LAPORTE v. VLAD (2020)

MEMORANDUM AND ORDER PURSUANT TO RULE 1:28

In 2015, the plaintiff, Donald J. Laporte, as personal representative of the estate of Patricia Laporte, filed this action against Steven C. Vlad, Tufts Medical Center, Inc. (Tufts), Pratt Medical Group, Inc. (Pratt), and Pharmacia & Upjohn Company, LLC (Pharmacia). His second amended complaint contained nine counts.⁴ Essentially, he alleged medical malpractice against Vlad; wrongful death against Vlad, Tufts, and Pratt; and product liability against Pharmacia.

On July 30, 2018, Pharmacia filed a motion for summary judgment and a motion to exclude the testimony of the plaintiff's expert witness, Dr. Brian Flyer; on October 29, 2018, Vlad, Tufts, and Pratt filed a motion for summary judgment. The motion judge allowed both motions for summary judgment as well as Pharmacia's motion to exclude Flyer as an expert witness. For the following reasons, we affirm the summary judgment for Pharmacia, and affirm in part and vacate in part the summary judgment for Vlad, Tufts, and Pratt. Accordingly, we need not decide Pharmacia's motion to preclude Flyer's expert testimony.

Background. The following undisputed facts are taken from the summary judgment record, supplemented with some disputed facts construed in the light most favorable to the plaintiff. See Attorney Gen. v. Bailey, 386 Mass. 367, 371 (1982). On July 1, 2012, Patricia Laporte, the decedent (Laporte), was treated in the emergency department at Tufts, where she was diagnosed with a Baker's cyst in her left knee. In July, 2012, while at the hospital, she developed a urinary tract infection, and the pain and redness in her leg increased; she was also diagnosed with cellulitis and C-difficile in her left leg.

On December 18, 2012, Laporte saw Vlad. She had severe pain and swelling, again in her left knee. After examination, Vlad removed fluid from Laporte's knee, personally examined the fluid for infection, and then sent it to the laboratory for bacteria culture and gram stain to determine whether Laporte had an infection in her knee. Based on his evaluation of the joint fluid, Vlad diagnosed Laporte with pseudogout, a symptom of which is knee pain. Vlad prescribed eighty milligrams of Depo-Medrol, an anti-inflammatory medication manufactured by Pharmacia. Vlad expected the procedure to relieve the pain and discomfort in the left knee, and, with Laporte's consent, he injected two forty-milligram vials of Depo-Medrol into her left knee. Approximately three days later, the testing of the fluid came back negative for any infection.

On December 23, 2012, Laporte presented to the Tufts emergency department with worsening pain in her left knee and was diagnosed with septic arthritis, a joint inflammation due to a bacterial or fungal infection. Fluid from her knee tested “positive for Staph Aureus” (Staph A). Laporte then underwent left knee irrigation and debridement; doctors also prescribed antibiotics.

Laporte's issues with her knee persisted, however. In May 2013, she was diagnosed with osteomyelitis in her left knee. In June 2013, doctors again debrided her knee and provided antibiotics. At that time, test results of joint fluid extracted from her left knee showed no growth for gram stain and cultures. Nearly a year later, in April 2014, Laporte's left leg was amputated above the knee. Sixteen months after the amputation, on October 15, 2015, Laporte suffered a cardiac arrest associated with pneumonia and died.

Although the vials of Depo-Medrol injected into Laporte's knee were not recovered, it is undisputed that Pharmacia manufactured the Depo-Medrol at issue in this case. However, Pharmacia did not distribute Depo-Medrol directly to healthcare providers or patients. It is undisputed that, for the relevant period, McKesson Corporation (McKesson) was the distributor of Depo-Medrol to Tufts. Pharmacia's records reflect that, for the relevant time period (twenty-four months), each of the vials of Depo-Medrol manufactured by Pharmacia and distributed by McKesson met all requirements, including those for sterility. From 1959 to 2018, the Food & Drug Administration had never found any issues with the manufacture of Depo-Medrol related to sterility or quality.

The plaintiff brought this action against Vlad, Tufts, Pratt, and Pharmacia. The claims against Vlad alleged medical malpractice and wrongful death; the claims against Tufts and Pratt alleged vicarious liability for Vlad's actions; and the claims against Pharmacia were grounded in product liability for a manufacturing defect. The plaintiff's expert opined that Pharmacia's “manufacturing and/or delivery process” for Depo-Medrol caused the vials to crack or crimp, causing the contents of the specific vials injected into Laporte to be compromised, allowing the introduction of Staph A bacteria into the vials and then into Laporte's knee.

The plaintiff also alleged that the applicable standard of care for administering a vial of Depo-Medrol required, among other things, that Vlad check a vial of Depo-Medrol for signs of compromise prior to administering the drug. The plaintiff alleged that Vlad breached the standard of care by not checking the vials, thereby injecting Depo-Medrol that was contaminated with Staph A, thereby causing Laporte's subsequent infection.

