An Aduhelm lawsuit is a claim against Biogen for selling the Alzheimer’s drug Aduhelm, which may cause patients ARIA symptoms – including brain bleeding and swelling.
Shouse Law Group is a personal injury and mass tort firm representing Alzheimer’s patients who took Aduhlem (aducanumab) and where then diagnosed with ARIA-E or ARIA-H and either had a seizure, had a stroke, or died. We accept cases from all 50 states plus D.C.
In this article, our Aduhelm lawsuit attorneys discuss:
- 1. Does Aduhelm cause ARIA?
- 2. What are the grounds for a lawsuit?
- 3. What is the status of the Adulhem litigation?
- 4. What money damages can I expect to get?
- 5. Who makes Aduhelm?
- 6. How does Aduhelm work?
- 7. What is ARIA?
- 8. How can an attorney help?
1. Does Aduhelm cause ARIA?
Data is still emerging. But according to a recent JAMA Neurology article, about four out of ten of early Alzheimer’s patients on Aduhelm participating in phase 3 studies got ARIA-E (brain swelling) or ARIA-H (brain bleeding). Some suffered ARIA symptoms including:
- confusion/mental disorientation
At worst, ARIA can result in a seizure, stroke, or death. The FDA Adverse Event Reporting System (FAERS) shows events where Aduhelm patients experienced ARIA-related events.1
On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) decided preliminarily to limit coverage of Aduhelm only to clinical trials. This move seems to be in response to the growing concern about the drug’s safety.2
2. What are the grounds for a lawsuit?
Aduhelm victims may have grounds to sue Biogen on the basis of defective design. The argument is that Aduhelm’s chemical compound is innately dangerous and prone to causing ARIA. Therefore, Biogen is strictly liable for producing and selling a defective product.
Another potential cause of action against Biogen is failure to warn. Had Aduhelm’s labeling disclosed ARIA risks, then doctors may have chosen not to prescribe it, and patients (or their families) may have chosen to use other therapies.
If the victim dies, then the victim’s family or estate can bring a wrongful death action.3
3. What is the status of the Aduhelm litigation?
Litigation is in a very early stage. Currently, Aduhelm victims will be bringing individual lawsuits against Biogen for their ARIA symptoms. But it is expected that these lawsuits will eventually join into a multi-district litigation (MDL).
MDLs are a way to expedite litigation – and settlements – by having one federal judge oversee the pretrial process for all the cases. Eventually a few cases will go to trial. The results of these bellwether trials will serve as the starting point for negotiations with the rest of the plaintiffs.
4. What money damages can I expect to get?
Plaintiffs’ attorneys for Aduhelm victims are fighting to recover the following compensatory damages:
- Medical expenses, including hospital stays, medication, surgeries, and other healthcare provider bills;
- Lost wages (if applicable);
- Pain and suffering, including emotional distress;
- Reimbursements for all other out-of-pocket costs, including expenditures by family members to care for the plaintiff; and/or
- Funeral expenses if the patient died.
In cases that go to trial, the plaintiff may also ask for punitive damages.
5. Who makes Aduhelm?
Neurimmune developed Aduhelm, which was then licensed to Biogen. Biogen is a “Big Pharma” drugmaker company based in Cambridge Massachusetts. In 2020, Biogen generated more than $13 billion in revenue.
The U.S. Food and Drug Administration‘s drug approval of Aduhelm for the treatment of Alzheimer’s occurred only in early June of 2021. In protest over the drug’s effectiveness and safety, various members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee quit. The Mayo Clinic’s Dr. David Knopman – a behavior neurologist – said:
“[T]he evidence that aducanumab is that therapy and has any benefits in persons with AD is terribly weak…Contrary to the hope that aducanumab will help Alzheimer patients, the evidence shows it will offer improvement to none, it will harm some of those exposed, and it will consume enormous resources. The straightforward solution is this: Biogen needs to do a third trial with high dose aducanumab. If the drug’s benefits are truly substantial, such a trial could recruit quickly and only several hundred patients would need to be randomized.”
And Dr. Aaron Kesselheim said FDA’s approval of Adulhem was, “probably the worst drug approval decision in recent US history.”
Aduhelm is the first FDA-approved drug Alzheimer‘s treatment since 2003. It is not an Alzheimer’s cure – no drug is.4
6. How does Aduhelm work?
Aduhelm (a.k.a. aducanumab) is an antibody to amyloid beta plaques in the brain. This interaction is meant to slow the progression of cognitive decline caused by Alzheimer’s. Aduhlem is infused monthly intravenously into patients.
Aduhelm carries a steep drug price tag of $56,000 annually. According to the Institute for Clinical and Economic Review, Adulhelm should instead cost no more than $3,000 to $8,400 a year.
