Carol MACK; Aaron Mack, wife and husband, Plaintiffs–Appellants v. STRYKER CORPORATION, a Michigan corporation; Stryker Sales Corporation, a Michigan corporation, Defendants–Appellees.
Before BYE, SMITH, and BENTON, Circuit Judges. Jessica A. Andrew, counsel who presented argument on behalf of the appellants, Andrew, Colin P. King, Paul M. Simmons, appeared on the appellants' brief, Salt Lake City, UT. Hall R. Marston, counsel who presented argument on behalf of the appellees, Marston, Ralph A. Campillo, Matthew A. Reed, appeared on the appellees' brief, Los Angeles, CA, Timothy P. Griffin, Bryan W. Thomson, Minneapolis, MN.
Carol Mack underwent shoulder surgery in 2002. The surgeon inserted a pain pump designed to infuse anesthetic into Mack's shoulder to mitigate her pain while she recovered from surgery. Following surgery, Mack developed a painful shoulder condition known as chondrolysis. Mack, along with her husband, sued Stryker Corporation and Stryker Sales Corporation (collectively, “Stryker”), the manufacturer and seller of the pain pump. Mack alleged negligence and strict products liability for design defect and failure to warn. Her husband asserted a claim for loss of consortium. The district court1 granted Stryker's motion for summary judgment. On appeal, Mack contends that the district court misapplied the summary judgment standard by construing the facts in a light more favorable to Stryker. Furthermore, Mack contends that “[t]he district court ․ disregarded admissible expert testimony and instead relied upon the court's own inexpert interpretation of technical evidence and its relevance to conclude that there was no evidence that Stryker should have known of the risk to cartilage posed by its pain pump.” We affirm.
Mack underwent arthroscopic shoulder surgery on August 1, 2002, to alleviate persistent pain in her left shoulder. Near the surgery's conclusion, the surgeon inserted a pain pump that Stryker had manufactured, marketed, and sold to him. The pump consisted of a pumping mechanism and anesthetic reservoir attached to a catheter. The pain pump was designed to deliver a set dosage of an anesthetic, in this case bupivacaine, at regular intervals into a patient's surgically repaired shoulder for approximately two days to assist in the patient's recovery from surgery. Specifically, the pump was designed to inject bupivacaine directly into the glenohumeral joint space of the patient's shoulder. Stryker marketed its pain pumps for this use.
The glenohumeral joint consists of a ball (humeral head) and socket (the glenoid). During shoulder movement, the ball glides (articulates) against the socket. A layer of articular cartilage acts as a cushion by covering the ball and socket, thus preventing painful bone-on-bone contact during shoulder movement. Articular cartilage is found only in enclosed joint spaces like the glenohumeral joint. Articular cartilage is somewhat unique in that synovial fluid, not blood, nourishes the cartilage cells. When these cartilage cells no longer receive nourishment from synovial fluid, they die. Eventually, the cartilage matrix comprised of these dead cells dissipates until no cartilage remains. When no cartilage remains, shoulder movement is accompanied by painful bone-on-bone contact where the ball and socket interact without the protective cushion. Chondrolysis is the painful medical condition whereby an individual loses articular cartilage in a joint.
Following her surgery, Mack began to experience additional shoulder pain. She began receiving additional treatment and therapy on the shoulder in 2003. By January 2004, Mack was diagnosed with chondrolysis. Mack underwent several additional shoulder surgeries to combat chondrolysis's effects.
Mack brought this diversity suit against Stryker on July 13, 2010. Mack asserted several theories of recovery, including negligence and strict products liability based on a design defect and failure to warn.2 The district court granted Stryker's motion for summary judgment. Mack v. Stryker Corp., 893 F.Supp.2d 976, 978 (D.Minn.2012). The district court reasoned that, based on the medical literature existing at the time of Mack's surgery in 2002, it was not reasonably foreseeable to Stryker that the use of its pain pump in an articular joint would lead to joint damage. Id. at 987. In fact, the medical community was unaware of any link between pain pumps and chondrolysis until at least 2007.3 Id. The district court noted that it was “troubled by the hindsight and speculation necessary to find in favor of Mack.” Id . The district court added that “[t]he law does not obligate Stryker to be a pioneer, particularly when existing literature did not objectively forewarn of injury,” id. at 987 (citation omitted), and “[i]t would be nothing short of rank speculation to suggest that any testing Stryker may have undertaken prior to 2002 would necessarily have revealed the causal connection that is still arguably unsettled today,” id. at 988 (citation omitted).
Mack contends on appeal that the district court erred by failing to recognize the extent of the medical community's knowledge of the risks associated with intraarticular pain pumps at the time of Mack's surgery. Mack also disputes the effect of the Food and Drug Administration's (FDA) failure to clear intra-articular pain pumps for postoperative use.
