Generic Drug Makers Cannot be Sued for Lack of Warnings

Generic drug companies cannot be sued for failing to provide adequate warnings about their products' potential side effects, the Supreme Court ruled Thursday. Brand-name drug makers are required by federal law to label drugs with government-approved warnings, and to update those warnings when new problems arise. But the court ruled 5 to 4 that while brand-name drug makers can be found liable for injuries that may have been caused by insufficient warnings, the same legal duty does not apply to those who make copy-cat, lower-cost generic drugs, which account for about 75 percent of the prescriptions written nationally. Under federal law, generics are required to carry the same warning labels as their brand-name counterparts—but if a brand-name drug doesn't display the appropriate warning, the generic can't be held responsible if it doesn't either. States, on the other hand, hold both parties responsible. The court ruled that federal law trumps state law. The justices acknowledged that the ruling, which brought strong dissent from the divided court, creates a double standard: "As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug," Justice Sonia Sotomayor wrote, according to The Washington Post. "The court gets one thing right: This outcome makes little sense."

Overmedication: Are Americans Taking Too Many Drugs?

Socrates once declared that medicine "acts as both remedy and poison" and that "this charm, this spellbinding virtue, this power of fascination, can be­—alternately or simultaneously—beneficent or maleficent." Modern America clearly appreciates the benefits. Today, a full 61 percent of adults use at least one drug to treat a chronic health problem, a nearly 15 percent rise since 2001, U.S. News reported in October 2010. More than 1 in 4 seniors gulp down at least five medications daily. The trend has multiple causes: a spike in diabetes, heart disease, and arthritis related to obesity; revised medical guidelines that treat high blood sugar, hypertension, and high cholesterol sooner; and a multibillion-dollar push by pharmaceutical companies to speak directly to consumers about the payoff in trusting our hearts to Lipitor, say, or taking Boniva to help stop bone loss.

Therapeutic advances have, no question, proved lifesaving for many. Heart disease deaths have dropped steadily over the past 15 years, for example, thanks in large part to cholesterol-lowering statins and clot-busting drugs administered during heart attacks and strokes. But a growing chorus of experts worries that one unintended effect of all the pharmacological success is that many people may be blithely taking drugs they don't need, potentially setting themselves up for severe consequences. Clinical trials that prove a medicine safe and effective may demonstrate nothing about long-term risks or whether it benefits elderly folks or people with multiple health issues; usually new drugs are tested for just three or so years in a few thousand middle-age adults with a single particular problem. Given that a drug's serious side effects might show up only after months or years on the market, someone whose dangerous heart disease can't be controlled by existing meds has a much clearer incentive to try a new drug than people with a mild condition. [Read more: Overmedication: Are Americans Taking Too Many Drugs?]

A Doctor's Practical Guide to Prescription Drugs

A study of nearly 200,000 outpatient electronic prescriptions published last year in the Journal of General Internal Medicine drew a stunning conclusion: nearly 3 in 10 new prescriptions were never filled at the pharmacy. To make matters worse, patients who pick up their medications frequently find the instructions difficult to understand, family physician Kenny Lin writes for U.S. News. There is little consistency in how pharmacies format their prescription labels, which can lead to confusion if a patient uses more than one pharmacy. Taking several medications is even more challenging. According to a recent report in the journal Archives of Internal Medicine, only 15 percent of older adults were able to correctly consolidate a 7-drug regimen into 4 doses per day, and adults with lower literacy or less formal education were even less capable of doing so.

The good news is that efforts are underway to design standard prescription labels that are easier to read and follow; the bad news is that these common-sense changes probably won't be coming to your pharmacy any time soon. So what can you do to make sure that you and your doctor are on the same page regarding your prescriptions?

First, don't be afraid to ask how much a new medication costs. If you can't afford it, chances are you won't take it. A previous Healthcare Headaches post discusses several options for saving money on medications, including substituting older medications or generics. Also, make a point to communicate concerns about unwanted side effects; your doctor can usually manage these by lowering the dose or switching to a different drug. [Read more: A Doctor's Practical Guide to Prescription Drugs.]

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