Frequent medical device recalls: What's happening with Johnson & Johnson?

On December 6th, the National Medical Products Administration (NMPA) issued an announcement that Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a recall of 2,585 units of its USS Ⅱ Polyaxial multi-axial pedicle screw fixation system. However, prior to this, Johnson & Johnson has experienced a series of recalls involving medical devices and contact lenses, including some Class I recalls representing the most serious level of risk, leading to industry questioning.

Frequent voluntary recalls of Johnson & Johnson medical devices and contact lenses

In addition to the recall on December 6th, Johnson & Johnson initiated other voluntary recalls in 2019 at intervals of several months: November 28th, a recall of 14 boxes of Thermocool SF steerable ablation catheters due to missing Chinese instructions; November 18th, a recall of 432 units of an absorbable bone anchor system and intervention screws, none of which had been sold; September 9th, Johnson & Johnson Vision Care (Shanghai) Co., Ltd. recalled 250 boxes of Acuvue Oasys for Astigmatism contact lenses (five specific batches), of which 246 boxes had been sold; April 11th and May 7th, a recall of 114,501 curved and straight end-to-end anastomosis devices and endoscopic curved end-to-end anastomosis devices, with 98,047 already sold; April 11th, Johnson & Johnson Vision Care recalled 16 boxes of Acuvue Oasys for Astigmatism and 1050 boxes of 1-DAY ACUVUE MOIST contact lenses; March 19th, Johnson & Johnson Vision Care recalled 444 boxes of Acuvue Define contact lenses; March 18th, Johnson & Johnson recalled 14,057 boxes of VICRYL Plus absorbable sutures.

Johnson & Johnson's recalls this year ranged from Class I to Class III, including two Class I recalls (the most serious), three Class II recalls, and three Class III recalls. According to the revised "Regulations on the Supervision and Administration of Medical Devices" issued by the NMPA in January 2017, Class I recalls are implemented when the use of a medical device may or has already caused serious health hazards; Class II recalls are implemented when the use may or has already caused temporary, reversible health hazards; and Class III recalls are implemented when the possibility of harm is small but a recall is still necessary.

Johnson & Johnson issued statements regarding some of the recalls. On May 21st, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. issued a statement on its official website regarding the voluntary recall of curved and straight end-to-end anastomosis devices and endoscopic curved end-to-end anastomosis devices, stating: "In the interest of patient and customer safety, we have promptly reported to the relevant regulatory authorities and initiated specific voluntary recall actions." The statement also said that they had proactively contacted hospitals and distributors to retrieve the affected products.

Recalls also involved pharmaceuticals; pharmaceuticals and consumer products were also penalized.

Founded in 1886, Johnson & Johnson is a large multinational corporation with over 230 subsidiaries in 57 countries worldwide, with three major business segments: consumer products, pharmaceuticals, and medical devices. Johnson & Johnson Medical China's main products are medical devices used in minimally invasive and open surgeries (such as wound closure, anastomosis devices, ultrasonic scalpels, and absorbable hemostatic gauze), electrophysiology (such as catheters and related technologies), orthopedics (such as joint reconstruction, trauma, spine, sports medicine, maxillofacial, and power tools), aesthetics (such as breast implants), and infection prevention (such as hydrogen peroxide plasma low-temperature sterilization series).

However, in recent years, Johnson & Johnson has experienced numerous recalls of its manufactured and distributed medical devices, as well as pharmaceuticals such as cold medicines, antihistamines, and analgesics. This year, Johnson & Johnson was fined $4.7 billion for talc-related cancer issues, its shampoo was found to contain carcinogenic formaldehyde and asbestos, and it was ordered to pay $572 million for contributing to the opioid crisis. Analysts suggest that the frequent recalls may be the reason Johnson & Johnson was included in Forbes's "Top Ten Corporate Blunders" list.

Voluntary recalls impact overall Brand, but are not without benefits.

In fact, the medical device recall system is a well-established international model for effectively managing medical devices with potential hazards. China's medical device regulatory model largely draws on the regulatory experience of the United States and the European Union. Like most countries, it implements a classified management system for medical devices, with both pre-market approval and post-market surveillance, completing a transition from focusing on pre-market approval to post-market surveillance. China's regulatory authorities have established effective coordination with manufacturers on medical device surveillance inspections, flying inspections, and voluntary recalls, initially forming a joint regulatory force.

The public generally believes that a company's voluntary recall of products indicates problems in the production process and poor product quality. However, industry insiders believe that medical devices have many components and complex manufacturing processes, making it inevitable that some defective products will occur. Actively recalling products after discovering problems is responsible and reduces the risks associated with using medical devices. However, analysts also point out that frequent recalls of products with defects or potential safety hazards will lead to market questioning of the company's management, production, and R&D, and will still affect the company's overall Brand.