d 772, 787 (3rd Cir. 1994), citing Cipollone v. Liggett Group, Inc., 785 F.2d 1108, 1121 (3d Cir.1986), cert. denied, 484 U.S. 976 (1987). See also General Dynamics Corp. v. Selb Mfg. Co., 481 F.2d 1204, 1212 (8th Cir.1973), cert. denied, 414 U.S. 1162 (1974).

If DDL doesn’t like all the work necessary to comply with the law regarding protective orders, the solution is simple: Don’t request a protective order. 

DDL next makes a questionable statement about the laws of public access to court documents:

It’s well-established that there is no public or press right of access to discovery documents.

Source: DDL – Lack of Confidence

Actually, the 7th Circuit held that "pretrial discovery must take place in the [sic] public unless compelling reasons exist for denying the public access to the proceedings.”  Jepson, Inc. v. Makita Elec. Works, Ltd. 30 F.3d 854, 858 (7th Cir. 1994), quoting American Tel. & Tel. Co. v. Grady, 594 F.2d 594, 596 (7th Cir. 1978), cert. denied, 440 U.S. 971 (1979). 

The 1st Circuit also ruled that parti

es have “a constitutionall
y protected right to disseminate information gained by them through the discovery process absent a valid protective order…”  Public Citizen v. Liggett Group, Inc. 858 F.2d 775, 780 (1st Cir. 1988)., quoting Oklahoma Hospital Ass’n, 748 F.2d 1421, 1424 

And finally, one might consider San Jose Mercury News, Inc. v. U.S. Dist. Ct., 187 F.3d 1096, 1103 (9th Cir. 1999)  which held that “[i]t is well established that the fruits of pre-trial discovery are, in the absence of a court order to the contrary, presumptively public.” 

Perhaps DDL’s assertion isn’t as well-established as it thinks.

Next, DDL argues that courts may decline to dedesignate documents based upon the motive of the individual requesting the dedesignation:

Courts need to ask whether parties seek dedesignation in the service of a legitimate litigation need, which is fine, or something else, which is not. And that "not" might amount to an effort to apply leverage via the press or stock price impact. How does that sort of thing square with your local ethics rules?

Source: DDL – Lack of Confidence

The most popular test in federal courts to determine whether to designate a document is called the Pansy test, after Pansy v. Borough of Stroudsburg 23 F.3d 772, (3rd Cir. 1994)  The Pansy test has seven factors, and only one of them relates to the motives of the party seeking dedesignation.  And two of the Pansy factors favor dedesignation in pharmaceutical cases: Whether confidentiality is being sought over information important to public health and safety, and whether the case involves issues important to the public.  The safety and efficacy of a drug will always be a matter of public interest and important to public health and safety. 

DRLB fired back at DDL with the following:

[M]ass “tort defense lawyers are the undisputed kings of making plaintiffs’ lawyers work for pure sport. Plaintiffs’ lawyers in drug and device cases largely just want to get from Point A to Point B as quickly as possible. I think this is a function both of the personality types attracted to these very different jobs (and I’ve done both) and fundamental economics: plaintiffs’ lawyers get paid for success while defense lawyers get paid for working, even if they are just creating work. 

* * * *

Moreover, making documents public that show what drug companies are actually doing may serve plaintiffs’ lawyers’ interests but it also serves the public good. If you are taking a drug and the manufacturer has documents showing they are burying studies that reveal the drug has risks not fully disclosed, isn’t it a good thing if the patient and the doctor read about this in The Washington Post?

(Source: DRLB – Pot Calling the Kettle Black)

I agree wholeheartedly with both major points that (a) the defense lawyers are the ones with incentive to create work, and (b) the public is better off knowing if internal corporate documents cast doubt on the safety and efficacy of a drug.  DDL, however, strongly disagrees:

Third, the claim that defense lawyers seek to jack up the costs of litigation is out of date…

Source: DDL – Come at Me Bro

No, it isn’t.  The entire compensation model at most mass tort defense firms hinges upon the billable hour.  The more hours you bill your client, the more money your firm earns, and to some extent, the better your chances are at making partner.  It is a fundamental principal of economics that when you reward a type of behavior, you’re going to get more of it.  As long as defense lawyers bill by the hour, there will be defense lawyers who bill more hours than are necessary.

and the claim that the public benefits from selective dissemination of internal documents is more than a tad self-serving.