“We review de novo a district court's grant of summary judgment.” Rester v. Stephens Media, LLC, 739 F.3d 1127, 1130 (8th Cir.2014) (citation omitted). Summary judgment is appropriate “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.” Fed.R.Civ.P. 56(a). “We view the facts in the light most favorable to the nonmoving party and give that party the benefit of all reasonable inferences that can be drawn from the record.” Spencer v. Jackson Cnty. Mo., 738 F.3d 907, 911 (8th Cir.2013) (quotation, alteration, and citation omitted). The parties agree that Minnesota substantive law applies.
In Minnesota, a plaintiff who asserts a strict products liability claim must demonstrate “that (1) the product was in fact in a defective condition, unreasonably dangerous for its intended use; (2) such defect existed when the product left defendant's control; and (3) the defect was the proximate cause of the injury sustained.” Lee v. Crookston Coca–Cola Bottling Co., 188 N.W.2d 426, 432 (Minn.1971). To recover on a negligence theory, the plaintiff must show “(1) the existence of a duty of care; (2) a breach of that duty; (3) an injury; and (4) the breach of the duty being the proximate cause of the injury.” Schafer v. JLC Food Sys., Inc., 695 N.W.2d 570, 573 (Minn.2005). The Supreme Court of Minnesota has stated that, in the design defect context, there is little or no distinction between strict liability and negligence. See Lee, 188 N.W.2d at 432 (“While in conventional tort terms no proof of negligence is necessary [in a strict products liability action], in many cases proof of a defect may simply be a substitute word for negligence.”); see also Piotrowski v. Southworth Prods. Corp., 15 F.3d 748, 751 (8th Cir.1994) ( “Where design defect cases are involved, Minnesota merges the theories of strict liability and negligence.”) (citation omitted).
A manufacturer is obligated to exercise that degree of care in his plan or design so as to avoid any unreasonable risk of harm to anyone who is likely to be exposed to the danger when the product is used in the manner for which the product was intended, as well as an unintended yet reasonably foreseeable use.
What constitutes “reasonable care” will, of course, vary with the surrounding circumstances and will involve a balancing of the likelihood of harm, and the gravity of harm if it happens, against the burden of the precaution which would be effective to avoid the harm.
Bilotta v. Kelley Co., Inc., 346 N.W.2d 616, 621 (Minn.1984) (quotations, alteration, and citations omitted).
Drug and medical device manufacturers have “the duty to exercise ordinary and reasonable care not to expose the potential consumer to an unreasonable risk of harm from the use of its products.” O'Hare v. Merck & Co., 381 F.2d 286, 291 (8th Cir.1967) (adjudicating a negligence claim under Minnesota law). They have a duty to test and investigate their products based upon the foreseeable risk of harm to potential users in light of current medical knowledge and discoveries. Id. Manufacturers are held to the skill of an expert in the field that their products enter, and they are obligated to keep informed of medical knowledge and discoveries in that field. Id. Thus, “[t]he manufacturer is held accountable as an expert in its field only for those dangers of which it has knowledge or those which it could discover through the exercise of reasonable care.” Id. (footnote omitted).
However, drug manufacturers are not insurers of the products that they sell. Id. at 290–91. Consequently, no liability attaches where the harmful effects of a product are those that no human skill or foresight could have predicted. Id. at 291. “The manufacturer's duty to warn users of the potential danger inherent in its product is commensurate with its actual knowledge of the risk involved to those users or the knowledge constructively imparted to it by available scientific or other medical data.” Id.
According to Minnesota law, therefore, the foreseeability of potential harm determines the existence and extent of the manufacturer's duty to warn. See id.; see also Whiteford by Whiteford v. Yamaha Motor Corp., U.S.A., 582 N.W.2d 916, 918 (Minn.1998) (“In Minnesota, it is well settled that a manufacturer has a duty to protect users of its products from foreseeable dangers. But if the danger is not foreseeable, there is no duty.”) (footnotes omitted). “In determining whether a danger is foreseeable, courts look at whether the specific danger was objectively reasonable to expect, not simply whether it was within the realm of any conceivable possibility.” Whiteford, 582 N.W.2d at 918 (footnote omitted).
Finally, the Supreme Court of Minnesota has acknowledged that “[f]oreseeability of injury is a threshold issue related to duty that is ordinarily ‘properly decided by the court prior to submitting the case to the jury.’ “ Domagala v. Rolland, 805 N .W.2d 14, 27 (Minn.2011) (quoting Alholm v. Wilt, 394 N.W.2d 488, 491 n. 5 (Minn.1986)). The court submits the issue of foreseeability to the jury only “in close cases.” Domagala, 805 N.W.2d at 27. Minnesota's foreseeability test “look[s] to the defendant's conduct and ask[s] whether it was objectively reasonable to expect the specific danger causing the plaintiff's injury.” Id . (citation omitted). However, “[t]he test is not whether the precise nature and manner of the plaintiff's injury was foreseeable, but whether the possibility of an accident was clear to the person of ordinary prudence.” Id. (quotation and citations omitted).
