Opiate Litigation: What’s on the Horizon?

Posted by and on August 22, 2017

This article was authored by George Talarico, Esq. of Locke Lord, LLP and David Schwartz, PhD and Giovanni Ciavarra, PhD of Innovative Science Solutions. This article was previously published in Law360.

Historical Context

In 1996, James Campbell, a neurosurgeon at Johns Hopkins Medical School, gave a keynote speech at the American Pain Society’s annual conference. Campbell argued that hospitals must change their views on pain management by treating it as “The Fifth Vital Sign,” elevating it to the importance of collecting standard signs and symptoms (e.g., blood pressure, temperature, heart rate, and respiratory rate) as part of a standard medical exam.

Campbell’s idea spread rapidly, changing basic hospital protocol to nurses getting patients’ medical histories, taking vital signs, and then asking, “do you have any pain today?” Patients’ pain would be evaluated on a scale of 1 to 10 with increasing severity and even include charts or pictures of relevant pain scales in every case, even if pain was not at all what the patient was hospitalized for. An example of a pain scale is shown below.

Though this attitude towards pain certainly raised awareness, in terms of management it simply resulted in increased rate of opioid prescriptions so that hospitals could demonstrate results. Further, patients developed the attitude that their pain should always be “at a zero”, whether this was doable or not.

 

As Campbell’s ideas gained momentum in the practice of clinical medicine, another factor conspired to dramatically increase the use of opioid pain killers in modern medicine. In January 1980, Jane Porter and Hershel Jick, two young researchers at Boston University Medical Center, published a short letter to the editor (100 words total) in January 1980’s edition of the New England Journal of Medicine.

The short letter described the incidence of narcotic addiction in nearly 40,000 hospitalized medical patients who the authors claim were closely monitored. They report only four cases of “reasonably well documented addiction” in their patient population, with only one “major” addiction. They conclude that “despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”

Since its publication this short paragraph was cited nearly a thousand times (as of July 2017) as a way to downplay the addictive potential of pain medication. Importantly, the scope of Porter and Jick’s study was extremely narrow and only evaluated pain medication administered in hospital settings – i.e., it did not evaluate pain medications that were being taken home by the patient. This finding, combined with physicians’ aggressive approach to pain management as “the Fifth Vital Sign,” fostered a huge increase in the prescribing of pain medication.

Recently, this letter has come under attack in the medical community as partially responsible for the opioid epidemic. For example, a recent letter to the editor published in June 2017 concluded that the 1980 letter has been “heavily and uncritically cited as evidence that addiction was rare with long-term opioid therapy.”

The Opioid Epidemic

OxyContin, a slow-release form of the now generic narcotic oxycodone, is seen by many as the biggest player in the current opioid epidemic. Developed in Germany in 1916 in response to the heroin ban, oxycodone was designed to be a better, less addictive pain management medication as compared to other available opioids (e.g., heroin, codeine, and morphine). Ironically, it turns out that oxycodone has itself since been found to be highly addictive. Oxycodone was first introduced to America in 1939 and though it was used in a variety of drugs throughout the following decades such as Percodan and Percocet, the opiate did not become widely used until Purdue Pharma began manufacturing its brand of oxycodone (OxyContin) in 1996. OxyContin went on to become the best-selling narcotic pain reliever in the country in 2001 and its use remains prominent today.

Like all opiates, Oxycodone functions by binding to and activating opioid receptors in the brain and spinal cord, which are responsible for both the drug’s pain control attributes and for its euphoric effects. It is, of course, the euphoric effects resulting from the stimulation of opioid receptors that is pursued by addicts as these effects are highly addictive.

And addiction can, in many cases, lead to overdose and death. Usage of opioid drugs like OxyContin has increased drastically over the past few decades with staggering statistics. It was even decided by the FDA in 2015 that OxyContin could be prescribed to children as young as 11 years old.  However, with all these prescriptions, addiction often followed. One study reports that over 2.4 million people in the US alone suffer from opioid use disorders. Consistent with the fact that addiction can often lead to death, another study reported that “an average of 91 people in the United States die every day from an opioid-related overdose.” However, even given both these statistics, the number of prescriptions for pain drugs is still growing. Though this increase in prescriptions for opioids has put pain problems at an all-time low, it has also put opioid addition at an all-time high.

However, in addition to the rise in prescription volume, patients also turn to other opioid agents. One recent study published found that as opioids became unavailable to users, those users turn to heroin and other elicit opioids. Due to an increase in accessibility, its use as a primary opioid has risen sharply. It was also noted by the study that because of the lack of experience these users have with serious opioids, there is an expected increase the amount of fatalities associated with heroin use.

