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Wisner Baum is investigating claims involving ICU / Smiths Medical implantable port catheters. If you or a family member was injured by an ICU / Smiths Medical port catheter device, contact us today or call (310) 207-3233 for a free, confidential case evaluation.
For the latest developments across all port catheter litigation, including the Bard PowerPort MDL and AngioDynamics MDL, see our port catheter lawsuit hub page.
Attorneys continue to file product liability lawsuits against ICU Medical, Inc. as successor in interest to Smiths Medical ASD, Inc.
Recent filings in the U.S. District Court for the Central District of California allege that patients who received Smiths Medical port catheter devices suffered serious complications, including blood clots, infection, thrombosis, and pain requiring device removal. These allegations apply to a variety of port catheter devices manufactured by ICU Medical / Smiths Medical. At present, there is no multidistrict litigation (MDL) for ICU Medical port catheter cases. ICU Medical lawsuits are, for now, proceeding as individual cases.
On February 13, 2025, Smiths Medical sent affected customers an urgent medical device recall letter for its ProPort Plastic Implantable Ports. The recall was triggered by a manufacturing defect that could cause the plastic port housing to separate from the port reservoir. On March 19, 2025, the FDA published the recall notice, classifying it as Class I — the most serious category, reserved for situations where use of the device may cause serious injury or death. According to the FDA notice, two injuries had been reported at the time of the recall. No deaths were reported.
The lawsuits currently on file are not necessarily related to this specific recall and include numerous devices other than the ProPort manufactured by ICU Medical / Smiths Medical.
The Smiths Medical ProPort is an implantable port catheter system designed to provide repeated access to the venous system, allowing the delivery of medications, intravenous fluids, parenteral nutrition solutions, blood products, and the withdrawal of blood samples. Like other implantable port catheters, the ProPort consists of two primary components: an injection port with a self-sealing septum and a flexible catheter that is inserted into a central vein.
Smiths Medical manufactured and sold the ProPort system before being acquired by ICU Medical, a Delaware corporation headquartered in San Clemente, California. ICU Medical completed its acquisition of Smiths Medical from London-based Smiths Group in January 2022 for more than $2 billion. In July 2024, Smiths Medical ASD, Inc. formally merged into ICU Medical, Inc., making ICU Medical the legal successor in interest — and assuming the liabilities — of the former Smiths Medical entity.
In February 2025, Smiths Medical (now operating under ICU Medical) issued an urgent recall of its ProPort Plastic Implantable Ports after identifying a manufacturing defect that could cause the plastic port housing to separate from the port reservoir. This separation could occur before, during, or after implantation.
The FDA classified the recall as Class I, the most serious recall classification. FDA determined that the defect could lead to the following serious adverse health consequences:
At the time of the recall, Smiths Medical had received two reports of injuries. No deaths had been reported. The recall instructed healthcare providers to monitor patients with implanted ProPort devices for signs of adverse events, to ensure the housing and reservoir feel secure and stable when palpating the device, and to watch for symptoms such as swelling, redness, or discomfort at the implant site that may indicate leakage or system failure.
Customers were directed to stop use and distribution of affected products, quarantine remaining inventory, and return all affected devices.
Patients who were injured after receiving Smiths Medical port catheter devices have filed product liability lawsuits against ICU Medical, Inc. These suits do not necessarily involve the ProPort recalled device, and allege different issues with the port catheter devices.
While each case involves different facts and injuries, port catheter lawsuits against ICU Medical share common allegations about the design, manufacturing, and marketing of the devices.
In addition to the ProPort recall — which involved the port housing separating from the reservoir — separate lawsuits have been filed alleging that other Smiths Medical port catheter products, including the Port-A-Cath II Power P.A.C., suffer from material and design defects related to barium sulfate concentration in the catheter tubing. The allegations summarized below are drawn from those filed complaints.
Lawsuits allege that the manufacturing process used to construct the catheter involved an excessively high concentration of barium sulfate particles relative to the polymer formulation. Barium sulfate is added to the catheter tubing to make it visible under X-ray imaging.
According to complaints, the concentration of barium sulfate used in these devices was too high for the polymer formula, which made the raw catheter material excessively thick before it hardened. That thickness allegedly prevented the barium sulfate from mixing evenly throughout the plastic, leaving some sections of the catheter with significantly more of the additive than others — and therefore weaker and more prone to degradation.
Lawsuits further allege this manufacturing process produced a catheter with an uneven composition, meaning the barium sulfate was not distributed uniformly throughout the tubing. The result was a catheter surface riddled with tiny cracks, pits, and fissures, with some sections containing more than 30% barium sulfate by weight, per the complaints. Plaintiffs allege that these concentrated areas were structurally weaker, making the catheter more likely to degrade over time, attract bacteria that could lead to infection, and ultimately fail.
These are allegations made in litigation. The manufacturer has not publicly admitted to these specific claims, and the legal and scientific questions remain in dispute.
