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Monday, March 30, 2020

Drug companies say City of Chicago’s revised complaint ‘still fails,’ seek dismissal

By Jessica Karmasek | Nov 23, 2015


CHICAGO (Legal Newsline) - A group of pharmaceutical companies being sued by the City of Chicago over the marketing of opioid painkillers wants a federal judge to dismiss the city’s newest complaint in its entirety, calling it “profoundly deficient.”

On Friday, the defendants in the case, City of Chicago v. Purdue Pharma LP et al., filed a joint motion to dismiss the city’s second amended complaint.

The defendants argue that, despite “ballooning” to 325 pages, the city’s third attempt to plead claims against them remains “profoundly deficient” and fails to cure the “defects” the federal court outlined in a May 8 dismissal order.

“Most glaringly, the City still fails to plead the details of any fraud, still fails to connect any supposed misrepresentation to any City-reimbursed prescription, and still fails to plead that any City-reimbursed prescription was ineffective or harmed any patient,” the defendants wrote in a joint memorandum.

In June 2014, the city sued Purdue Pharma, Purdue Pharma Inc., The Purdue Frederick Company Inc., Johnson & Johnson, Janssen Pharmaceuticals Inc., Endo Health Solutions Inc., Actavis PLC, Teva Pharmaceutical Industries Ltd. and Cephalon Inc.

In the lawsuit that was later removed from state court to Chicago’s federal court, the city accused the companies of overstating the benefits of their drugs in a way that increased addiction and the city’s prescription and health care-related costs.

The city filed a public, partially redacted version of its second amended complaint in the U.S. District Court for the Northern District of Illinois, Eastern Division, on Nov. 5.

The defendants argue in their 40-page joint memorandum that the city’s pleading is deficient for multiple reasons.

First, they argue, the second amended complaint lumps the defendants -- who are competing manufacturers of a wide range of opioid products -- together as if they were a single company manufacturing an undifferentiated product.

The complaint also still fails to plead any of the city’s claims with the “who, what, where, when and how” that federal rules require, the defendants note.

Second, the complaint still does not adequately plead causation. The defendants point out that the city does not identify any prescriber who relied on their supposed “misrepresentation” in prescribing the medication, as the court required. Nor does the city allege, the defendants contend, that it relied on any of the defendants’ alleged misrepresentation when it approved any prescription reimbursement request.

“The City simply ignores the many factors that defeat proximate causation as a matter of law, including prescribers’ exercise of their independent medical judgment and their evaluation of the FDA-mandated product warnings, which prominently delineated the risks of opioid therapy,” the pharmaceutical companies wrote.

Third, the amended complaint still does not plead a cognizable injury, the defendants argue.

“Under its health and workers’ compensation plans, the City is required to cover drugs prescribed for FDA-approved uses, and the FDA has approved multiple opioid medications for the treatment of chronic non-cancer pain,” they wrote. “In addition, the SAC (second amended complaint) fails to identify any prescription that was ineffective or harmed any patient.

“And the SAC concedes that during most of the relevant time period, the City paid fixed premiums to a third party for all prescription drug costs -- meaning that the City paid the same amount and suffered no economic loss no matter how many prescriptions were reimbursed.”

Finally, the defendants argue, each count suffers from claim-specific “deficiencies,” which require dismissal.

“The Court should dismiss with prejudice because the City’s repeated inability to cure pleading deficiencies demonstrates that further amendment would be futile and only cause undue prejudice to Defendants,” the pharmaceutical companies wrote.

In an accompanying 16-page brief, also filed Friday, the defendants note that the Food and Drug Administration, since the federal court’s May order, has completed its review and acceptance of final protocols for mandated studies that will “further address” the benefits and risks of Extended-Release/Long-Acting opioids for the long-term treatment of chronic pain.

“As is now plain, this is not a case where the underlying science is settled. Many of the alleged misrepresentations concern disputed scientific issues now under review at FDA,” the pharmaceutical companies explained.

“The City would have this Court (or a lay jury) adjudicate that use of Extended-Release and Long-Acting (ER/LA) opioids for long-term treatment of chronic pain is inappropriate and award both damages for representing otherwise and sweeping injunctive relief -- all while FDA is assessing that very issue.

“As a California court recently found when staying a parallel lawsuit asserting nearly identical deceptive marketing claims concerning Defendants’ opioids, FDA should complete its current scientific examination before courts address such claims.”

The protocols, recently finalized, provide details demonstrating that these studies will assess the “precise scientific issues” underlying the second amended complaint’s claims, the defendants argue.

“These protocols show FDA’s active regulatory assessment of long-term opioid use for the treatment of chronic non-cancer pain,” they wrote. “That FDA has ordered a rigorous scientific study of these issues makes plain that the SAC’s repeated unqualified assertion that opioids are not medically necessary for chronic non-cancer pain is not accepted science.

“Trying the City’s false marketing claims will require resolution of that core disputed assertion.”

Earlier this year, the judge presiding over the case -- Jorge L. Alonso -- denied a request by the pharmaceutical companies asking him to invalidate the contract between the city and Cohen Milstein Sellers & Toll PLLC -- the law firm the city hired to investigate and litigate the opioid matter -- and issue an injunction barring the city from using the firm in this or any similar suit.

The defendants claimed they were entitled to the relief because the city improperly delegated governmental police power to a financially interested private party -- Cohen Milstein.

Further, the companies argued, the firm’s involvement violates city ethics rules and its financial interest in the outcome of the case creates a conflict of interest that violates their due process rights.

In denying the motion, Alonso rejected those arguments and the defendants’ latest attempt to get Cohen Milstein -- a firm with 80 attorneys and offices in Washington, D.C., New York, Chicago, Philadelphia, Denver and Florida that is representing two California counties in similar litigation -- booted from the case.

Last year, a judge denied a request to disqualify the firm and its partner, Linda Singer, based on Singer’s past position as attorney general for the District of Columbia, which received a hefty settlement after suing one of the drug companies in a similar action during her time in office.

The City of Chicago retained Cohen Milstein in April 2013 to represent it in its investigation and potential litigation over the marketing of opioid drugs like OxyContin and Percocet. The agreement provided the firm would be paid on a contingent fee basis and the city would have complete control over the investigation and litigation.

The plaintiffs law firm, known for its class action lawsuits, has been hired by a number of state attorneys general in recent years, including some of those to whom it donated, calling into question its relationship with the states’ top lawyers and its motives.

Alonso, in a minute entry appearing on the case docket Monday, said the defendants’ motions to dismiss will be “taken under advisement.”

The city’s response is due Dec. 23; the defendants’ replies in support are due Jan. 20. A motion hearing date set for Dec. 1 has been stricken, according to the entry.

From Legal Newsline: Reach Jessica Karmasek by email at

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Cohen MillsteinCity of Chicago