Selling heroin's lethal cousin

Orange and Santa Clara counties have filed a major civil case against the drug companies making and marketing OxyContin and related opioids. At the outset, let us acknowledge the miraculous attributes of many medicines that relieve pain. From post-operative recovery to longer term pain management, it is a Godsend. But let us also remember the wise admonition of Aristotle about "moderation, moderation in all things." And that brings us to the OxyContin story. For it is not one of targeted, beneficent use. Rather, its patent-provided excess profit has led to marketing abuses and serious external costs.

Regrettably, OxyContin and related opioids are not just used for pain; they have become their own vehicle for fatal addiction. That expansion has been stimulated by irresponsible marketing of heroin's highly addictive cousin. Let's review just a few of the alleged facts cited in the 105-page complaint:

In 2010, 254 million prescriptions were written for opioids; almost the entire adult population received the equivalent of a one-month dose.

In 2000, a disturbing 10 percent of doctor visits resulted in an opioid prescription. By 2010 it had doubled to 20 percent.

The U.S., with 4.6 percent of the world's population, is swallowing 80 percent of the world's opioids.

87 percent of opioid prescriptions are for "chronic therapy" extending well beyond medical need.

2010 Centers for Disease Control data records over 16,000 annual deaths from the opioids themselves. It is double the combined deaths from heroin and cocaine. It is well over all of the annual deaths from even auto accidents. And for every such death, at least 30 are in an emergency room being resuscitated.

And the impact on often less expensive heroin addiction is receiving increasing concern. OxyContin is the "gateway" drug to heroin or cocaine. But it is possible to get a patent on something with an important but properly limited use, and to pursue profit without conscience. Query: what is the difference between the Mexican drug cartels and those who have achieved this opioid record? The latter wear suits.

Collateral facts that make this picture even more troublesome. First, teens are taking and selling these drugs. Second, this underground marketing abuse is exacerbated by regulatory highjinks. The Controlled Substance Utilization Review and Evaluation System, known as CURES, that allows doctors and pharmacists to monitor duplicative prescriptions (common for those selling in high school cafeterias) is not used by many medical professions, and legislation to require a simple quick look at its electronic record has been stymied. Coroners must be required to report to the state Medical Board incidents of opioid overdose deaths (or other prescription drug caused deaths). That way, the board could let the doctors know they were being had, or discipline them for irresponsibly prescribing. Legislation to that effect was vetoed by Gov. Jerry Brown.

The drug companies have many lobbyists, and are given often extravagant patent monopoly profits. And they give heavily to campaigns. After the Citizens United decision, the money can - and is - really flowing.

These abuses should have stopped well short of this important filing. We know that the major defendant drug company already has an outstanding judgment for similar abuses in place in 2007 and allegedly violated it. Why did that one not work? Let's examine the checks we have in place to enforce basic marketing abuses.

Ironically, federal preemption is not an issue here. The 2009 Wyeth v. Levine Supreme Court case held that Food and Drug Administration approval of a drug's label did not provide a complete defense to "failure to warn" claims. Indeed, that is one reason we all see drug ads featuring 10 warnings that the product behind the happy cavorting of the beautiful people on screen may cause "hearing loss, impotence, the loss of the ability to walk or limb use, uncontrollable diarrhea, and death by asphyxiation." Certainly this prevalence now denigrates all warnings into a "cry wolf" status, but they were not the preferred approach of the real Don Drapers on Madison Avenue. They do not work here, because much of the abuse runs from drug company to doctor or even to scholars allegedly providing peer review guidance.

What about the national level? Should not the enforcement emanate here given the fact that many states are affected? Class actions are one such check. But that has limitations, beyond even the scandalous Supreme Court Concepcion allowance for a "terms and conditions" "consent" to waive any class action remedy. For we have the separate problem here of class commonality. Not everyone is affected the same by OxyContin. What patients were told by their doctors varies widely. And much of the abuse is not to consumers but from industry to doctors - a dynamic also not amenable to the kind of commonality preferred for class actions. See the over 130 such cases brought and dismissed over the last two decades.

So where is the FDA? It has approved a "reformulation" to prevent "immediate access to the full dose by cutting, chewing or breaking the tablet." Attempts to dissolve the tablets into a liquid form for injection will be more difficult. But such a "reformulation" does not seriously address the abuse, its illicit promotion, marketing and use. Part of the problem is overprescribing, and avoiding the prescription barrier altogether. The FDA is not addressing it seriously and perhaps it is beyond its capability.

What about the FTC? Here is an agency that has authority to address "unfair" marketing broadly defined. Indeed, the California statute which is the basis of the recent filed public case is our state's "Little FTC Act." But the powers of this agency hardly provide the kind of deterrent punch needed. An FTC Section 13 action could be brought similar to the California case just filed, but they are disappointingly rare. And the other powers of this agency are problematical.

What about the U.S. Department of Justice? The U.S. attorneys work in various regions in an uncoordinated, fragmented fashion. They individually look at possible violations. And marketing abuse that does not come down the "mail fraud" or other typical federal statutes are rarely pursued. These cases could invoke the Food, Drug and Cosmetics Act and the False Claims Act. The former has an attached "responsible corporate officer" doctrine. One exception to a spotty record was provided by the Virginia U.S. Attorney in Roanoke. He conducted a lengthy investigation with much evidence and brought criminal charges. See the plea agreements at U.S. v. Purdue Frederick Co., 495 F.Supp. 2d 569, 575 (W.D. Va. 2007). He filed a criminal case yielding $630 million in fines, and a court judgment that allegedly has been violated from day one. No jail time was suffered for the three executives pleading guilty. The case was important to be sure, but the focus on three executives and a company fine (all but $34.5 million paid by the company, not the enriched executives) has not yielded the result required. There are huge profits to be made here which are not easily addressed by these remedies. The remedy must involve a real sanction, such as loss of the corporate charter, surrender of patent rights, and/or jail time, billions in "take back" monies, and/or required future monitoring.

Interestingly, one avenue of redress are the Little FTC Acts now in place in about half of the states. They allow public prosecutors to bring actions with far more punch. In California, they can impose an injunction, assess restitution, and impose civil penalties. And the last can amount to $2,500 per violation - with each misleading utterance a separate offense. We even may have the possibility of revoking a corporate charter. There are drawbacks. This is a national problem and ideally should be so addressed. What about the fragmentation and even unfairness to defendants in having multiple lawsuits over the same issue? And, indeed, Kentucky has filed a state public action against the same defendants for similar marketing abuses. The attempt by defendant Purdue Pharmaceutical to remove the case to federal court under the Class Action Fairness Act predictably failed (See Purdue v. Kentucky, 704 F.3d 208 (2d Cir. 2013)). And it may well proceed.

But California is feeling the damage disproportionately. The state has a system so that a single case can be brought by the People of the State. No standard class action standard defenses are available. And the state has organized to prevent disorganized or distracting multiple prosecutions for the same offense from within the state. The attorney general has a critical clearance mechanism that compels notice in advance by any public prosecutor with authority to file under these relevant sections (chiefly the Unfair Competition Law). The attorney general can coordinate or even take over a case. Once brought, a great deal of reliance now attaches to the work of these two counties. The result needs to be an injunction that stops the abuses - radically and generally, ideally remedies that will apply outside of California, or will in practice compel national compliance. In the perfect world, we would have such a clearance system supervised by the U.S. Department of Justice. But here that has yielded a challenge that is well warranted and will hopefully yield some mechanism to reach beyond any one state.