Source: DDL – Come at Me Bro

Markets (including the market for prescription drugs) work most efficiently when there is little information asymmetry; buyers are best off when they know as much as they can, and sellers are best off when they control the flow of information to the buyers.  Let’s use the timely example of Ortho-Evra.  It was recently revealed that a VP resigned from Johnson & Johnson because he had safety concerns over the patch.  Buyers are better off knowing that information because it may cause them to investigate the products of competitors.  Consumers are therefore better off, and competitors are therefore better off.  The only market participant worse off is Johnson & Johnson.

DDL also makes the patently absurd suggestion that plaintiffs’ lawyers can outspend big pharma:

There may have been a time when mass tort litigation was a war of attrition. But plaintiff lawyers got very good very fast at combining resources and coordinating attack angles. To deny that the playing field is now level is to deny reality.

Source: DDL – Come at Me Bro

Pfizer had nearly $50 billion dollars in sales and $8 billion dollars in profit in 2008.  The top 100 plaintiffs’ firms in the nation combined don’t make that much profit.  No matter how many trial lawyers “combine resources and coordinate attack angles,” they can’t outspend a major pharmaceutical. (And that says nothing of the additional millions of dollars that the pharmaceutical company’s insurers can spend.)

So DDL is wrong to say that the “playing field is now level” if you define the playing field as the ability to spend money.  But I’ll be fair and point out that in some mass tort litigation, the playing field is level.  It’s level because of the declining marginal utility of dollars spent in litigation.  That’s just a fancy way of saying that throwing more money at a lawsuit doesn’t mean you’re going to win it.  For example, if the best experts in the world cost $1 million dollars, you won’t get any additional benefit from spending $2 million on experts. 

What has happened is that certain large plaintiffs firms are able to team up and spend money up to the point where the marginal utility of additional spending begins to plummet.  Saying that plaintiffs’ firms and pharmaceuticals can both spend the optimal amount of money to prosecute their case is entirely different from saying that plaintiffs’ firms and pharmaceuticals can spend the same amount of money.

Next, DDL turns to a little sour grapes:

Meanwhile, we don’t know any defense lawyers who fly in private jets. We know plenty of plaintiff lawyers who do. A lot of clients don’t even want us flying first class. No hard feelings, by the way.

Source: DDL – Come at Me Bro

Except there are hard feelings.  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 be

tter 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. 

Let’s look at why some plaintiffs’ lawyers are so financially successful.  I can sum it up in one word: Capitalism.  In our system, those who take the greatest risks earn the greatest reward.  There is little risk in taking a job at a top defense firm.  You’ll get an exceptional salary (more than most plaintiffs’ lawyers make), good benefits, and a relatively stable company to work for.  The downside is that you’ll never be able to buy your own private jet.  Plaintiffs’ lawyers, on the other hand, take a huge risk.  They risk their capital in funding lawsuits that take years to prosecute.  In addition to the financial costs of pursuing a mass tort case, there is also an even larger opportunity cost in dedicating years of your life to a single docket. 

If you’re a defense lawyer who is irritated that some plaintiffs’ lawyer has a nicer car than you do, or has his own plane, or some other bauble that you envy, there is a solution: Quit your job and start your own law firm.  If you don’t have the guts to do that, then don’t complain that people who did have the guts have more money than you do.

DDL then returns to complaints about discovery:

We have been in cases where plaintiffs insist on the production of enormous electronic databases, and after getting them, it turns out that plaintiffs don’t even look at them.

