FDA Loophole Permitted Becton, Dickinson and Co. to Obscure Bard Powerport Product Defects

FDA Loophole Permitted Becton, Dickinson and Co. to Obscure Bard Powerport Product Defects

With the August 2023 decision to consolidate outstanding Bard PowerPort lawsuits into a multidistrict litigation in the U.S. District Court for the District of Arizona, justice for the victims of the defective port-a-caths is closer than ever. The lawsuits allege, amongst other things, that Bard and, after a 2017 acquisition, its parent company, Becton, Dickinson and Co., failed to warn users about the structural weaknesses of their products. 

A closer look reveals that C.R. Bard Inc. and Bard Access Systems, two of the named defendants in the product liability MDL, relied upon a statutory loophole that enabled them to evade oversight and upload concerns to a private FDA database that the agency never publicly advertised. In an effort to untangle when exactly Bard knew of its port-a-caths’ design flaws and how it avoided any scrutiny, we have scrutinized the since-published content of the formerly secretive shadow database the FDA maintained. 

Alternative Summary Reporting (ASR) Thwarts Consumer and Expert Review of Bard PowerPorts

The U.S. Food and Drug Administration serves a critical role in pre- and post-marketing for new medications and devices. Aside from conducting extensive testing to determine the readiness of a particular product for sale, it also tracks the product’s trajectory after it has gone to market. 

One way in which the FDA conducts necessary oversight is by collating reports from the users and prescribers of products it has approved while simultaneously mandating manufacturers and importers to submit reports whenever complications from their products arise. In the context of medical devices, the FDA has long used medical device reports (MDRs) to field sweeping statements from a diverse audience of users, makers, and physicians. 

Importantly, these MDRs could be submitted through a public-facing and publicly accessible database known as the Manufacturer and User Facility Device Experience (MAUDE). Medical experts and patients have made use of the data located on the MAUDE to make important determinations about prescribing or using certain devices for treatment. 

FDA ASR Creates Blindspot for Bard PowerPort MDRs

However, unbeknownst to the public and lawmakers alike, the FDA had created a shadow database in the late 1990s to collect reports pursuant to §510 (k) of the Federal Food, Drug, and Cosmetics Act (FFDCA). The 1976 amendment to the act permits the FDA to fast-track the review process for new medical devices, provided they are sufficiently analogous to a preexisting model already on the market. 

The FDA Alternate Summary Reporting (ASR) depository, over the years, acquired hundreds of thousands of highly alarming reports from manufacturers who had received a selective “exemption” from the FDA. Amongst the clandestine submissions were thousands of reports about the defective design of C.R. Bard Inc.’s various port-o-cath PowerPort products. 

Reports Indicate Bard PowerPort Was Related to Severe Health Complications Since 2006

In 2019, Kaiser Health, an authoritative media organization in the medical community, released a series of high-profile exposés about the FDA’s ASR database and its consequences for physicians and patients alike. The publications resulted in a flurry of secondary investigations and mounting public pressure on the FDA to divulge its secretive program, which it did three months after the initial piece ran. 

The annual Excel documents listed on the FDA’s website date back to 1999, and each contains tens of thousands of formerly undisclosed reports indicating the defective designs of certain products. Beginning in 2006, Bard Access System, a subsidiary of C.R. Bard Inc., began to report through the ASR mechanism catheter design flaws and incidents of product failures, a trend that continued throughout the subsequent years. 

At around the same time that Bard Access System and C.R. Bard Inc. were submitting reports about their own products at an unnervingly high frequency, the FDA was busily approving a bevy of Bard PowerPort products for the market. All the while, none of the information that the FDA was actively collecting and storing was disclosed to medical professionals and their patients. 

Becton, Dickinson and Co. Acquires C.R. Bard Inc. 

Becton, Dickinson and Company, a self-described “global medical technology” company, further expanded its influence when it acquired C.R. Bard Incorporated on December 29, 2017. It is unclear whether BD & Co. was aware of the extent to which its new subsidiary, rechristened as Bard, knew of the defects and dangers of its devices in the transitional period of acquisition. 