On July 30, 2018, as noted, Pharmacia filed a motion for summary judgment and a motion to exclude the expert opinions and testimony of the plaintiff's expert. On October 29, 2018, Vlad, Tufts, and Pratt filed a motion for summary judgment. On January 4, 2019, the motion judge allowed both motions for summary judgment as well as Pharmacia's motion to exclude Flyer as an expert. The plaintiff appeals from the resulting judgment.

Discussion. 1. Standard of review. We review the allowance of a motion for summary judgment de novo “without deference to the motion judge's reasoning.” All Am. Ins. Co. v. Lampasona Concrete Corp., 95 Mass. App. Ct. 79, 80 (2019). We must determine “whether, viewing the evidence in the light most favorable to the nonmoving party,” Meyer v. Veolia Energy N. Am., 482 Mass. 208, 211 (2019), “the pleadings, depositions, answers to interrogatories, and responses to requests for admission under Mass. R. Civ. P. 36, 365 Mass. 795 (1974), together with the affidavits ․ [present] any genuine issue as to any material fact.” Fannie Mae v. Hendricks, 463 Mass. 635, 637 (2012), citing Mass. R. Civ. P. 56 (c), as amended, 436 Mass. 1404 (2002).

2. Pharmacia. Each of the plaintiff's claims against Pharmacia is based on the theory that the Depo-Medrol injected into Laporte was tainted with bacteria due to a manufacturing defect. Accordingly, the plaintiff must establish that (1) the Depo-Medrol at issue had a defect, which was created during the manufacturing process before it left Pharmacia's hands; and (2) that the manufacturing defect allowed the medication to become contaminated with bacteria, which caused the plaintiff's injury. See Carney v. Bereault, 348 Mass. 502, 506-507 (1965); Carter v. Yardley & Co., 319 Mass. 92, 96 (1946) (Yardley); Niedner v. Ortho-McNeil Pharm., Inc., 90 Mass. App. Ct. 306, 313 (2016), citing Yardley, supra.

Flyer's expert disclosure posited three potential sources of Laporte's staph infection, and then eliminated two as “medically improbable.” Specifically, Flyer opined that the infection (1) could have preexisted Vlad's injection, (2) could have been introduced at injection because Vlad followed unsterile procedures, or (3) could have been introduced by the Depo-Medrol that was actually injected. Flyer first eliminated possibilities one and two based upon the medical evidence, and accordingly concluded that the “only medically reasonable explanation for the Staph A infection that Ms. Laporte suffered after her injection of Depo Medrol is that the Depo Medrol vial was compromised during the manufacturing and/or delivery process allowing for the introduction of Staph A bacteria into the vial. All other potential causes of Ms. Laporte's infection that developed after the December 18, 2018 injection have been considered by Dr. Flyer and have been determined to be medically improbable” (emphasis added).

Assuming arguendo that this opinion satisfied the Daubert/Lanigan standard,⁵ it is insufficient to defeat summary judgment in favor of Pharmacia in view of the undisputed record. It is undisputed that McKesson, not Pharmacia, was responsible for distribution of the Depo-Medrol to Tufts and that following distribution Tufts was responsible for storing the product until used by Vlad. Beyond speculation that something might have gone wrong in the manufacturing, nothing in Flyer's opinion addressed the details of the manufacturing process at Pharmacia. The only, and undisputed, evidence regarding the manufacturing process itself was that Pharmacia's records showed that for the relevant period (indeed going back to 1959) all of the vials of Depo-Medrol manufactured by Pharmacia had passed all requirements, including those for sterility, before leaving Pharmacia's control. Flyer's acknowledgement -- that the defect may have occurred in the delivery or transportation process -- is fatal to the plaintiff's claims against Pharmacia. The plaintiff has failed to come forward with any evidence upon which a reasonable fact finder could rely to conclude that the defect occurred before the product left Pharmacia's control, an essential element of product liability.⁶ See Carney, 348 Mass. at 507, quoting Yardley, 319 Mass. at 99-100 (“[W]here the thing in question is subject to change by ․ improper handling ․ there is danger that juries may overlook the nearer causes and wrongly attribute the injury to some antecedent neglect of the manufacturer or supplier, and do so at a time when he cannot recall forgotten events”). Accordingly, summary judgment is appropriate as to all claims against Pharmacia, as the plaintiff presents no issue of material fact on the issue of whether the manufacturing defect occurred while the product was in Pharmacia's control. For that reason, we do not reach the issues raised in Pharmacia's motion to exclude Flyer's expert testimony.

