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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Defendants’ Motion for Summary Judgment in Adams Duragesic Fentanyl Patch Lawsuit

Posted in Duragesic / Fentanyl

In virtually every fentanyl lawsuit, the lawyers for the defendant are going to file what’s called a Motion for Summary Judgment with the court.  A Motion for Summary Judgment asks the court to decide that the case should not go forward to a jury, but should instead be “thrown out.”  Because any fentanyl lawyer or Duragesic lawyer who represents an injured person will have to respond to one of these, I posted this one. 

I.INTRODUCTION

The independent medical examiner in this case determined that James Adams (“Adams”) died of a heart attack and also suffered from what is known as a “fatty liver.” These two conditions are unrelated to either the product at issue in this case, Duragesic, or the drug it delivers, fentanyl. Merely because Adams was wearing a Duragesic patch at the time of his heart attack, Adams's wife, Plaintiff Linda Adams, filed a wrongful death product liability lawsuit against Defendants Johnson & Johnson (“J&J“), ALZA Corporation (“ALZA “), Janssen, L.P. (now known as Ortho-McNeil-Janssen Pharmaceuticals, Inc.) (“OMJPI”), and Hook-SupeRx, L.L.C. (“Hook-SupeRx”) (collectively referred to as “Defendants”).[FN1] ALZA and OMJPI manufacture and distribute Duragesic, a prescription pain patch that delivers fentanyl transdermally through the skin of the person to whom it is applied. Hook-SupeRx is the owner and operator of the CVS pharmacy that filled the prescription at issue.

    FN1. CVS Pharmacy #6386, CVS 6386 IL, L.L.C., Hook-SupeRx, Inc., and CVS Corporation were also initially named as defendants. The latter three defendants were never served and CVS Pharmacy #6386 is not a legal entity capable of being sued. (Notice of Removal, ¶4, at 2.)

The two counts of Plaintiffs complaint raise negligence and strict liability product liability claims which, under Illinois law, both require expert testimony of a defect. Defendants are entitled to judgment as a matter of law on both counts because Plaintiff presents no testimony, expert or otherwise, that the patches worn by Adams were defective in any way. Without expert testimony of a defect, Plaintiff cannot avoid summary judgment by relying on circumstantial evidence to establish a non-specific defect because there is a reasonable secondary cause for this injury, there is no “smoking gun” evidence of a defect, and any alleged defect is outside the common knowledge of jurors. Shawgo v. General Motors Corp., 2007 WL 2301315 at * 6 (S.D.I1, August 09, 2007, Judge Murphy). (Ex. 1.)

In addition to the lack of expert testimony, the negligence claims found in Count I fail as a matter of law because Plaintiff has no evidence that Defendants were negligent in the manufacture, design, sale, or labeling of the Duragesic(R) patches used by Adams. Defendants are also entitled to summary judgment on the strict product liability claims found in Count II because Plaintiff has not identified either a manufacturing expert, a design expert, or a warnings expert to support these claims. Specifically, Plaintiff's manufacturing defect claims fail by virtue of the absence of any evidence related to the manufacture of the patches worn by Adams. Her design defect claim suffers from a lack of evidence that an alternate design would have prevented Adams's death. Moreover, her design defect claim is barred by Illinois's adoption of comment k to Restatement §402A regarding “unavoidably unsafe” products like Duragesic(R). Defendants are further entitled to summary judgment on the failure-to-warn claims because the prescribing physician was sufficiently apprised and adequately warned of the risks of Duragesic(R). Additionally, Plaintiff's state tort law claims based on design defect and failure to warn are preempted by federal law. Finally, the strict product liability count against Hook-SupeRx should be dismissed as a matter of law because it has, pursuant to 735 ILCS 5/2-621, certified the correct “identity of the manufacturer of the product which allegedly caused the injury.”

Thus, for these reasons, this Court should grant summary judgment in Defendants' favor.

II. STATEMENT OF FACTS

A. Decedent's Medical History

Adams's medical history is very limited as he never went to doctors prior to 2005. (See Ex. 2, Plaintiff Dep., at 29-31.) His family medical history was significant for diabetes, cancer, and heart disease. (Ex. 3, Tri-State Orthopaedic Records, at JEA:00488; Ex. 4, Willow Creek Pain Center Records, at JEA:00470.) Adams related to one of his doctors that both of his parents died of heart attacks. (See Ex. 4, Willow Creek Records, at JEA:00470.) Three of his seven siblings have died of cancer and two others have cancer and heart problems. (Ex. 2 at 34-36.)