Source: DDL – Come at Me Bro

I know a very dirty little secret about e-discovery, because I spent ten years in IT before I went to law school.  The dirty little secret is that e-discovery is a total ripoff.  Regardless of what DDL or anyone else says, it isn’t very costly at all to produce a copy of an “enormous electronic database,” or reams of email, or anything of the sort.  I did contract work for a financial services company that got sued.  They needed me to produce a copy of every email a specific employee sent or received in the past three years.  Guess how long it took me to do that?  Ten minutes to produce it, plus another five to burn it on CD.  Major corporations have disaster recovery plans that enable them to completely reproduce every piece of electronic information overnight (or within a few days) at a different location if disaster strikes.  That also means they can reproduce that information just as quickly for a lawsuit. 

Besides, some repeat defendants turn discovery into a profit-center.  One asbestos defendant went through all the trouble of compiling all of the thousands of documents that plaintiffs’ firms always want onto one nice little CD.  If you’re a plaintiffs’ lawyer, they charge you $1,500 bucks for the CD.  Now, I don’t know about you, but I can burn a CD for under a buck.  So can they.  Instead, they’re just ripping off the other side. 

DDL next argues that defense lawyers who overdesignate are actually just being conscientious:

We agree that defense designation of confidential documents is seldom flawless, and if it’s a close call we’re going to err on the side of confidentiality.

Source: DDL – Come at Me Bro

I’m working on another case in which a defendant’s entire ad campaign was designated as confidential.  The full-page ad in People?  Confidential.  The back cover of Redbook?  Confidential.  The cardboard cutout of a celebrity endorsing the product?  Yep, also confidential.  Is it erring on the side of confidentiality to designate advertisements seen by millions of people, or is designation in bad faith? 

Next, DDL denies that the public benefits from knowing more information about a product’s safety or efficacy:

The other side’s propaganda is just as baseless. There is no merit whatsoever to the suggestion that the public benefits when plaintiff lawyers strategically hand discovery documents to the press. Those documents almost never contain anything that the FDA hasn’t seen.

Source: DDL – Come at Me Bro

This is where DDL went off the rails.  The general public doesn’t make prescribing decisions.  Doctors do.  Trained medical doctors.  And when a trained medical doctor learns new information about a prescription drug, he or she should be capable of evaluating the materiality of that information to his or her medical practice.  We have a learned intermediary doctrine because we subscribe to the notion that medical doctors are capable of evaluating all available information about a drug before prescribing it.  And if a doctor learns that (for example) a study he believed was reliable was actually ghostwritten by a pharmaceutical company, he might want to look for third-party sources of information about the drug.  Pharmaceutical companies want to have absolute control over the information available to prescribing doctors.  But again, information asymmetry benefits one seller at the expense of the efficiency of the market.

I already see the rebuttal: “But what if some patient gets scared and stops taking his medication?  That patient could be hurt by those dastardly plaintiffs’ lawyers!”  Such an argument is offensively paternalistic.  First, it presumes that people are incapable of evaluating information for themselves.  Will someone stop taking a needed drug because a news story scared them?  Maybe, but so what?  Every American has a fundamental right to make medical decisions for themselves, regardless of whether those choices are wise, or are based on appropriate information.  Second, the argument implies that a pharmaceutical company should be the one who decides what information regarding a drug an individual has access to.  This goes back to information asymmetry and market efficiency.  Disclosing negative information about a drug benefits consumers and competitors.

Or perhaps they’ll argue that a doctor might decide to take a patient of a drug because of an out-of-context, cherry-picked document.  Well then, that doctor may be sued for malpractice.  Doctors have a financial incentive to provide the best care for their patients.  (Perhaps you’ve heard that doctors fear being sued for malpractice?)  No competent doctor is going to base his prescribing decisions upon an out-of-context document. 

DDL tries to use a quote from the Zyprexa litigation to bolster themselves, but it doesn’t work out:

"[Defendant]. . .has created a product with substantial benefits that even now – after many years of litigation, research, testing, and controversy – is still favored by many physicians and patients."

Biased, one-sided press-accounts based upon documents selectively disclosed by the other side don’t do the public any favors.

