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Bertini v. Smith & Nephew, Inc.

United States District Court, E.D. New York

March 17, 2014

LOUIS BERTINI and DEBRA BERTINI, Plaintiffs,
v.
SMITH & NEPHEW, INC., Defendant

Decided March 14, 2014

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[Copyrighted Material Omitted]

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For Louis Bertini, Debra Bertini, Plaintiffs: Eric T. Chaffin, Roopal Premchand Luhana, LEAD ATTORNEYS, Steven D. Cohn, Chaffin Luhana LLP, New York, NY.

For Smith & Nephew, Inc., Defendant: Glenn S. Kerner, LEAD ATTORNEY, Nilda Maria Isidro, Goodwin Procter LLP, New York, NY.

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MEMORANDUM DECISION AND ORDER

Brian M. Cogan, U.S.D.J.

This is a diversity products liability action involving a hip replacement system

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manufactured by defendant. Defendant has moved to dismiss plaintiffs' second amended complaint on the grounds that federal law regulating these devices preempts plaintiffs' state law claims, and that beyond the preemption issue, the pleading is inadequate to state a claim.

In their initial complaints, plaintiffs attacked a particular part in the defendant's hip replacement system as defective. Recognizing that claims against this part are preempted, they now seek to attack the system itself. But this does not solve plaintiffs' problem, because a factfinder could not find that the system is defective without finding that the particular part is defective. Accordingly, defendant's motion to dismiss is granted.

BACKGROUND

I. History of Defendant's R3 Acetabular System

The hip is a ball and socket joint; the femoral head is the ball and the acetabulum is the socket. During total hip replacement surgery, the femoral head is removed and replaced with a prosthetic ball. The acetabulum is removed and replaced with a prosthetic shell. The prosthetic femoral head attaches to the taper of a stem which is implanted in a patient's femur.

Smith & Nephew, Inc. (" Smith & Nephew" )'s R3 Acetabular System (" R3 System" ) is a hip implant system used in total hip replacement procedures. The R3 System is made up of the Acetabular Cup (shell) (" R3 acetabular shell" ) and one of several possible liners. It is used in conjunction with Smith & Nephew's portfolio of hip stems and femoral heads. The liner's purpose is to prevent the loosening of the hip components, which is a defect in total hip replacement systems that often results in pain and a decrease in the hip implant's stability. The R3 locking mechanism is a feature of the R3 acetabular shell, designed to ensure that a liner remains secure within the R3 acetabular shell. Smith & Nephew received approval from the U.S. Food and Drug Administration (the " FDA" ) to market and sell the R3 System.[1]

Smith & Nephew later developed the Birmingham Hip Resurfacing (BHR) System (" BHR System" ), an implant used in hip resurfacing surgery. In contrast with total hip replacement surgery, during hip resurfacing, the femoral head is trimmed and capped with a covering, rather than replaced. The BHR System was approved for sale through the pre-market approval (" PMA" ) process, which requires a device manufacturer to provide the FDA with " reasonable assurance" that its device is safe and effective. Medtronic. Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 2243, 135 L.Ed.2d 700 (1996). The FDA granted Smith & Nephew supplemental PMA to sell its R3 acetabular metal hip liner (" R3 metal liner" ) specifically with the BHR System.

II. Plaintiff's Operation

After being diagnosed with osteoarthritis, plaintiff Louis Bertini underwent total hip replacement surgery for his left hip on October 26, 2009. Mr. Bertini's surgeon

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implanted the R3 System with the R3 metal liner.

In 2011, Mr. Bertini began experiencing physical problems with his left hip, including popping and clicking sensations. Less than 16 months after Mr. Bertini's original hip replacement surgery, he was forced to undergo revision surgery. Mr. Bertini's surgeon discovered mechanical problems with Mr. Bertini's R3 System. Specifically, the surgeon " was able to easily remove the R3 metal liner from the R3 shell as it had loosened within the shell." Also, the " R3 System's locking mechanism . . . failed to hold the R3 metal liner in a secure and stable position, which allowed the R3 metal liner to become unsecure and loosen within the R3 shell. . . ." These failures caused Mr. Bertini " pain and mechanical symptoms."

On June 1, 2012, Smith & Nephew recalled all batches of R3 metal liners, including the type implanted in Mr. Bertini. Smith & Nephew explained that the recall was in response to a higher number of revision surgeries than expected, due in part to the premature loosening of the liner. Mr. Bertini claims that neither he nor his physicians would have used the R3 System had they known of the R3 System's " increased rate of failure." On August 14, 2013, Plaintiffs filed their second amended complaint against Smith & Nephew.

III. The Instant Motion

Defendant has moved to dismiss the amended complaint, arguing that plaintiffs' claims are preempted under the Medical Device Amendments of 1976 (MDA), 21 U.S.C. § 360c (" MDA" ) or, alternatively, that plaintiffs have failed to state any claims upon which relief could be granted.

DISCUSSION

I. Federal Preemption of State-Law Claims Under ...


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