Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Horowitz v. Stryker Corp.

February 20, 2009


The opinion of the court was delivered by: Trager, J


Plaintiff, Lindsay Horowitz ("plaintiff" or "Horowitz"), brings this action against Stryker Corporation ("Stryker") and Howmedica Osteonics Corporation ("Howmedica") d/b/a Stryker Orthopaedics (collectively, "defendants") claiming damages resulting from the implantation of an allegedly defective artificial hip that was marketed, manufactured and distributed by defendants. Defendant Howmedica moves to dismiss plaintiff's complaint pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure arguing that all but one of plaintiff's claims are preempted by the Medical Device Amendments Act ("MDA") to the federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360c et seq. and that her remaining claim is improperly pled. For the reasons set forth below, defendant's motion to dismiss is granted.*fn1



On February 3, 2003, defendants received approval from the United States Food and Drug Administration ("FDA") to distribute the TridentTM Ceramic Acetabular System ("Trident System") in the United States. Pl.'s Am. Compl. ¶ 12. Under the MDA, the Trident System is classified as a Class III medical device. In order for any Class III device to obtain federal approval it must go through a pre-market approval ("PMA") process, in which the FDA analyzes whether the device is reasonably safe and effective. 21 U.S.C. § 360c(a)(1)(C). On obtaining FDA approval, defendants proceeded to develop, manufacture and distribute the Trident System. See Pl.'s Am. Compl. ¶ 4. Two years later, on February 16, 2005, plaintiff underwent total hip arthroplasty surgery at Lenox Hill Hospital in New York, where the Trident System was implanted in her body. Id. at ¶ 18. Following her surgery, plaintiff began "hear[ing] an audible sound emanating from the location of the [Trident System]." Id. at ¶ 21. According to plaintiff, the sound caused her to experience "constant irritation and discomfort in the location of the artificial hip replacement device." Id. at ¶ 22. She further claims that "[a]s a result of the implantation of the Defective Device, Plaintiff has suffered additional and resultant bone loss and is at an increased risk for requiring a premature revision surgery." Id. at ¶ 23.

Plaintiff asserts that the Trident System's current federally approved labeling information states that:

An audible noise during motion, such as a squeak, has been reported for patients receiving a ceramic-on-ceramic bearing couple. A 0.5% rate of squeaking noise has been reported in the clinical study with the Trident(r) Alumina Insert.

Id. at ¶ 65. However, she claims that she was not informed of these prevalence rates prior to surgery. Id. (alleging that "Defendants [sic] label failed to provide any substantive or quantitative prevalence rates whatsoever to Plaintiff prior to her surgery.").

Plaintiff further alleges that on March 13, 2006 and August 30, 2007, defendants initiated recalls of two batches of Trident PSL HA Solid Back Acetabular Shells. According to plaintiff, the stated reason for the March 13th recall was that:

Defendants had identified dimensional anomalies in the recalled components . . . due to an alleged discovery of a machine operator's failure to inspect product dimensional features prior to release wherein shells where [sic] found to be out of tolerance.

Pl.'s Am. Compl. ¶ 31. The stated reason for the August 30th recall was that:

Defendants had identified that "specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the differences in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference."

Id. at ¶ 32. On January 22, 2008, defendants recalled a batch of Trident PSL and Hemispherical Cups manufactured at defendants' Ireland facilities between January 2000 and December 2007 after a deviation was identified between the required specifications and processes for manufacturing. Id. at ¶ 33. Plaintiff admits that neither the Trident System, which is the subject of the current action -- nor any of its components -- were included in any of these recalls. Id. at ¶ 35 ("[U]pon information and belief, Defendants have failed to properly initiate a recall including Defendants' Defective Devices beyond the limited scope of the above reference [sic] recalls.").

On March 15, 2007 the FDA issued a warning letter to defendants concerning federal regulatory violations it found when it inspected defendants' Ireland facilities between October 31, 2006 and November 3, 2006. See Pl.'s Mem. in Opp'n to Def.'s Mot. to Dismiss ("Pl.'s Opp'n") Ex. A. The inspection revealed that the orthopedic implants manufactured by defendants, including the Trident System:

[A]re adulterated within the meaning of section 501(h) of the [Federal Food, Drug, and Cosmetic] Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820.

Id. at 1.

The FDA issued another warning letter to defendants on November 28, 2007, after finding violations during its inspection of defendants' New Jersey facilities between June 1, 2007 and July 12, 2007. See Pl.'s Opp'n Ex. B. Similar to the previous warning letter, the federal investigation revealed that defendants' hip implants with ceramic bearing components were adulterated within the meaning of 21 U.S.C. § 351(h) in that defendants failed to conform to the Current Good Manufacturing Practice ("CGMP") requirements of the Quality System ("QS") regulation. Pl.'s Opp'n Ex. B at 1. The letter specified, among other things, that defendants received numerous complaints:

(1) between January 2005 and May 2007 regarding hip implant components with poor fixation;

(2) between January 2005 and April 2007 regarding squeaking noises emanating from hip implants with ceramic bearing components; and

(3) between January 2005 and June 2007 regarding improper seating of hip implants in broached bones. Id. at 2. According to the warning letter, defendants violated federal regulations in failing to:

[E]stablish and maintain procedures for identifying all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, and verifying or validating the corrective and ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.