The U.S. is the number one consumer of prescription drugs and medical devices in the world. While Americans are able to gain access to many new treatments and life-saving medical devices, it is also big business for Big Pharma and device companies.
Prescription drug sales reached an all-time high of $425 billion in 2015, and they could reach $610 billion by 2020. According to the U.S. Department of Commerce, the U.S. medical device market is roughly $148 billion, making it the largest market in the world.
With such a large number of drugs and devices on the market, maintaining their safety can be difficult. Each year, the U.S. Food and Drug Administration receives more pressure from drug and device companies to approve their products for sale faster. In 2015, FDA drug approvals hit a 66-year high of 51. But, approved drugs and devices are not necessarily safe.
While Americans may have quicker access to new and experimental treatments, there is also a risk that they will be exposed to potentially dangerous products. Some people injured by drugs and devices file lawsuits against manufacturers.
How the FDA Approves Drugs and Devices
After an untested toxic drug called Elixir Sulfanilamide killed 100 people in 15 states in 1937, Congress passed the 1938 Food, Drug and Cosmetic Act. The new act gave the FDA more authority to regulate drugs. Then, the Medical Device Amendments of 1976 gave the agency more regulatory power over medical devices.
A common misconception about drug and device approval is that the FDA conducts its own tests before allowing products on the market. The truth is the FDA does not have the resources to conduct its own trials and relies on data provided by drug and device manufacturers. The FDA must determine whether the benefits of a drug or device outweigh its risks based on this data.
The approval process for drugs is more extensive than it is for medical devices. While new drugs must go through a series of clinical trials, often a new medical device must only prove it is "substantially equivalent" to a product already on the market — even if the predicate device was recalled.
FDA Fast-Track Programs for Drugs
The FDA's fast-track drug programs — also referred to as expedited approval programs — allow drugs to make it to market faster. In 1992, the FDA created these programs under the Prescription Drug User Fee Act (PDUFA). The agency aimed to meet treatment needs for serious or life-threatening medical conditions more quickly. The FDA uses four different expedited approval programs, and each has its own set of criteria.
- Fast-track designation hastens the review of drugs for unmet medical needs and serious conditions. Drugs that treat a condition that has no current treatment automatically qualify.
- Breakthrough therapy designation expedites the approval of drugs that treat serious conditions. To qualify, manufacturers must prove their drug is more effective or safer than drugs already on the market.
- Accelerated approval allows the FDA to expedite drugs that can provide a "surrogate endpoint" — results that are likely to provide a benefit. For example, a surrogate endpoint is cancer drug that can prove it can shrink a tumor. The FDA can say a drug that shrinks a tumor is likely to improve survival.
- Priority review designation is granted to drugs that are very effective at treating, diagnosing or preventing a condition. The drug may also lessen or eliminate adverse reactions that prevent people from adhering to treatment and be safe and effective for a new subpopulation — such as children or the elderly.
Medical Devices and the FDA 510(k)
Medical Devices and the FDA 510(k) The 510(k) premarket notification process allows manufacturers to sell their medical devices without rigorous clinical trials. The rule applies to devices the FDA deems as low risk, such as hip implants or hernia mesh. These devices are considered Class II devices.
Manufacturers submit an application with basic info about their device and the predicate device. Along with the application, the company pays a user fee. For regular businesses, the fee in 2017 is $4,690. Then, the FDA allows the company to sell its device.
Class III devices, which are considered to be life sustaining, must go through a more stringent process called premarket approval (PMA). Defibrillators and pacemakers are examples of these devices. The FDA requires more substantial testing and proof of safety and efficacy. They also pay more fees for device approval. Because of this supposed rigorous safety process, certain laws protect manufacturers of Class III devices from liability.
But a PMA does not guarantee safety. For example, the FDA classified the Essure Permanent Birth Control System as a Class III device, but more than 30,000 women claim the device injured them. The FDA received more than 10,000 reports of adverse events — including the deaths of unborn children.
Drug and Medical Device Recalls
Manufacturers recall products that are known to be faulty or cause harm. One of the first drug recalls occurred in 1937 with S.E. Massengill Co.'s Elixir Sulfanilamide. A doctor learned of deaths linked to the drug and informed the FDA. The agency's inspectors confirmed the deaths of eight children and one adult after taking the drug.
