An em­ploy­ee at a phar­ma man­u­fac­tur­ing plant that has drawn the ire of the FDA and the DOJ, is bring­ing a suit against her for­mer em­ploy­er.

Phar­ma com­pa­ny Eli Lil­ly is be­ing brought to court in New Jer­sey by a for­mer em­ploy­ee who is seek­ing dam­ages af­ter act­ing as a whistle­blow­er.

The case cen­ters around the plain­tiff Am­rit Mu­la, a for­mer as­so­ciate di­rec­tor of em­ploy­ee re­la­tions at Lil­ly’s plant in Branch­burg, New Jer­sey.

Be­gin­ning in Au­gust 2018, and con­tin­u­ing un­til her ter­mi­na­tion, Mu­la be­gan to in­ves­ti­gate em­ploy­ee com­plaints of se­ri­ous vi­o­la­tions to the FDA con­cern­ing reg­u­la­tions in the man­u­fac­tur­ing of Lil­ly phar­ma­ceu­ti­cal drugs. Mu­la is al­so to have al­leged­ly wit­nessed and re­port­ed em­ploy­ees fail­ing to ad­here to cur­rent GMPs.

Mu­la al­so no­ti­fied the FDA that the plant failed to com­ply with FDA-man­dat­ed stan­dard op­er­at­ing pro­ce­dures, along with fail­ing to re­port batch con­t­a­m­i­na­tions, im­prop­er­ly dis­pos­ing of caus­tic sub­stances in­to wa­ter­ways as well as fal­si­fy­ing qual­i­ty as­sur­ance test­ing.

In par­tic­u­lar, the fail­ures of pro­duc­tion Mu­la ob­served and re­port­ed were pri­mar­i­ly re­lat­ed to the sale of the di­a­betes drug Trulic­i­ty.

The case al­leges that through­out Mu­la’s in­ves­ti­ga­tions, Lil­ly of­fi­cials con­tin­u­al­ly told Mu­la to stop in­ves­ti­gat­ing or to un­der­play the sever­i­ty of the vi­o­la­tions, and af­ter Mu­la re­peat­ed­ly pres­sured site lead­er­ship to rem­e­dy the sit­u­a­tion, Lil­ly ex­ec­u­tives al­leged­ly re­spond­ed by mar­gin­al­iz­ing, ha­rass­ing and even­tu­al­ly ter­mi­nat­ing her po­si­tion around March 28, 2019.

The case doc­u­ments said that Mu­la con­duct­ed a da­ta in­tegri­ty in­ves­ti­ga­tion, which re­vealed that at least sev­en em­ploy­ees fal­si­fied records and that the man­u­fac­tur­ing de­part­ment was con­sis­tent­ly over­due on cGMP train­ing. She al­so un­cov­ered that sev­er­al Branch­burg site em­ploy­ees re­peat­ed­ly record­ed that SOPs were per­formed while know­ing that a re­quired step had been in­ten­tion­al­ly omit­ted and then mis­rep­re­sent­ed da­ta was be­ing record­ed in cGMP doc­u­ments. She al­so found that sev­er­al em­ploy­ees had failed to com­plete manda­to­ry cGMP train­ing, among oth­er in­frac­tions.

Mu­la is seek­ing re­in­state­ment and oth­er in­junc­tive re­lief as well as com­pen­sato­ry dam­ages.

Lil­ly’s Branch­burg plant has been in the gov­ern­ment’s crosshairs for a while. In 2021, the FDA was in­ves­ti­gat­ing the lo­ca­tion, which pro­duces Covid-19 an­ti­body bam­lanivimab, for in­ad­e­quate qual­i­ty and lab­o­ra­to­ry con­trols.

The DOJ al­so hit Lil­ly with a sub­poe­na re­quest­ing ad­di­tion­al doc­u­men­ta­tion on its work at a Branch­burg.

This is not the end of Lil­ly’s le­gal woes as in May, Lil­ly, along with two oth­er com­pa­nies, is al­so fac­ing a law­suit brought on by the Arkansas At­tor­ney Gen­er­al al­leg­ing that the phar­ma com­pa­nies col­lud­ed with ben­e­fits man­agers (PBMs) to ar­ti­fi­cial­ly dri­ve up in­sulin prices.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

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