Healthcare

Decisions levied against pharmaceutical companies, health professionals, and patients often have long-term consequences which may impact the health and safety of Americans. The Foundation believes and has argued that individuals should not be denied access to quality healthcare and low-cost alternatives, such as generic drugs, should be made available whenever possible as quickly as possible. We have argued against approval of a Michigan statute on pharmaceutical price controls for Medicaid recipients that could results in substandard care for the poor as well as against excessive regulation and product liability lawsuits that undermine and could slow down any new drug approval processes where the drug has been determined to be safe and effective by the FDA. AEF sided with a team of doctors who provided emergency medical aid to children in Nigeria suffering from meningitis, when activists claimed that a pharmaceutical company violated international law by treating patients before informed consent was obtained. The Foundation works for the best interests of the people in all areas, but healthcare has always been at the core of our mission.

Read about these Foundation legal actions and more in our Amicus Briefs below.

Case Name:
Johnson & Johnson v. Reckis
Date Filed:
11/09/2015
Court:
Supreme Judicial Court of Massachusetts
Foundation Action:

Here, the Foundation argued to overturn a $140 million dollar judgement against an ibuprofen drug manufacturer because a label, which was drafted the the FDA, did not include sufficient health warnings. We partnered with the Washington Legal Foundation on this action.

Verdict:
Pending

Case Name:
Pfizer Inc. v. Kaiser Foundation Health Plan
Date Filed:
10/04/2013
Court:
U.S. Supreme Court
Foundation Action:

The Foundation argued here that the Kaiser Foundation Health Plan (a health insurance company) is not due any damages from Pfizer for covering the cost of Neurontin for off-label uses for its members since Pfizer's promotion of the drug for off-label use was not a proximate cause of the reimbursement decision. We partnered with the Washington Legal Foundation on this action.

Verdict:
Loss

Case Name:
Novartis Pharmaceuticals Corp. v. Fussman
Date Filed:
06/27/2013
Court:
U.S. Supreme Court
Foundation Action:

Here, the Foundation argued that the ability of a private plaintiff to sue under state law to impose punishment (punitive damages) on a prescription drug manufacturer who fully satisfied the FDA's rigorous approval and labeling requirements should be limited. We partnered with the Washington Legal Foundation on this action.

Verdict:
Loss

Case Name:
Medtronic, Inc. v. Stengel
Date Filed:
06/13/2013
Court:
U.S. Supreme Court
Foundation Action:

Here, AEF argued that once the FDA has determined a medical device to be safe and effective by its rigorous Pre-Market Approval process (PMA), this limits the ability for plaintiffs to file product liability suits related to these devices based on individual state laws. We partnered with the Washington Legal Foundation on this action.

Verdict:
Loss

Case Name:
Jones v. Abbott Laboratories
Date Filed:
05/31/2013
Court:
Tennessee Supreme Court
Foundation Action:

The Foundation argued in this case in support of the "learned intermediary doctrine" which has been upheld in 48 states that holds that as long as a drug manufacturer has supplied adequate safety warnings to the consumer's doctor to pass along to their patients, there is no additional duty to provide safety warnings directly to a consumer. We partnered with the Washington Legal Foundation on this action.

Verdict:
Victory

Case Name:
Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. State of Arkansas
Date Filed:
04/04/2013
Court:
Arkansas Supreme Court
Foundation Action:

In this case, the Foundation argued against a $1.2 billion dollar civil penalty levied against a drug manufacturer based on claims the manufacturer included inadequate risk information on the label of one of its products. We partnered with the Washington Legal Foundation on this action.

Verdict:
Victory

Case Name:
Mutual Pharmaceutical Co. v. Bartlett
Date Filed:
01/22/2013
Court:
U.S. Supreme Court
Foundation Action:

We argued here that once generic drugs are determined to be safe and effective by the FDA, state-law product liability suits alleging that the generic prescription drug is defectively designed are limited. We partnered with the Washington Legal Foundation on this action.