In the 2018 ASR annual document, however, Bard reported 147 adverse events associated with a range of its PowerPort catheter products and their paraphernalia. It is both possible and probable that Becton, Dickinson and Co. itself was aware of these reports and actively sought to avoid repairs and the necessary requisite recalls. 

When users of Bard PowerPort products discovered that the manufacturer of the seemingly transformative port-a-cath series sought to withhold information about the risks associated with its products, they were outraged. BD & Co.’s response was revealing and set the tone for future product liability litigation. It continually insisted that physicians’ failures to insert the Bard PowerPort devices correctly were responsible for the health complications. 

Multidistrict Litigation in Arizona Consolidates Bard PowerPort Lawsuits

In response to the blockbuster reporting from Kaiser Health, the subsequent FDA disclosures, and, finally, public blowback, 10 Bard PowerPort lawsuits emerged in 2023 targeting Becton, Dickinson and Co., Bard Access Systems, and C.R. Bard, Inc. On account of the widespread use of the Bard PowerPorts, many suspected that the number of litigants would grow, prompting the plaintiffs’ counsel to pursue a coordinated consolidation of the outstanding suits into a multidistrict litigation. 

The D.C.-based U.S. Judicial Panel for Multidistrict Litigation (JPML) held a hearing in July 2023 where the Bard PowerPort lawsuit parties addressed the necessity and appropriateness of an MDL to handle the claims. The defense strongly opposed the move, rejecting not only its usefulness but also alleging malfeasance on the part of the plaintiffs’ counsel. 

In her decision granting the Bard PowerPort transfer order, Judge Karen K. Caldwell, the chair of the panel, refers to disturbing allegations made by the defense impugning the conduct of the plaintiffs' counsel. Stating that in a desperate move to acquire more clients, certain law firms had made “false representations”, it reasoned that the approval of an MDL consolidation would “reward” such misbehavior. Judge Caldwell rejects these potent charges on the grounds that the JPML’s precedents did not justify an accommodation. 

What Do Bard PowerPort Lawsuits Allege?

The personal injury lawsuits in the Bard PowerPort MDL argue that the composition of the port-a-caths contained an unstable combination of barium sulfate and polyurethane which resulted in their degradation, displacement, and fracturing. The fact that Bard PowerPort knew of the defective design of their products over a decade before the lawsuits were filed only strengthens the additional claim that Becton, Dickinson and Co. “failed to warn” users of the dangers associated with their products. 

In fact, Becton, Dickinson and Co. has repeatedly sought to defend itself against the charges by shifting blame for Bard PowerPort complications from the manufacturer to physicians, who, it claims, do not correctly install the product. Nevertheless, the number of legitimate Bard PowerPort lawsuits continues to grow as plaintiffs seek compensation for:

• Medical expenses
• Lost income or wages
• Decreased quality of life
• Emotional and psychological distress

Experienced Bard PowerPort Attorneys Can Help 

Bard PowerPort complications can result in blood infections, hematomas, necrosis, and sepsis. Physicians are not to blame despite what Bard PowerPort manufacturers would like you to believe. Bard Access Systems and C.R. Bard Inc. knew that their PowerPorts had profound structural weaknesses. Becton, Dickinson and Co. failed to correct its subsidiary’s errors after their acquisition of C.R. Bard Inc. and continued to exploit a regulatory loophole that permitted them both to evade traditional oversight. 

Now that the public has paid the price for their recklessness, it is time for Bard and its parent company to reimburse the victims, in full, for lost time, money, and peace of mind. Our Bard PowerPort Lawyers provide free consultations and can determine the merits of your case and the compensation to which you may be entitled. If you believe that you may be eligible to pursue a claim against Bard and Becton, Dickinson and Co., contact us today before the expiration of your state’s statute of limitations for product liability lawsuits.