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Product liability and Medical Devices/Software

Avery Marshall, Clarissa Ruelas-Gastelum, Neomie Almario, Viviana Ortega, Yvette Salinas

California State University – Channel Islands

HLTH-308: Introduction to Health Law

Dr. Carol H. Mack

March 28, 2023

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Product liability and Medical Device/Software

Lawsuits for faulty products and product liability are a point of concern. In this writing

strict liability will be defined and the three defects that warrant a product liability case will be

looked at. In addition, it will be shown how these product liability cases apply to medical

devices, IV pumps, and medical software. From this potential liability cases which went to court

involving these products will be explored.

Strict Liability and Defects

Strict liability is a legal theory known as strict liability that holds a person or organization

accountable for the harm brought on by their products. Or otherwise defined as “a concept

applied in both civil and criminal law that holds a defendant responsible for their actions

regardless of their intent at the time of the action” (Hasner, n.d. para. 1). It also acts as a legal

doctrine that imposes liability for damage caused by a product regardless of fault or negligence

by the manufacturer or seller, whether they did so intentionally or negligently. It is a legal

principle that places responsibility on the defendant even without their having done anything

wrong. Strict liability can be applicable in several circumstances, including environmental law,

product liability, and personal harm. Manufacturers and sellers may be held strictly accountable

for any injury brought on by a defective product, for instance, even if they were unaware of the

defect at the time of sale, in the context of product liability. The plaintiff needs to demonstrate

that the product was flawed and that the flaw caused the harm; they do not need to confirm that

the defendant was careless or meant to cause damage. Strict liability protects consumers and

ensures that manufacturers and sellers take every possible precaution to make their products safe.

It is a powerful legal concept that places a significant responsibility on those who produce or sell

products, but it is also an essential safeguard against harm and injury. Product liability refers to
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the legal responsibility of manufacturers, distributors, and sellers for damage caused by their

products. “When a product is defective and causes an injury, there are three types of defects

possible.” (H.G.org, n.d, para. 1.). Manufacturing defects are errors that arise throughout the

production process that cause the result to differ from the original design. A product with a

broken component due to a manufacturing error is an example of a manufacturing defect. Design

defects are a product's construction flaws that render it inherently risky or unsafe. A design

problem, for instance, could exist in a car model that causes it to flip over when making quick

curves. Marketing defects or cautions are examples of marketing faults, which are flaws in how a

product is advertised or sold. An illustration of a marketing flaw would be a drug sold without

adequate disclosure of potential adverse effects. A person suffering harm due to a defective

product may file a product liability claim against the seller, distributor, or manufacturer. A

plaintiff must establish three things to win a product liability claim: the product's flaw, the injury

it caused, and the fact that the product was being used following its design at the time of the

harm. Product liability is crucial to safeguard customers and guarantee that producers and dealers

take all reasonable precautions to make their products safe. The wounded party may sustain

considerable losses, such as restitution for pain and suffering, lost wages, and medical expenses.

In addition, product responsibility is a crucial legal principle that guarantees dealers and

producers are held responsible for the quality of their products.

Liability and Medical Products

Product liability can apply to medical products when a patient is injured from a defective

drug or medical product that was used on them and did not receive an adequate warning about

the possible risks or side effects of the use of the product. A medical products liability claim can

be a lawsuit against a physician and a manufacturer, but the liability claim is not a medical
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malpractice claim (Broussard & David, n.d.). A common case that occurs during a medical

products liability claim is the “learned intermediary” doctrine. This is when the injured patient

files a suit against all of the parties in the chain of distribution of the used medical product,

which includes the manufacturer and the physician (Husgen, 2014). However, the ultimate

decision of using the medical product on the patient was from the physician, and not the

manufacturer, making the physician serve as the learned intermediary. The manufacturer gave

the physician and the clinic or hospital all the adequate warning information about their medical

drug or device when it was given to them. Because of this, there is no longer any connection

between the manufacturer to the patient since the decision of the product being used was by the

physician, allowing the manufacturer to avoid liability. There are three rationales that support the

learned intermediary doctrine (Husgen, 2014). First, the physician is the superior decision-maker

of the patient, therefore they should know best if the product will cause harm to the patient.

Second, manufacturers do not communicate with the patients. Third, if the manufacturers were to

communicate with the patient, it would impose on the physician-patient relationship. To legally

protect everyone from the risk of the use of medical products, both the manufacturer and the

physician should be responsible for their duties of warning the potential risks and side effects of

using medical products and letting patients know about these risks.

Liability and IV pumps

Another example of product liability is the Medfusion 3500 and 4000 Syringe Infusion

Pumps. These infusion pumps were primarily used to give patients fluid in a controlled manner,

“They deliver blood or blood products, lipids, drugs, antibiotics, enteral feedings and other

therapeutic fluids through infusion tubing into a patient’s vein or through other cleared routes of

administration,” (FDA, 2022, para. 2). This was one of the most dangerous recalls within the
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medical community, this is, because of the cases where there were over infusions or delays due

to the system containing approximately eight different malfunction systems, which resulted in

serious harm or potentially lead to death. According to the article from the FDA, there have

already been few lawsuits against the manufacturer. During this case, the plaintiff who had

originally decided to open the lawsuit suffered severe permanent injuries that were caused by the

Medtronic pumps to malfunction, consequently leading in withdrawal from a medication that is

supposed to be used to treat cerebral palsy and spastic quadriplegia.

In addition, in an article that was released by the U. S. Department of Justice, the FDA

“seized 7,140 intravenous infusion pumps, alleging they were faulty and violated the federal

Food, Drug and Cosmetic Act” (U. S. Department of Justice 2006, para. 1), after recalling the

infusion pumps the manufacturer agreed to stop any sort of distribution within the United States.

