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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Adding my two cents to the debate between Drug and Device Law and the Drug Recall Lawyer Blog

Posted in DangerousDrugs.US

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.”

DDL

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.