Albuterol Asthma Death and OptumRx Lawsuit

Madison, WICole Schmidtknecht suffered from asthma for most of his short life. He died in January 2024, just 22-years-old, allegedly because his prescription for the Advair Diskus inhaler suddenly and unexpectedly went beyond his price range because it was no longer covered by his insurance. Instead, he bought generic Albuterol, for a $5 co-pay, and used Albuterol exclusively in the time leading up to his death.

Albuterol Asthma Death and OptumRx Lawsuit Cole’s parents have filed a lawsuit against Walgreens, its parent company Boots Alliance and Optum Rx (owned by United Health Group), the pharmacy benefits manager, for negligence.

Cole’s cause of death was allegedly status asthmaticus, which the National Library of Medicine describes as “an extreme form of asthma exacerbation”. His parents told the Washington Post that Cole’s early childhood meant being tethered to an albuterol emergency inhaler and unexpected trips to the emergency room. At age 13, he was prescribed Advair Diskus, a preventative corticosteroid inhaler, that the pharmacy filled every three months: three 30-day Advair inhalers cost him $67. In early 2023, Cole started working in parts sales for a trucking company and earned a “modest hourly wage”, along with medical coverage.

Optum Rx told ABC News that Walgreens filled a generic Albuterol inhaler prescription for Cole on January 10th and that it “also has available clinically appropriate options and formulary information” for when medication is not covered by a provider. Five days later Cole had a severe asthma attack and started to asphyxiate; his roommate rushed him to an emergency room but it was too late. Cole died eleven days later.

Albuterol NOT Medical Equivalent

Schmidtknecht’s family claims in their lawsuit that “Walgreens Defendants failed to exercise reasonable care in that they knew, or should have known, of the unreasonable risk of harm to asthmatic patients, including Cole Schmidtknecht, that would result from their failing to provide him with Advair Diskus or a medically equivalent alternative medication at an affordable price at the point of service.” Clearly, Albuterol was not medically equivalent to the Advair Discus. Here is the difference:

Albuterol (albuterol sulfate) is a short-acting beta agonist used for quick relief of asthma symptoms, such as wheezing or difficulty breathing. (ProAir HFA, Ventolin HFA) Not intended for long-term control or prevention of asthma.

Advair Diskus is a combination inhaler containing fluticasone propionate (a corticosteroid) and salmeterol (a long-acting beta-agonist). Used for the long-term control and prevention of asthma and COPD symptoms.
Not intended for quick relief of acute asthma symptoms.

Wixela Inhub is a generic version of Advair Diskus, containing the same active ingredients (fluticasone propionate and salmeterol).
FDA approved as a generic equivalent to Advair Diskus.

AIRSUPRA

AIRSUPRA received FDA approval in January 2023. It became available in the US in January 2024, the month Cole died, but not to be used as a maintenance treatment for asthma. The drug maker AstraZeneca demonstrated in a DENALI Study that its inhaled anti-inflammatory rescue medication significantly benefited in comparison to albuterol.

The list price for each inhaler of AIRSUPRA is $489.25. On its website, AstraZeneca says for those who can’t afford AIRSUPRA and if you have employer-provided or individual private (commercial) insurance, you may be able to get the med for as low as $0. If you are uninsured or have Medicare Part D and cannot afford AIRSUPRA, you may be eligible for its patient assistance program, AZ&Me.

Compare that price of $0 to the Advair Discus charge to Cole: In March 2024, two months after Cole’s death, GSK announced in a press release that it will cap out-of-pocket costs for eligible patients at no more than $35 per month for all of its asthma and chronic obstructive pulmonary disease (COPD) medicine. It states:

GSK is taking this action as part of its longstanding commitment to improving access to respiratory medicines in the U.S. and to help asthma and COPD patients who are least able to afford the care they need. The out-of-pocket price cap will provide a significant benefit to patients taking these medicines whose monthly costs currently exceed $35.

Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide, including over 25 million in the US. Patients with mild asthma comprise at least 50% of the US asthma population and are at risk of severe exacerbations.

Data from the Centers for Disease Control and Prevention in 2019 shows that more than 60 percent of asthmatic adults had uncontrolled asthma, frequently sending them to the emergency department or forcing them to miss work. Severe asthma can also be fatal; an average of 10 Americans die every day because of it, and in nearly every case, the death is preventable with the right treatment.