Prior to 2000, what was known by medical science about joints and the fragility of cartilage would have put a careful and prudent and reasonable medical device maker on notice that continuous infusion of commonly used anesthetics over a period of two to three days into a joint space would likely risk injury to the cartilage. There was enough information available, even before studies investigating the effect of irrigation solutions and local anesthetics on articular cartilage, to raise serious concern that there would likely be a problem if the articular cartilage were continually exposed to these substances for two to three days.
Stryker moved to exclude Dr. Trippel's testimony, arguing that his “opinion [that] Stryker was on notice that continuous infusion of local anesthetics into the intraarticular space was likely unsafe is unreliable because his own reliance literature does not support his opinion.” In granting Stryker's motion for summary judgment, the district court denied as moot Stryker's motion to exclude Dr. Trippel's testimony. The district court agreed with Stryker that the medical literature at the time of Mack's surgery “d[id] not support the conclusion that in 2002 Stryker should have known that its pain pump could ca [u]se cartilage damage.” Mack, 893 F.Supp.2d at 987. Consequently, we must determine whether the district court correctly concluded that the existing medical literature in 2002 was insufficient to allow Stryker to foresee the risk of articular cartilage damage from the use of its pain pumps for infusion of intraarticular anesthetics.
Dr. Trippel also relied on an article whereby researchers studied the effect of inundating articular cartilage from pigs and dogs with bupivacaine for up to two hours. See Roberta Nole et al., Bupivacaine and Saline Effects on Articular Cartilage, 1 Arthroscopy 123, 126 (1985). Dr. Trippel noted that the researchers found that bupivicaine inhibited cartilage cells; however, articular cartilage cells recovered from a maximum two-hour exposure within three days. The fourth article upon which Dr. Trippel relied was a literature review whereby the authors stated that, based on the Nole article, little was known about the long-term effects of the acute inhibition of articular cartilage cells. See John P. Fulkerson & Thomas F. Winters, Jr., Articular Cartilage Response to Arthroscopic Surgery: A Review of Current Knowledge, 2 Arthroscopy 184 (1986). The Fulkerson article contained no new findings.
Dr. Trippel also relied on an article detailing a study wherein researchers repeatedly injected rabbit joints with saline solutions and determined that repeated injections of saline over four weeks inhibited the synthesis of a vital protein used to generate cartilage cells. See J. Neidel et al., Intra-articular Injections and Articular Cartilage Metabolism: An Experimental Study in Rabbits, 111 Archives of Orthopaedic and Trauma Surgery 237 (1992). The study concluded that prolonged exposure to the saline solution prevented the cartilage from ever recovering.
The sixth study upon which Dr. Trippel relied showed how cartilage exposure to various solutions, none of which were anesthetics, over periods of two, four, and twenty hours demonstrated a “softening effect” upon the cartilage, indicating cartilage damage. See J.S. Jurvelin et al., Effects of Different Irrigation Liquids and Times on Articular Cartilage: An Experimental, Biomechanical Study, 10 Arthroscopy 667 (1994). Next, Dr. Trippel relied on a study in which researchers immersed the knee joints of rats into various solutions to determine the effect of these solutions on articular cartilage. See S.K. Bulstra et al., The Effect In Vitro of Irrigating Solutions on Intact Rat Articular Cartilage, 76–B Journal of Bone & Joint Surgery 468 (1994). Dr. Trippel averred that the study demonstrates that a variety of substances harm articular cartilage upon contact.
The eighth article upon which Dr. Trippel relied involved the testing of morphine (a different anesthetic) on human articular cartilage. See John W. Jaureguito et al., The Effects of Morphine on Human Articular Cartilage of the Knee: An In Vitro Study, 18 Arthroscopy 631 (2002). The researchers in this article used saline solutions, saline solutions mixed with different concentrations of morphine, and combinations of morphine and bupivacaine.
The ninth and tenth articles upon which Dr. Trippel relied contained case reports regarding patients who lost cartilage in their shoulders following surgery. See Y. Shibata et al., Chondrolysis of the Glenohumeral Joint Following a Color Test Using Gentian Violet, 25 International Orthopedics 401 (2001); Kazuya Tamai et al., Chondrolysis of the Shoulder Following a “Color Test”—Assisted Rotator Cuff Repair—A Report of 2 Cases, 68 Acta Orthopaedica Scandinavica 401 (1997). The cartilage loss resulted from direct injection of gentian violet (a dye) into the glenohumeral joint.
The penultimate article upon which Dr. Trippel relied detailed six reports where patients' knees were accidentally irrigated with chlorhexidine 1% in aqueous solution during arthroscopy. See C.M. Douw et al., Clinical and Pathological Changes in the Knee After Accidental Chlorhexidine Irrigation During Arthroscopy. Case Reports and Review of the Literature, 80–B The Journal of Bone and Joint Surgery 437 (1998). All six patients developed chondrolysis in the knee. Similarly, the last article upon which Dr. Trippel relied described three patients who developed chondrolysis after receiving 0.02% aqueous chlorhexidine solution during arthroscopic knee surgery. See A.L. Van Huyssteen & D.J. Bracey, Chlorhexidine and Chondrolysis in the Knee, 81–B Journal of Joint and Bone Surgery 995 (1999). Dr. Trippel used this study to demonstrate that joint exposure to low concentrations of chlorhexidine can cause extensive damage to articular cartilage.
