In late Feb­ru­ary, John­son & John­son won a con­tro­ver­sial case sur­round­ing its bank­rupt­cy fil­ing de­signed to set­tle 38,000 law­suits ac­cus­ing its talc-based prod­ucts of caus­ing can­cer. How­ev­er, it ap­pears that bank­rupt­cy case is far from over as the US ap­peals court has now agreed to re­vis­it that rul­ing.

The dis­pute stems from J&J’s use of a “Texas Two-step”: ap­ply­ing a law that en­abled it to spin out its li­a­bil­i­ties re­lat­ed to the on­go­ing talc law­suits in­to a sep­a­rate com­pa­ny. That com­pa­ny, known as LTL Man­age­ment, then filed for bank­rupt­cy — a move that shield­ed LTL (and there­fore J&J) from fur­ther ju­di­cial ac­tion in the talc law­suits.

The claimants in the case said that J&J’s moves are a mis­use of the US bank­rupt­cy code, though J&J main­tained that pre­vi­ous com­pa­nies have done the same.

The law­suits al­lege that J&J’s wide­ly-used ba­by pow­der and oth­er talc-based prod­ucts were con­t­a­m­i­nat­ed with as­bestos and caused mesothe­lioma and ovar­i­an can­cer.

Judge Michael Ka­plan of New Jer­sey, where J&J is head­quar­tered, sided with J&J in the bank­rupt­cy case, who said at the time J&J’s fil­ing “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.”

How­ev­er, Ka­plan lat­er grant­ed ex­pe­dit­ed ap­peal to the case, al­low­ing it to skip dis­trict courts and head di­rect­ly to the 3rd US Cir­cuit Court of Ap­peals, which has now agreed to re­view the case.

J&J stopped sell­ing its ba­by pow­der in 2020, though the megaphar­ma said it was due to de­clin­ing sales. The com­pa­ny has main­tained that its icon­ic talc prod­ucts do not con­tain as­bestos.

The phar­ma is al­so fac­ing a sep­a­rate law­suit in New Jer­sey from the fam­i­ly of a for­mer work­er that al­leges the com­pa­ny hid ev­i­dence of the pres­ence of as­bestos at a for­mer J&J sub­sidiary. In that case, Ka­plan ruled that J&J’s bank­rupt­cy fil­ing did not ap­ply.

The mesothe­lioma claimants com­mit­tee de­clined to com­ment on the ap­peals up­date. John­son & John­son did not re­spond to a re­quest for com­ment be­fore pub­li­ca­tion.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.