Opinion
NO. 03913
September 30, 2016, Decided
Judges:[*1]Mark I. Bernstein, J.
Opinion by:Mark I. Bernstein
On May 31, 2013 Plaintiff Patricia Hammons commenced this action by filing a complaint against defendants for injuries stemming from the implantation of Pro Lift Pelvic Mesh. On July 15, 2013 this matter was removed to The United States Eastern District Court. On February 24, 2014 this matter was Remanded by The United States Eastern District Court. In March 2014, Ms. Hammons's case was transferred to the mass tort program In re: Pelvic Mesh Litigation supervised by the Honorable Arnold L. New. On September 24, 2014 Defendants filed an answer to Plaintiffs' Master Long Form Complaint In Re: Pelvic Mesh Litigation. On October 07, 2014 Plaintiff filed a Short Form Complaint in this Matter. On October 28, 2014 Defendants' filed Preliminary Objections to Plaintiff's Short Form Complaint. On November 12, 2014 Plaintiff filed an Answer to Defendants' Preliminary Objections. On March 30, 2015 Defendants' Preliminary Objections were Overruled. On August 31, 2015, Ethicon moved for summary judgment on all of Plaintiff's claims on sufficiency grounds. On August 31, 2015 Defendant Ethicon filed a summary judgment on statute of limitations grounds. On Nov.[*2] 23, 2015, Judge New entered partial summary judgment in favor of Ethicon and against Plaintiff Trial proceeded on claims of design defect and failure to warn sounding in strict liability and negligence. On November 30, 2015 trial commenced before this Court. On December 21, 2015, the jury returned a verdict for Plaintiff and against Ethicon and awarded Ms. Hammons $5.5 million in compensatory damages. After receiving additional evidence and argument from the parties and instructions from the Court, the jury returned to deliberate on the amount of the punitive damages award. On December 22, 2015, the jury assessed $7 million in punitive damages, raising the total verdict to $12.5 million plus the addition of delay damages. On January 4, 2016 Defendant filed post-trial motions. On January 13, 2016 Plaintiff filed an answer to Defendant's post-trial motion. On March 15, 2016 Defendants post-trial motions were Denied. Defendant timely appeals the 2016 Denial of its post-trial motions.
On December 22, 2015 Plaintiff filed a Motion for Delay Damages. On January 8, 2016 Plaintiffs Motion for Delay damages was Granted. Delay Damages of $797,602.70 were added to the Verdict. The Delay Damages were apportioned between the Plaintiff's claims in the same Proportion as these actions were represented in the Jury Verdict with 44% assessed the Compensatory Damages ($350,945.18) and 56% to the Punitive Damages Claim ($446,657.51). On February 08, 2016 Defendant filed a Motion for Reconsideration of the January 08, 2016 Order awarding Delay Damages, On February 12, 2016 Plaintiff filed an Answer to the Motion for Reconsideration. On February 19, 2016 Defendant filed a Reply to the Motion for Reconsideration. On March 4, 2016 Defendant's Motion for Reconsideration was Granted. This Court's January 08, 2016 Order was Modified to exclude the Jury's Punitive Damages award from the Calculation of Delay Damages. The final amount of Delay Damages Awarded totaled $350,945.18. On April 14, 2016 Judgment in the Amount of $12,850,945.18 was entered in Favor of Patricia Hammons and Against Ethicon. Plaintiff timely cross appeals the Decision of April 14, 2016.
Patricia Hammons is a 65-year old woman. Mr. Hammons lives in Washington, Indiana. Ms. Hammons was diagnosed with pelvic organ prolapse in 2009. Pelvic organ prolapse occurs when the pelvic organs drop from their normal place in the abdomen and push against the walls of the vagina. Ms. Hammons was diagnosed with an anterior prolapse of her uterus and bladder. At the time of her diagnosis, Mrs. Hammons was sexually active and the condition was mild and painless.
Michael Baker, D.O., an obstetrician-gynecologist, treated Mrs. Hammons. He recommended Ms. Hammons undergo an anterior repair of her bladder prolapse and removal of her uterus and ovaries. Dr. Baker performed the surgery on May 5, 2009. He used the Prolift kit to repair the prolapse. Prolift is a product designed, manufactured, and sold by Ethicon. The Prolift kit is made up of a precut piece of surgical mesh and implanting tools called obdurators. The Prolift mesh is woven from non-absorbable polypropylene sutures. The mesh is pre-cut into distinct shapes for anterior, posterior, or total pelvic repairs. There are approximately 260 yards of Prolene sutures woven together in the Prolift anterior mesh. Ethicon originally sold the mesh under the name Prolene Soft. Prolene Soft was for implantation in abdominal muscles to repair hernias. Ethicon rebranded the Prolene Soft as Gynemesh PS and sold it for pelvic floor repair in 2003. Ethicon placed the Prolift kit on the market on March 10, 2005.
