Deceptive Marketing of Drugs and the Failure To Warn
When most people hear the term "product liability lawsuit," they assume the case is about a dangerous product. However, thousands of cases are filed yearly over dangerous drugs and deceptive marketing of prescription drugs.
What Drug Manufacturers Must Disclose
When a pharmaceutical company releases a new drug on the market, it is legally required to identify risks and side effects. For example, they must disclose any clinical trial data.
The Food, Drug, and Cosmetic (FD&C) Act also requires drug manufacturers to include the following information in their drug packaging:
- Possible side effects
These three pieces of information are often called the "brief summary" of a medication. This information must be communicated to prescribing doctors, healthcare providers, and patients or consumers.
Drug manufacturers must also avoid making false claims about the effectiveness and safety of their products. They cannot provide any off-label use recommendations.
Drug Labeling and Marketing Requirements
When a company releases FDA-approved drugs and medical devices to the American consumer market, it must comply with all regulatory and statutory requirements. For example, the FDA has special rules in place about drug labeling and marketing. The Food and Drug Administration requires manufacturers to disclose, in plain language, any limitations on the drug's effectiveness.
The FDA also requires the packaging and marketing material to provide balanced information about the drug's effectiveness, risks, and limitations.
How Misbranding and False Claims Impact Patients
Most new drugs released to the market are available by prescription only. However, there are many direct-to-consumer medications and medical devices invented every year. There's no doctor to warn the patient about possible side effects or risks in these situations.
The Federal Trade Commission (FTC) enforces over-the-counter medicine advertisements. The law requires claims to be truthful—they cannot be misleading or unfair. The labels and packaging are the only information the consumer will have.
There can be devastating results if the pharmaceutical company doesn't provide the patient with accurate and detailed information. Some medications can be life-threatening if not taken correctly. Patients can also get sick or die if they mix certain medications.
If a drug manufacturer has a press release and promises patients that their new drug is safe, consumers will take them at their word. This is true for medications, medical devices, and even supplements. This is why the companies' marketing materials must be true and accurate.
Deceptive Drug Marketing Example: Opioid Painkillers
The opioid crisis has become a major health topic. Doctors, medical organizations, government health authorities, and patients nationwide have dealt with the fallout of opioid drugs. These prescription painkillers are highly addictive. They impact not only thousands of patients but the healthcare system, as well.
Many state and local governments have responded. For example, the city of Chicago and two California counties have filed lawsuits against companies selling prescription opioid drugs. These suits contend that manufacturers used deceptive marketing campaigns to boost opioid drug sales and increase profit margins.
Before the 1990s, doctors primarily prescribed opioids to patients with severe health problems. However, prescribing practices have changed. Drug companies began aggressive marketing campaigns to promote opioid drugs among doctors and patients. These campaigns succeeded. Since 1990, prescriptions for opioid painkillers have increased ten times over.
The rise in opioid prescriptions has had severe public health consequences. Opioid addiction and overdoses contribute to a rising number of emergency room visits.
State and local governments have borne much of the burden during this crisis. Government agencies pay for emergency room visits and administer substance abuse programs. Government health care also covers millions of people who take prescription drugs.
The rise in opioid use impacts these agencies and costs taxpayers millions annually. This is why the government has cracked down on pharmaceutical companies in recent years.
Drug Warning Lawsuits and Enforcement Actions
Numerous lawsuits have been filed against drug manufacturers, especially in recent years. A prime example is the lawsuits filed by consumers, government agencies, and municipalities or states against opioid manufacturers. While some of these cases have settled, many are still ongoing.
One common response by pharmaceutical companies to this type of litigation is to file bankruptcy (or try to). In August of 2023, Purdue Pharma attempted to file bankruptcy to avoid civil liability in the opioid litigation. The U.S. Supreme Court put a halt to the bankruptcy. This shows that the government and legal system will not let these drug companies off the hook.
Some other recent dangerous drug and medical device litigation include:
- Hernia mesh litigation
- Philips CPAP Litigation
- Hip replacements
- Transvaginal mesh litigation
There are dozens, if not hundreds, of class action lawsuits against drug manufacturers yearly. If you are the victim of a dangerous drug or medical device, you should immediately contact a qualified personal injury attorney. You may be entitled to significant compensation.
Government Response To Dangerous Drug Litigation
Some local governments have taken legal action against the drug companies. In May 2014, two California counties filed a consumer protection lawsuit against five drug companies. The initial civil complaint contends that several companies, including Purdue Pharma and Johnson & Johnson, used deceptive marketing practices. They allege that the companies misrepresented the safety of their products to boost sales and increase profit margins. The city of Chicago has filed a similar lawsuit.
In these two cases, California and the city of Chicago contend that various drug companies and their sales representatives overstated the benefits of opioid drugs, such as oxycontin, while understating the risks. They claim that drug companies violated state consumer protection laws against deceptive marketing. The lawsuits claim such deceptive marketing practices prevented doctors and patients from making informed healthcare decisions. Both lawsuits seek a court order preventing the companies from inaccurately advertising their drugs. They also request restitution for the costs imposed on taxpayers.
What Options Are Available To Injured Patients and Consumers?
Product liability law holds manufacturers responsible for patient injuries when those companies fail to warn the public about a drug's risks. Drug commercials and advertisements carry a long list of potential side effects because of this requirement.
While sometimes tedious, these warnings exist to inform patients and prospective customers. Doctors and patients need reliable information about a drug's risks and benefits to make sound medical decisions. Deceptive marketing campaigns or drug warnings that do not provide this information put patients at risk.
Patients injured by a dangerous or defective product have rights. A product liability lawsuit can help you recover compensation from the manufacturer (and other responsible parties). Such compensation can cover medical bills, lost income from time off work, pain and suffering, and other damages related to the injury. Get in touch with a local product liability attorney today.
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Contact a qualified product liability attorney to make sure your rights are protected.