Plavix (Photo: Shutterstock.com)

Lawyers from Arnold & Porter and Dentons on Tuesday sued the state of Hawaii on behalf of Bristol-Myers Squibb and Sanofi-Aventis—a move that comes in response to a massive suit by the state against the companies that's barreling towards trial in April.

At issue: the warning label on the blood thinner Plavix.

In 2014, Hawaii—represented by plaintiffs counsel working on contingency from Hawaii's Cronin Fried Sekiya Kekina & Fairbank and Texas-based Baron & Budd—sued the drugmakers in state court. They allege that Bristol-Myers and Sanofi failed to disclose that Plavix has "diminished or no effect" on about 30% of people of East Asian or Pacific Islander descent because they metabolize it poorly, and say genetic tests should be used to identify patients who are "poor metabolizers" before prescribing the drug.

Invoking Hawaii's Unfair or Deceptive Acts or Practices statute, the plaintiffs' lawyers claim that every Plavix label without that warning from 1998 until 2010 was false or misleading. They're seeking a $10,000 civil penalty for each Plavix prescription issued in Hawaii during that time. If they succeed, the fine could range from $417 million to $8.3 billion. 

Oh, and the plaintiffs firms get 20% of the net proceeds from any judgment or settlement.

No wonder the drug companies have launched a counter-strike. 

Arnold & Porter's Anand Agneshwar, Daniel Pariser, Robert Weiner and Sally Pei, along with Paul Alston and Louise K. Y. Ing in Dentons' Honolulu office, sued the state in U.S. District Court for the District of Hawaii, seeking declaratory and injunctive relief.

They argue that Hawaii's central contention—that Plavix is less effective for Asian and Pacific Islander patients and that doctors should genetically test those patients before prescribing the drug—is controversial and untrue. In addition, they say that Hawaii's "effort to compel the companies to parrot the state's contrary position violates the First Amendment … [T]he state's lawsuit effectively compels the companies to espouse scientific conclusions with which they steadfastly disagree."

The drugmakers assert that the "overwhelming consensus of scientific experts, cardiology organizations and regulatory authorities is that no evidence supports a need for routine genetic testing, or a warning that East Asian or Pacific Islander patients have worse clinical outcomes while on Plavix."

That argument is fully fleshed out in the complaint with a panoply of studies and experts—but defense lawyers also spend a fair amount of time blasting plaintiffs counsel for ginning up the original suit.

"Before private law firms approached the Attorney General proposing that the state hire them on a contingency fee basis to litigate a UDAP enforcement action seeking hundreds of millions of dollars in civil penalties, the state had exhibited no concern about the issue of variability of response to Plavix," the Arnold & Porter and Dentons lawyers wrote. 

"It appears that the state itself had never conducted any investigations or inquiries regarding Plavix, and never took steps to alert doctors about any concerns regarding genetic variability of response to Plavix," they continued. "Even today, the state's Medicaid insurers continue to recommend and cover Plavix for patients of all races."

Moreover, the state doesn't allege a single person in Hawaii was actually harmed by any deceptive statements or omissions on the Plavix label.

Baron & Budd partner Dan Alberstone could not immediately be reached for comment. 

The Arnold & Porter and Dentons team also note that the Hawaii AG's office seems to have all but abdicated responsibility for the case. 

"As far as can be discerned from the public, non-privileged aspects of the case, the state has left the direction of the litigation to its private contingency- fee counsel," they wrote. "No state attorney has entered any appearance as counsel of record, signed any significant pleadings or motions, argued at a hearing, or taken or defended a deposition."

But when constitutional rights are at stake, this is a problem. 

"Counsel for private parties are not elected or appointed to serve the public interest, are not subject to public oversight and supervision, are not stewards of limited public resources, and do not have to exercise prosecutorial discretion in their day-to-day practice," they wrote. "Private lawyers spend their careers seeking to win cases on behalf of clients whether or not the public interest or the interests of justice require it."