Dr. Baker followed the implantation protocol taught by Ethicon. Plaintiff testified that Dr. Baker did not explain the crucial risks of the procedure before she consented to the surgery. These risks included sexual dysfunction, prolapse recurrence, injury to the bladder, and "mesh erosion." He also did not explain that there was no protocol for removal of the mesh should that become necessary. Less than three months later Ms. Hammons returned to Dr. Baker with complaints of pinching, sharp pain, and pain during sexual intercourse. These issues caused her to stop engaging in intimate relations. Dr. Baker diagnosed Mrs. Hammons with Dysperunia (persistent vaginal pain). However, Dr Baker did not offer any explanation for her sexual dysfunction. When Plaintiff next visited Dr. Baker, he observed that while the bladder repair had continued to hold up, she was experiencing posterior prolapse of her rectum. Dr. Baker did not offer a resolution to the issue. Ms. Hammons sought referral to a different physician.
O.M. Lackey, M.D., a second obstetrician-gynecologist, saw Ms. Hammons on November 30, 2009. Dr. Lackey noted rectal prolapse, pelvic pressure, and pain with intercourse, and incontinence. Dr. Lackey did not know that the product implanted in Ms. Hammons was Prolift. Dr. Lackey surgically repaired the rectal prolapse on December 15, 2009. He performed a native tissue repair in which he used Ms. Hammons's own tissue to provide support for her rectum. Ms. Hammons continued to experience pain with intercourse after this second surgery. Ms. Hammons continued to experience bouts of incontinence. Ms. Hammons's anterior and posterior prolapse recurred within a year. Neither Dr. Baker nor Dr. Lackey ever mentioned Prolift as a possible cause of Ms. Hammons continuing pain issues.
Ms. Hammons was referred by Dr. Lackey to Dr. Michael Heit, M.D., a urogynecologist. Dr. Heit performed a series of specialized tests on August 30, 2012. and told Ms. Hammons that her symptoms were caused by the implantation of the Prolift mesh. This was the first indication to Ms. Hammons that her dyspareunia had been caused by the Prolift. Dr. Heit recommended additional surgery to repair her entire pelvic floor and excise the mesh. In November 2012, Dr. Heit excised the Prolift mesh from Ms. Hammons's anterior vaginal wall, repaired two cystotomies (holes in the bladder), placed a ureteral stent, and repaired her recurring rectocele. Two months later Dr. Heit removed the ureteral stent. He noted a new penetration of the Prolift mesh into the left lateral bladder wall. On January 28, 2013. Dr. Heit removed additional mesh from Plaintiff's bladder. In all Dr. Heit performed three surgeries.
At trial Plaintiff introduced testimony from four experts and from company employees and consultants, as well as evidence documenting the development process for Prolift. Ralph Zipper, M.D., Plaintiff's expert urogynecologist, reviewed plaintiff's medical history and examined Ms. Hammons. He testified that the Prolift had contracted and caused severe, persistent inflammation. The inflammation and contraction caused pain as the Prolift shrank and deformed her vagina. Dr. Zipper, also further opined that the Prolift caused prolapse of other organs, after Ms. Hammons initial surgery. Dr. Zipper concluded that Ethicon's product was the cause of Ms. Hammons's injuries. Dr. Zipper reached this conclusion while specifically excluding other potential causes.
N.T., 12/9/15 (P.M.), at 31.
Id.
Id. at 155.
Issues Appealed by Defendant
a. Statute of limitations.
Defendant argues that plaintiff's claim is time-barred, that the Court erred when it permitted this claim to go to the jury and denied post trial relief. The substantive law of Indiana governs Ms. Hammons's claims against Ethicon. Product liability claims under Indiana law are governed by the Indiana Products Liability Act ("IPLA"). The IPLA states that "in any product liability action in which the theory of liability is negligence or strict liability in tort . . . [the] product liability action must be commenced: (1) within two (2) years after the cause of action accrues. . . ." The word "accrues" is not expressly defined in the language of the IPLA. The meaning of the terms in IPLA actions is governed by Indiana's discovery rule. The Indiana Supreme Court addressed this issue in the case of Degussa Corp. v. Mullens. In Degussa, the plaintiff suspected that chemicals in her workplace were causing her persistent cough and respiratory infections, and questioned her physician about this possibility on March 17, 1992. The physician diagnosed her with bronchitis and told the Plaintiff there were many explanations for her coughing and breathing problems. Her problems could be work related but there were several other potential causes. The plaintiff continued to follow up with the physician over the next two years. Plaintiff filed her complaint on March 25, 1994 immediately after receiving a diagnosis that her lung disease was caused by exposure to chemicals at work. The Indiana Supreme Court held that the plaintiff's complaint had been timely filed. The court explained that the statute of limitations had not been triggered on March 17, 1992. The Degussa court said that "[t]he two-year statute of limitations begins 'to run from the date the plaintiff knew or should have discovered that she suffered an injury or impingement, and that it was caused by the product or act of another.'" Once the plaintiff has discovered facts, which place her on notice of a potential claim, the question is whether the Plaintiff exercised reasonable diligence to discover the tortious act and resulting injury.
