Pharmaceutical Industry Wants Shield Law to Limit Liability for Dangerous Drugs, Medical Devices: SB 377 Passes Buck to State Doctors and Medical Professionals
February 19, 2015
Charleston, W.Va. – The pharmaceutical industry is pushing the West Virginia Legislature to pass SB 377, which will shield drug and medical device manufacturers from liability when patients are harmed or killed. Instead of holding the manufacturer accountable, it shifts responsibility onto doctors and other “learned intermediaries.”
“When pharmaceutical companies and medical device manufacturers put dangerous products on the market, they should be held responsible for it—they should not be allowed to pass the buck to the prescribing physician or another party,” said Anthony Majestro, president of the West Virginia Association for Justice.
Under the learned intermediary doctrine, the manufacturer has a duty to warn only prescribing physicians, pharmacists or another individual with advanced medical knowledge—a “learned” person between the manufacturer and the patient. Doctors and other intermediaries are supposed to understand and weigh the benefits and risks to each patient and, because of that assessment, assume any liability should the patient be harmed. There is no duty to warn the patients, even when the company is marketing its products to consumers directly.
“The United States is one of only two countries in the world that allows pharmaceutical companies to advertise their products to consumers. A recent analysis by the World Health Organization showed that our country’s pharmaceutical industry spent more than $3.1 billion on direct consumer advertising in 2012. If you are marketing to consumers directly, then you have a duty to warn consumers about the dangers your medicines and medical devices pose,” said Majestro.
It is estimated that every $1 spent on direct to consumer advertising results in more than $4 in retail sales. A 2011 Congressional Budget Office study found that drugs marketed through direct to consumer advertising led to sales rates nine times higher than drugs marketed only to health care providers. A 2013 study found that 60 percent of claims made in direct to consumer ads “left out important information, provided opinions or made meaningless associations with lifestyles. It also found that 55 percent of those claims were “potentially misleading” and two percent were “false.” (Adrienne E. Faerber and David H. Kreling, "Content Analysis of False and Misleading Claims in Television Advertising for Prescription and Nonprescription Drugs,” Journal of Internal Medicine, Sep. 2013)
The U. S. pharmaceutical industry is worth $300 billion. According to a report issued by the Pew Charitable Trust, in 2012 the pharmaceutical industry spent more than $27 billion marketing its products to physicians. Eighty-four percent of physicians reported receiving payments, gifts, meals, travel or drug samples from the industry. Pew’s data shows that sales increased 17 percent when a physician received meals, speaking/consulting fees or other payment by the industry. In contrast, sales of promoted drugs declined 34 percent when the hospital limited physicians’ contact with manufacturers. According to data compiled by West Virginians for Affordable Health Care, state physicians reported receiving $1,190,844.20 from pharmaceutical companies over just five months, August – December 2013. The receipts were reported to the federal government under the Physician Payment Sunshine Act.
Another issue is that many pharmaceuticals are marketed to consumers before their risks are fully known. A recent example was Vioxx, which was on the market five years before being pulled. A 2013 survey of doctors found that 68 percent believed that prescription drugs are marketed before all safety concerns are known (Richard Meyer, "Majority of Physicians Believe DTC Ads Should Be Cut Back,” Apr. 30, 2013). In 2006, the Institute of Medicine recommended that direct to consumer advertising be banned for new drugs for two years.
“These manufacturers want to increase their profits by marketing to consumers directly and then push the ads out before all the risks or defects are known. At the same time, they’re now insisting they have no responsibility to those consumers,” said Majestro. “It doesn’t work that way. It’s a two-way street. You can’t advertise these products to the consumer and then demand a free pass if someone gets hurt or dies. It’s not fair to West Virginia patients, and it’s not fair to West Virginia doctors.”
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