Product Liability Against Medical Device Manufacturers
The advancement of medical technology allowing for knee and hip replacements has been a godsend for many people who otherwise would have been rendered immobile. However, inadequate testing of these products due to an FDA loophole has led to a rush of unsafe devices onto the market – and into people’s bodies.
Boston product liability attorneys at The Law Offices of Jeffrey S. Glassman are prepared to take on these manufacturers for failure to keep their promises and uphold their legal obligations to consumers.
When these devices fail prematurely, don’t work as intended or pose an unreasonable risk of serious side effects, patients can suffer grave ills. Often, revision surgery is required and long-term damage is not uncommon.
It’s estimated more than 710,000 people undergo knee replacement surgery annually, while more than 500,000 undergo hip replacement surgery.
In 2013, Consumer Reports indicated some 540,000 adults living with knee implants had to undergo surgical revisions to replace defective implants. That was following more than 700 recalls of knee implants and components by half a dozen manufacturers over the course of a decade. During that same time, there were nearly 600 recalls of hip replacement implants and components by those same six manufacturers.
Potential defendants in a product liability case may include:
- Testing laboratory
- Medical sales representatives
- Doctors (failure to warn or provide adequate instruction; medical malpractice)
- Hospitals or clinics in the chain of distribution
- Retail suppliers
Companies most frequently cited include:
- Biomet – Producer of hip replacement models such as the M2a-38, M2a-Magnum, M2a-Taper, M2a-22mm, Exceed ABT and Stanmore. It also produces the knee replacement models Vanguard XP and Oxford Partial Knee. The company issued a total of 100 recalls of these products and components between 2003 and 2013.
- DePuy – A subsidiary of Johnson & Johnson, the company sells hip replacement parts including the Pinnacle Hip Replacement System, the ASR XL Acetabular System and the ASR hip resurfacing system. It’s also the world’s second-largest manufacturer of artificial knee implants, including Sigma, LCS Complete and LPS product lines. In 10 years, the company recalled 150 hip replacement implants and components and 277 knee replacement implants and components.
- Smith & Nephew – A British corporation, the company is known for its R3 Acetabular System hip replacement models and knee replacement models including Oxinium Genesis II, Profix II and Journey Uni Tibial Baseplates. The company issued 51 joint replacement recalls in a single decade.
- Stryker – Maker of the ABG II and Rejuvenate hip replacement models and the knee replacement models of Scorpio CR and PS and Duracon Total Knee. Between 2003 and 2013, the company issued 231 hip parts recalls and 118 knee parts recalls.
- Wright – Maker of Conserve Plus Total Resurfacing Hip System, the Profemur Z Hip Stem and Evolution Medial-Pivot Knee System, the company initiated 32 recalls in 10 years.
- Zimmer – This company, which recently purchased Biomet, produces the Durom Acetabular Component, NexGen Knee Implants has had to initiate 104 hip replacement recalls and 224 knee replacement recalls from 2003 to 2013.
As a result of the defects that led to these recalls, thousands of patients have initiated litigation against these companies. Although there are a wide range of factors that affect the value of each individual claim, which can range from a few thousand dollars to multi-million dollar damage awards.
In 2013, Johnson & Johnson, owner of DePuy, inked a $4 billion settlement deal to resolve thousands of pending product liability lawsuits.
In 2014, Stryker agreed to a $1.4 billion settlement claim for people injured by its Rejuvenate and ABG II modular neck hip systems. However, that amount isn’t capped, and the final payout is expected to substantially exceed this amount. The settlement only covers claims for revision surgery prior to Nov. 3, 2014.
Despite these significant settlements, more individual trials are expected as there are thousands of lawsuits still pending against each of these manufacturers.Proving Manufacturer Product Liability
Those asserting claims for product liability must successfully prove one of the following:
- Design Defect. Here, plaintiff alleges manufacturer could reasonably foresee the product would cause injury due to defective design. Manufacturer could have avoided or reduced injury by altering product design.
- Manufacturing Defect. While design may be proper, problems can arise when there are errors in the manufacturing process leading to a serious defect.
- Marketing Defect. In these situations, manufacturers or distributors fail to give adequate warnings or instructions or don’t inform customers about the foreseeable risks of the product.
If you have had to undergo revision surgery following a hip replacement or knee replacement surgery, contact our offices today to learn more about how we can help.