Mack contends that the district court “failed to understand and analyze the literature” that supported Dr. Trippel's conclusion that pain pump manufacturers like Stryker should have known about potential risks inherent in continuously infusing any type of solution into articular joints. Stryker responds by noting that even Dr. Trippel admitted that the medical community had not drawn a connection between continuous infusion of a local anesthetic into an intra-articular joint and chondrolysis until 2005 or 2007. The question thus becomes whether the 12 articles support Dr. Trippel's opinions such that a jury should determine whether a device manufacturer could reasonably foresee that continuous infusion of bupivacaine into Mack's glenohumeral joint would harm her articular cartilage, notwithstanding that the medical community did not discern chondrolysis specifically as a risk until years after Mack's surgery.
We agree with the district court that the 12 articles underpinning Dr. Trippel's opinions do not support his conclusions. As the district court recognized, most of the articles that Dr. Trippel cites do not involve the study of the effects of continuous infusion of bupivacaine or other anesthetics in articular joints. See Mack, 893 F.Supp.2d at 986. The Key, Reagan, Jurvelin, Bulstra, and Neidel articles involve the injection of saline solutions rather than anesthetics, so the manufacturer of a device designed to infuse anesthetics into the articular joint would have no reason to conclude that anesthetic infusion could harm the joint based on these articles. See id. The same problem arises with the Tamai and Shibata articles (gentian dye) and the Douw and Van Huyssteen articles (antiseptic chlorhexidine). See id.
The remaining articles, which involved the study of anesthetics, also fail to alert reasonable manufacturers like Stryker to the dangers of continuous infusion of bupivacaine into articular joints. For example, the conclusions of the Nole article directly conflict with Dr. Trippel's opinions. The Nole article would not alert a reasonable medical device manufacturer like Stryker of the risk of its pain pumps. The district court explained that Nole concluded that “b[u]p[i]vacaine itself seems to be fairly well tolerated by articular cartilage, but the saline solution in which it is prepared is transiently inhibitory of the uptake of sulfates in articular cartilage.” Mack, 893 F.Supp.2d at 986 (quoting Nole, supra, at 126). Furthermore, “Nole also concluded that there was ‘[no] immediate need to stop the use of intraarticular bupivacaine.’ “ Id. (alteration in original) (quoting Nole, supra, at 126). Finally, the district court stated that “Nole further reported that affected cells recovered after three days, thereby suggesting that any impact was fleeting and reversible.” Id. (citing Nole, supra, at 126). Consequently, even careful study of the Nole article would fail to alert pain pump manufacturers of the dangers that Dr. Trippel asserts.
Furthermore, the articles that Dr. Trippel identifies fail to capture the full context of the relevant medical knowledge at the time of Mack's surgery. First, surgeons have used “pain pumps to provide anesthetics to post-operative joints for years.” Rodriguez, 680 F.3d at 570. Second, Stryker provides several articles that recognize the safety and effectiveness of placing pain pumps in articular joints. See, e.g., Barber et al., The Effectiveness of an Anesthetic Continuous–Infusion Device on Postoperative Pain Control, 18 Arthroscopy 76 (2002); Narinder Rawal et al., Postoperative Patient–Controlled Local Anesthetic Administration at Home, 86 Anesthesia & Analgesia 86 (1997). In one study, researchers set out “to examine the effectiveness of an intra-articular pain catheter for controlling postoperative pain following arthroscopic” surgery. Ken Yamaguchi et al., Postoperative Pain Control Following Arthroscopic Release of Adhesive Capsulitis: A Short–Term Retrospective Review Study of the Use of an Intra–Articular Pain Catheter, 18 The Journal of Arthroscopic and Related Surgery 359, 360 (2002). The researchers studied 20 patients who received continuous infusion of bupivacaine in their articular joints. Id. at 361–62. Out of 20 patients, only one patient experienced any complication from use of the pain pump—a temporary complication unrelated to chondrolysis. Id. at 363. The article concluded that “[t]he results of this study suggest that delivery of bupivacaine through an indwelling intra-articular pain catheter can be a highly effective means of achieving pain control following arthroscopic” surgery, especially where “[t]here were no direct complications with this method, including no infections.” Id. at 364.
While the pre–2004 medical articles raise the general notion that health of (usually animal) cartilage could be weakened by prolonged exposure to certain “foreign elements,” it is a bridge way too far to say that Stryker—in the context in which infusion pumps were broadly used and medically accepted without reservation—should have, prior to marketing the pain pump, culled through seven decades of literature, found the sporadic articles raising this concern, ignored all the authority/evidence to the contrary, and then independently concluded that its pain pump could cause chondrolysis, particularly where no one in the medical community connected the destruction of cartilage to the use of pain pumps until after the plaintiff's surgery.
