Pipitone v. Biomatrix, Inc.

• Decision Date: 18 April 2002
• Docket Number: No. 01-30654.,01-30654.
• Citation: 288 F.3d 239
• Parties: Thomas PIPITONE, and Bonnie Pipitone, Plaintiffs-Appellants, v. BIOMATRIX, INC., et al., Defendants, Biomatrix, Inc., Defendant-Appellee.
• Court: U.S. Court of Appeals — Fifth Circuit

288 F.3d 239

Thomas PIPITONE, and Bonnie Pipitone, Plaintiffs-Appellants, v. BIOMATRIX, INC., et al., Defendants Biomatrix, Inc., Defendant-Appellee.

No. 01-30654.

United States Court of Appeals, Fifth Circuit.

April 18, 2002.

L. Kevin Coleman (argued), Law Office of L. Kevin Coleman, New Orleans, LA, for Plaintiffs-Appellants.

Stanton E. Shuler, Jr. (argued), Karen M. Dicke, Leake & Andersson, New Orleans, LA, for Defendant-Appellee.

Appeal from the United States District Court for the Eastern District of Louisiana.

Before GARWOOD, JOLLY and DAVIS, Circuit Judges.

W. EUGENE DAVIS, Circuit Judge:

Thomas Pipitone and his wife, Bonnie, brought suit against Biomatrix, Inc. ("Biomatrix"), alleging that a product that Biomatrix manufactures, known as Synvisc, caused Mr. Pipitone to develop a salmonella infection in his knee after a physician injected his knee with Synvisc. The district court excluded the testimony of the plaintiffs' experts, Doctors Millet and Coco, under the standard set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc.¹ The district court concluded that without the testimony of their two witnesses, the plaintiffs could not establish their case and granted summary judgment in favor of Biomatrix. Because we conclude that the district court abused its discretion in excluding the testimony of Dr. Coco, we reverse the district court's grant of summary judgment in favor of Biomatrix and remand the case to the district court.

I.

In June 1999, Thomas Pipitone sought treatment from his physician, Dr. Murray, for an ulcer that had developed on his toe. Because Pipitone was a 58 year-old, insulin-dependent diabetic, Dr. Murray hospitalized Pipitone and placed him on antibiotics as a precaution. Dr. Chad Millet, an orthopedic surgeon, examined Pipitone in the hospital and agreed with Dr. Murray's diagnosis and prescription of antibiotics. Dr. Millet continued treating Pipitone for the ulcer on his toe until September 1999, when Dr. Millet noted that the ulcer was healing.

In October 1999, Pipitone returned to Dr. Millet, this time complaining of severe osteoarthritic pain in his knees. Dr. Millet specializes in joints, especially hips and knees, for which he undertook an additional year of training at John Hopkins Hospital. Dr. Millet injected Pipitone's left knee with Cortisone in an attempt to alleviate the pain.

In November 1999, Pipitone suffered a stroke. As a result, when Pipitone returned to Dr. Millet on January 11, 2000, still complaining of knee pain, he was no longer a candidate for knee replacement surgery. As an alternative to surgery, Dr. Millet suggested treatment with Synvisc.

Synvisc is a replacement synovial fluid manufactured by Biomatrix. Synvisc is made from rendered rooster combs, which are bathed in formaldehyde for a full day and then subjected to other chemical and detergent treatments. The product is put through a sterile filtration system and into syringes. Biomatrix packages Synvisc in boxes of three, factory-sealed syringes to be administered by injection directly into the knee once a week for three weeks. When injecting Synvisc, the doctor supplies only the needle.

The Food and Drug Administration ("FDA") granted Biomatrix's pre-market approval application in August of 1997, and classified Synvisc as a "Class III" device for purposes of the Medical Devices Act. Over four million syringes of Synvisc have been manufactured since 1998, but it is unclear from the summary judgment record how many have actually been consumed.

Pipitone decided to go forward with the Synvisc treatment. He filled the prescription for Synvisc at a Walgreen's pharmacy and returned to Dr. Millet's office on the morning of January 25, 2000, to receive the injection. Dr. Millet's nurse, who was not scrubbed down, opened the Synvisc package and one of the shrink-wrapped syringes inside. She also opened the packaging for the needle and aspiration syringe, both of which Dr. Millet's office supplied. The nurse then attached the needle, still in its sterile sheath, to the empty aspiration syringe, and placed all of these items on an injection tray next to unsterile gauze.

