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Judith Pusey, et al. v. Becton Dickinson and Co.

June 7, 2011

JUDITH PUSEY, ET AL.
v.
BECTON DICKINSON AND CO.



The opinion of the court was delivered by: Dalzell, J.

MEMORANDUM

Plaintiffs Judith ("Judith") and Donald Pusey ("Donald") sue defendant Becton, Dickinson and Co. ("Becton") in this product liability action.*fn1 Plaintiffs' claims arise out of a left breast expansion procedure performed upon Judith using a syringe Becton manufactured. Following this procedure, Judith's breast became infected, necessitating the removal of her left breast expander. At around the same time, Becton recalled all 60 mL syringes produced between 2005 and 2007, as well as some produced in 2008, due to packaging issues. This recall included the syringe used in Judith's procedure.

Specifically, plaintiffs assert five claims against Becton: (1) negligence, (2) strict liability under § 402A of the Restatement (Second) of Torts, (3) breach of express and implied warranty of merchantability, (4) breach of express and implied warranty of fitness for a particular purpose, and (5) loss of consortium (on Donald's behalf only).*fn2 Becton filed a motion for summary judgment, to which the plaintiffs responded. Becton then replied. For the reasons set forth below, we will grant Becton's motion and dismiss plaintiffs' claims.

I. Factual Background

Under Fed. R. Civ. P. 56(a), "[t]he court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law," where "[a] party asserting that there is a genuine dispute as to a material fact must support that assertion with specific citations to the record." Bello v. Romeo, 2011 WL 1519389, at *3 (3d Cir. 2011) (citing Rule 56(c)). Ordinarily, we would begin by reciting the undisputed facts in this matter, and would then consider the disputed facts that the parties have supported with specific citations to the record. This case, however, presents a somewhat unusual scenario: plaintiffs seek to avoid being bound by their citations to defendant's exhibits.

The plaintiffs preface their response to Becton's facts with the caveat that "[i]n responding to defendant's allegations, plaintiff has merely reviewed defendant's documentation. Plaintiff's [sic]*fn3 responses are predicated upon defendant's own documentation. Plaintiff's responses are not an admission that defendant's documentation is correct." Pls.' Resp. to Def.'s Facts in Supp. of Mot. Summ. J. ("Pls.' Resp. to Facts") at 1. This disclaimer is consistent with plaintiffs' argument that "defendant seeks summary judgment without affording plaintiff any discovery or the opportunity of engaging in any discovery," and their assertion that Becton has declined to respond to deposition notices or interrogatories that they served in July and September of 2010, respectively. Pls.' Mem. in Supp. of Resp. to Def.'s Mot. Summ. J. ("Pls.' Resp.") at 5-6. Plaintiffs thus claim that Becton's motion for summary judgment is premature, presumably in an attempt to (1) excuse any failure on their part to support factual assertions with citations to the record, and (2) qualify any citations on their part to Becton's exhibits.

It is true that we issued an order in a related case, Civil Action No. 10-348,*fn4 "authorizing defendant to get a copy of Judith Pusey's medical records" and instructing Becton to "DELIVER to plaintiffs' counsel all documents related to the decision to recall the product at issue in this case," Mar. 10, 2010 Order, ¶¶ 1-2 (docket entry # 7), and that we have not since broadened the scope of discovery in this case. Plaintiffs have also attached letters to their response to defendant's motion for summary judgment that document Becton's July 12, 2010 refusal to provide dates for depositions and its September 27, 2010 confirmation that it would not respond to plaintiffs' interrogatories until after the deposition of Judith's doctor, R. Barrett Noone. Exs. A and C to Pls.' Resp.

As Becton points out, however, plaintiffs have not identified any hitherto unavailable avenues of discovery that might produce information relevant to the disputed issues in this matter. Def.'s Reply in Supp. of Mot. Summ. J. ("Def.'s Reply") at 6. Thus, the parties have available to them all of Becton's documentation regarding its recall of the 60-mL syringes,*fn5 as well as all of Judith's medical records and the deposition testimony of the physician who performed Judith's procedure. It is by no means clear that deposing Becton's representatives or propounding interrogatories upon them would add to these materials and, more to the point, plaintiffs certainly have not explained how it might. Moreover, though counsel for the parties have met at length with the Court three times since the issuance of our March 10, 2010 Order, plaintiffs' counsel has not once expressed to us any need for expanded discovery.*fn6

In particular, plaintiffs' counsel voiced no objection when we, at a January 3, 2011 conference, proposed that Becton file any motion for summary judgment by January 18, 2011. All relevant discovery in this matter has thus been completed and plaintiffs long ago waived any objections they might have had regarding the ripeness of this matter for summary judgment. We consequently reject any attempt on plaintiffs' part to rely "upon defendant's own documentation" in responding to Becton's motion for summary judgment without "admi[tting] that defendant's documentation is correct." Pls.' Resp. to Facts at 1. The record is complete. We will not credit any of plaintiffs' assertions as to supposed genuine disputes of material fact unless they are supported, as Rule 56(c) requires, with specific citations to the record, and we will take as undisputed any facts that are not contested in the record.