Id. at 573. We agree.6 The 12 articles that Dr. Trippel submits do not warn against the continuous infusion of bupivacaine in articular joints. Furthermore, other articles trumpeted the use of bupivacaine-inj ecting pain pumps into articular spaces. See, e.g., Yamaguchi, supra, at 364. Mack fails to show that any “specific danger was objectively reasonable to expect”; therefore, we hold that Mack has demonstrated merely that articular cartilage damage “was within the realm of any conceivable possibility.” See Whiteford, 582 N.W.2d at 918. “[N]o developed human skill or foresight” could have led a medical device manufacturer to select Dr. Trippel's articles, read them between the lines, ignore their conclusions, and ignore the plethora of other articles that recommended to the contrary. See O'Hare, 381 F.2d at 291 (quotation and citation omitted). Consequently, we conclude that Stryker could not have foreseen the potential for articular cartilage damage as the result of the surgical implementation of its pain pump based on the medical community's knowledge in 2002. Stryker, as a matter of law, had no duty to protect or warn Mack of the harm that Stryker's pain pumps may inflict. See Domagala, 805 N.W.2d at 27.
Stryker and its predecessors in interest sought FDA approval for the use of pain pumps in the late 1990s. Typically, a company has two avenues by which to obtain FDA approval. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 477–79 (1996). First, the company could pursue the more rigorous premarket approval (PMA) process whereby the FDA scrupulously evaluates the device's safety and effectiveness. See id. at 477. To avoid the costly, time-consuming PMA process, device manufacturers can seek clearance by providing “premarket notification” to the FDA. Id. at 478. Known as the “ § 510(k)”7 process, the FDA would then approve a device if the manufacturer demonstrates that a “substantially similar” product is currently in use for that purpose. See id. at 478–79.
Stryker obtained § 510(k) clearance for its pain pump for “intraoperative” use; the parties agree that “intraoperative use” generally means a location on the body where surgery is performed. However, Stryker twice sought § 510(k) clearance for use of its pain pump in articular spaces, yet the FDA denied § 510(k) clearance on both occasions. These denials occurred before Mack's surgery. The FDA denied clearance because of the lack of a “substantially similar” predicate device. As the district court noted, Mack does not contend that the FDA denials alone subject Stryker to liability. Mack, 893 F.Supp.2d at 985. Furthermore, Mack presents no evidence that the FDA denied Stryker's applications because of safety concerns or that Stryker violated any FDA regulation. Id. at 985–86. Mack contended before the district court that the FDA denials should have prompted Stryker to conduct safety tests on its pain pumps. Id. at 986. The district court rejected Mack's argument, stating that “[i]t would be illogical to conclude that the FDA denial, which was not based on safety concern, and did not raise a safety concern within Stryker, triggered to duty to undertake safety testing or to warn of safety concerns.” Mack, 893 F.Supp.2d at 986.
The Supreme Court has already rejected such arguments. See Medtronic, 518 U.S. at 492–93. The Medtronic Court explained that, pursuant to the § 510(k) process, medical device manufacturers must demonstrate that their devices are substantially equivalent to devices that were on the market before Congress passed the Medical Device Amendments of 1976. Id. at 477–78. Congress enacted this exception because several pre–1976 devices were grandfathered into the market such that they need not obtain PMA approval. Id. Thus, the § 510(k) exception exists to prevent these manufacturers from monopolizing the market while new devices cleared PMA and to ensure that improvements to existing devices could be introduced into the market quickly. Id. at 478. Because § 510(k) allows more recent devices to be grandfathered into the market without undergoing the PMA process, § 510(k) is concerned with “equivalence, not safety.” Id. at 493 (citation omitted). The § 510(k) process protects the public little. Id. Post Medtronic, § 510(k) rejections typically do not alert device manufacturers that their products are unsafe.
Medtronic applies here. The FDA denials did not indicate to Stryker that use of its pain pumps in intra-articular spaces was unsafe or could result in foreseeable harm.
Therefore, we affirm the district court's decision to grant summary judgment to Stryker.
I believe Carol Mack is entitled to have a jury determine whether the use of pain pumps in articular joints presented a foreseeable risk of harm at the time of her August 2002 shoulder surgery. I therefore respectfully dissent.
As the court acknowledges, the issue of foreseeability under Minnesota law is reserved for the jury's determination in “close cases.” Ante at 6 (quoting Domagala v. Rolland, 805 N.W.2d 14, 27 (Minn.2011)). In Huggins v. Stryker Corp., 932 F.Supp.2d 972 (D.Minn.2013), a federal district court addressed a similar claim involving a February 2002 surgery date and determined “a jury could reasonably find by a preponderance of the evidence that Stryker should have known the risks of intraarticular pain pump use [in February 2002].” Id. at 990. In denying Stryker's motion for summary judgment, the court noted that Minnesota requires the issue of foreseeability to be submitted to the jury in “close cases .” Id. at 986.