Due to potential ARIA side effects, the clinical benefits of Aduhlem – as well as the FDA’s decision’s for an accelerated approval pathway for Aduhelm – are under question.5
Other Alzheimer’s drugs include rivastigmine, galantamine, and donepezil, which temporarily increase the brain’s number neurotransmitters in the brain. Another treatment option is memantine, which protects brain receptors from stimulation that can damage nerve cells.
7. What is ARIA?
ARIA is short for amyloid-related imaging abnormalities. Alzheimer’s patients with ARIA exhibit abnormal differences in MRI scans.
ARIA manifests as either:
- ARIA-E swelling (cerebral edema) and/or
- ARIA-H bleeding (cerebral hemorrhages).
Patients with ARIA typically experience headaches, confusion, vomiting, and tremors. At worst, the patient may have a seizure, have a stroke, or die.6
8. How can an attorney help?
An experienced personal injury attorney will handle the entire litigation process against Biogen, including:
- Gathering all medical records of the Aduhelm victim;
- Composing and filing all legal documents;
- Keeping in contact with the victim and his/her family throughout the lawsuit; and
- Negotiating the best settlement possible with Biogen.
And through the MDL process, an attorney can usually achieve a favorable resolution without having to subject the plaintiff or their families to depositions or any other unpleasant legalities.
- Stephen Salloway et. al, Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease, JAMA Neurol. (November 22, 2021). See also Danielle Abi-Saab et al, The Effect Of 6 Months’ Dosing On The Rate Of Amyloid-related Imaging Abnormalities (Aria) In The Marguerite Road Study, Alzheimer’s Association International Conference: P1: Poster Presentations (July 1, 2017)(6-month dosing at 105 mg gantenerumab before increasing to 225 mg caused an overall ARIA rate of 10.8% in study subjects). Laura Antolini, et al., Spontaneous ARIA-like Events in Cerebral Amyloid Angiopathy–Related Inflammation: A Multicenter Prospective Longitudinal Cohort Study, Neurology (November 2, 2021). H. Michael Arrighi et. al., Amyloid-related imaging abnormalities-haemosiderin (ARIA-H) in patients with Alzheimer’s disease treated with bapineuzumab: a historical, prospective secondary analysis, J Neurol Neurosurg Psychiatry (January, 2016). J Barakos et al., MR imaging features of amyloid-related imaging abnormalities, Meta-Analysis (October, 2013).
- Pam Belluck, Medicare Proposes to Cover Aduhelm Only for Patients in Clinical Trials, New York Times (January 11, 2022).
- See also Jacqueline Howard, US lawmakers launch investigation into FDA approval and price of new Alzheimer’s drug, CNN (June 29, 2021). Biogen probes death of Aduhelm user after brain swelling, Reuters (November 9, 2021). William Newton, The incomplete safety data on Aduhelm’s brain swelling side effect, Clinical Trials Arena (August 23, 2021). Mark Terry, Biogen Investigates Death of 75-Year-Old on Aduhelm, BioSpace (November 20, 2021).
- FDA Grants Accelerated Approval for Alzheimer’s Drug, FDA.gov (June 7, 2021). Pam Belluck and Rebecca Robbins, Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug, NY Times (September 2, 2021).Public Submission, Comment from David Knopman, Posted by the Food and Drug Administration on Oct 29, 2020, Regulations.gov. Jeffrey Toobin, The road to Aduhelm: What one ex-FDA adviser called ‘probably the worst drug approval decision in recent US history’ for an Alzheimer’s treatment, CNN (September 27, 2021). Jonathan Saltzman, Retired neurologist with Alzheimer’s knows firsthand the risks of Biogen’s new drug, Boston Globe (July 31, 2021). Zachary Brennan, UPDATED: Panel of neuroscience experts lays out the complications with using Biogen’s new Alzheimer’s drug, Endpoints News (July 27, 2021).
- Aduhelm (Aducanumab), Alzheimer’s News Today. See note 3. ICER Publishes Final Evidence Report and Policy Recommendations on Aducanumab for Alzheimer’s Disease, ICER (August 5, 2021). Michael Hiltzik, How the FDA’s lousy judgment and a greedy drug company combined to hit Medicare members hard, LA Times (November 22, 2021). Juliette Cubanski, FDA’s Approval of Biogen’s New Alzheimer’s Drug Has Huge Cost Implications for Medicare and BeneficiariesKaiser Family Foundation (KFF) (June 10, 2021).
- See also Reisa Sperling, et. al., Amyloid Related Imaging Abnormalities (ARIA) in Amyloid Modifying Therapeutic Trials: Recommendations from the Alzheimer’s Association Research Roundtable Workgroup, Alzheimers Dement. (July, 2011).