Having resolved this issue, we proceed to a recitation of the undisputed facts. In February of 2008, after a mastectomy following a diagnosis of breast cancer, Judith came under the care of R. Barrett Noone, M.D. for reconstruction of her left breast. Def.'s Facts in Supp. of Mot. Summ. J. ("Def.'s Facts") ¶¶ 3, 73; Pls.' Resp. to Facts ¶¶ 3, 73. Over the course of a series of office visits between February and July of 2008, Dr. Noone used a saline solution to inflate a temporary tissue expander implanted in Judith's chest, making the final scheduled inflation on July 11, 2008. Def.' Facts ¶¶ 4-5, 76; Pls.' Resp. to Facts ¶¶ 4-5, 76. Dr. Noone used a variety of medical products to perform the inflations, including saline solution manufactured by Baxter International, Inc. and Baxter Healthcare Corporation; a winged infusion set manufactured by B/Braun Medical, Inc.*fn7 ; a 60 mL syringe manufactured by Becton; a 16-gauge needle to withdraw the saline; an anesthetic product; and a 9-inch needle to inject the anesthetic. Def.'s Facts ¶¶ 77-79; Pls.' Resp. to Facts ¶¶77-79.

After developing swelling and redness in her chest, Judith saw Dr. Noone on July 17, 2008, and the next day Dr. Noone came to the belief that Judith had an infection. Def.'s Facts ¶¶ 80-81; Pls.' Resp. to Facts ¶¶ 80-81. According to the complaint, Judith developed this infection in her chest within forty-eight hours after her final scheduled inflation on July 11, 2008, Def.'s Facts ¶ 5; Pls.' Resp. to Facts ¶ 5. Dr. Noone's deposition testimony corroborates this claim. Dep. of Dr. Noone, Ex. 11 to Def.'s MSJ ("Dep. of Dr. Noone"), at 177. On July 20, 2008, Dr. Noone drained an abscess on Judith's chest and removed the tissue expander, which had indeed become infected. Tests upon fluid aspirated from Judith's chest revealed the presence of a bacterial infection known as coagulase negative staphylococcus, "a Gram-positive organism which is commonly on the skin" and is "the most common cause of implant infections." Def.'s Facts ¶¶ 82-84 (quoting Dep. of Dr. Noone at 155); Pls.' Resp. to Facts ¶¶ 82-84.

Between July 15 and July 23, 2008, Dr. Noone received a notice of recall from Becton, Def.'s Facts ¶ 85; Pls.' Resp. to Facts ¶ 85, dated July 15, 2008. Def.'s Facts ¶ 51 (citing Ex. 2). Becton's notice concerned its 60-mL Luer-Lok Syringes. The notice explained that "unit package seal integrity (and resulting product sterility) can be adversely affected when the product is exposed to low atmospheric pressure experienced at high altitudes (e.g. during product shipping)," and urged all distributors and customers to return syringes from lots beginning with 5, 6, or 7, as well as some lots beginning with 8. Def.'s Facts ¶¶ 21, 52, 55-56 (quoting Ex. 2*fn8 ); Pls.' Resp. to Facts ¶¶ 21, 52, 55-56. The notice stated that:

In order to make the recall practical for customers to implement, BD has requested the return of lots beginning with the numbers 5, 6, or 7. While not all lots beginning with the digits 5, 6 and 7 exhibit the issue, it is much easier to instruct customers to return these lots, rather than have customers examine/check a more comprehensive list of affected and unaffected lots.

Def.'s Facts ¶ 58 (quoting Ex. 2); Pls.' Resp. to Facts ¶58.

Upon receiving Becton's recall notice, Dr. Noone instructed his staff to check their supply of 60 mL syringes to determine whether any fell within the lot numbers identified in the notice. Dr. Noone's staff identified one box of syringes that matched a lot number mentioned in the notice, and found that a 60 mL syringe from this box had been used to treat Judith.

