Hand v. Smith & Nephew, Inc. (In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litig.)
| Decision Date | 17 May 2022 |
| Docket Number | MDL No. 2775,Master Docket No. 1:17-md-2775,Civil Case No. 1:17-cv-935-CCB |
| Parties | IN RE: SMITH & NEPHEW BIRMINGHAM HIP RESURFACING (BHR) HIP IMPLANT PRODUCTS LIABILITY LITIGATION This Document Relates to the Following BHR Track Actions: Marla H. Hand et al. v. Smith & Nephew, Inc. |
| Court | U.S. District Court — District of Maryland |
Pending before the court is Smith & Nephew's motion for summary judgment in BHR track action Marla H. Hand et al. v. Smith & Nephew, Inc. , No. 1:17-cv-0935. Smith & Nephew seeks summary judgment (ECF 644 in 17-cv-0935; ECF 3574 in master docket 17-md-2775) as to all remaining claims brought by Hand and her spouse James Nyeste (together, "Hand") — breach of express warranty, a variety of negligence-based claims, punitive damages, and (for Nyeste) loss of consortium. Hand responded in opposition (ECF 655), and Smith & Nephew replied in support of its motion (ECF 663). The court heard oral arguments on May 4, 2022. For the reasons stated herein, the court will grant Smith & Nephew's motion.
This case concerns injuries suffered by plaintiff Marla Hand and her spouse, James Nyeste, as a result of Hand's use of the Birmingham Hip Resurfacing Device ("BHR"), an artificial hip implant
developed, designed, manufactured, and sold by defendant Smith & Nephew.
The Birmingham Hip Resurfacing (BHR) system is a Smith & Nephew prosthetic hip replacement product that, unlike a traditional total hip replacement
, trims and caps — that is, resurfaces — the head of the femur. That femoral head component fits into a hemispherical acetabular cup that fits into a patient's hip socket. The two pieces rub against one another during movement of the patient's hip joint; both are made of cobalt and chromium metal alloys, and the BHR is thus a "metal-on-metal" product. The BHR received Pre-Market Approval from the U.S. Food and Drug Administration on May 9, 2006.
The friction between the metal components allegedly can cause metal debris to accumulate within the joint and bloodstream of the patient. Metal debris from the device can then cause pain, metallosis
, and other serious complications that may require corrective surgery or revision to a different device.
In June 2015, about nine years after initial approval, Smith & Nephew voluntarily recalled some BHR devices due to unreasonably high failure rates (including for complications due to metal debris) for certain demographic groups, including women, men age 65 or older, and men with femoral head sizes 46 millimeters or smaller.
Hand, 66, and Nyeste are residents of Illinois. Hand had long had problems with her right hip, beginning in the late 1990s and including a hip dysplasia diagnosis and four surgical procedures from August 1998 to sometime before May 2001.
These difficulties with her right hip were unrelated, however, to her left hip. She first saw Dr. Craig Della Valle in November 2004 with complaints of left hip pain. He noted mild dysplasia
on the left side, and Hand underwent non-surgical treatment for several years. By May 2007, however, her left hip pain had advanced to the point where she was significantly disabled and could no longer walk her dog or exercise.
Dr. Della Valle recommended a hip resurfacing for Ms. Hand's left hip. He had been trained on the BHR by Smith & Nephew in November 2006 and had by then performed 20 to 30 BHR implants, about two of which, he estimated, had been for women. (ECF 644-6, Ex. D, Della Valle Dep. at 10–11). In making recommendations or treatment decisions, Dr. Della Valle relies most on "peer-reviewed published data and peer-reviewed publications" as well as his experience, training, and conferences he has attended. (Id. at 99).
Hand and Dr. Della Valle had several discussions about the risks and benefits of a BHR and how it compared to a traditional total hip replacement; Hand also attended a patient education class and sought a second opinion from Dr. Scott Sporer. (ECF 644-5, Ex. C, Hand Dep. at 71, 84–86; ECF 644-6, Ex. D, Della Valle Dep. at 45). Dr. Della Valle told Hand that, compared to total hip replacement
, resurfacing would preserve more of the femoral head, that the recovery theoretically would be easier, and that resurfacing could keep a young patient like her active. (ECF 644-5, Ex. C, Hand Dep. at 75). He did not guarantee the BHR's outcomes. (Id. at 82).
Dr. Della Valle warned Hand that, as a female, she was at a higher risk for revision. (ECF 644-6, Ex. D, Della Valle Dep. at 138–39). He was aware of this higher risk at the time and discussed the risk with his female patients. (Id. at 13–14, 110–11). At the time, that higher risk appeared specifically tied to femoral neck fractures
, which tend to occur early, not long after implantation.