Source: DDL – Come at Me Bro

Even after the “biased, one-sided press-accounts” about Zyprexa, the drug “is still favored by many physicians.”  And that is proof positive that medical doctors are in fact basing their prescribing decisions upon objective medical evidence and not “biased, one-sided press-accounts.”


continues arguing that big pharma should be able to keep the cat in the bag:

Maybe there was a person in a particular company who thought some piece of data meant a drug’s label should be revised, but so what? Especially so what if other people at the company disagreed and — here’s the important point — the FDA saw the same data and didn’t ask to revise the label.

Source: DDL – Come at Me Bro

DDL engages in a nice rhetorical trick here.  They draw your attention to a “piece of data” and point out that the FDA (probably) saw the same data, but didn’t ask for a label revision.  But what the FDA did NOT see was the internal evaluation of that data.  In DDL’s eyes, turning 5,000 pages of documents over to the FDA for them to “go fish” is satisfactory.  Regardless of how the FDA analyzes those documents, don’t you think it would like to know that scientists at the drug company interpret the data as raising a red flag?  The FDA isn’t going to base a label change upon one company employee’s opinion.  What it will do is perhaps give additional scrutiny to the data the individual employee believes is  negative.  The FDA may then, after making its own reasoned analysis of the data, decide that a label change is warranted. 

You can look at the relationship between pharmaceutical companies and the FDA as a buyer-seller relationship.  The pharmaceutical companies, as sellers, are better off if they control the flow of information to the buyer.  But the market is most efficient if there is little or no information asymmetry between the parties.  The FDA should always see documents in which company employees raise concerns about the safety or efficacy of a drug.  But the FDA rarely does, because (a) pharmaceutical companies don’t  turn anything over to the FDA that they don’t have to, and (b) the FDA (unlike every single lawyer in the country) doesn’t have subpoena power to get those documents.

Unfortunately, I’m not very culturally literate, so I can’t end with a quip about Jersey Shore.  Instead, I’ll end with something a little more sobering.  Once upon a time, a group of individuals with a serious disease filed a lawsuit against the manufacturer of the product that caused their disease.  The manufacturer settled confidentially with the plaintiffs, on the express condition that the entire record be sealed.  The plaintiffs agreed, and the record was sealed.  No public health authorities were notified, there were no news stories, and the manufacturer kept on selling their product.

The defendant was Johns Manville, and the product was asbestos.  Literally hundreds of thousands of deaths might have been averted had the public been alerted way back in 1933 that asbestos can cause mesothelioma and lung cancer. 

One wonders how many cases of tardive dyskinesia could have been prevented had Wyeth been more forthcoming about the risks of long-term use of Reglan; or how many strokes could have been prevented had Merck been more open about Vioxx; or how many pulmonary embolisms could have been prevented had J&J updated the label for Ortho-Evra sooner.

The cold, hard truth is that pharmaceutical companies and the lawyers who work for them have every reason to overdesignate documents as being confidential, and the fact that they do so puts lives at risk.

I was not aware that Avandia was the #2 seller for GSK.  This is really going to hurt for them:

(Reuters) – European officials moved to pull GlaxoSmithKline’s diabetes drug Avandia off the market and U.S. authorities imposed tight restrictions over heart risks, effectively spelling the commercial end to the once-lucrative medicine.

Once a top treatment choice and Glaxo’s No. 2 seller, the rulings attempted to resolve a bitter, three-year debate over Avandia’s safety that has dogged the reputation of the medicine and its maker, and divided staff inside the U.S. Food and Drug Administration.

Source: EU pulls plug on Glaxo’s Avandia, FDA restricts | Reuters

The question I have is whether the FDA’s new actions are sufficient to trigger a new statute of limitations for people who want to file an Avandia lawsuit.  Traditionally, when the FDA adds a black box warning or recalls a drug, that acts as sufficient information to trigger a new statute under the discovery rule.  Regardless, I’m sure that this will trigger a new wave of Avandia lawsuits.

Bruesewitz v. Wyeth looks like it will be the Wyeth v. Levine of vaccine lawsuits:

Erwin Chemerinsky, a liberal scholar, and Kenneth Starr, a conservative, may appear to be the Oscar and Felix of constitutional law, but they’re also friends and, perhaps surprisingly, share essentially the same view in one, increasingly hard-fought area of constitutional law. They both believe that federal law should trump state tort actions only when Congress has clearly stated that it must.

