The opinion
Opinion issued June 30, 2005
In The
Court of Appeals
For The
First District of Texas
IN RE HEART VALVE LITIGATION II
On Appeal from the 215th District Court
Harris County, Texas
Trial Court Master Cause No. 2002-27580-B
NO. 01-03-00883-CV
HOWARD BOYLE, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 113th District Court
Harris County, Texas
Trial Court Cause No. 2002-26969-B
NO. 01-04-00348-CV
LAVERNE BROWN, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 127th District Court
Harris County, Texas
Trial Court Cause No. 2002-02865-B
NO. 01-04-00349-CV
SAUNAIE BROWN, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 125th District Court
Harris County, Texas
Trial Court Cause No. 2002-02867-B
NO. 01-04-00350-CV
JACK CALHOUN, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 295th District Court
Harris County, Texas
Trial Court Cause No. 2002-02981-B
NO. 01-04-00351-CV
ARTURO CARDENAS, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 270th District Court
Harris County, Texas
Trial Court Cause No. 2002-26971-B
NO. 01-04-00352-CV
NEIL CHANDLER, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 269th District Court
Harris County, Texas
Trial Court Cause No. 2002-26968-B
NO. 01-04-00353-CV
RONALD COOPER, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 334th District Court
Harris County, Texas
Trial Court Cause No. 2002-26961-B
NO. 01-04-00354-CV
DANIEL DIXON, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 333rd District Court
Harris County, Texas
Trial Court Cause No. 2002-26962-B
NO. 01-04-00355-CV
MARY JANETTE DOWELL, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 215th District Court
Harris County, Texas
Trial Court Cause No.2002-02993-B
NO. 01-04-00356-CV
GLORIA EVERITT, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 61st District Court
Harris County, Texas
Trial Court Cause No. 2002-26970-B
NO. 01-04-00357-CV
ELIDA FLORES, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 295th District Court
Harris County, Texas
Trial Court Cause No. 2002-42469-B
NO. 01-04-00358-CV
ROBERT FOLTZ, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 152nd District Court
Harris County, Texas
Trial Court Cause No. 2002-02987-B
NO. 01-04-00359-CV
EARL FUTRELLE, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 333rd District Court
Harris County, Texas
Trial Court Cause No. 2002-02992-B
NO. 01-04-00360-CV
CAROLYN GIBBENS, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 133rd District Court
Harris County, Texas
Trial Court Cause No. 2002-02964-B
NO. 01-04-00361-CV
RICHARD GILBERT, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 61st District Court
Harris County, Texas
Trial Court Cause No. 2002-42468-B
NO. 01-04-00362-CV
CLIFFORD HAMILTON, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 295th District Court
Harris County, Texas
Trial Court Cause No. 2002-02994-B
NO. 01-04-00363-CV
EDGAR HENDERSON, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 55th District Court
Harris County, Texas
Trial Court Cause No. 2002-26967-B
NO. 01-04-00364-CV
LINWOOD HEBERT, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 129th District Court
Harris County, Texas
Trial Court Cause No. 2002-02975-B
NO. 01-04-00365-CV
FRANCIS HITESHEW, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 55th District Court
Harris County, Texas
Trial Court Cause No. 2002-02871-B
NO. 01-04-00366-CV
THOMAS HOVANEC, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 334th District Court
Harris County, Texas
Trial Court Cause No. 2002-02961-B
NO. 01-04-00367-CV
STEVEN HUGGHINS, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 125th District Court
Harris County, Texas
Trial Court Cause No. 2002-02982-B
NO. 01-04-00368-CV
JAMES IVIE, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 280th District Court
Harris County, Texas
Trial Court Cause No. 2002-02991-B
NO. 01-04-00369-CV
DAMON KOEN, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 152nd District Court
Harris County, Texas
Trial Court Cause No. 2002-02962-B
NO. 01-04-00370-CV
FRAN LANE, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 127th District Court
Harris County, Texas
Trial Court Cause No. 2002-02966-B
NO. 01-04-00371-CV
WILLIAM LEWELLYN , Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 281st District Court
Harris County, Texas
Trial Court Cause No. 2002-02870-B
NO. 01-04-00372-CV
GLADYS LIPSCOMB, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 157th District Court
Harris County, Texas
Trial Court Cause No. 2002-02866-B
NO. 01-04-00373-CV
ROBERT LOPEZ, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 11th District Court
Harris County, Texas
Trial Court Cause No. 2002-02965-B
NO. 01-04-00374-CV
BEULAH MALINA, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 280th District Court
Harris County, Texas
Trial Court Cause No. 2002-02863-B
NO. 01-04-00375-CV
MARIO MARTINEZ, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 11th District Court