Wearing unsterile gloves, Dr. Millet prepared Pipitone's knee with an antibiotic cleanser and then with alcohol. Following Biomatrix's instructions, Dr. Millet inserted the needle attached to the empty aspiration syringe into Pipitone's knee and withdrew a small amount of synovial fluid. He noted that the fluid was clear and normal in appearance and indicated no sign of infection. Dr. Millet then detached the fluid-filled aspiration syringe from the needle, which remained in place in Pipitone's knee, removed the rubber tip from the Synvisc syringe, and attached the Synvisc syringe to the needle. Dr. Millet then injected the Synvisc and removed the needle. He placed a bandage over the entry site, and Pipitone went home.

Later that evening, Pipitone began having severe pain in his knee. His wife took his temperature, which was 101 degrees, but they did not report these symptoms to a doctor at that time because they believed that they were attributable to the injection. As Pipitone's knee pain worsened, the Pipitones made several attempts to contact Dr. Millet's office and succeeded in meeting him on the morning of January 27, two days after the injection. Dr. Millet aspirated some of the synovial fluid from Pipitone's knee and found that it was cloudy and turbid, indicating infection. Dr. Millet immediately hospitalized Pipitone and drained Pipitone's infected knee completely. The hospital laboratory tested the fluid from Pipitone's knee and discovered that the infection was salmonella, which is extremely rare in joints.

Because the culture showed such a rare infection, Dr. Millet asked Dr. Jeffrey Coco, a physician who limits his practice to infectious diseases, to examine Pipitone. When Dr. Coco evaluated Pipitone in the hospital, he found that Pipitone had no fever, chilled sweats, diarrhea, nausea, or vomiting. Dr. Coco also found that the ulcer on Pipitone's toe had scabbed over and was healing nicely. Dr. Coco ordered a second check of the synovial fluid from Pipitone's knee, but the laboratory had already rechecked the fluid due to the rarity of the result. The second test showed again that the infection was salmonella.

When Biomatrix was informed of Pipitone's infection, it tested the other two syringes in the Synvisc package that Pipitone purchased and found no evidence of salmonella. It also tested the twenty syringes held back from the production lot that had included the Synvisc sold to Pipitone and found no salmonella.

In April 2000, the plaintiffs filed suit against Biomatrix and Wyeth Laboratories² in Louisiana state court alleging causes of action arising under state tort, products liability, and redhibition laws. The defendants timely removed the suit to federal court.

In February 2001, the Pipitones filed a medical malpractice action against Dr. Millet. After taking Dr. Millet's and Dr. Coco's depositions, however, the plaintiffs were persuaded that fault must have been in Biomatrix's manufacture of the Synvisc. The plaintiffs then voluntarily dismissed their action against Dr. Millet.

In April 2001, the district court held a hearing to consider Biomatrix's motion for summary judgment. The court first granted defendant's motion in limine to exclude the testimony of Dr. Millet and Dr. Coco as unreliable under Daubert. The district court then held that the Medical Devices Act preempted most of plaintiffs' state law claims.³ The only claims that survived preemption were the plaintiffs' claims for manufacturing defect and redhibition.⁴ After holding that redhibition claims are limited to economic loss only, the district court granted summary judgment to Biomatrix on both claims. The district court reasoned that without the testimony of Dr. Millet and Dr. Coco, the plaintiffs had not presented a genuine issue of material fact tending to show that the injection of Synvisc into plaintiff's knee caused his salmonella infection.⁵ The Pipitones now appeal the district court's exclusion of the experts' testimony, grant of summary judgment, and holding that redhibition is limited to economic loss only.

II.

The plaintiffs first argue that the district court erred in excluding the testimony of Dr. Millet and Dr. Coco as unreliable under the standard set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc.⁶ We review the district court's determination of admissibility of expert evidence under Daubert for abuse of discretion.⁷

A.

The Supreme Court's landmark case of Daubert v. Merrell Dow Pharmaceuticals, Inc.⁸ provides the analytical framework for determining whether expert testimony is admissible under Rule 702 of the Federal Rules of Evidence.⁹ Under Daubert, Rule 702 charges trial courts to act as "gate-keepers," making a "preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue."¹⁰ In short, expert testimony is admissible only if it is both relevant and reliable.¹¹ This gate-keeping obligation applies to all types of expert testimony, not just scientific testimony.¹²

Many factors bear on the inquiry into the reliability of scientific and other expert testimony.¹³ In Daubert, the Supreme Court offered an illustrative, but not an exhaustive, list of factors that district courts may use in evaluating the reliability of expert testimony.¹⁴ These factors include whether the expert's theory or technique: (1) can be or has been tested; (2) has been subjected to peer review and publication; (3) has a known or potential rate of error or standards controlling its operation; and (4) is generally accepted in the relevant scientific community.¹⁵ In the later case of Kumho Tire Co. v. Carmichael,¹⁶ the Supreme Court emphasized that the Daubert analysis is a "flexible" one,...