Manufacturers of prescription drugs often claim that they cannot provide a warning label in accordance with state law because the changes would be prohibited by federal law, a defense known as impossibility preemption. Impossibility preemption is a situation where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce.

In Wyeth v. Levine (2009), the U.S. Supreme Court held that drug manufactures who claimed impossibility prevention were required to produce “clear evidence” that the FDA would have prohibited their additional warning as required under state law. This ruling lacked a strong test to determine what “clear evidence” meant, which caused confusion and allowed drug manufacturers to bring forward weaker claims of impossibility preemption.

The Merck Sharp & Dohme Corp. v. Albrecht decision in May of 2019 provides those injured by prescription drugs with much-needed clarity in combatting a claim of impossibility preemption. The Supreme Court stated that “the possibility of impossibility” is not enough, meaning that it is not sufficient to say that it was “possible” that state and federal law were in conflict. Under Merck, drug manufacturers claiming impossibility preemption must now provide clear evidence of an actual conflict between state and federal law that makes it impossible to comply with both.

By Lindsay Proskey

Recently, the Seventh Circuit dismissed thousands of claims against Pfizer, the manufacturer of a generic testosterone drug, Depo-T, for inadequately warning consumers that Depo-T increased heart attacks in older men.[1] The consumers' right to relief hinged on Depo-T’s classification as a generic or brand name drug. The Seventh Circuit found the plaintiff’s claims preempted under federal law and barred by Supreme Court precedent, leaving these consumers without recourse. The controlling Supreme Court precedent and outdated FDA rules collectively frustrate state tort laws, impede on consumer rights, prevent injured consumers from judicial relief, and insulate generic drug companies from state product liability law under the guise of preemption.

Federal Preemption

Federal law “preempts” or displaces state law when state and federal law conflict. The doctrine of preemption derives from the Supremacy Clause[2] of the United States Constitution. Upon state ratification, federal law became superior over state law, within the realm of constitutionally delegated authority, thereby granting states the rights and powers “not delegated to the United States.”[3]  Traditionally, states have the power to establish and enforce laws protecting the welfare, safety, and health of the public. Since federal and state governments have both exclusive and concurrent powers, a problem exists when both levels of government regulate the same subject matter. Where preemption applies, federal law trumps state legislatures, courts, administrative agencies, and constitutions. Thus, the Supreme Court accepts the Supremacy Clause as a “basic constitutional command that all conflicting state provisions be without effect.”[4]

By Timothy Tomasik

If you or a loved one have been recently diagnosed with cancer, there is no doubt that you have a multitude of questions racing through your mind. What sort of treatment options are available? What are side effects of chemotherapy? How will my, or my family member’s body handle the drugs that they are prescribed after treatment? And of course, ultimately will the treatment be successful?

It is no secret that a cancer diagnosis can be one the most frightening and uncertain times for a family. Once diagnosed, patients typically consult with their doctor to determine what chemotherapy options are available to target and destroy cancer cells. Unfortunately, chemotherapy cannot tell the difference between a cancer cell and a healthy cell making temporary hair loss from a common side effect of treatment. While most patients grow their hair back after treatment ends, some chemotherapy drugs are making this loss permanent. Sadly, patients, (especially female breast cancer survivors), are beginning to experience permanent hair loss after using the chemotherapy drug Taxotere ®.

All medications come with risks, but some have more than others. Unfortunately, the risks are not adequately researched, or worse, properly disclosed to prescribing physicians and patients. The warnings, in many instances, are inadequate. Such instances involving dangerous or defective drugs can wreak havoc on the lives of unsuspecting victims. Case in point: the recent study that revealed popular heartburn medications may carry an elevated risk of dementia.

Proton Pump Inhibitors and Their Uses

Proton pump inhibitors, or PPIs, are a class of drugs used to treat certain gastric conditions, including peptic and stomach ulcers, acid reflux, and gastroesophageal reflux disease (GERD). Available both by prescription and over the counter, they are used by an estimated 15 million Americans. Some who take them claim they are difficult to stop because the condition returns with an increase in severity. But, in light of recent studies, cessation of use may very well be the best course of action, particularly for those who suffer from milder versions of the treated conditions.

By Daniel M. Kotin

Many times, injuries caused by prescription drugs are the fault of a medical doctor committing medical malpractice.  Other times, the injury is caused by a defective drug and the claim is a product liability case against the drug manufacturer.  A third category of cases involves injuries caused by prescription errors due to misfiling of prescriptions at pharmacies.