3. Vlad, Tufts, and Pratt. As an initial matter, count V alleging breach of implied warranty of merchantability, under G. L. c. 106, § 2-314; and count VI alleging breach of implied warranty of fitness for a particular purpose, under G. L. c. 106, § 2-315, fail as a matter of law. Breach of warranty under art. 2 of the Uniform Commercial Code is not available where “the predominant factor, thrust, or purpose of the [transaction] is ․ the rendition of service, with goods incidentally involved.” Mattoon v. Pittsfield, 56 Mass. App. Ct. 124, 141 (2002), quoting White v. Peabody Constr. Co., 386 Mass. 121, 132 (1982). Here, the predominant factor of the transaction between Laporte and Vlad, Tufts, and Pratt was rendering the service of treating Laporte's diagnosed condition, and the Depo-Medrol was an incidental transfer of goods made in the course of performing the service. Compare G. L. c. 106, § 2-316 (5) (sale of human blood considered medical service and excluded from implied warranties of merchantability and fitness).⁷

Furthermore, because we conclude that Vlad, Tufts, and Pratt provided Laporte with a medical service, and, because the plaintiff failed to raise any issue with entrepreneurial or business aspects of the medical service provided, the claim under G. L. c. 93A fails as a matter of law. See Darviris v. Petros, 442 Mass. 274, 279 (2004) (“we have no hesitancy in concluding that the negligent provision of medical care, without more, does not give rise to a claim under G. L. c. 93A ․”). Accordingly, summary judgment is appropriate for count VIII.

We next turn to count III, alleging medical malpractice against Vlad. “To prevail on a claim of medical malpractice, a plaintiff must establish the applicable standard of care and demonstrate both that a defendant physician breached that standard, and that this breach caused the patient's harm.” Palandjian v. Foster, 446 Mass. 100, 104 (2006). Here, viewing the evidence in the light most favorable to the plaintiff, the relevant standard of care required that Vlad check the Depo-Medrol vials for cracks or compromises before injecting the contents.

Vlad testified at his deposition that he was unaware that the procedure required more than sterilization of the injection site and that he relied on the manufacturer to ensure the integrity of the vials. The standard requiring him to check the vials in advance is intended to safeguard patients against the harm that the plaintiff alleges Laporte suffered. Viewing the evidence in the light most favorable to the plaintiff, a fact finder could conclude that Vlad failed to follow the applicable standard of care.

An issue of material fact also exists as to whether Vlad's alleged breach caused the harm; in other words, whether the vials of Depo-Medrol at issue were, in fact, compromised or contaminated allowing the introduction of Staph A into the vials that Vlad injected into Laporte. We do not agree with the motion judge that failing to establish a manufacturing defect claim against Pharmacia necessarily precludes the medical malpractice claim against Vlad, given the possibility of damage to the vial after the manufacturing process had ended. Accordingly, we conclude that genuine issues of material fact remain as to the medical malpractice claim against Vlad, thus making summary judgment inappropriate in counts I, II, and III.

Conclusion. The portion of the judgment allowing summary judgment as to counts I, II, and III is vacated. In all other respects, the judgment is affirmed. The case is remanded for further proceedings consistent with this memorandum and order.

So ordered.

Affirmed in part; vacated in part and remanded

FOOTNOTES

4.   Count I (“Wrongful Death, G. L. c. 229 et seq. v. Tufts Medical Center and Pratt”); count II (“Wrongful Death, G. L. c. 229 et seq. v. Dr. Vlad”); count III (“Medical Malpractice v. Dr. Vlad”); count IV (“Negligence v. Pharmacia”); count V (“Breach of Implied Warranty of Merchantability [G. L. c. 106, § 2-314] for Sale of Defective Product v. Dr. Vlad, Pratt, Tufts Medical Center, and Pharmacia”); count VI (“Breach of Implied Warranty of Fitness for a Particular Purpose [G. L. c. 106, § 2-315] for Sale of Defective Product v. Dr. Vlad, Pratt, Tufts Medical Center, and Pharmacia”); count VII (“Defective Design/Manufacturing v. Pharmacia”); count VIII (“Breach of G. L. c. 93A, §§ 2, 9 v. Dr. Vlad, Pratt, Tufts Medical Center, Pharmacia”); and count IX (“Wrongful Death, G. L. c. 229 et seq. v. Pharmacia”).

5.   See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993); Commonwealth v. Lanigan, 419 Mass. 15 (1994).

6.   Further, it is undisputed that “none of [Vlad's, Tufts', and Pratt's] other patients suffered any ill effects from the Depo-Medrol shipped to and used by [Vlad, Tufts, and Pratt] during the relevant period.” As the motion judge concluded, “Pharmacia has satisfied its burden to demonstrate a lack of evidence that the specific Depo-Medrol prescribed to Mrs. Laporte was contaminated when it left Pharmacia's control.”

7.   We note that Laporte's bill from Tufts for the procedure at issue included billing codes for the services provided.