Plaintiffs have also alleged that safer alternative designs existed and were commercially available at the time the devices were manufactured and sold. Specifically, complaints assert that the defendant could have incorporated antimicrobial coatings, antifouling surface modifications, or encapsulation of the barium sulfate additive within the polyurethane to reduce or prevent the surface degradation, biofilm formation, and infection risks associated with the unmodified catheter design.
Lawsuits allege that if the defendant had incorporated these commercially available technologies, the incidence of device-related infections, thrombosis, and catheter failures would have been reduced.
Filed complaints allege that ICU Medical (and its predecessor Smiths Medical) failed to adequately warn healthcare providers or patients about known or reasonably foreseeable risks associated with the device, including the specific risk of infection related to the catheter’s material composition and surface characteristics. Lawsuits contend that the warnings, labels, and instructions provided by the manufacturer were inaccurate and misleading, and that neither patients nor their physicians were informed of the device’s allegedly heightened propensity for infection, thrombosis, and fracture compared to other available devices.
Certain complaints further allege that the manufacturer knew or should have known the device had a substantially higher failure rate than comparable products, yet failed to disclose this to patients or the medical community. Plaintiffs in some cases allege that the manufacturer intentionally concealed the severity of complications and the likelihood of their occurrence, and continued to market the device as safe despite accumulating adverse event reports.
A significant focus of the lawsuits against ICU Medical involves the device materials and manufacturing processes, which plaintiffs allege may cause infection. The following summarizes the scientific research cited in filed complaints against ICU Medical, as well as the allegations plaintiffs have drawn from that research.
Barium sulfate (BaSO₄) is a chemical compound added to catheter tubing to make the device visible on X-rays, allowing doctors to confirm that the catheter is positioned correctly. Published research has found that over time, barium sulfate particles can separate from the surface of the catheter, leaving behind tiny cracks and weak spots in the plastic. This process can compromise the structural integrity of the catheter material.
How well a catheter holds up over time depends in large part on how much barium sulfate was mixed in and how evenly it was distributed throughout the tubing. When the additive is concentrated unevenly (for example, if more of it is packed into some sections than others) those areas tend to be weaker and more vulnerable to cracking, breakdown, and bacterial buildup.
When the surface of a catheter becomes rough or uneven (for example, from barium sulfate particles separating out of the plastic) it can become easier for blood proteins and bacteria to stick to it. Those bacteria can then multiply and form what researchers call a biofilm: a thin, sticky layer of microorganisms that coats the catheter surface and is protected by a shell-like barrier.
Once a biofilm takes hold, it is extremely difficult to treat. The protective barrier shields bacteria from both the patient's immune system and antibiotics. A 2024 study found that approximately 60 to 70% of hospital-acquired infections were linked to medical devices, with biofilm formation identified as the primary mechanism of device-related infection. In most cases, antibiotics alone cannot eliminate a biofilm infection; the device itself has to be surgically removed.
Plaintiffs in ongoing port catheter lawsuits point out that technologies already exist that could reduce or prevent biofilm formation and the infections it can cause. These include catheter coatings designed to kill bacteria on contact, surface treatments that prevent bacteria and blood proteins from sticking to the catheter in the first place, and combination approaches that do both. Lawsuits allege that the manufacturer's decision not to use any of these commercially available options was unreasonable given the known risks.
The scientific and legal questions regarding whether these alternative designs would have prevented specific patient injuries are actively disputed in litigation.
Patients who have filed lawsuits against ICU Medical have reported a range of serious injuries associated with the Smiths Medical ProPort and Port-A-Cath II Power P.A.C. devices. Based on filed complaints and the FDA recall notice, reported injuries include:
The severity and type of injury vary from patient to patient. Not every patient implanted with a recalled or allegedly defective device will experience complications. However, when complications do occur, they can be serious and may require hospitalization, emergency surgery, or prolonged medical treatment.
If you received an implantable port catheter and are unsure whether it was manufactured by Smiths Medical or ICU Medical, the following steps may help:
Device names to look for include: Smiths Medical ProPort, ProPort Low Profile, ProPort Plastic Venous Access System, Port-A Cath, and Port-A-Cath II Power P.A.C. If your records reference any of these product names or Smiths Medical or ICU Medical as the manufacturer, your device may be relevant to this litigation.
For guidance on identifying port catheter devices from other manufacturers, see our port catheter lawsuit overview.
Because ICU Medical merged with Smiths Medical ASD, Inc. in 2024, ICU Medical is the legal successor in interest to the former Smiths Medical entity. This means that product liability claims arising from Smiths Medical port catheter devices are brought against ICU Medical.
Lawsuits currently being filed against ICU Medical generally assert the following causes of action:
There is currently no multidistrict litigation (MDL) for ICU Medical port catheter cases. This is in contrast to the Bard PowerPort litigation (MDL 3081), which has consolidated thousands of cases in the District of Arizona. ICU Medical cases are currently proceeding as individual lawsuits filed in federal district courts. Whether an MDL will be formed in the future depends on the volume and similarity of filed claims.
