Raborn v. Albea

144 So. 3d 1066, 2013 La.App. 1 Cir. 0633, 2014 WL 1584502, 2014 La. App. LEXIS 1026
CourtLouisiana Court of Appeal
DecidedApril 16, 2014
DocketNo. 2013 CA 0633
StatusPublished
Cited by7 cases

This text of 144 So. 3d 1066 (Raborn v. Albea) is published on Counsel Stack Legal Research, covering Louisiana Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Raborn v. Albea, 144 So. 3d 1066, 2013 La.App. 1 Cir. 0633, 2014 WL 1584502, 2014 La. App. LEXIS 1026 (La. Ct. App. 2014).

Opinion

THERIOT, J.

|2In this products liability case, the plaintiff appeals the dismissal of his products liability claim against the manufacturer of a medical device on the basis of prescription. We affirm.

FACTS AND PROCEDURAL HISTORY

Plaintiff, Frank Raborn, was born with a spinal deformity called spondylolisthesis which eventually resulted in an impingement of his spinal cord. On June 6, 2006, Mr. Raborn underwent a one-level fusion and laminectomy. Dr. Jeffrey R. Albea, the surgeon who performed this surgery, used a medical appliance consisting of rods and collars to support the fusion. Dr. Albea moved his practice out of state shortly after Mr. Raborn’s surgery, so Mr. Raborn visited a Dr. Waguespaek for his post-operative care. Dr. Waguespaek referred Mr. Raborn to a neurologist, Dr. Shawn G. Dunn, in October 2006. In December 2006, x-rays revealed that a pedi-cle screw on the medical appliance placed by Dr. Albea during the June 2006 surgery was broken. Mr. Raborn alleges that Dr. Albea installed the medical appliance supporting the fusion incorrectly, leading to the breaking of the screw and failure of the appliance. Dr. Dunn performed a dis-eogram, which Mr. Raborn alleges caused a spinal fluid leak, resulting in headaches and other symptoms. To treat the spinal fluid leak, Dr. Dunn performed two blood patches at the location of the leak in March of 2007, after which Mr. Raborn began to experience more problems. An MRI revealed a subdural hematoma in his spine, allegedly caused by the second blood patch. Mr. Raborn began to recover from the hematoma in May of 2007.

Once Mr. Raborn recovered from the subdural hematoma, he sought treatment with a different neurosurgeon in Houston, Texas, Dr. Jerry Bob Blacklock. Dr. Blacklock performed an extensive corrective surgery on Mr. |sRaborn’s back on June 12, 2007, in which the broken hardware was removed and replaced with oversized screws, his congenital deformity was repaired, and his back was successfully refused. The fusion performed in this 2007 surgery was a two-level fusion, performed from both the anterior and posterior sides. In performing the fusion, Dr. Blacklock sought and received Mr. Raborn’s permission to use a medical device called “InFUSE,” manufactured by Medtronic, Inc., to promote bone development at the fusion site. Dr. Blacklock’s use of the Medtronic product in Mr. Raborn’s surgery was considered off-label because the product was used in a posterior fusion and in more than one level in an anterior fusion. Mr. Ra-born continued to have back problems after his second surgery.

[1069]*1069Mr. Raborn filed a request for a medical review panel in accordance with La. R.S. 40:1299.47, alleging malpractice by Drs. Dunn1 and Albea and The NeuroMedical Center Surgical Hospital. The Medical Review Panel issued a decision on July 21, 2009, finding that there was no deviation from the standard of care in the treatment Mr. Raborn received from Drs. Dunn and Albea and The NeuroMedical Center Surgical Hospital.

Mr. Raborn filed a medical malpractice and products liability suit on October 19, 2009 for damages arising from the June 6, 2006 back surgery performed by Dr. Albea and the subsequent procedures performed by Dr. Dunn. On May 18, 2012, Mr. Ra-born filed a Third Superseding Petition in which he asserted a products liability claim against Medtronic arising from the use of the InFUSE product in his June 12, 2007 surgery. Mr. Raborn |4alleged that Med-tronic “covered up and did not disclose that there have been many incidences of serious complications including occurrences of ectopic bone growth ..., inflammatory reactions, urinary problems, etc.— particularly when the product is used in an off-label fashion.” Mr. Raborn further alleged that following the off-label use of the Medtronic product in his surgery, he developed ectopic bone growth in his spine, demyelinating disease, additional bowel and bladder complications, inflammatory response, neural scarring, and further complications of Arachnoiditis. As a result of these complications, he alleged that he is disabled, has to use assistive devices for mobility, has developed a spinal fluid pressure problem, has developed mental fogginess, has to catheterize three to four times per day to treat urinary retention, and is in constant pain.

Medtronic filed a peremptory exception raising the objections of no cause of action and prescription on July 16, 2012. Med-tronic pointed to the express warnings contained in the FDA-approved InFUSE labeling that warned of the sort of adverse events Mr. Raborn experienced. Med-tronic introduced evidence in support of its motion, including the InFUSE package insert. This insert states, in part:

INDICATIONS:

The InFUSE Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. DDD is defined as disco-genic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level.... The InFUSE Bone Graft/LT-CAGEtm Lumbar Tapered Fusion Device is to be implanted via an anterior open or an anterior laparoscopic approach.
[[Image here]]

1 .WARNINGS:

The safety and effectiveness of the InFUSE Bone Graft component ... used in surgical techniques other than [an] anterior open or anterior laparoscopic approaches have not been established. When degenerative disc disease was treated by a posterior lumber [sic] inter-body fusion procedure with cylindrical [1070]*1070threaded cages, posterior bone formation was observed in some instances.

PRECAUTIONS:

[[Image here]]

Bone Formation

[[Image here]]
While not specifically observed in the clinical study, the potential for ectopic, heterotopic or undesirable exuberant bone formation exists.

ADVERSE EVENTS:

Potential Adverse Events:
The following is a list of potential adverse events which may occur with spinal fusion surgery with the InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device. Some of these adverse events may have been previously reported in the adverse events table.
• Bone fracture.
• Bowel or bladder problems
• Cessation of any potential growth of the operated portion of the spine. Loss of spinal mobility or function.
• Change in mental status.
• Damage to blood vessels and cardiovascular system compromise.
• Damage to internal organs and connective tissue.
• Death.
• Development of respiratory problems.
• Disassembly, bending, breakage, loosening, and/or migration of components.
• Dural tears.
• Ectopic and/or exuberant bone formation.
• Fetal development complications.
• Foreign body (allergic) reaction.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Shannon v. Vannoy
251 So. 3d 442 (Louisiana Court of Appeal, 2018)
Brown v. Biomet Orthopedics, LLC
244 F. Supp. 3d 810 (N.D. Indiana, 2017)
Guidry v. USAgencies Casualty Insurance Co.
213 So. 3d 406 (Louisiana Court of Appeal, 2017)
Arnouville v. Crowe
203 So. 3d 479 (Louisiana Court of Appeal, 2016)
Clark v. East Baton Rouge Parish Department of Public Works
196 So. 3d 142 (Louisiana Court of Appeal, 2016)
Kelley v. General Insurance Co. of America
168 So. 3d 528 (Louisiana Court of Appeal, 2014)

Cite This Page — Counsel Stack

Bluebook (online)
144 So. 3d 1066, 2013 La.App. 1 Cir. 0633, 2014 WL 1584502, 2014 La. App. LEXIS 1026, Counsel Stack Legal Research, https://law.counselstack.com/opinion/raborn-v-albea-lactapp-2014.