With the growing desire and number of prescriptions for pain-suppressing opioids like OxyContin, some have speculated that litigation will follow, some forecasting that it could be a mass tort the size of Vioxx or other high-profile cases. This litigation could potentially take a number of forms, including personal injury lawsuits making design defect and/or failure to warn claims. Alternatively, plaintiffs could raise consumer fraud statutes, arguing liability based on specific promotional language being made for the products.

Not surprisingly, plaintiffs have advocated that states’ consumer fraud laws are applicable to the sale of prescription drugs.[1]  For example, parents of a five-year-old child who began to experience seizures allegedly resulting from improperly high dose of neurotoxin (Botox) prescribed off-label for complications of cerebral palsy brought an action against Allergan alleging violations of the Vermont Consumer Fraud Act.  Drake v. Allergan, Inc., 63 F. Supp. 3d 382 (D. Vt. 2014).  In this case, the court denied Allergan’s motion for summary judgment on the Vermont Consumer Fraud Act.  Id. In New Jersey, the trial-level Superior Court recognized the validity of bringing suit under the New Jersey Consumer Fraud Act for deceptive labeling in a putative class action concerning Vioxx where the plaintiff sought “economic damages resulting from the purchase and not personal injury damages.”  See Kleinman v. Merck & Co., 417 N.J. Super. 166, 188, 8 A.3d 851, 865 (Law Div. 2009) (devoting extensive analysis to the N.J. Consumer Fraud Act claim but denying class certification because “the court cannot find that a class action is a superior mechanism for adjudication of these claims”).  Similarly, it has been held that New York’s Consumer Protection from Deceptive Acts and Practices, Gen. Bus. § 349–350-f extends to prescription drugs.[2]  Plaintiffs have even sued under consumer fraud statutes where the injury is transient or perceived merely because they could have been injured—many of those suits have failed.  See, e.g., Williams v. Purdue Pharma Co., 297 F. Supp. 2d 171, 172 (D.D.C. 2003) (dismissing class action suit and finding plaintiffs could not sue for money damages under D.C. law as consumers injured by the drug manufacturers’ allegedly-fraudulent advertising claims where patients were prescribed a drug for pain that lacked efficacy but where patients suffered no ill effects); Rivera v. Wyeth-Ayerst Labs., 283 F.3d 315 (5th Cir. 2002) (finding insufficient injury where purchasers of prescription drugs sought recovery of economic damages after learning the drug had been withdrawn from the market because it caused liver damage in other patients).

Liability of Manufacturers and Retailers

The manufacturers of these drugs are not the only defendants as retailers have become targets as well. In fact, in addition to the pharmaceutical companies that manufactured these drugs, there have already been lawsuits filed that name big retailers as defendants.  In one such case, the Cherokee nation in West Virginia is suing 3 major distribution companies as well as 2 retailers for profiting from “sale of prescription opioids to the citizens of the Cherokee Nation in quantities that far exceeded the number of prescriptions that could reasonably have been used for legitimate medical purposes.”

Other law suits have also been filed. For example, another law suit, filed by the DEA’s Detroit Field Division alleged that Mallinckrodt, LLC failed to design and implement an effective system to detect and report “suspicious orders” for controlled substances.  These suspicious orders are those that are unusual in frequency, size or other patterns. The charges allege that Mallinckrodt supplied distributors who in term supplied various pharmacies and pain clinics without notifying DEA of these suspicious orders. Mallinckrodt has agreed to pay $35 million to settle these allegations.

In late June 2017, Oklahoma Attorney General Mike Hunter filed a state court lawsuit against four corporate defendants that manufactured opioid pain medication, Purdue Pharma, Allergan, Cephalon and Janssen Pharmaceuticals, alleging that defendants’ deceptive marketing caused the state’s opioid epidemic.  The lawsuit alleges that defendant manufacturers “executed massive and unprecedented marketing campaigns . . . misrepresent[ing] . . . risks of addiction from their opioids” and also “touted unsubstantiated benefits.”  As to relief, the Oklahoma Attorney General seeks injunctive relief and money damages and penalties, including: punitives, legal fees, Medicaid reimbursement and consumer reimbursement.[3]

Several counties in New York State have sued opioid manufacturers after hiring a private law firm to prosecute the matter, notably with Suffolk County filing last August (2016).  The suit alleges that the manufacturers utilized deceptive practices in their promotion and in advertising of the drug’s effectiveness and safety in pain management.   In April 2017, plaintiffs’ counsel for three New York Counties (Suffolk, Erie and Broome counties) remarked that his law firm has been notified by an additional 10 counties in New York State including Schenectady County.  Meanwhile, other communities ranging from states to counties to cities in Washington, California, Illinois, and West Virginia have likewise sued corporate plaintiffs concerning opioids.