At the time, Dr. Della Valle also was aware that the BHR's metal-on-metal configuration might result in the release of metal ions into the bloodstream as a result of wear between the components. (Id. at 140–41). At the time of Hand's implant surgery, Dr. Della Valle's custom and practice with resurfacing procedures was to tell patients that a metal-on-metal bearing carried additional risks such as this. (Id. at 41, 45). During the second opinion consultation with Hand, Dr. Sporer discussed the potential for increased metal ion concentration. (ECF 644-5, Ex. C, Hand Dep. at 78–79; ECF 644-7, Ex. E, May 23, 2007, Office Visit Notes with Dr. Scott Sporer).
Before her BHR implant surgery, Hand read the Smith & Nephew BHR Patient's Guide, which Dr. Della Valle gave her in order to show her illustrations of resurfacing compared to total hip replacement
. In a section describing the BHR's bearing surface, the Patient's Guide explained:
There may be risks associated with metal-on-metal implants, though. While no evidence has been established on the subject, some are concerned that the increased level of metal ions found in the blood of metal-on-metal hip recipients may have negative effects on the human body. For this reason, some surgeons may not implant such a device in a patient with kidney disease
(since healthy kidneys filter ions from your body) or in women who are or may become pregnant.
(ECF 655-10, Patient's Guide at 13) (emphasis added).
In a "Frequently Asked Questions" section addressing the expected outcomes of a BHR implant, the Guide explained:
It is impossible to say how long your implant will last because so many factors play into the lifespan of an implant. In the case of resurfacing, for instance, the metal-on-metal bearing surfaces of your new joint may extend its life longer than that of a traditional total hip replacement
, but failure to comply with your physical rehabilitation regime may cause your implant to fail within months. A clinical study showed the BIRMINGHAM HIP Resurfacing implant had a survivorship of 98.4-percent at the five-year mark, which is comparable with the survivorship of a traditional total hip replacement in the under-60 age group.
(ECF 655-10, Patient's Guide at 22) (emphasis added). A 98.4% five-year survivorship rate in the under-60 age group represents a 1.6% revision rate.
Hand received a 42mm-head BHR implant in her left hip on June 25, 2007, when she was age 51.1 Within several weeks, she had much less pain than before the surgery and had resumed exercise and dog-walking. She was back doing aerobics by October 2007. Her left hip was pain-free for almost ten years, but at a May 2013 annual BHR follow-up appointment, she reported new pain in her right (non-BHR) hip. (ECF 644-5, Ex. C, Hand Dep. at 112–15; ECF 644-6, Ex. D, Della Valle Dep. at 129). A blood test revealed elevated metal ion levels. (ECF 644-5, Ex. C, Hand Dep. at 112:10–114:22). In July 2013, she told her physical therapist that she was worried she might need a revision on the left hip (Id. at 143), and the records from that meeting state that she had recently been diagnosed with metal toxicity due to an implant malfunction (ECF 644-9, Ex. G, July 12, 2013 Physical Therapy Notes). By late 2016, Hand started to complain of pain on the left side. Her metal ion levels were elevated, and an MRI showed what Dr. Della Valle suspected was an adverse local tissue reaction.
Nine and a half years after Hand received the BHR — on December 5, 2016 — Dr. Della Valle performed a revision surgery on Hand's left hip. Hand had no pain on the left side by March 2017 and was back to a normal gait and unlimited moderate activities by December 2017.
Earlier cases in this multidistrict litigation have hinged on Smith & Nephew's October 2009 receipt of detailed data about the BHR's performance and elevated revision risk in women and patients with smaller femoral head sizes — the so-called "ad hoc" data from the Australian Orthopaedic Association's (AOA's) National Joint Replacement Registry (the "Australian registry"). Hand argues that Smith & Nephew in fact knew about the elevated revision risk in women long before October 2009, as early as 2006.
In October of 2004, 2005, and 2006, the Australian registry published annual reports covering their data from the prior year. (See ECF 3477-14, AOA 2006 Annual Report). These reports were posted publicly and sent to Smith & Nephew by Australian registry director Stephen Graves. (ECF 655-2, Graves Dep. at 136:14-18).2 The reports, Hand argues, revealed the gender difference in resurfacing product revision outcomes, though they were not disaggregated by company. Still, about 63.5% of the resurfacing data points in 2006 represented Smith & Nephew products.
The record contains no explicit confirmation that Smith & Nephew received the annual reports, but Smith & Nephew did periodically initiate contact with the Australian registry around that time. Most relevant to this litigation, Graves said that, in 2006,3 Smith & Nephew initially...
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