John­son & John­son cel­e­brat­ed a win in bank­rupt­cy court on Fri­day, with a US judge rul­ing in fa­vor of its con­tro­ver­sial Chap­ter 11 fil­ing meant to set­tle 38,000 law­suits al­leg­ing its talc-based prod­ucts caused can­cer.

The tri­al stems back to a moun­tain of claims that J&J’s wide­ly-used ba­by pow­der and oth­er talc prod­ucts con­tained as­bestos and caused mesothe­lioma and ovar­i­an can­cer. In an at­tempt to dig it­self out, the phar­ma gi­ant spun the li­a­bil­i­ties in­to a sep­a­rate com­pa­ny called LTL Man­age­ment and filed for bank­rupt­cy back in Oc­to­ber. But a cou­ple of weeks ago, plain­tiffs kicked off a five-day tri­al seek­ing to dis­miss the bank­rupt­cy case as mis­use of the Chap­ter 11 sys­tem.

Michael Ka­plan

Judge Michael Ka­plan of New Jer­sey re­ject­ed those mo­tions, adding that “the fil­ing of a chap­ter 11 case with the ex­pressed aim of ad­dress­ing the present and fu­ture li­a­bil­i­ties as­so­ci­at­ed with on­go­ing glob­al per­son­al in­jury claims to pre­serve cor­po­rate val­ue is un­ques­tion­ably a prop­er pur­pose un­der the Bank­rupt­cy Code.”

While J&J touts the de­ci­sion as a “pos­i­tive de­vel­op­ment and step for­ward,” oth­ers are fir­ing back. Jon Ruck­de­schel, an at­tor­ney who’s lit­i­gat­ed mesothe­lioma and oth­er as­bestos cas­es for 20 years (in­clud­ing against J&J), said in a state­ment that the de­ci­sion keeps vic­tims from their right to a ju­ry de­ci­sion.

“The bank­rupt­cy code was nev­er in­tend­ed to be abused in this way by mas­sive­ly prof­itable cor­po­ra­tions as a means to de­lay or pre­vent can­cer vic­tims from hav­ing their day in court,” he said. “We are dis­ap­point­ed that J&J’s stooge ‘bank­rupt­cy’ fil­ing for its fall-guy sub­sidiary LTL Man­age­ment was not dis­missed, but this mat­ter will be ap­pealed and oth­er reme­dies will be sought against LTL and J&J as part of the bank­rupt­cy pro­ceed­ing in the mean­time.”

Jon Ruck­de­schel

To spin off its li­a­bil­i­ties, J&J in­voked a Texas law for­mal­ly known as a di­vi­sion­al merg­er but col­lo­qui­al­ly called a “Texas two-step” bank­rupt­cy. The phar­ma gi­ant said in Oc­to­ber that it had racked up about $3.5 bil­lion in pay­ments for set­tle­ments and ver­dicts — and dur­ing the tri­al, it claimed that from Jan­u­ary 2020 to now, it’s been served on av­er­age with one or more ovar­i­an can­cer com­plaints every hour of every day.

Mean­while, those on the claimants’ side — in­clud­ing a group of law pro­fes­sors who filed a “friend of the court” brief — ar­gue that the Texas two-step move is a “di­rect at­tack on the fun­da­men­tal in­tegri­ty of the Chap­ter 11 sys­tem.”

On­ly a hand­ful of talc-re­lat­ed suits have made it to tri­al and been re­solved over the last decade — and though J&J says it has pre­vailed in a ma­jor­i­ty of cas­es, it’s al­so ex­pe­ri­enced some sting­ing loss­es in­clud­ing a Mis­souri case in 2018 when a ju­ry award­ed plain­tiffs more than $4.7 bil­lion in dam­ages.

J&J main­tains that it “nev­er man­u­fac­tured a prod­uct that con­tained as­bestos,” and that its talc prod­ucts are safe. The phar­ma gi­ant stopped man­u­fac­tur­ing the talc-based pow­der in May 2020 but cit­ed de­clin­ing sales as its rea­son­ing.

“LTL stands ready to work with claimants’ coun­sel and the me­di­a­tor to reach an eq­ui­table and ef­fi­cient res­o­lu­tion as or­dered by the Bank­rupt­cy Court,” the com­pa­ny said in a state­ment on Fri­day.

Ka­plan not­ed in his opin­ion that “many of these can­cer vic­tims will not live to see their cas­es through the tri­al and ap­pel­late sys­tems, but cer­tain­ly de­serve the com­fort in know­ing that their fam­i­lies’ fi­nan­cial needs will be ad­dressed time­ly.”

“The Court is aware that its de­ci­sion to­day will be met with much angst and con­cern,” he wrote. “Nonethe­less, the mat­ter be­fore the Court is so much more than an aca­d­e­m­ic ex­er­cise or pub­lic pol­i­cy de­bate. These is­sues im­pact re­al lives.”

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”