State supreme court rules in fa­vor of Eli Lil­ly in case over warn­ing pa­tients of risks when DTC ads are in play

In a con­tentious case cen­ter­ing on prod­uct li­a­bil­i­ty, Wash­ing­ton state’s top court re­cent­ly ruled that Eli Lil­ly and oth­er drug­mak­ers do not need to pro­vide spe­cif­ic warn­ings to pa­tients, in ad­di­tion to the warn­ings they pro­vide to pre­scrib­ing physi­cians re­gard­ing the side ef­fects of drugs, even if a drug is ad­ver­tised di­rect­ly to pa­tients.

The suit in ques­tion in­volved David Dearinger, who suf­fered a stroke that caused him per­ma­nent dis­abil­i­ties less than two hours af­ter tak­ing Lil­ly’s erec­tile dys­func­tion drug Cialis. Dearinger sued Lil­ly in fed­er­al court un­der the Wash­ing­ton prod­ucts li­a­bil­i­ty act, claim­ing Lil­ly knew or should have known Cialis pre­sent­ed a risk of stroke to its users and failed to ad­e­quate­ly warn users of this risk.

Part of Dearinger’s ar­gu­ment is that over time, the in­creased use of di­rect-to-con­sumer ad­ver­tis­ing from phar­ma com­pa­nies has erod­ed the typ­i­cal pa­tient-doc­tor re­la­tion­ship, and un­der­mined pa­tients’ re­liance on doc­tors’ ex­per­tise.

But the Wash­ing­ton Supreme Court didn’t seem fazed by the ar­gu­ment and stood be­hind what’s known as the “learned in­ter­me­di­ary doc­trine,” which has been around since 1978 and is used in every state and Wash­ing­ton, D.C. The doc­trine pro­vides that drug­mak­ers sat­is­fy their du­ty to warn pa­tients of the risks of their prod­ucts if com­pa­nies prop­er­ly warn the pre­scrib­ing physi­cians.

“In short, Wash­ing­ton law ef­fec­tive­ly cre­ates a pre­sump­tion that a physi­cian will ex­er­cise in­de­pen­dent judg­ment in pre­scrib­ing med­ica­tion to a pa­tient. The ex­is­tence of di­rect-to-con­sumer ad­ver­tis­ing does noth­ing to al­ter a physi­cian’s du­ties,” the rul­ing said. “By le­gal de­sign, a physi­cian must ex­er­cise in­de­pen­dent judg­ment in pre­scrib­ing med­ica­tion, and a con­sumer must re­ly on this judg­ment in ob­tain­ing a pre­scrip­tion for a drug like Cialis.”

On the ques­tion of whether Wash­ing­ton state law rec­og­nizes an ex­cep­tion to the learned in­ter­me­di­ary doc­trine that re­quires pre­scrip­tion drug man­u­fac­tur­ers to warn pa­tients, not just pre­scrib­ing physi­cians, when the man­u­fac­tur­er di­rect­ly ad­ver­tis­es to con­sumers, the court called Dearinger’s claims “large­ly un­sub­stan­ti­at­ed,” say­ing some of the ar­ti­cles and stud­ies he cites “of­fer weak sup­port to jus­ti­fy an ex­cep­tion oth­er courts have flat­ly re­ject­ed.”

“Wash­ing­ton law does not rec­og­nize an ad­ver­tis­ing ex­cep­tion to the learned in­ter­me­di­ary doc­trine,” the rul­ing sup­port­ed by 7 mem­bers of the court said. “Rather, a drug man­u­fac­tur­er is pro­tect­ed un­der the learned in­ter­me­di­ary doc­trine even when they ad­ver­tise di­rect­ly to con­sumers, pro­vid­ed they give ad­e­quate warn­ings to the pre­scrib­ing physi­cian. Of course, whether a warn­ing is ad­e­quate re­mains a ques­tion of fact for a ju­ry to de­cide.”

But two oth­er judges, who al­so con­curred, on the whole, took is­sue with the ma­jor­i­ty’s “un­sup­port­ed as­sump­tions that all physi­cians ‘com­pre­hend … com­plex in­for­ma­tion’ bet­ter than all pa­tients. And I can­not agree with the con­se­quence of that as­sump­tion, that is, that it is bet­ter to with­hold com­plex in­for­ma­tion from pa­tients about their own med­ical con­di­tion than to re­veal it to them in a com­mon­sense, un­der­stand­able way.”

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

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.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.