In a rare legal defeat, Bristol Myers Squibb and Sanofi fined $834M for ‘deceptive marketing’ on best-selling blood thinner Plavix

Amber Tong

Senior Editor

By the time the FDA slapped a black box warn­ing on Plav­ix in 2010, the block­buster blood thin­ner had been on the mar­ket for 13 years and reaped bil­lions of dol­lars — enough to give it a sol­id spot among the best-sell­ing drugs of all time even to this day, de­spite reach­ing peak sales in 2011.

On Mon­day, a judge in Hawaii sided with the state in or­der­ing its mak­ers, Bris­tol My­ers Squibb and Sanofi, to hand back $834 mil­lion of that.

Hawaii first sued the phar­ma gi­ants in 2014 for fail­ing to warn that the drug had poor ef­fects on peo­ple who can’t me­tab­o­lize it — and that those of East Asians and Pa­cif­ic Is­land an­ces­try are more like­ly to be “poor me­tab­o­liz­ers” of Plav­ix, or clopi­do­grel, due to their ge­net­ic pre­dis­po­si­tion. It all amount­ed to de­cep­tive and un­fair mar­ket­ing, ac­cord­ing to then-At­tor­ney Gen­er­al David Louie.

To make mat­ters worse, Louie’s of­fice ar­gued that Bris­tol My­ers Squibb and Sanofi could have point­ed to a sim­ple ge­net­ic test that was avail­able even be­fore the 1997 FDA OK.

His suc­ces­sor Clare Con­nors said in a state­ment, re­port­ed by Reuters, that the new court rul­ing “puts the phar­ma­ceu­ti­cal in­dus­try on no­tice that it will be held ac­count­able for con­duct that de­ceives the pub­lic and places prof­it above safe­ty.”

Bris­tol My­ers Squibb and Sanofi said they would ap­peal.

“The court’s rul­ing is un­sup­port­ed by the law and at odds with the ev­i­dence at tri­al,” the drug­mak­ers said in a joint state­ment to Bloomberg. “The over­whelm­ing body of sci­en­tif­ic ev­i­dence demon­strates that Plav­ix is a safe and ef­fec­tive ther­a­py, in­clud­ing for peo­ple of Asian de­scent.”

In­di­vid­ual con­sumers and oth­er states alike have waged sim­i­lar law­suits over the past decade. While a fed­er­al judge has dis­missed the sci­en­tif­ic ba­sis for a con­sol­i­da­tion of suits, sev­er­al state cas­es, in­clud­ing New Mex­i­co’s, are still pend­ing.

In a 43-page rul­ing, Judge Dean Ochi­ai of Hawaii wrote that the com­pa­nies put pa­tients at “grave risk of se­ri­ous in­jury or death in or­der to sub­stan­tial­ly in­crease their prof­its.”

“The court finds that de­fen­dants knew at the time of launch that there was a sig­nif­i­cant is­sue re­gard­ing di­min­ished pa­tient re­sponse to Plav­ix, par­tic­u­lar­ly in those of non-Cau­casian races,” he wrote, adding “that for many years de­fen­dants de­lib­er­ate­ly turned a blind eye to­ward the prob­lem out of con­cern that ad­dress­ing it might ad­verse­ly af­fect Plav­ix sales and de­fen­dants’ prof­its.”

He based the to­tal fine on 834,000 pre­scrip­tions dur­ing the 12-year pe­ri­od Hawaii cit­ed, with $1,000 per pre­scrip­tion, and or­dered Bris­tol My­ers Squibb and Sanofi to pay $417 mil­lion each.