744 N.E.2d 407 (Ind. 2001).
Degussa Corp. v. Mullens, 744 N.E.2d 407, 409 (Ind. 2001)
Id.
Id.
Id at 411. This was the date when the plaintiff "merely suspected that work products had something to do with her illness and [her physician] said nothing to confirm, deny, or even strengthen her suspicions."
Id. at 410-11.
A cause of action under the IPLA, accrues when a plaintiff's doctor expressly informs a plaintiff of the probability that her injury was caused by an act or product of another. Events short of a diagnosis may provide notice to a plaintiff of her claim, but "a plaintiff's mere suspicion or speculation that another's product caused the injuries is insufficient to trigger the statute." The question of when the limitations period begins to run is one of fact. The Degussa court said that "circumstances where a physician tells a patient that a product or act is one of several 'possible' causes of an injury present a complex of factually and legally relevant questions about how the physician conveyed the information to the patient and what emphasis the physician placed on the potentially tortious cause over other causes."
Degussa Corp., 744 N.E.2d at 411.
Id. at 411.
In the case of Allied Resin Corp. v. Waltz the Indiana Supreme Court said that judgment as a matter of law is appropriate only where there are no disputed issues of fact. Where the evidence is in conflict, "[t]his fact-sensitive question is appropriate for resolution by a jury with appropriate instruction from the trial court." In Allied Resin, the defendant argued that the plaintiff should have discovered his alleged injury following a 1984 doctors visit. The plaintiff's physician testified that he informed the plaintiff that his symptoms were "possibly caused" by exposure to chemicals. The plaintiff denied that that the physician had made those comments to him. The Indiana Supreme Court held that the evidence relevant to when the plaintiff should have discovered the causal connection was in conflict. They also concluded that lower court's decision to enter judgment on statute of limitations grounds in favor of the defendant was in error. The jury must decide the issue.
See Allied Resin Corp. v. Waltz, 574 N.E.2d 913, 915 (Ind. 1991).
Id at 914
In this case Plaintiff introduced ample evidence to overcome the argument that her claims were time-barred as a matter of law. When viewed in a light favorable to the verdict winner, the evidence was sufficient to permit a jury to conclude that Ms. Hammons neither knew, nor should have reasonably discovered, that Prolift was the cause of her urinary dysfunction, sexual dysfunction, and dyspareunia. Ms. Hammons did not know or suspect that her symptoms were caused by the Prolift mesh rather than the result of several surgical interventions or her age. Knowledge did not occur until August 30, 2012 when Dr. Michael Heit, M.D., performed a series of tests and informed her that Prolift had caused her symptoms. There was sufficient evidence for a jury to conclude that Ms. Hammons complaint had been timely filed. The dispute was properly submitted to and decided by the jury
b. Design Defect Claim
Ethicon claims it was entitled to JNOV on Plaintiff's Design Defect Claim. Plaintiff introduced sufficient evidence to establish every element of her design defect claim under the IPLA. There are facts, which were undisputed at trial. Ms. Hammons was diagnosed with anterior pelvic prolapse, and her treating physician (Dr. Baker) recommended and used the Prolift kit to repair that prolapse. Ethicon designed, manufactured, and sold the Prolift kit. Prolift is a medical device designed for use by physicians for implantation in women for the purposes of repairing anterior, posterior, or total pelvic floor prolapse. Dr. Baker used a standard Prolift kit in the Hammons surgery. The Prolift kit and all its components reached Dr. Baker without substantial alteration. Ms. Hammons suffered personal injuries and sought compensation under the IPLA. These undisputed facts are sufficient to satisfy Indiana Code § 34-20-2-1(1), (2) and (3).
The IPLA imposes liability upon a seller for physical harm caused to the plaintiff by a "product in a defective condition unreasonably dangerous to any user or consumer" under the following circumstances: (1) the user or consumer is in the class of persons that the seller should reasonably foresee as being subject to the harm caused by the defective condition; (2) the seller is engaged in the business of selling the product; and (3) the product is expected to and does reach the user or consumer without substantial alteration in the condition in which the product is sold by the person sought to be held liable under this article. The statute also states that in an action based on a design defect or a failure to provide adequate warnings or instructions regarding the use of the product, the party making the claim must establish that the manufacturer or seller failed to exercise reasonable care under the circumstances in designing the product or in providing the warnings or instructions.
