United States District Court, W.D. Kentucky
Decided: April 1, 2013.
[Copyrighted Material Omitted]
For Kris Prather, Plaintiff: Gary J. Douglas, Michael A London, LEAD ATTORNEYS, Michael D. Sharp, Rebecca G. Newman, Douglas & London, PC, New York, NY.
For DJO, Inc., formerly known as DJ Orthopedics, Inc., Defendant: Jeannine M. Davanzo, Morris Duffy Alonso & Faley, New York, NY.
For B. Braun Medical, Inc., Defendant: Edward H. Stopher, LEAD ATTORNEY, Ian Charles Baird Davis, Boehl Stopher & Graves, LLP - Louisville, Louisville, KY; Lauren A. Tulli, LEAD ATTORNEY, Jill M. Caughie, Mary Teresa Soltis, Cozen & O'Connor - Philadelphia, Philadephia, PA; Terry M. Henry, LEAD ATTORNEY, Blank Rome LLP, Philadelphia, PA; Maria J. Ciccia, Cozen & O'Connor - New York, New York, NY.
For DJO, LLC, DJO, Inc., Cross Claimants: Jeannine M. Davanzo, Morris Duffy Alonso & Faley, New York, NY.
For B. Braun Medical, Inc., Cross Defendant: Edward H. Stopher, LEAD ATTORNEY, Ian Charles Baird Davis, Boehl Stopher & Graves, LLP - Louisville, Louisville, KY; Lauren A. Tulli, LEAD ATTORNEY, Jill M. Caughie, Cozen & O'Connor - Philadelphia, Philadephia, PA; Maria J. Ciccia, LEAD ATTORNEY, Cozen & O'Connor - New York, New York, NY; Terry M. Henry, LEAD ATTORNEY, Blank Rome LLP, Philadelphia, PA.
For Kris Prather, Cross Defendant: Michael A London, Rebecca G. Newman, LEAD ATTORNEYS, Douglas & London, PC, New York, NY.
For DJO, LLC, DJO, Inc., Cross Defendants: Jeannine M. Davanzo, Morris Duffy Alonso & Faley, New York, NY.
For B. Braun Medical, Inc., Cross Claimant: Edward H. Stopher, LEAD ATTORNEY, Ian Charles Baird Davis, Boehl Stopher & Graves, LLP - Louisville, Louisville, KY; Lauren A. Tulli, LEAD ATTORNEY, Jill M. Caughie, Cozen & O'Connor - Philadelphia, Philadephia, PA; Maria J. Ciccia, LEAD ATTORNEY, Cozen & O'Connor - New York, New York, NY; Terry M. Henry, LEAD ATTORNEY, Blank Rome LLP, Philadelphia, PA.
MEMORANDUM OPINION AND ORDER
John G. Heyburn, II, United States District Judge.
This is a products liability and negligence case in which Plaintiff, Kris Prather, alleges that a medical device, the Pain Control Infusion Pump (" PCIP" ), manufactured by Defendant, B. Braun Medical, Inc., caused severe and permanent damage to her shoulder. The PCIP is a medical device prescribed to alleviate the pain of a post-operative patient by delivering a continuous infusion of a local anesthetic into the post-operative site. Prather alleges several tort claims related to the PCIP after she developed chondrolysis in her shoulder, including strict products liability, negligence, breach of express and implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, and fraud. She seeks compensatory and punitive damages.
This case is now before the Court on a motion for summary judgment filed by Defendant. For the following reasons, the Court will grant the motion, and this case will be dismissed.
On June 18, 2001, Prather underwent arthroscopic surgery on her left shoulder to treat a posterior labral tear. Her orthopedic surgeon, Dr. Felix Savoie, performed the surgery. At the end of the procedure, Dr. Savoie implanted the PCIP in the intra-articular space of Prather's shoulder to help alleviate any post-surgery pain. Essentially, the PCIP is a medical device designed to administer the continuous injection of pain medication, in this case bupivacaine, directly into certain areas of the body. Defendant manufactured the PCIP for Sgarlato pursuant to a distribution agreement. Sgarlato marketed the PCIP and sold it to hospitals, including River Oaks Hospital, the location of Prather's surgery. Dr. Savoie testified that he was not involved in the hospital's decision to buy a particular pain pump brand.
Initially, Prather's post-surgery recovery looked promising. However, two years later, Prather complained of shoulder pain. Several appointments and surgeries later, doctors formally diagnosed Prather as having glenohumeral chondrolysis, a painful condition involving the rapid and permanent breakdown of the cartilage in the shoulder joint.
Next, the Court will summarize the regulatory history of the PCIP's, which provides a necessary backdrop to this case. The Federal Food and Drug Administration (" FDA" ) regulates medical devices such as the PCIP, a Class II device. 21 C.F.R. § 880.5725(b). Prior to marketing a Class II medical device, the manufacturers must satisfy the FDA premarket approval process. 21 U.S.C. § 360e. A device manufacturer can do this in one of two ways: (1) by obtaining Premarket Approval (" PMA" ) following a rigorous application process in which the applicant must establish that a new or modified device is both safe and effective, or (2) by obtaining Premarket Notification, which a manufacturer can procure under section 510(k) of the Federal Food, Drug and Cosmetic Act (a " 510(k) clearance" ). See id. This second avenue is available to manufacturers who can demonstrate to the FDA that the device to be marketed is at least as safe and effective, that is " substantially equivalent," to an existing FDA-approved device (known as a " predicate device" ). 21 U.S.C. § 360(k); 21 C.F.R. § 807. If the FDA determines that the applicant's device is " substantially equivalent" to a " predicate device," it can obtain 510(k) clearance. 21 U.S.C. § 355(b)(1)(F); see Medtronic, Inc. v. Lohr, 518 U.S. 470, 478, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)(" If the FDA concludes on the bases of the § 510(k) notification that the device is 'substantially equivalent' to a preexisting device, it can be marketed without further regulatory analysis." ).
On March 19, 1999, the FDA approved Sgarlato's 510(k) clearance for the PCIP. In the application, Sgarlato claimed substantial equivalence to the Ambulatory Drug Delivery System, an infusion device designed to deliver medicine intravenously
through a catheter during surgery. The FDA cleared the PCIP for the following use, as set out in Sgarlato's Statement of Indications for Use:
The Pain Control Infusion Pump is a single use device intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery. Medication is intended to be delivered percutaneously through a catheter.
ECF No. 266-10. The label for the PCIP stated that it was " for continuous delivery of medication for control of pain." ECF No. 266-8.
Prather's main allegation is that Defendant failed to consider scientific and medical literature, published prior to the June 2001 surgery, which put Defendant on notice that the use of pain pumps to deliver anesthetic medications directly into the shoulder joint could cause severe harm. According to Prather, Defendant failed to perform any tests concerning the safety of the intra-articular infusion of anesthetics, and that Defendant manufactured the device for such a use under ...