Def.'s Facts ¶¶ 86-88; Pls.' Resp. to Facts ¶¶ 86-88. Dr. Noone's office returned the remaining syringes in the box to Becton. Def.'s Facts ¶ 89; Pls.' Resp. to Facts ¶ 89. Dr. Noone did not observe any package seal failure in any 60 mL syringe used to treat Judith, and Dr. Noone did not believe that any member of his staff checked any of the syringes in the recalled box to see if any of the seals were open. Def.'s Facts ¶¶ 104-05; Pls.' Resp. to Facts ¶¶ 104-05.

Until Dr. Noone received Becton's recall notice, he had no opinion as to what might have caused Judith's infection.

Def.'s Facts ¶ 95. After receiving the notice, Dr. Noone determined that "this could be a cause of the infection because of the timing of the use of that syringe," id. at 96 (quoting Dep. of Dr. Noone, Ex. 11 at 190), and discussed this possibility with Judith. Id. at 97. Dr. Noone admitted, however, that his only source of information about the recall was the recall notice itself, Def.'s Facts ¶ 90; Pls.' Resp. to Facts ¶ 90, and agreed that "the only reason that [he] believe[d] that the syringe is the more likely source of the infection than the other products [is] because of the recall notice that [he] received." Def.'s Facts ¶ 107 (quoting Dep. of Dr. Noone at 192). Dr. Noone offered only a qualified opinion, moreover, that the syringe was the source of Judith's infection, with "other potential sources" such as "needle used, saline inflation." Id. ¶¶ 98-100 (quoting Dep. of Dr. Noone at 191-92).

Becton's recall of the 60 mL syringes resulted from the discovery in 2007 of products with open seals and the internal investigation that followed.*fn9 Becton manufactured its 60 mL syringes in Columbus, Nebraska. Def.'s Facts ¶ 22.*fn10 In June of 2007, Becton discovered that six lots of 60 mL Luer Lok syringes at its distribution center in Cuautitlan, Mexico contained product with open seals. Def.'s Facts ¶ 26; Pls.' Resp. to Facts¶ 26. Failure rates among the defective lots discovered in Cuautitlan varied between 5.0% and 16%, which exceeded the Acceptable Quality Limit of 0.25%. Def.'s Facts ¶ 27 (citing Ex. 3 at BD000044); Pls.' Resp. to Facts ¶ 27. Becton then initiated an investigation, id. ¶ 29 (citing Ex. 4 at BD000057), that revealed that no additional complaints had been recorded in 2007, id. ¶ 30 (citing Ex. 4 at BD000057; Ex. 5 at BD000069),*fn11 and showed that the affected 60 mL syringes were manufactured on 860 Line 2 in Columbus, Nebraska. Def.'s Facts ¶ 31 (citing Ex. 4 at BD000057; Ex. 5 at BD000069). The normal route for lots shipped to Mexico was by truck from Swedesboro, New Jersey, on a route which passes over elevations upwards of 8,000 feet. Def.'s Facts ¶ 36 (citing Ex. 3 at BD000046).*fn12 Visual inspections of lots from Mexico and from the distribution center in Plainfield, Indiana, revealed an open seal rate of 3.13% to 4.69% in the lots from Mexico and of 0.00% to 0.31% in the lots from Plainfield. Ex. 3 at BD000046. Becton's investigation thus focused on the effects of altitude on the syringes. Id. ¶ 35 (citing Ex. 3 at BD000046).

Becton produced experimental packages on 860 Line 2 in Columbus and subjected them to real-world conditions in high-altitude areas and in an altitude chamber at its headquarters. Id. ¶ 37; Pls.' Resp. to Facts ¶ 37. This testing produced no open seals under real-world conditions, but did show "seal creep that could potentially lead to an open package." Def.'s Facts ¶ 38 (quoting Ex. 3 at BD000047); Pls.' Resp. to Facts ¶ 38. Becton also compared package integrity between two groups of 60 mL syringes manufactured on 860 Line 2 -- one manufactured in July of 2007, the other in November of 2007. Def.'s Facts ¶ 39; Pls.' Resp. to Facts ¶ 39. On November 28, 2007, Becton conducted maintenance on 860 Line 2 which improved package robustness. Def.'s Facts ¶ 40 (citing Ex. 3 at BD000052). The testing showed package failures in the July of 2007 product --"[t]he real world product made in mid-July (7187506) had multiple open seals and package integrity following the real world testing. However, when altitude chamber testing was conducted, a very high level of open seals was found," Pls.' Resp. to Facts ¶ 41 (quoting Ex. 3 at BD000048); Def.'s Facts ¶ 40 -- with failure rates at 26%. Ex. 3 at BD000048. Real world testing revealed ...


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