Significantly, the medical literature at issue in Huggins is essentially the same medical literature at issue in this case. See id. at 978–79 & n. 4 (involving ten of the same twelve published studies dating between 1933 and 1999 which were relied upon by Mack's experts). The district court indicated cases “across the country” have addressed whether pain pump manufacturers such as Stryker knew or should have known intra-articular pain pump use could cause cartilage damage based on the existing medical literature, and noted the courts “have confronted this issue with inconsistent results.” Id. at 986–87 (citing cases where summary judgment has been both granted and denied). In addition to Huggins, summary judgment has been denied in several cases involving surgery dates comparable to Mack's August 2002 surgery. See Hackett v. Breg, Inc., Civ. No. 10–1437, 2011 WL 4550186, at *1 (D.Colo. Oct. 3, 2011) (involving an April 3, 2002, surgery date); Creech v. Stryker Corp., No. 2:07CV22 DAK, 2012 WL 33360 at *1 (D.Utah Jan. 6, 2012) (involving six surgeries between February 2003 and July 2004); Kildow v. Breg, Inc., 796 F.Supp.2d 1295, 1298 (D.Or.2011) (involving surgeries in July 2003 and March 2004).8 Huggins also noted “multiple juries have found that the risks were foreseeable” when the jury was allowed to consider the issue. See Huggins, 932 F.Supp.2d at 987 (citing the final judgment in Hackett, and Beale v. I–Flow Corp., No. 0801–01554 (Ore. Cir. Ct. Multnomah Cnty. Dist. Jan. 22, 2010)).
Given the inconsistent decisions reached on the issue of foreseeability by both reasonable judges and reasonable jurors, I fail to see how we can conclude Mack's claim on foreseeability is anything but a “close case.” Minnesota law thus allows her to have a jury decide her claim. I therefore disagree with our decision to affirm the grant of summary judgment in favor of Stryker. I would reverse the district court and remand this “close case” for a jury trial.
1. The Honorable Paul A. Magnuson, United States District Judge for the District of Minnesota.
2. Mack also asserted causes of action for fraud, negligent misrepresentation, and breach of warranties. Mack abandoned these causes of action prior to the district court's summary judgment determination.
3. Other courts have determined that the medical community did not find a specific link between intra-articular use of pain pumps and chondrolysis until 2005. See Rodriguez v. Stryker Corp., 680 F.3d 568, 570–71 (6th Cir.2012). We need not determine the specific date of the medical community's discovery because the parties agree that it was years after Mack's surgery in 2002.
4. Additionally, the Jaureguito study was published only one month before Mack's surgery. Id. at 986 n. 9. Because we conclude that it would not have provided Stryker with notice of potential harm, we need not decide whether publication of an article one month before a patient's surgery gives a medical device manufacturer enough time to read, understand, and adapt to the article's findings.
5. In fact, Dr. Trippel relied on a thirteenth study in Rodriguez because Rodriguez underwent shoulder surgery in 2004.
6. A separate panel of the Sixth Circuit decided a similar case to Rodriguez less than three months later, and it reversed a district court's decision to grant summary judgment to a pain pump manufacturer without acknowledging Rodriguez. See Krumpelbeck v. Breg, Inc., 491 F. App'x 713 (6th Cir.2012) (unpublished). Krumpelbeck and Rodriguez directly conflict. We decline to consider Krumpelbeck because it is not the law of this circuit and likely not the law of the Sixth Circuit due to Rodriguez's prior publication. See Rutherford v. Columbia Gas, 575 F.3d 616, 619 (6th Cir.2009) (“A published prior panel decision remains controlling authority unless an inconsistent decision of the United States Supreme Court requires modification of the decision or this Court sitting en banc overrules the prior decision.” (quotation and citation omitted)). Additionally, we do not find it persuasive.
7. The “510(k)” process is named after the section number given to this process in the Medical Device Amendments of 1976.
8. The slight difference in surgery dates is immaterial where the majority of the medical literature at issue was published by 1999.


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S.B., a Minor by her Parent and Legal Guardian Azania Muwwakkil; Azania Muwwakkil, in her own right, Appellants v. KINDERCARE LEARNING CENTERS, LLC.
Before SMITH, HARDIMAN & SLOVITER, Circuit Judges. Rhonda H. Wilson, Esq., Philadelphia, PA, for Appellants. Edward A. Greenberg, Esq., Kristin A. Topolewski, Esq., Ward Greenberg, Philadelphia, PA, for Appellee.
S.B. and Azania Muwwakkil appeal from an order of the District Court granting in part and denying in part their motion for voluntary dismissal without prejudice. For the reasons that follow, we lack jurisdiction and will dismiss the appeal.
