J&J’s ‘Texas two-step’ talc bank­rupt­cy case heads back to ap­peals court

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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.