Drug infusion pumps and pain pumps are electronic devices that deliver drugs or other fluids to patients intravenously, in regulated time intervals. Problems with drug infusion pumps in recent years have led to numerous lawsuits and U.S. Food and Drug Administration (FDA) recalls. Malfunctions in drug infusion pumps have reportedly injured and killed patients. And hundreds of lawsuits allege that certain uses of pain pumps after shoulder surgery can cause chondrolysis, a painful breakdown of shoulder cartilage.
According to the FDA, in the last five years it has received 56,000 reports of problems caused by drug infusion pumps, including 500 deaths. Between 2005 and 2009, 87 drug infusion pumps have been recalled because of safety issues.
Read on to learn more about when drug infusion pumps are used, how they malfunction, and what legal claims and defenses are available in drug infusion pump lawsuits.
Drug Infusion Pumps: What They Are and How They Work
A drug infusion pump is an electronic device that delivers intravenous drugs or fluids in very small amounts at a carefully regulated rate over a period of time. Some drug infusion pumps are external and can be used in the hospital and at home. Others are surgically implanted into the patient.
Drug infusion pumps can be used to deliver a number of drugs and fluids. Some of the more common uses include:
- providing high-risk patients with critical fluids and nutrients
- delivering antibiotics (the majority of external drug infusion pumps administer antibiotics)
- delivering pain relieving drugs -- pumps administering these types of drugs are often called pain pumps or anesthetic infusion pumps
- delivering drugs to treat spasticity (continuous muscle contractions), and
- delivering drugs to treat cancer.
Problems Associated with Drug Infusion Pumps
According to the FDA, the most common problems associated with drug infusion pumps include:
- software glitches such as failures of safety alarms
- confusing instructions leading to dosing errors, and
- mechanical or electrical failures -- such as battery failures, sparks, or pump fires.
When drug infusion pumps malfunction, the resulting underdose or overdose of the drug or intravenous liquid could lead to severe injury or even death. The nature of injury depends on the type of drug and the patient's condition.
Problems Associated With Pain Pumps: Chondrolysis
Some drug infusion pumps are used to deliver pain management medications to patients post-surgery -- these are sometimes called pain pumps or anesthetic infusion pumps. The FDA has approved the use of pain pumps for injecting anesthetics directly into the muscle. Since 2000, doctors have commonly used pain pumps to inject pain relieving drugs into patients' shoulder joint space (or synovial space) following shoulder surgery. This use, which some say is encouraged by pain pump manufacturers, is not approved by the FDA.
In recent years, medical literature has discussed a possible link between using pain pumps to inject drugs into joint space and the development of chondrolysis, a breakdown of cartilage in the shoulder joint, which can cause severe pain and stiffness in the affected joints and muscles and can severely limit range of motion. Lawsuits involving pain pumps allege that manufacturers encouraged doctors to use the pumps to inject drugs into joint spaces.
Legal Claims in Drug Infusion Pump Litigation
For the most part, lawsuits over drug infusion pumps fall under the category of "product liability" claims. In these legal claims, plaintiffs argue that patients were killed or injured by a drug infusion pump because of one or more of the following:
- The pump was defectively manufactured. For example, during the manufacturing process, the engineers installed a bad battery, which later caused a shutdown of the pump.
- The pump had a design defect. In these claims, plaintiffs argue that even though the pump was properly manufactured, it had an inherent design defect which made it dangerous to use.
- The manufacturer engaged in defective marketing. The "marketing" of a medical device refers to a manufacturer's recommendation, warning (or lack of a warning), or instruction concerning the use of that medical device. For example, in pain pump lawsuits involving chondrolysis, plaintiffs argue that pain pump manufacturers failed to adequately warn doctors that the FDA had not approved the use of pumps to inject drugs directly into the joint space. (To learn more about legal claims in these types of cases, read Nolo's articles Product Liability Claims Involving Medical Devices and Types of Defective Product Liability Claims.)
Drug infusion pump manufacturers employ various legal defenses in these lawsuits. The most common include:
- Federal preemption. State laws dealing with the same matters as federal laws cannot be enforced if Congress has asserted exclusive power over the matter. This is called federal preemption -- the state law is preempted, or superseded, by the federal law or regulation. Drug infusion pump manufacturers may argue that the FDA's pre-market approval of their device (the FDA's scientific and regulatory review to evaluate the safety and effectiveness of certain medical devices) preempts any state law claim based on the marketing of that device.
- Learned intermediary. A manufacturer in a product liability case may argue that it warned a "learned intermediary" (the doctor) of the dangers of using the drug infusion pump, and therefore the manufacturer is not obligated to warn the consumer of those dangers.
- Causation. In a product liability lawsuit, the plaintiff must prove that the product defect actually caused the plaintiff's injury or death. Defendants almost always argue that something else caused the patient's injury or that it is impossible to pin causation on the device in question.
- Statute of limitations. Every state sets certain time limits for bringing product liability claims, called the "statute of limitations." If the plaintiff fails to bring the lawsuit in a timely fashion, the manufacturer can argue that the lawsuit or legal claim is barred. To learn more about the statute of limitations in medical device lawsuits, see Nolo's article Time Limits for Filing a Defective Products Liability Claim.
The legal and medical issues in drug infusion pump cases are typically complex and sophisticated and usually aren't easily handled without an attorney. If you want to retain the services of a lawyer who specializes in products liability (and perhaps even one who specializes in drug infusion pump cases), read Nolo's article Finding a Personal Injury Lawyer. Or go to Nolo's Lawyer Directory for a list of personal injury attorneys who handle medical device cases in your geographical area.