S.B., a minor, was allegedly injured at a daycare center operated by Appellee KinderCare Learning Centers, LLC (“KinderCare”) when another child tore a hair braid from her scalp. Based on this incident, her mother, Muwwakkil, retained counsel and filed a complaint against KinderCare in the Court of Common Pleas of Philadelphia County. The complaint alleged that KinderCare is responsible for S.B.'s injuries because it was negligent in operating the daycare center. KinderCare removed the action to the District Court for the Eastern District of Pennsylvania.
After removal, Muwwakkil retained a different attorney who promptly filed a motion for voluntary dismissal without prejudice pursuant to Federal Rule of Civil Procedure 41. According to counsel, the lawsuit was prematurely filed because S.B., as a four-year-old, is too young to articulate details about the alleged incident and how it has affected her. KinderCare opposed the motion. The District Court granted the motion in part, denied the motion in part, and dismissed the case without prejudice. In doing so, the District Court imposed two conditions on the right of S.B. and Muwwakkil to refile the case: (1) that they pay KinderCare reasonable attorneys' fees, to be determined by the District Court upon receiving an affidavit of costs; and (2) that they refile their complaint by June 24, 2019, approximately four years from the date of the order, with the possibility of extending that deadline by a showing of good cause. Instead of submitting an objection to KinderCare's affidavit of costs, and before the District Court entered a final order, S.B. and Muwwakkil filed the instant appeal challenging the imposition of these conditions on their right to refile.
Our jurisdiction is limited generally to reviewing the “final decisions” of district courts. 28 U.S.C. § 1291. A final decision is one that “ends the litigation on the merits and leaves nothing for the court to do but execute the judgment.” Quackenbush v. Allstate Ins. Co., 517 U.S. 706, 712, 116 S.Ct. 1712, 135 L.Ed.2d 1 (1996) (quoting Catlin v. United States, 324 U.S. 229, 233, 65 S.Ct. 631, 89 L.Ed. 911 (1945)). Typically, a dismissal without prejudice is not a final decision because the plaintiff may refile the complaint, thereby creating the risk of “piecemeal” appellate litigation.1 Camesi v. Univ. of Pittsburgh Med. Ctr., 729 F.3d 239, 244 (3d Cir.2013). This is particularly true where, as here, the party appealing is a plaintiff who moved for voluntary dismissal under Rule 41(a)(2). See Empire Volkswagen Inc. v. World–Wide Volkswagen Corp., 814 F.2d 90, 94 (2d Cir.1987).
Although we have not yet had occasion to consider it, other courts have applied an exception to this jurisdictional bar where a district court dismisses a case without prejudice but, in doing so, imposes unreasonably onerous conditions on the plaintiff's right to refile the dismissed action. These courts have used the term “legal prejudice” to describe such conditions. See, e.g., LeCompte v. Mr. Chip, Inc., 528 F.2d 601, 604 (5th Cir.1976) (finding legal prejudice where, as an additional condition of refiling, plaintiff was required to “prove his case preliminarily to the district court” by “affirmatively demonstrat[ing] that the case should be reopened and that he possesses a valid cause of action”); Versa Prods., Inc. v. Home Depot, USA, Inc., 387 F.3d 1325, 1327–28 (11th Cir.2004) (no legal prejudice where payment of attorney's fees was condition of refiling); Duffy v. Ford Motor Co., 218 F.3d 623, 627–29 (6th Cir.2000) (no legal prejudice where conditions were the imposition of fees and the requirement that evidentiary rulings of dismissed action would apply prospectively to any refiled action); Bowers v. St. Louis Sw. Ry. Co., 668 F.2d 369, 369 (8th Cir.1981) (per curiam) (no legal prejudice where condition was that lawsuit, if refiled, must be brought in “either the state or federal courts of Arkansas”).
The legal prejudice exception is consistent with case law in this circuit holding that a dismissal without prejudice may be appealed under circumstances where the plaintiff's ability to refile is foreclosed. See, e.g., Ahmed v. Dragovich, 297 F.3d 201, 207 (3d Cir.2002) (noting that an order dismissing a case without prejudice was a final, appealable order where the statute of limitations had expired and any attempt at refiling would have been unsuccessful); Welch v. Folsom, 925 F.2d 666, 668 (3d Cir.1991) (summarizing circuit authority concerning circumstances where dismissal without prejudice was appealable). We therefore follow other circuits in adopting the legal prejudice exception to the final judgment rule.
This case, however, does not fall within the legal prejudice exception because the conditions imposed by the District Court do not “severely circumscribe” or render “uncertain” the ability of S.B. and Muwwakkil to refile their complaint. LeCompte, 528 F.2d at 604.
Second, the condition that S.B. and Muwwakkil refile their case by June 24, 2019, does not amount to legal prejudice because it does not result in uncertainty as to whether they will be permitted to refile their action. S.B. and Muwwakkil are correct that, were it not for this condition, Pennsylvania's applicable statute of limitations would not expire until S.B.'s twentieth birthday. Rule 41(a), however, authorizes the District Court to condition a voluntary dismissal “on terms that the court considers proper,” Fed.R.Civ.P. 41, as long as they are designed to protect the defendant and do not create burdensome obstacles to refiling, see Versa Prods., Inc., 387 F.3d at 1327–28. Here, the District Court imposed a deadline on refiling to accommodate KinderCare's concern that defending against a refiled lawsuit would become increasingly difficult with the passage of time. The Court, however, emphasized that the deadline can be extended for good cause, considering such factors as S.B.'s cognitive ability and readiness to proceed.