For purposes of a design defect claim the IPLA defines a "defect" as: "a product is in a defective condition if, at the time it is conveyed by the seller to another party, it is in a condition: (1) not contemplated by reasonable persons among those expected users or consumers...; and (2) that will be unreasonably dangerous to the expected user or consumer when used in reasonably expectable ways...." In a failure to warn claim, a product is defective if the seller fails to: (1) properly package or label the product to give reasonable warnings of danger about the product; or (2) give reasonably complete instructions on proper use of the product; when the seller, by exercising reasonable diligence, could have made such warnings or instructions available to the user or consumer."
The IPLA also states that the defendant may raise defenses to product liability claims. In particular it says: "It is a defense to an action under this article . . . that a cause of the physical harm is a modification or alteration of the product made by any person after the product's delivery to the initial user or consumer if the modification or alteration is the proximate cause of physical harm where the modification or alteration is not reasonably expectable to the seller." The defendant has the burden of proof as to these defenses. "The burden of proof of any defense raised in an action under this article . . . is on the party raising the defense." This trial turned on whether the Prolift was in a defective condition under the IPLA and whether that defective condition caused Plaintiff's injuries. Ms. Hammons introduced testimony from four experts, company employees, and consultants, and evidence documenting the development process for Prolift.
Ind. Code §§ 34-20-6-1 and 34-20-6-2.
The Plaintiff's expert Dr. Zipper testified that the Prolift kit was neither safe nor effective. Plaintiff's expert Dr. Anne Weber testified that the risk-benefit profile was, absolutely unacceptable. On the issue of causation, Plaintiff introduced the testimony of Ralph Zipper, M.D. Dr. Zipper reviewed Ms. Hammons's medical history, the records of her treating physicians, and performed a physical examination, all of which he described for the jury. Dr. Zipper testified that the anterior Prolift repair caused prolapse of her posterior organs. He added that Dr. Heit specifically identified the Prolift mesh as the cause of Plaintiff's injuries. The jury had a sufficient basis upon which to conclude that Ethicon failed to exercise reasonable care in designing the Prolift kit and that Prolift was in a defective condition under the IPLA.
N.T., 12/3/15 (P.M.), at 67 (video dep. P-3402, at 23-25, 32, 35, 39); N.T., 12/11/15 (P.M.), at 140 (video dep. P 3408, at 14-15); N.T., 12/8/15 (A.M.), at 26, 85.
N.T., 12/9/15 (P.M.), at 29-163.
Ethicon also argues that it was entitled to INOV because plaintiff failed to offer evidence of a safer alternative design. Proof of alternative safer design is not an element of a product defect claim under Indiana law. The IPLA imposes liability on a manufacturer for physical harm caused a plaintiff by a product in a defective condition unreasonably dangerous to the consumer.
In TRW Vehicle Safety Sys., Inc. v. Moore the Indiana Supreme Court stated: "The statute itself prescribes the applicable standard of care." The Court said that, proof of feasible alternative design is not prescribed as "specific sub-elements of a claim for strict product liability based on design defect." Proof of alternative design is not an "additional or more particular standard of care in product liability actions alleging a design defect." Testimony of an alternative design can be probative evidence as to the issue of the defendant's failure to use reasonable care and can support a reasonable inference of negligent design but is not required.
TRW Vehicle Safety Sys., Inc. v. Moore, 936 N.E.2d 201, 209 (Ind. 2010).
Id. at 209 n.2.
Id. at 209.
Id. at 209-10. The Supreme Court's TRW decision vacated the appellate court opinion of Ford Motor Co. v. Moore, 905 N.E.2d 418, 424-25 (Ind. Ct. App. 2009) vacated by TRW, 936 N.E.2d 201, which had approved the trial court's instruction to the jury that the plaintiff was "required to establish . . . that there existed a feasible, safer, more practicable alternative vehicle design that would have prevented plaintiff's death. . ." and that "the safety benefits of her alternative designs were foreseeably greater than all of the costs of the alternative designs."
Defendant incorrectly argues that proof of an alternative design is a required element of design defect claims. Defendant also seeks a narrow interpretation of the evidence that could be probative of this element. Defendant's interpretation forecloses claims of defective design where plaintiff claims that the product is so dangerous that it should never have produced, or when the product is new without any predecessor in the market. If the Indiana legislature had intended to foreclose such claims, it would have explicitly stated these exceptions in the language of the statute. The IPLA contains no such exceptions. The Indiana courts have articulated no such exceptions.