The onslaught of suits against retailers (among others) is not likely to abate.  Sophisticated plaintiff firms have ramped up plaintiff recruitment to municipalities, counties and States, as evidenced by websites such as Baron & Budd’s, which likens the effort to tobacco litigation.  That website advertises that the firm’s “lawyers . .  . want to help communities hold negligent opiate distributors and pharmaceutical companies accountable for the Opioid epidemic in the United States” and specifically mentions targeting retailers and the prime corporate opioid defendants that can be named.[4]  Taken together, the vigorous plaintiff recruitment and host of new lawsuits likely presage others to follow, and should they succeed, could open a Pandora’s box for many household-name retailers.

Steps Retailers Can Take

If these forecasts prove to be accurate, manufacturers and marketers will certainly find themselves in the crosshairs of future litigation. These lawsuits are being brought by state attorneys general, with New Hampshire having filed suit most recently.[5]  Additional suits may well be forthcoming from individual plaintiffs recruited by the Plaintiff bar (alleging consumer fraud actions), as well as health and welfare funds and insurers seeking recovery for having reimbursed injured persons. These actions, in turn, could provide opportunities for retailers to be proactive and take specific actions to minimize risk.

For example, one recent study found that when ward pharmacists reviewed doctor-prepared prescriptions of oxycodone, both pre- and post-intervention, the proportion of patients who were supplied oxycodone was reduced, but the amount supplied per patient was not. Thus, intervention by a retailer can have a great deal of impact on prescribing practices, in this case, reducing the amount of oxycodone supplied.

Should retailers decide to intervene, there are many steps they could take. One such step would be to work with organizations like The Center for Retail Compliance (CRC), an initiative of the Retail Industry Leaders Association (RILA) created to help retailers with compliance and regulatory needs. The CRC believes that there is not enough regulation in place to help the retailers do what they need to, and thus their vision is to “develop a resource that will help retailers develop, enhance, and evaluate their compliance programs”. They aim to provide both resources and a community throughout the industry. Organizations like the CRC could be great resources for retailers, especially those with high potential for liability.

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REFERENCES

[1] Certainly, third party payors have advanced litigation based upon states’ consumer fraud acts where there are allegations that the drugs harmed patients. See, e.g., International Union of Operating Engineers Local # 68 Welfare Fund v. Merck & Co., Inc., 384 N.J.Super. 275, 894 A.2d 1136, 1144–45 (N.J.Super.A.D.2006) (third-party payor may state a claim against pharmaceutical manufacturer under New Jersey’s consumer fraud act for concealing information about a drug’s safety).

[2] See also 1 McLaughlin on Class Actions § 5:58 (13th ed.)(“Disclaiming personal injury recovery and focusing on economic injury, class action plaintiffs have migrated toward state Consumer Protection Acts (“CPA”), such as § 349 of the N.Y. General Business Law and Cal. Bus. & Prof. Code § 17200, usually seeking recovery on behalf of residents of a single state and usually narrowing the products involved to one or two brands.”); see id. (citing In re Bayer Corp. Combination Aspirin Products Marketing and Sales Practices Litigation, 701 F. Supp. 2d 356, 377–78 (E.D.N.Y. 2010) (“Economic injuries are sufficient for standing. Moreover, courts have long held that a plaintiff is injured, suffering an ascertainable loss, when he receives less than what he was promised. Thus, plaintiffs’ allegations that they were misled into purchasing a product that was less than what they bargained for are sufficient for Article III standing.”)).

[3] See Okla. Atty. Gen., Attorney General Mike Hunter files Lawsuit against four Opioid Manufacturers: State seeks damages for misleading marketing practices and misrepresentation (June 30, 2017), available at https://www.ok.gov/triton/modules/newsroom/newsroom_article.php?id=258&article_id=34200 (last accessed Aug. 10, 2017).

[4] See Baron & Budd, COMMUNITIES SEEK JUSTICE, FILE OPIOID LAWSUIT AGAINST DISTRIBUTORS, RETAILERS & BIG PHARMA, available at https://baronandbudd.com/public-entities/opioids/ (last accessed Aug. 10, 2017).

[5] N. Raymond, New Hampshire sues Purdue Pharma over opioid marketing practices. Reuters, available at https://www.reuters.com/article/us-new-hampshire-purdue-idUSKBN1AO29W (last accessed Aug. 10, 2017).