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Montoya v. Mentor Corp.5/29/1996
APODACA, Chief Judge.
{1} Plaintiffs Abel and Joann Montoya appeal the trial court's order granting summary judgment and dismissing their complaint alleging product liability claims against Defendant Mentor Corporation. The trial court ruled that the Medical Device Amendments of 1976, 21 U.S.C. Sections 360c-360l (1994) (the MDA), preempted Plaintiffs' causes of action. We disagree, reverse the trial court, and remand for trial.
I. FACTUAL AND PROCEDURAL BACKGROUND
{2} This appeal arose as a result of injuries suffered by Plaintiff Abel Montoya and allegedly caused by a medical implant. In January 1986, a device known as the Angelchik prosthesis, manufactured and sold by Defendant, was implanted in Mr. Montoya by Dr. Oberdorfer at St. Joseph Hospital, as treatment for a hiatal hernia. The Angelchik is a C-shaped silicone-filled device encased in a silicone shell. A Dacron strip surrounds the silicone shell and is laminated with silicone on the outer surface to make the strip a smooth surface. The device was secured around Mr. Montoya's esophagus at the gastroesophageal junction with the strip of Dacron. The device is designed to be placed unsecured in this motile area of the gut so that it moves whenever the person breathes, talks, swallows, eats, and digests food.
{3} With the passage of time, the device bled silicone, and the movement of the device caused silicone debris to be released into Mr. Montoya's abdominal cavity, causing damage to adjacent organs, an inflammatory reaction, adhesions, and immunodeficiency. As the silicone wore off the outer surface of the Dacron strip, an abrasive surface was left, causing irritation. As a result of that irritation, the device became surrounded by dense scar tissue, and eventually it migrated into Mr. Montoya's stomach. The device had to be surgically removed in December of 1986, at which time the damage to Mr. Montoya's internal organs was repaired. He developed serious complications from the surgery, and, since the removal of the device, his condition has worsened. We will develop additional facts in the Discussion.
{4} Plaintiffs' complaint against Defendant specifically alleged claims of strict products liability, negligence in products liability, negligence per se, and strict liability for a peculiar risk or ultrahazardous activity. Defendant's answer raised the affirmative defense of federal preemption. Defendant's motion for summary judgment contended that, under any state of facts, Plaintiffs could not recover because all of Plaintiffs' claims were preempted by federal law and regulations governing medical devices. The trial court agreed and granted summary judgment.
II. DISCUSSION
A. Standard Of Review
{5} The relevant facts are not disputed. In reviewing the grant of summary judgment in a case where there are no disputed issues of material fact, this Court considers whether the trial court correctly interpreted the relevant law. .
B. General Preemption Principles
{6} The principle of federal preemption of state law arises directly from Article VI of the United States Constitution. Article VI states that "This Constitution, and the Laws of the United States which shall be made in Pursuance thereof[,] . . . shall be the supreme Law of the Land; . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI, cl. 2. Under this constitutional authority, Congress may preempt state law. Whether a federal law preempts state law is ultimately a question of congressional intent. Hawaiian Airlines v. Norris, 129 L. Ed. 2d 203, 114 S. Ct. 2239, 2243 (1994).
{7} There is a stro
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