N.T., 12/14/15 (A.M.), at 87-92.
c. Failure To Warn Claim
Likewise Ethicon was not entitled to JNOV on Plaintiff's failure to warn claim. Ethicon argues that Plaintiff failed to prove her failure to warn claim, as a matter of law, because either the warnings were adequate and Dr. Baker was aware Prolift carried a risk of the injuries she sustained or that he had warned Ms. Hammons of the potential for these complications before surgery.
Under the IPLA, a manufacturer is liable for physical harm caused the plaintiff by a "product in a defective condition unreasonably dangerous to any user or consumer." In a failure to warn claim, a product is defective under the IPLA if the seller fails to "properly package or label the product to give reasonable warnings of danger about the product; or (2) give reasonably complete instructions on proper use of the product; when the seller, by exercising reasonable diligence, could have made such warnings or instructions available to the user or consumer." The plaintiff has the burden to show that the manufacturer "failed to exercise reasonable care under the circumstances. . . in providing the warnings or instructions."
The duty to warn exists because a product manufacturer has superior knowledge of its product. The injured person is helpless to protect himself from a product which is actually defective. Although a manufacturer may not delegate its duty to warn, when sold to a learned intermediary, the duty to warn is limited to warning that intermediary. A manufacturer has no duty to warn where the intermediary actually knows the dangers posed by the product. To determine whether a manufacturer has reasonably relied upon the learned intermediary to satisfy its duty to warn, Indiana courts consider several factors: the product's nature, complexity and associated dangers, the likelihood that the intermediary will communicate warnings to the ultimate consumer, the dangers posed to the ultimate consumer by an inadequate or nonexistent warning, and the feasibility of requiring the manufacturer to directly warn the product's ultimate consumers. In order for the warning to be adequate the product label must make apparent the potentially harmful consequences and the warning should be of such intensity as to cause a reasonable physician to exercise caution commensurate with the potential danger. A warning must be adequate in the manner in which that content is expressed, its factual content, and the method of conveying these expressed facts. The question of whether the manufacturer discharged the duty to warn is for the jury. Under Indiana law, the evidence presented in this case was sufficient for a jury to conclude that the Defendant failed to exercise reasonable care in providing adequate warnings of Prolift's known risk profile and to make apparent Prolift's potential harmful consequences to the teamed intermediary, Dr. Baker.
See: Nat. Gas Odorizing, Inc. v. Downs, 685 N.E.2d 155, 163 (Ind. Ct. App. 1997).
See: Nat. Gas Odorizing, Inc., 685 N.E.2d at 163 & n.10.
See: Nat. Gas Odorizing, Inc., 685 N.E.2d at 164
See: Jarrell v. Monsanto Co., 528 N.E.2d 1158, 1162-63 (Ind. Ct. App. 1988).
d. Jury Instructions Relating to Design Defect and Failure To Warn Claims
Defendant was not entitled to a new trial because of jury instructions relating to the design defect and the failure to warn claims. Ethicon claims several jury instructions were given in error. Charging the jury on a theory of the case is permissible where evidence was introduced to support the party-requested instruction. The trial judge has wide latitude in instructing a jury and may use any particular language, as long as the words sufficiently and fully convey the rules of law applicable to the case.
See: Pollet v. Pub. Commc'ns. Inc., 2013 PA Super 320, 83 A.3d 205 (2013), rev'd 126 A.3d 895 (2015)
Ethicon claims the jury should have been instructed and required to answer a verdict sheet interrogatory on alternative design as an element of the IPLA claim. The current Indiana Model Civil Jury Instructions on product liability omit any reference to alternative design as an element of Plaintiff's burden of proof. Defendant's proposed instruction on alternative design was inconsistent with Indiana law. The Court properly instructed the jury based upon Indiana standard instructions. This court did not err by declining to give an incorrect instruction.
See Ind. Model Civil Jury Instructions 2103 (Product Liability Against Manufacturer — Elements — Burden of Proof); Ind. Model Civil Jury Instructions 2305 (Product Negligence — Elements — Burden of Proof).
Defendant claims that the Court erred in failing to give a separate charge and verdict interrogatory on the issue of substantial alteration. Defendant argues that the jury should have been instructed on an "alteration or modification of product" defense because Dr. Baker cut the Prolift. There was no evidence presented that any alteration or modification was in any way involved in plaintiff's injury. This Court appropriately and comprehensively instructed the jury on proximate causation under Indiana law. The Court gave a general causation instruction that covered the substance of the IPLA's superseding cause instruction:
Ind. Code § 34-20-6-5; Amato, 116 A.3d at 622.
See N.T., 12/18/15, at 35-36.
