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.
The Foundation argued in this case that the settlement of a patent infringement lawsuit did not illegally restrain trade, in violation of the Sherman Act. Settlements are to be encouraged and the settlement of a patent-infringement claim should never be subject to antitrust scrutiny unless, at a minimum, the patent holder is alleged to have paid cash to the generic drug company. In this case, a class action antitrust suit filed against Pfizer and Ranbaxy (a generic company), claimed that Pfizer had, in effect, paid Ranbaxy to agree not to compete. Because patent litigation is so expensive, parties often settle claims before trial. In the case of drug patents, that generally entails: (1) the generic company agreeing to drop its patent-invalidity claim and to delay marketing the drug for at least a portion of time that the patent remains in effect; and (2) the brand-name company giving the generic company something of value in return. In this case, Pfizer (the brand-name company) did not pay any cash; it simply agreed to settle unrelated legal claims for an amount
less than those claims arguably were worth. We partnered with Washington Legal Foundation on this action.
Here, the Foundation argued to overturn a $140 million dollar judgement against an ibuprofen drug manufacturer because a label, which was drafted by the FDA, did not include sufficient health warnings. We partnered with the Washington Legal Foundation on this action.
Here, the Foundation argued that the U.S. Supreme Court should review and reconsider an appeals court decision that requires exacting antitrust scrutiny for virtually any agreement between a brand-name drug company and a generic drug company to settle patent-infringement litigation. The decision expands antitrust liability dramatically and makes it almost impossible for litigants to settle drug-patent disputes. We partnered with the Washington Legal Foundation on this 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.