The drug company already knew of the deaths and sent telegrams to 1,000 doctors, druggists and salesmen instructing them to return the product. But, it did not explain the risk of death.
But, the FDA requested Massengill send a second wave of messages properly explaining the urgency of the recall. The telegram read: "Imperative you take up immediately all elixir sulfanilamide dispensed. Product may be dangerous to life. Return all stocks, our expense."
The FDA sent agents to physically ensure patients, doctors and druggists returned all bottles of Elixir Sulfanilamide.
The Modern Recall Process
Often, a manufacturer issues a recall, and the FDA issues a safety alert on its website. According to the FDA, "Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority." The FDA rarely uses its authority to force a recall.
Recalls are classified by severity:
- Class I recall: reasonable probability that product will cause serious adverse health consequences or death.
- Class II recall: product may cause temporary or reversible adverse health consequences or there is remote chance of injury.
- Class III recall: product has a low risk of adverse health concequences.
- Market withdrawal: "occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal."
- Medical device safety alert: "issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls."
Manufacturers of medical devices begin recalls by sending letters to health care providers and hospitals. Only rarely do patients actually receive direct notification. Then, the FDA issues a recall notice as a courtesy on its website and to people who signed up for notifications. Manufacturers are required to inform the public the reason for the recall.
In spite of many injuries and issues, it may take years for a manufacturer to recall a product. For example, approximately 30,000 people died of heart attacks linked to the painkiller Vioxx before Merck withdrew the medication.
Johnson & Johnson's Ethicon unit did not recall its DePuy ASR hip implant until independent study data from National Joint Registry of England and Wales found that as many as 12 percent of the implants could fail within 5 years. At the time, surgeons implanted more than 93,000 devices. Later, internal documents presented during the Kransky trial revealed that J&J knew the failure rate was as high as 40 percent.
Manufacturers don’t issue recalls for all dangerous drugs or devices, many remain on the market for years and are never recalled.
Drug and Device Lawsuits
When dangerous drugs and devices injure people, they may file a lawsuit to seek compensation for damages. Product liability lawyers specialize in filing drug and device lawsuits against manufacturers. These types of lawsuits operate on a contingency fee basis, this means the lawyer will not charge a fee unless the case settles or obtains a jury verdict.
If a settlement is not reached, a plaintiff may choose to proceed to trial. Typically, fees and costs are higher if the case goes to trial.
Counts of negligence in these lawsuits include:
- Faulty design
- Improper and deceptive marketing
- Failure to warn
- Failure to properly test
- Breach of warranty
- Manufacturing a defective product
- Willful and reckless endangerment
When a large number of people claim the same injury from the same drug or device, the Judicial Panel on Multidistrict Litigation may choose to consolidate the claims in multidistrict litigation (MDL). Unlike a class action lawsuit, MDLs consolidate cases to move litigation more quickly but each plaintiff retains their own lawyer. Because each case remains individual, plaintiffs may also have more control over accepting or rejecting a settlement and going to trial.
- Cortez, M. (2016, April 14). Prescription Drug Spending Hits Record $425 Billion in U.S. Bloomberg. Retrieved from https://www.bloomberg.com/news/articles/2016-04-14/prescription-drug-spending-hits-record-425-billion-in-u-s
- FDA. (2009). The 1938 Food, Drug, and Cosmetic Act. Retrieved from https://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/ucm132818.htm
- FDA. (2017). FY2017 MDUFA User Fees. Retrieved from https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm452519.htm
- Munos, B. (2016). 2015 New Drug Approvals Hit 66-Year High! Retrieved from https://www.forbes.com/sites/bernardmunos/2016/01/04/2015-new-drug-approvals-hit-66-year-high/#5640db567874
- FDA. (n.d.) Drug Recalls. Retrieved from https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm
- Ballentine, C. (1981). Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident. Retrieved from https://www.fda.gov/aboutfda/whatwedo/history/productregulation/sulfanilamidedisaster/
- Understanding Mass Personal Injury Litigation. (n.d.) Rand Corporation. Retrieved from http://www.rand.org/pubs/research_briefs/RB9021/index1.html
- Merck to pay $4.85 billion over Vioxx suits. (2007, November 9). Associated Press. Retrieved from http://www.nbcnews.com/id/21701212/ns/business-us_business/t/merck-pay-billion-over-vioxx-suits/#.U3UW0ygQTmQ