1. A plaintiff who agrees to “stand” on the dismissed complaint by refraining from refiling the same action may obtain appellate review because there is no risk of multiple appeals. Fassett v. Delta Kappa Epsilon (New York), 807 F.2d 1150, 1156–57 (3d Cir.1986). Here, however, the assertion of S.B. and Muwwakkil that they “will stand on the complaint” is of no consequence. See Appellant's Br. at 8. They cannot stand on their complaint when they have made it clear that they plan to refile a different complaint in the future.
2. The fact that there is no final order identifying the amount of costs imposed is an additional reason we lack jurisdiction. The order under review states only that S.B. and Muwwakkil must pay “Defendant reasonable attorneys' fees and costs as determined by the Court.” App. at 3. Without knowing what fees (if any) the District Court might find are “reasonable,” we lack a basis for review. See Duffy, 218 F.3d at 626 (explaining case history and noting that previously dismissed appeal would have been “premature” because “the amount of fees payable to the defendant had not yet been specified”).
3. In doing so, we note that S.B. and Muwwakkil are not permanently foreclosed from obtaining appellate review of the conditions imposed by the District Court. For instance, an order dismissing the case with prejudice for failure to comply with these conditions would constitute a final, appealable order. See Mortg. Guar. Ins. Corp. v. Richard Carlyon Co., 904 F.2d 298, 301 n. 5 (5th Cir.1990) (“Another option traditionally open to a plaintiff who disagrees with the conditions imposed by the court upon a Rule 41(a)(2) dismissal is to refuse to comply with the condition. In such a case, the court may convert the dismissal into a dismissal with prejudice. The dismissal would then be appealable as a decision on the merits.”); Herring v. City of Whitehall, 804 F.2d 464, 466 & n. 2 (8th Cir.1986) (permitting appeal from dismissal with prejudice ordered after plaintiffs failed to comply with condition that they pay attorney's fees upon refiling a case voluntarily dismissed under Rule 41); Yoffe, 580 F.2d at 131 n. 13.
4. As an alternative basis for jurisdiction, S.B. and Muwwakkil argue that the collateral order doctrine permits us to hear their appeal. One of the requirements for the collateral order doctrine to apply is that the issues raised must be “effectively unreviewable on appeal from a final judgment.” We, Inc. v. City of Philadelphia, 174 F.3d 322, 324 (3d Cir.1999) (internal quotation omitted). Here, there has been no showing that the propriety of the conditions imposed on the right of S.B. and Muwwakkil to refile is an issue that is “effectively unreviewable,” or that this appeal otherwise “falls within the ‘narrow class of decisions that do not terminate the litigation, but must, in the interest of achieving a healthy legal system, nonetheless be treated as final.’ “ New Jersey, Dep't of Treasury, Div. of Inv. v. Fuld, 604 F.3d 816, 822 (3d Cir.2010) (quoting Digital Equip. Corp. v. Desktop Direct, Inc., 511 U.S. 863, 867, 114 S.Ct. 1992, 128 L.Ed.2d 842 (1994)).


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STATE v. MORRIS December 19, 2002 No. 2002-KK-1778.
WYATT v. AVOYELLES PARISH SCHOOL BOARD December 4, 2002 Nos. 2001-C-3180, 2002-C-0131, 2002-C-0259.
STATE v. G.B.B. December 4, 2002 No. 2002-CJ-1715.
STATE v. PAYNE December 4, 2002 No. 2001-KK-3196.
LAFLEUR v. CITY OF NEW ORLEANS December 4, 2002 No. 2001-C-3224.
STATE v. GREEN December 4, 2002 No. 2002-KK-1022.
SS LMW BAW CLW v. STATE DEPARTMENT OF SOCIAL SERVICES December 4, 2002 No. 2002-C-0831.
WILLIAMS v. CITY OF NEW ORLEANS PUBLIC BELT RAILROAD COMMISSION OF CITY OF NEW ORLEANS December 4, 2002 No. 2002-CC-1127.
ROLLINS v. RICHARDSON December 4, 2002 No. 2002-C-0556.
ST BERNARD PARISH POLICE JURY v. DUPLESSIS December 4, 2002 No. 2002-C-0632.
IN RE: Jerry F. PALMER. December 4, 2002 No. 2002-B-1780.
IN RE: Nicholas Sebastian MORPHIS. December 4, 2002 No. 2001-B-2803.
IN RE: Gordon L. HACKMAN. December 4, 2002 No. 2002-B-1692.
STATE v. WRIGHT December 4, 2002 No. 2001-KA-0322.

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