Harris County, Texas
Trial Court Cause No. 2002-02971-B
NO. 01-04-00376-CV
RAMIRO MARTINEZ, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 80th District Court
Harris County, Texas
Trial Court Cause No. 2002-03213-B
NO. 01-04-00377-CV
JANIE MCDANIEL, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 151st District Court
Harris County, Texas
Trial Court Cause No. 2002-02969-B
NO. 01-04-00378-CV
PHILIP MEUSER, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 127th District Court
Harris County, Texas
Trial Court Cause No. 2002-02977-B
NO. 01-04-00379-CV
JAVIER MUNOZ, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 152nd District Court
Harris County, Texas
Trial Court Cause No. 2002-26963-B
NO. 01-04-00380-CV
TONY NAVARRO, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 151st District Court
Harris County, Texas
Trial Court Cause No. 2002-026966-B
NO. 01-04-00381-CV
HUMBERTO NUNEZ, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 129th District Court
Harris County, Texas
Trial Court Cause No. 2002-02872-B
NO. 01-04-00382-CV
MARY ONESTY, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 165th District Court
Harris County, Texas
Trial Court Cause No. 2002-02967-B
NO. 01-04-00383-CV
BELINDA PEREZ, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 270th District Court
Harris County, Texas
Trial Court Cause No. 2002-02976-B
NO. 01-04-00384-CV
WESLEY PERREN, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 234th District Court
Harris County, Texas
Trial Court Cause No. 2002-02985-B
NO. 01-04-00385-CV
GERALD PETSCH, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 127th District Court
Harris County, Texas
Trial Court Cause No. 2002-02979-B
NO. 01-04-00386-CV
SANDELLA PHILLIPS, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 269th District Court
Harris County, Texas
Trial Court Cause No. 2002-02972-B
NO. 01-04-00387-CV
JOHNNEY POLLAN, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 295th District Court
Harris County, Texas
Trial Court Cause No. 2002-26965-B
NO. 01-04-00388-CV
OSCAR RAMIREZ, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 55th District Court
Harris County, Texas
Trial Court Cause No. 2002-42470-B
NO. 01-04-00389-CV
LILLIE REED, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 151st District Court
Harris County, Texas
Trial Court Cause No. 2002-02986-B
NO. 01-04-00390-CV
FRANK RIOS, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 127th District Court
Harris County, Texas
Trial Court Cause No. 2002-02978-B
NO. 01-04-00391-CV
PETRA RODRIGUEZ, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 164th District Court
Harris County, Texas
Trial Court Cause No. 2002-46754-B
NO. 01-04-00392-CV
HENRY ROTHSCHILD, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 269th District Court
Harris County, Texas
Trial Court Cause No. 2002-02869-B
NO. 01-04-00393-CV
EARL SADLER, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 189th District Court
Harris County, Texas
Trial Court Cause No. 2002-02990-B
NO. 01-04-00394-CV
DAVID V. SALAS, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 129th District Court
Harris County, Texas
Trial Court Cause No. 2002-02960-B
NO. 01-04-00395-CV
SYLVIA SANCHEZ, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 133rd District Court
Harris County, Texas
Trial Court Cause No. 2002-02968-B
NO. 01-04-00396-CV
LEE A. SIAS, VERNELL SIAS, WILLIAM CRON, NORMAN HAUGEN,
GLENDA BREWER, JARVIS CHRISTIAN, BILLY BAKER, RONNIE
KING, JANET KING, DONALD IRVIN, SANDRA K. SAM, and KENNETH
E. KANTOROWICZ, Appellants
V.
SPIRE CORPORATION, Appellee
On Appeal from the 333rd District Court
Harris County, Texas
Trial Court Cause No. 2002-55917-B
NO. 01-04-00397-CV
MARTIN SOUTHWICK, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 151st District Court
Harris County, Texas
Trial Court Cause No. 2002-02959-B
NO. 01-04-00398-CV
JOHN STARK, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 281st District Court
Harris County, Texas
Trial Court Cause No. 2002-02980-B
NO. 01-04-00399-CV
ROGER STEWART, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 270th District Court
Harris County, Texas
Trial Court Cause No. 2002-02963-B
NO. 01-04-00400-CV
ROBERT STROBEL, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 55th District Court
Harris County, Texas
Trial Court Cause No. 2002-02973-B
NO. 01-04-00401-CV
MOLLY TAPIA, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 234th District Court
Harris County, Texas
Trial Court Cause No. 2002-26959-B
NO. 01-04-00402-CV
JOSE R. VALENTIN, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 215th District Court
Harris County, Texas
Trial Court Cause No. 2002-02970-B
NO. 01-04-00403-CV
OLA MAE WILLIAMS, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 190th District Court
Harris County, Texas
Trial Court Cause No. 2002-02868-B
NO. 01-04-00404-CV
ELIANA ZADIK, Appellant
V.