If you believe you have been injured by an ICU Medical port catheter, here are some steps to take:
Seek medical attention first. If you have not already done so, consult a physician. Documenting your medical condition is important both for your health and for any potential legal claim.
Request and preserve your medical records. Ask your treating physician, hospital, and any imaging centers for copies of records related to the port implantation, any follow-up care, and any procedures performed to address complications. If the device was explanted (removed), ask whether it was preserved. Physical evidence of a malfunctioning device can be important in litigation.
Identify your device. Your medical records should include the brand, model, catalog number, and lot number of the port catheter. This information helps an attorney evaluate whether your device was part of the recall and which legal theories apply to your case.
Consult a qualified attorney. Product liability cases involving medical devices are complex, particularly when they involve a corporate acquisition and successor liability. Working with an attorney experienced in defective medical device litigation helps ensure that your rights are protected and that you meet applicable statute of limitations deadlines. These deadlines vary by state and typically run from one to six years from the date of injury or discovery.
You do not need to know the manufacturer. Many patients do not know who made the device implanted in them. An experienced attorney can help obtain your medical records and identify the specific device.
Wisner Baum is a national plaintiffs’ law firm with decades of experience holding medical device manufacturers and pharmaceutical companies accountable in litigation. Since 1985, Wisner Baum attorneys have obtained more than $4 billion in verdicts and settlements on behalf of clients.
Our defective medical device attorneys handle cases on a contingency fee basis, which means you pay no attorneys’ fees unless we recover compensation for you. We offer free, confidential case evaluations, and there is no obligation to proceed after your initial consultation.
If you or someone in your family suffered a serious injury from a Smiths Medical ProPort or another ICU Medical port catheter device, we want to hear from you. Give us a call at (310) 207-3233 or fill out our contact form today.
The information on this page is for general informational purposes only and does not constitute legal advice. Reading this page does not create an attorney-client relationship. Every case is different; outcomes depend on the specific facts and law applicable to your claim.
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In May of 2019, the jury in the case of Pilliod et al. v, Monsanto Company ordered the agrochemical giant to pay $2.055 billion in damages to the plaintiffs, Alva and Alberta Pilliod, a Bay Area couple in their 70s. R. Brent Wisner served as co-lead trial attorney for the Pilliods, delivering the opening and closing statements and cross-examining several of Monsanto’s experts. Wisner Baum managing shareholder, Michael Baum and attorney Pedram Esfandiary also served on the trial team in the Pilliod case.
The judge later reduced their award to $87M. Monsanto appealed the Pilliod’s verdict which the California Court of Appeal for the First Appellate District denied on August 9, 2021. Monsanto then requested the California Supreme Court review the appeal’s court decision, which the court denied on Nov. 17, 2021. Monsanto (Bayer) then submitted a petition for a writ of certiorari with the U.S. Supreme Court which SCOTUS denied on June 27, 2022, allowing the final judgment of $87M to remain intact.
$289.2 million jury verdict in Monsanto Roundup trial
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In 2016, Wisner Baum attorney Timothy A. Loranger and six other attorneys in the Plaintiffs’ Management Committee were able to secure a $265 million settlement for victims of the 2015 Amtrak 188 derailment in Philadelphia, one of the largest in the U.S. for 2016.
The Bard PowerPort MDL (MDL 3081) involves a different manufacturer (C.R. Bard / Becton Dickinson) and centers primarily on allegations of design and material degradation in polyurethane catheters containing barium sulfate. The ICU Medical litigation involves numerous devices manufactured by ICU Medical / Smiths Medical that allege similar design and material degradation in the polymer catheters containing barium sulfate. In addition, however, the lawsuits may also involve injuries caused by Smiths Medical’s ProPort devices involved in the 2025 Class I FDA recall for a manufacturing defect that could cause the port housing to separate from the reservoir. For more on the Bard litigation, see our Bard PowerPort lawsuit page.
Not at this time. Unlike the Bard PowerPort litigation, ICU Medical port catheter cases are currently proceeding as individual lawsuits. Whether cases will be consolidated into an MDL in the future depends on the number and similarity of claims filed. Wisner Baum is monitoring this litigation closely.
Yes. In February 2025, Smiths Medical (now part of ICU Medical) issued a Class I recall for its ProPort Plastic Implantable Ports due to a manufacturing defect that could cause the plastic port housing to separate from the reservoir. The recall notice is available on the FDA’s Medical Device Recalls and Early Alerts page.
Yes. A product liability claim does not require that the specific device you received was formally recalled. Lawsuits allege that the design and manufacturing processes used across the product line may have contributed to infections, thrombosis, and other complications independent of the specific recall defect. Our attorneys evaluate each case on its individual facts.
Yes. Product liability claims are governed by state statutes of limitations, which set deadlines for when a lawsuit must be filed. These deadlines vary by state and can be as short as one year from the date of injury or from the date you discovered (or reasonably could have discovered) that the device caused your harm. Consult an attorney as soon as possible to protect your right to file.
No. Wisner Baum offers free, confidential case evaluations and handles defective medical device cases on a contingency fee basis. You pay nothing unless we recover compensation for you.