* * * *

In their brief in Bruesewitz v. Wyeth, they argue that the parents of a Pennsylvania girl, who was disabled by a vaccine, has the right to sue drug maker Wyeth. That’s despite a decision by the U.S. Court of Appeals for the 3d Circuit that held the claim was barred by federal law.

Source: Big names, high stakes in quartet of pre-emption cases

The fact that Chemerinsky and Starr are both signing onto this brief ought to give Wyeth a little heartburn.  I haven’t yet read their brief, but I’m sure it will be loaded with lots of useful arguments for practitioners who are fighting preemption at all levels.

I got an email from the FDA alerting me to new warnings about the usage of Avandia.  Apparently, the FDA has not decided to withdraw Avandia, but is severely restricting who may use it:

FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.

Source: Avandia (rosiglitazone): REMS – Risk of Cardiovascular Events

This will hurt GlaxoSmithKline (GSK) in two ways.  First, the obvious pain will come in the form of reduced sales.  Avandia can no longer be used as a first-line treatment for patients with diabetes.    New prescriptions are going to drop like a rock.

Second, this announcement will probably spur a second wave of Avandia lawsuits.  That’s because an entirely new batch of people will see this news announcement and decide to contact an Avandia lawyer.  I know that GSK has already settled quite a few Avandia lawsuits, but their defense attorneys should probably gear up for another round.

As I’ve mentioned before, the game plan for most pharmaceutical companies these days seems to be to (a) get a drug approved for a limited indication, and then (b) promote it as a cure for every ailment known to man.  I thought the figures below were interesting:

The Justice Department on Tuesday joined a whistle-blower lawsuit against Pfizer and its subsidiary Wyeth Pharmaceuticals that accuses Wyeth of illegal off-label marketing of Rapamune, a drug used to prevent rejection of kidney transplants.

* * * *

The filing continued a crackdown on drug industry fraud. Over the last three years, the government has also settled false claims suits against Bristol-Myers Squibb for $515 million, AstraZeneca for $520 million, Eli Lilly for $1.4 billion, and last week, a unit of Forest Laboratories for $313 million.

Source: U.S. Joins Whistle-Blower Suit Against Pfizer –

Over the last three years, the government recovered over $2 billion dollars.  If that’s what was actually recovered, one wonders how  much hasn’t yet been recovered.

Drug marketing 101: The FDA approves drugs for specific ailments.  Drug companies may not market the drug to treat any other type of ailment.  If they do, it’s called off-label marketing and it is illegal.

Drug marketing 201: It’s often very profitable to engage in off-label marketing, because the fines you pay are less than the money you make doing it:

Allergan, the maker of Botox, agreed on Wednesday to pay $600 million to settle charges that it illegally promoted and sold the drug through 2005 for unapproved uses like treating headaches.

Source: Maker of Botox Settles Inquiry on Off-Label Marketing –

Now, I don’t know for sure that off-label marketing netted Allergan more than $600 million dollars.  But, I do know that Allergan made several billion dollars selling Botox over the last few years.  $600 million is definitely a large fine, but it’s only effective if it is more money than they made by promoting it off-label.

An analogy I often use: If you only had to give back half of the money you got from robbing a bank, how many banks would you rob?

The FDA is reviewing the results of a study that may link bladder cancer with the diabetes drug Actos:

The agency said Friday that five-year results from an ongoing study show that patients who have taken Actos for the longest period of time had a higher risk of bladder cancer. Bladder cancer was also more prevalent in patients who had taken the largest cumulative dose of the drug.

Source: FDA reviewing cancer risk with diabetes pill Actos

Of course, just because people who took Actos developed bladder cancer that doesn’t mean that Actos caused bladder cancer.  Still, the fact that those who took the largest doses of the drug developed bladder cancer is a strong sign that there may in fact be a link. 

UPDATE: I am now accepting cases from individuals who developed bladder cancer while taking Actos.  More information on Actos lawsuits here.