A person's conduct is legally responsible for causing an injury if the injury would not have occurred without the conduct and the injury was a natural, probable and foreseeable result of the conduct. And that's what we call responsible cause or cause in all these questions that you're going to have about cause. And there can be more than one responsible cause of an injury. Now, sometimes an unrelated event can break the connection between a defendant's negligent action and the injury. If this event was not reasonably foreseeable, it is an intervening cause. When an intervening cause breaks the connection between the defendant's negligent act and a plaintiff's injury, a defendant's negligent act is no longer a responsible cause of that plaintiff's injury.
N.T., 12/18/15, at 35-36.
Defendant claims that the Court refused to instruct the jury on the learned intermediary doctrine, concerning Dr. Baker's knowledge of the complications associated with Prolift. The Court plainly instructed the jury on the learned intermediary doctrine. The Court instructed the jury in relevant part:
And a medical device manufacturer's warnings of the dangers associated with the product are directed to the physician. A medical device manufacturer doesn't have an obligation to tell all the patients everything about the product because it's the doctor in conjunction with the patient who are going to talk about it and the doctor who's going to make recommendations. He's what we call a learned intermediary. But the manufacturer does have an obligation to warn the physician so that the physician knows enough to make the decision and to discuss it with the patient.
You must determine whether the warnings given to the physician were reasonable under the circumstances. A product is defective if the seller fails to properly package or label the product with reasonable warnings about the dangers of the product or fails to give reasonably complete instructions about the proper use of the product. A manufacturer has a duty to warn of hidden dangers. If Ethicon -- if the Defendants -- knew that a surgeon using the product might place the Prolift incorrectly, then they're responsible for any harm which comes from the Prolift having been improperly placed. The Defendant claims that the Plaintiff's doctor knew of the danger of the product. The Plaintiff cannot recover if Defendant proves that the doctor knew of the product's defect or was aware of the danger in the product and, nevertheless, used the product. So was it defective? If you answer "Yes," go to question -- see, now we got that -- if you answer "Yes" to Question 5, proceed to Question 6: Was the defect a cause of harm suffered by Ms. Hammons? A person's conduct is legally responsible for causing an injury if the injury would not have occurred without the conduct and the injury was a natural, probable and foreseeable result of the conduct. And that's what we call responsible cause or cause in all these questions that you're going to have about cause. And there can be more than one responsible cause of an injury.
Now, sometimes an unrelated event can break the connection between a defendant's negligent action and the injury. If this event was not reasonably foreseeable, it is an intervening cause. When an intervening cause breaks the connection between the defendant's negligent act and a plaintiff's injury, a defendant's negligent act is no longer a responsible cause of that plaintiff's injury.
N.T., 12/18/15 at 34-36.
The instruction covered Dr. Baker's knowledge of Prolift's complications. Defendant argues that this court improperly directed the jury to find for Plaintiff if Ethicon knew that a physician might misplace the Prolift. This argument fails under the law and facts of this case. Indiana law requires a manufacturer to articulate warnings that protect all foreseeable consumers from a product's latent dangers. The law provides that an intervening cause, such as product misuse and its attendant risks, will not operate to relieve a manufacturer of liability unless the intervening acts could not have been reasonably foreseen by the manufacturer.
N.T., 12/18/15, at 34-36.
See: Nat. Gas Odorizing, Inc., 685 N.E.2d at 162.
See: Montgomery Ward & Co. v. Gregg, 554 N.E.2d 1145, 1156 (Ind. Ct. App. 1990).
The Court may use any particular language that adequately and fully conveys to the jury the law applicable to the facts of the case. A jury instruction can support a new trial only if the trial court committed a clear abuse of discretion or error of law that controlled the outcome of the case. A charge is adequate unless the issues are not made clear to the jury or the jury was palpably misled by what the trial judge said or unless there is an omission in the charge which amounts to a fundamental error. The charge given to the jury was Complete and accurate in all respects.
See: Schmidt v. Boardman Co., 2008 PA Super 203, 958 A.2d 498, 514 (Pa. Super. 2008).
N.T., 12/3/15 (P.M.), at 67 (video dep. P-3402, at 4-5).
e. Spoliation
Defendant argues that it was entitled to a new trial because Ethicon's nonproduction and destruction of documents was presented for jury consideration. Defendant claims error in allowing the jury to hear the deposition of James Mittenthal, Ethicon's corporate designee regarding document collection and preservation. The Court properly allowed testimony concerning defendant's failure to preserve and produce documents.
N.T. 12/3/15 (A.M.), at 16 (video deposition of James Mittenthal, P-3411)
Despite preservation notices concerning pelvic mesh litigation, thousands of documents were destroyed and could not be produced to plaintiff. Included, in this destruction were documents created by employees who were significantly involved in the development, testing, and marketing of Prolift. The custodial file of Dr. Owens, the world wide medical director of defendants Women's Health and Urology Program during the development of Prolift, the individual responsible for managing and improving premarket activities, had been destroyed. The Court allowed plaintiff to present evidence of the unavailability of documentation and also allowed defendant to present evidence concerning the reasons for the destruction, which they claimed, was appropriate and inadvertent.