In 2005, Baxter Healthcare Corp revealed that the reason the Infusion pumps were failing was

because of a design malfunction. The design malfunction was triggered by a temperature

sensitive component to the timing circuit, and while all manufacturing was being stopped in the

U.S by government officials, Baxter had decided to put a worldwide hold on all Syndeo Infusion

Pumps due to the failure within their designs.

Liability and Medical Software

When looking at the topic for Medical Software, this is good technology to use especially

when you use it for advanced technology. This helps health care professionals to have more

advanced technology to use in their profession, and to help to further them in their careers. So

although it is good to use, sometimes it creates liability issues, or creates problems that change

the way nature goes. I will be discussing issues that contribute to the liability risks for the

medical device software.

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This new software has been beneficial by pushing the edge of new medical technologies.

When it discusses the difficulties and challenges presented with the liability costs, it means cyber

breaches that occur when managing the software risks. This means safeguarding products from

hacking and infection. In an article by Med Tech Intelligence it states, “This number was just

$5.5 billion in 2014, but the increasing frequency of cyber attacks, regulatory and security

compliance requirements, and data leaks have forced life sciences companies to dedicate more

financial resources to preventing cyber breaches.” (Dyson, 2017, para. 2). This demonstrates

how many times this liability issue has happened over the course of time. This looks bad on the

software companies, so they have to find a way to prevent this issue to keep occuring. They do

not want to be liable, or else they will have to pay a lot of money to make it stop occurring.

When dealing with medical software liability, cyber attacks are not the only ongoing problem.

The other problem that occurs associated with liability issues is product liability

involving medical device manufacturers. So what happens when you are using a product for a

high end surgery and something happens to you in which the product does harm to you. As well

as properly damaging you for the rest of your life. This holds manufacturers liable for their

product they produced because it caused so much harm to the patient. The article states, “ What

underpins this theory of liability is the premise that a manufacturer that profits from the sale of a

defective product must bear the costs of remuneration when it injures someone” (Dyson, 2017,

para. 3). A lot of the times these cases go to court, involving issues rounded to the products such

as transvaginal mesh, as well as metal-on- metal hip implants. This mesh is widely prescribed to

treat pelvic organ prolapses in women, following childbirth. The problem with the mesh was it

would break into small pieces, or cut nearby organs.

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Another issue is the metal-on-metal hip implants. This product also has a lot of issues,

this product was manufactured by several companies but allegedly caused a lot of issues because

the product caused dangerous amounts of chromium and cobalt to enter the patient's

bloodstream. Although these cases are two very big cases that caused a lot of harm and issues to

patients, it never makes the headlines on TV because it settles in court. The article states, “[m]ost

of these cases settle out of court and never make the headlines . . . [n]evertheless, it is important

for manufacturers to attempt to identify those medical devices that may become the subject of

products liability actions” (Dyson, 2017, para. 5). This means that when new products arise they

should take into consideration the risks that may arise with the new upcoming product they are

working on and see if they can address the risks. This way they can prevent any harm or injury

from happening in the future from this new so-called product. Knowing all your product liability

risks is critical to formulate risk management strategies that can help prevent issues from arising.

So it is initially essential for these medical software companies and manufacturers to understand

what to do in these instances and how to avoid the risks later on.

In conclusion, cyber breaches that occur with software failure and products of medical

device liability occur in everyday life all the time, so it is important to understand the risks that

come with them. So just be sure to be careful when you make new technology and new products

to avoid causing liability issues.

Conclusion

From this writing the concept of strict liability was explored and its different facets. One

can see how this liability can apply to a wide range of medical devices and equipment. This

equipment ranges from IV pumps to medical software. Furthermore, it was seen how due to this

liability how court cases may ensue when products are faulty or there is malpractice.
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References

Broussard & David. (n.d.). Medical Products Liability | Lafayette Defective Product

Lawyers. Broussard & David. Retrieved April 3, 2023 from https://www.broussard-

david.com/medical-products-liability.html

Dyson, S. E. (2020, September 15). Medical Device Software & Products Liability: An

Overview (part i). MedTech Intelligence. Retrieved March 17, 2023, from

https://www.medtechintelligence.com/feature_article/medical-device-software-products-

liability-overview-part/

FDA (2022, July 20). Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe

Infusion Pumps for Software Issues That May Impact Infusion Delivery. FDA. Retrieved

April 3, 2023 from https://www.fda.gov/medical-devices/medical-device-recalls/smiths-

medical-recalls-certain-medfusion-3500-and-4000-syringe-infusion-pumps-software-

issues-may

Hasner Law PC. (n.d.). What is strict liability?. Hasner Law. Retrieved April 3, 2023

from https://www.hasnerlaw.com/atlanta-personal-injury-resources/what-is-strict-

liability/.

HG.org. (n.d.). Three types of product defects for product liability lawsuits. HG.org.

Retrieved April 3, 2023 from https://www.hg.org/legal-articles/three-types-of-product-

defects-for-product-liability-lawsuits-24105.

Husgen, J. (2014, November). Product Liability Suits Involving Drug or Device

Manufacturers and Physicians: The Learned Intermediary Doctrine and the Physician's

Duty to Warn. NCBI. Retrieved April 3, 2023 from

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173549/
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U.S. Department of Justice (2006, June 29). Baxter Healthcare Agrees to U.S. Court

Order to Remedy Infusion Pump Defects and to Comply with FDA Requirements. U.S.

Department of Justice. Retrieved April 3, 2023 from

https://www.justice.gov/archive/usao/iln/chicago/2006/pr0629_01.pdf