SPIRE CORPORATION, Appellee
On Appeal from the 157th District Court
Harris County, Texas
Trial Court Cause No. 2002-02652-B
MEMORANDUM OPINION
The plaintiffs in these appeals were implanted with allegedly defective heart
valves, which were manufactured by St. Jude Medical, Inc. (St. Jude) and Spire
Corporation (Spire). St. Jude and Spire filed motions for summary judgment, in
which they contended that plaintiffs’ claims were preempted by their compliance with
the Food and Drug Administrations’s pre-market approval procedures for certain
medical devices. The trial court granted the manufacturers’ motions for summary
judgment and these appeals followed. We affirm.
Factual Background
In 1982, the FDA approved St. Jude’s initial PMA application for a mechanical
heart valve. During the following years, St. Jude made several improvements to the
valve, which were also approved through a series of PMA supplements. One of these
improvements was the incorporation of a rotating sewing cuff, which eliminated the
need for surgeons to position the valve before sewing it in place.
In an effort to combat endocarditis, a life-threatening infection of the heart
muscle, St. Jude notified the FDA that it planned to develop a mechanical heart valve
with an infection-resistant, sterile, silver coating on the sewing cuff. St. Jude
contracted with Spire to use Spire’s patented ion beam assisted deposition process to
apply a thin silver coating to St. Jude’s heart valves. In May 1997, after an FDA-required animal test was completed, St. Jude submitted a PMA supplement to add the
Silzone
coating to its already approved heart valve.
In March 1998, the FDA approved St. Jude’s PMA supplement. As a part of
its approval, the FDA imposed several post-approval requirements, including how the
valve could be marketed. Specifically, the FDA prohibited St. Jude from making any
claims about the efficacy of the Silzone coating in preventing endocarditis. St. Jude
began marketing the Silzone valve accordingly.
St. Jude, however, continued to participate in studies to determine the efficacy
of the Silzone coating in preventing endocarditis. One of these studies was the
Artificial Valve Endocarditis Reduction Trial (AVERT). On January 21, 2000,
approximately one month before Baker’s death, an independent board reviewing the
AVERT data concluded that patients with the Silzone valve were more likely to
experience a post-operative complication, known as a paravalvular leak.
Approximately 2% of the patients with the Silzone valve experienced such leaks, as
opposed to .25% of patients with conventional valves.
The same day it became aware of the conclusions of the AVERT monitoring
board, St. Jude began a voluntary recall of all non-implanted Silzone valves, and so
informed the FDA. In response, the FDA, in a letter from Edwin Dee to St. Jude,
stated, “We agree with your firm’s decision to recall [the Silzone valve] . . . We have
reviewed your action and conclude that it meets the formal definition of a ‘Recall’”.
This is significant, as your action is an alternative to a Food and Drug Administration
legal action to remove the defective products from the market.” It is undisputed,
however, that the FDA never formally withdrew its PMA approval of the valve, and
that the valve had FDA approval on the date it was implanted in each of the plaintiffs.
Plaintiffs filed these suits against Spire based on theories of liability including,
but not limited to, negligence, product liability, and breach of warranty. Spire filed
a motion for summary judgment, contending that the plaintiffs’ state-court tort claims
were preempted by the FDA’s federal regulation over the valves at issue. The trial
court agreed and granted Spire’s motion for summary judgment.
Analysis
In Baker v. St. Jude Medical, Inc ., No. 01-02-00802-CV (Tex. App.—Houston
[1st Dist.] June 30, 2005, no pet. h.), which we issue concurrently with this opinion,
this Court considered the same arguments as those in these appeals. Specifically, the
Court addressed the issue of whether the plaintiffs’ claims in that case were
preempted by St. Jude’s compliance with applicable FDA pre-market approval
procedures. On a record that is nearly identical to that before us in these appeals, this
Court concluded that the plaintiffs’ negligence, products liability, deceptive trade
practices, fraud, and malice claims were, in fact, preempted by St. Jude’s compliance
with the FDA’s pre-market approval process for the manufacture and distribution of
the heart valve that was implanted in the deceased. See Baker, slip op. at 18, 21.
Accordingly, we affirmed the summary judgment granted in favor of St. Jude. Id. at
21.
This Court’s opinion in Baker v. St. Jude extensively discusses the Court’s
reasoning behind its conclusion that the doctrine of preemption applies. Neither the
briefing nor the record in these appeals shows a reason to distinguish the present
cases from Baker.
Accordingly, for the reasons given in Baker v. St. Jude , we overrule plaintiffs’
sole issue on appeal. Because we have held that all of plaintiffs’ claims against Spire
are preempted by federal law, we affirm the judgments.
Sherry Radack
Chief Justice
Panel consists of Chief Justice Radack and Justices Taft and Nuchia.