N.T. 12/3/15 (A.M.), at 16 (video deposition of James Mittenthal, P-3411 at 16-19).
Defendant contends that admission of Mr. Mittehnal's deposition testimony amounted to a sanction for spoliation. The decision to allow this evidence before the jury so that counsel could argue or explain the failure to produce documents from these files at trial is not a discovery sanction. Plaintiff specifically asked for an adverse jury instruction. This was rejected by the court.
A jury is entitled to know what documentation was and was not available to counsel in preparing and presenting their case. Given this information the jury without any need for instruction from the court could understand why other documents had not been presented to them draw whatever conclusions were appropriate from this evidence.
f. Punitive Damages
Defendant claims it was entitled to JNOV on punitive damages. The Parties stipulated that Punitive Damages in this case would be governed by New Jersey Law. To recover for punitive damages in New Jersey a plaintiff must prove by clear and convincing evidence "that the harm suffered was the result of the defendant's acts or omissions, and such acts or omissions were actuated by actual malice or accompanied by a wanton and willful disregard of persons who foreseeably might be harmed by those acts or omissions." "Wanton and willful disregard" is defined as "a deliberate act or omission with knowledge of a high degree of probability of harm to another and reckless indifference to the consequences of such act or omission."
N.J.S.A. § 2A:15-5.12a
Id.
In a products liability design defect claims, punitive damages can only be awarded where the jury finds the manufacturer wantonly disregarded a high probability that injury would occur once the defect manifested itself in the situation that the plaintiff encountered. In failure to warn claims, plaintiff must show that a reasonable person with defendants' knowledge about the product would consider sales of the product to be a serious risk. Defendants claim that the evidence was insufficient for punitive liability under these standards.
See: Zakrocki v. Ford Motor Co., 2009 N.J. Super. Unpub. LEXIS 2054, 2009 WL 2243986 (N.J. Super. App. Div. July 29, 2009).
See: DeGennaro v. Rally Mfg. Inc., 2011 U.S. Dist. LEXIS 126568, 2011 WL 5248153, at *4 (D.N.J. Nov. 2, 2011) (citing Smith v. Whitaker, 160 N.J. 221, 734 A.2d 243, 254 (N.J. 1999)).
Plaintiff's expert Anne Weber, M.D. testified that prior to the launch of Prolift, clinical studies showed that the Prolift had a high rate of failure, that prolapse recurrence occurred frequently and shortly after implantation. In his videotaped deposition which was played for the jury, Axel Arnaud, Ethicon's European Medical Director, testified the studies known to Ethicon demonstrated that nearly 20% of women would suffer from painful mesh shrinkage, leading to pain and dyspareunia, and approximately the same percentage would suffer erosion of the mesh within one year of the Prolift's implantation. Ethicon's corporate designee and medical affairs director, Piet Hinoul, M.D., admitted in his deposition that was played to the jury that defendants knew that there could be significant retraction of the mesh leading to pain, recurrence, erosion, dyspareunia, and the need for subsequent surgeries. Defendant knew that the risk of erosion was very common for all meshes, including the Prolift mesh. Ethicon also knew that human tissue would continue to react to the Prolift's mesh for decades after implantation. Despite this knowledge defendant made no effort to study the long-term consequences of the product which would permanently remain in women. Defendant knew by 2006 that "returning to surgery to deal with a bad Prolift" would be a "disaster," but neither studied nor developed a way to remove the Prolift in women who suffered complications. Evidence was presented that Ethicon rejected the use of an alternative mesh because it would have delayed the launch of the Prolift impacting profitability. The evidence presented at trial was sufficient to permit a jury to decide that defendant knew there was a likelihood of serious harm from the product.
See, e.g., N.T., 12/8/15 (A.M.), at 23-27, 85 (testimony of Anne Weber, M.D.).
N.T., 12/14/15 (A.M.), at 53 (video deposition of Axel Arnaud, M.D., P-3401 at 6, 14).
N.T., 12/10/15 (A.M.), at 81 (video deposition of Piet Hinoul, M.D., P- 3404 at 3-4).
N.T., 12/10/15 (A.M.), at 81 (video deposition of Axel Arnaud, M.D., P-3401 at 3-4).
N.T., 12/10/15 (A.M.), at 81 (video deposition of Net Hinoul, M.D., P-3404 at 4).
Id. (video dep. P-3404 at 11),
Exhibit P-0750.
Id. (P-3407 at 12).
Defendant claims that it is entitled to remittitur of the compensatory and punitive damages awards. The grant of remittitur is a matter within the sound discretion of the trial court. Pennsylvania law recognizes no certain formula for the measure of non-economic damages. Courts should not lightly disturb a jury's verdiet.