Earlier, I wrote about how doctors aren’t disclosing their financial ties to the pharmaceutical industry.  Turns out that they soon will be:

As part of the Patient Protection and Affordable Care Act, drug, device and medical supply companies are required to list payments worth $10 or more to doctors in a public database that can be easily searched by 2013.

Source: Doctors Given Millions by Device Makers Fail to Disclose Pay in Research – Bloomberg

This will be such a timesaver for product liability attorneys.  Instead of having to spend hundreds of hours and thousands of dollars investigating expert witnesses who work for pharmaceutical companies, we’ll just be able to hit this database.  I’m sure big pharma is less than thrilled.

If there is a Holy Grail among pharmaceutical companies, it isn’t a cure for cancer, AIDS, or another fatal disease.  It’s a weight-loss pill.  As any Fen Phen lawyer can tell you, the history of weight loss drugs has been mild weight loss and severe health risks.  Some are concerned that the Fen Phen story will repeat itself with Meridia:

Nearly all of Wednesday's discussion centered on results from a 10,000-patient study released last year, which showed patients with heart disease taking Meridia had a more than 11 percent risk of cardiovascular risks compared with 10 percent of those taking a placebo.

The study was designed to show that weight loss with Meridia led to improved outcomes for patients with heart disease, diabetes or both.

Because the study failed to show those benefits, some panelists questioned the rationale for keeping it on the market, considering its modest weight loss benefits. On average, patients lost 5 pounds while taking the drug and about 30 percent of patients achieved lasting weight loss while on the drug.

Source: The Associated Press: FDA panel split on withdrawing diet pill Meridia

Two things jump out at me.  First, the risk increases from 10 percent taking a placebo to 11 percent taking Meridia.  That evidence isn’t strong enough for an injured patient to prevail in federal court.  Generally, you need to show a doubling of risk; if people who took the drug were 20 percent more likely to have a cardiovascular event, that might work.

Second, the average weight loss was 5 pounds.  That’s not a significant amount of weight loss for any drug that carries with it a cardiovascular risk.  Want to lose ten pounds?  Eat 1,200 calories a day for a week and take a diuretic.  You’ll lose 5 to 7 pounds in a week.  Granted, it will all be water weight and will come right back within another week, but the point is that 5 pounds simply isn’t much weight.

I’m going to be keeping my eye on Meridia, if for no other reason than drug companies have a history of manipulating studies to show minimal risks.   

A big part of what I do for a living is investigate the safety of drugs and medical devices.  That means I spend time reading studies about the safety of a specific drug.  One of the things I look at is the author of the study.  If the author of the study discloses that he made $5 million dollars from Company X last year, then I’m going to assume that his multimillion-dollar gravy-train may have something to do with why he says Company X makes safe products.  Unfortunately, many doctors don’t disclose their ties to pharmaceutical companies:

Forty-one doctors accepted a total of $114 million in 2007, in amounts of $1 million to $8 million, David Rothman and his team report in the Archives of Internal Medicine. Yet half of the articles published by the doctors in the following year made no mention of corporate payments.

"If you can’t find information about a $1 million payment to an author in an orthopedic journal on issues that are directly relevant to products for which they’re being paid, then something’s wrong," Rothman says.

Source: Study: Doctors often fail to disclose company payments –

Those who know me know that the thing I hate most in the world is hypocrisy.  This gets me very angry because of what I perceive to be hypocrisy in the world of product liability lawsuits.  Let’s assume that Company X pays a doctor $5 million dollars to run a study that is intended to promote a specific drug.  That company will get to come into court and use that study as evidence that the drug is safe.  Yet if a lawyer pays a doctor money to run a study, the drug company will argue that the study shouldn’t be considered because it was conducted for litigation purposes.

The implication is that if a study is conducted for litigation purposes, it isn’t a neutral study.  Well guess what?  Neither are many of the “studies” that big pharma pays for?

At any rate, it’s discouraging to see that some doctors (who probably hate lawyers) have such low personal ethics that they don’t believe they need to disclose million-dollar payments they receive.