Verdict:
Victory

Case Name:
Christopher v. SmithKline Beecham
Date Filed:
03/26/2012
Court:
U.S. Supreme Court
Foundation Action:

In this case, AEF argued against a reinterpretation of the Fair Labor Standards Act (FLSA) by the Department of Labor which would require over 90,000 pharmaceutical sales representatives to be reclassified as overtime-eligible employees in contract to a decades-long and accepted practice. We partnered with the Washington Legal Foundation on this action.

Verdict:
Victory

Case Name:
Pharmaceutical Research and Manufacturers of America v. Medows
Date Filed:
02/19/2012
Court:
U.S. Supreme Court
Foundation Action:

In this case, AEF argued that a Florida law that seeks to impose price controls on pharmaceuticals sold to Medicaid recipients in the state would result in substandard care for the state's poorest citizens and deny them access to essential drugs that the state could deem too expensive. We partnered with the Washington Legal Foundation on this action.

Verdict:
Loss

Case Name:
Allergan v. United States
Date Filed:
11/19/2009
Court:
U.S. District Court for the District of Columbia
Foundation Action:

The Foundation argued here that a pharmaceutical companies should not be barred from speaking truthfully about off-label uses of their products to medical professionals. We partnered with the Washington Legal Foundation on this action.

Verdict:
Dispute settled and lawsuit voluntarily dismissed.

Case Name:
Shinseki v. Sanders
Date Filed:
10/21/2008
Court:
U.S. Supreme Court
Foundation Action:

In this case, we argued that when the U.S. Department of Veterans Affairs (VA) commits significant procedural errors in processing disability claims, if that veteran's claim is denied, a reviewing court should presume the veteran was prejudiced by the errors unless the VA demonstrates otherwise. We partnered with the Washington Legal Foundation on this action.

Verdict:
Loss

Case Name:
Pfizer, Inc. v. Abdullahi
Date Filed:
05/24/2006
Court:
U.S. Supreme Court
Foundation Action:

In this case, the Foundation argued in support of pharmaceutical company doctors who provided emergency aid to children in Nigeria suffering from meningitis. A suit against the pharmaceutical company alleges international law was violated because treatment was provided without first obtaining patients' informed consent. We partnered with the Washington Legal Foundation on this action.

Verdict:
Loss

Case Name:
Pharmaceutical Research and Manufacturers of America v. Thompson
Date Filed:
09/15/2003
Court:
U.S. Court of Appeals for the District of Columbia Circuit
Foundation Action:

The Foundation argued against a new Michigan statute that would impose price controls on pharmaceuticals. The statute conflicts with federal Medicaid law and would result in substandard care for Michigan's poorest citizens as a result of them being denied access to essential drugs the State has deemed too expensive. We partnered with the Washington Legal Foundation on this action.

Verdict:
Loss

Case Name:
Pharmaceutical Research and Manufacturers of America v. Michigan Department of Community Health
Date Filed:
04/05/2002
Court:
Michigan Supreme Court
Foundation Action:

Here, the Foundation argued that a Michigan program that seeks to impose price controls on pharmaceuticals sold to Medicaid recipients in the state would result in substandard care for the state's poorest citizens and deny them access to essential drugs that the state could deem too expensive. We partnered with the Washington Legal Foundation on this action.

Verdict:
Loss

Case Name:
Pharmaceutical Research and Mfrs. of America v. Walsh
Date Filed:
05/15/2001
Court:
U.S. Supreme Court
Foundation Action:

Here, the Foundation argued that a Maine law that seeks to impose price controls on pharmaceuticals sold to Medicaid recipients in the state should be struck down as it conflicts with federal laws regulating the sale of prescription drugs and may reduce access by Medicaid recipients to prescription drugs. We partnered with the Washington Legal Foundation on this action.

Verdict:
Loss