Botek v. Mine Safety Appliance Corp., 531 Pa. 160, 611 A.2d 1174, 1177 (Pa. 1992).
Nelson v. Airco Welders Supply, 2014 PA Super 286, 107 A.3d 146, 161 (Pa. Super. 2014).
Frank Burns, Inc. v. Interdigital Commc'ns Corp., 704 A.2d 678, 682 (Pa. Super. 1997).
Several factors should be considered when determining whether a verdict is excessive: the severity of the injury; whether the injury is manifested by objective physical evidence or whether it is only revealed by the subjective testimony; whether the injury is permanent; whether the plaintiff can continue with his or her employment; the size of out-of-pocket expenses.
Harding v. Consolidated Rail Corp., 423 Pa. Super. 208, 620 A.2d 1185, 1193 (Pa. Super. 1993).
The evidence presented clearly supports the verdict. The testimony demonstrated the surgical mesh used in Prolift had initially been developed for the repair of hernias and insufficient research was performed for its use in the pelvic environment. Significantly different plaintiff's experts testified that clinical studies prior to the release of the Prolift showed a high rate of failure and prolapse recurrence following implantation. Plaintiff's experts further explained that studies showed Prolift carried risks of injury to pelvic organs, dyspareunia and urinary and sexual dysfunction which were the result of the large amount of non-absorbable foreign body material implanted in the vagina and the small size of the pores in the mesh weave.
Plaintiff's experts further criticized the product and defendant because no process for excising the mesh had ever been developed prior to release. Although defendant knew that there was a significant risk of a natural inflammatory reaction to the mesh and scar tissue formation which could cause the mesh to become rigid or bunch up, eroding layers of tissue insufficient thought was given to the possibility that the mesh might need to be removed. Defendant's own research physicians developing the Prolift were concerned that the proposed mesh would cause these precise problems. Clinical results also supported these concerns.
Plaintiff's expert urogynecologist Dr. Zipper extensively described Ms. Hammons' injuries and prognosis. He testified that Ms. Hammons continual, persistent and permanent problems were caused when the Prolift contracted creating persistent inflammation. In his opinion plaintiff suffered a permanent loss of bladder capacity causing feelings of urgencies and frequency of urination and her pain during intercourse was unfortunately a permanent condition without any cure. She continues 10 suffer from pain, incontinence, and sexual dysfunction.
Plaintiff's expert Elliott, testified that the Prolift kit was defective because it contained a foreign plastic material containing non-absorbable propylene. In his opinion this was an improper product for use in these surgical kits and the pores were too small and the process of implementation caused those small pores to collapse. Dr. Elliott explained that the small pores and potential collapse made natural tissue growth difficult resulting in scar tissue which became rigid and contracted. This caused a painful pull on the pelvic muscles and a chronic inflammatory response. He also criticized the fact that the design prohibited any successful excision in the event that become necessary. Dr. Elliott and plaintiff's expert Dr. Weber concluded that defendant's clinical studies themselves demonstrated a higher than 20% rate of recurring prolapse which failed defendant's owned predefined criteria for the study. Finally, plaintiff's experts described surgical and non-surgical alternatives to mesh implantation, which would have been safe and effective for treating Ms. Hammons condition. Internal corporate documents offered into evidence described unacceptable rates of complication and suggested defendant internally knew that the risks may have outweighed the benefits.
Given the persistent pain and inability to have sex which Ms. Hammons has suffered, the effect on her relationship with her boyfriend, the effect on her self-image, and the embarrassment and humiliation she has suffered together with the multiple surgeries the evidence clearly supported the compensatory and punitive verdicts of the jury. The evidence presented concerning the issues in development including the questions specifically raised by defendant's own investigator supported the propriety of the punitive damage award.
Issue Appealed By Plaintiff
a. Plaintiff's Cross-Appeal of Delay Damages Award.
Plaintiff claims the court erred in not awarding delay damages on the punitive damages verdict. In the Colodonato v. Consol. Rail Corp case the Supreme Court of Pennsylvania held that delay damages under Rule 238 are not applicable to punitive damages. The plain language of Rule 238(a)(1) states: "... damages for delay shall be added to the amount of compensatory damages awarded..." Punitive damages are intended to punish and are irrelevant to the concern underlying Rule 238. Delay damages were properly awarded only on the compensatory damages portion of the verdict.
Colodonato v. Consol. Rail Corp., 504 Pa. 80, 470 A.2d 475 (1983)
Rule 238(a)(1)
For the reasons set forth above, Judgment of the Court was proper.
DATE
9/30/16
BY THE COURT:
/s/ Mark I. Bernstein
Mark I. Bernstein, J.