On January 21, 2005, while working as a farmhand and mechanic at Hasewinkle Farms in Sumner, Illinois, Adams was pushed up against and over a fence by a cow and landed on his back. (Ex. 2 at 25 & 40.) After the accident, Adams treated with several doctors for continuing complaints of uncontrollable back pain, as well as shoulder and knee pain. (Ex. 2 at 40 & 44-45; Ex. 5, Dr. Grimm Dep., at 7-8.) Treatment with these doctors provided little relief to Adams as he had continuing complaints of pain. (Ex. 2 at 42-46.) While it was initially believed that Adams had fractured his thoracic spine, a subsequent MRI showed no observable fractures in his spine or vertebrae. (Ex. 5 at 9-10.)

On February 23, 2005, Adams first treated with Dr. John Grimm, an orthopedic surgeon in Evansville, Indiana, after other doctors could not determine why Adams was continuing to have his complained levels of pain. (Ex. 5 at 8-11.) In March and April 2005, Dr. Grimm treated Adams with various medications, including Avinza, a long-lasting morphine pill, for back pain and spasms and an inability to sleep at night. (Ex. 5 at 17.) Dr. Grimm found Adams's complaints of pain to be “pretty excessive for what was wrong with him.” (Ex. 5 at 41.)

On April 25, 2005, Adams returned to Dr. Grimm complaining that his back pain had recently become markedly worse. (Ex. 5 at 18.) During this office visit, Dr. Grimm decided to switch Adams from Avinza to Duragesic(R) 75 mcg/hr patches (one patch every seventy-two hours) for back pain and wrote a prescription for five patches. (Ex. 5 at 19.) Plaintiff filled her husband's Duragesic(R) prescription that same day at CVS Pharmacy No. 6386 in Lawrenceville, Illinois. (Ex. 2 at 57; Ex. 6, CVS No. 6386 Records, at Hook/J.Adams/0004.) Later that day, Plaintiff then placed the first Duragesic(R) patch on Adams's left side of his lower back. (Ex. 2 at 57.) On April 28, 2005, Plaintiff then removed the first patch and applied the second one to her husband's left shoulder blade. (Ex. 2 at 58 & 63-64.)

B. Circumstances Surrounding Decedent's Death

On the morning of April 29, 2005, Plaintiff woke up and asked her husband -who was apparently sleeping – he wanted to sleep more. (Ex. 2 at 66.) Plaintiff believed that he mumbled “yes” and she left the room. (Ex. 2 at 66.) She returned to the bedroom sometime later that morning and found Adams unresponsive and his face and lips were blue. (Ex. 2 at 66.) Emergency personnel eventually arrived at the scene and found Adams cyanotic, pulseless, and breathless and his cardiac rhythm was asystole. (Ex. 7, Lawrence County Memorial Hospital Records, at JEA:00371-00372.) Adams was transported to the local hospital where his cardiac rhythm remained asystole and he was pronounced dead at approximately 11:30 a.m. (Ex. 7 at JEA:00372.)

An autopsy was performed later that afternoon in the hospital morgue by Dr. James Jacobi. (Ex. 8, Autopsy Report, at JEA:00595.) He determined the cause of death to be cardiac arrhythmia secondary to focal severe coronary artery atherosclerosis. (Ex. 9, Jacobi Dep., at 15-16.) Dr. Jacobi found 70% occlusion atherosclerotic plaque of Adams's circumflex coronary artery. (Ex. 9 at 15-16.) During the autopsy, Dr. Jacobi collected loose blood running from the neck veins after the body was opened and sent a sample to AIT Laboratories in Indianapolis, Indiana for toxicology testing. (Ex. 9 at 8-9 & 12-13.) The lab reported 12.2 ng/ml of fentanyl. (Ex. 10, Dr. Evans Dep., at 25.) Based on this post-mortem blood level, Dr. Jacobi concluded that “fentanyl toxicity” was a contributory factor to the cause of death. (Ex 8, Autopsy Report, at JEA:00599.) At deposition, however, Jacobi clarified his opinion, testifying that Adams's post-mortem fentanyl level may not have been toxic and likely played no role in his death. (Ex. 9 at 19-21.) He testified that Adams also had hepatic steatosis (fatty liver), which could have also led to the cardiac arrhythmia with or without coronary artery disease. (Ex. 9 at 17-19.) According to Dr. Jacobi, Adams had a “double whammy” of coronary artery disease and a fatty liver. (Ex. 9 at 19.)

C. The Duragesic(R) Patch

The product at issue in this action is Duragesic(R), a prescription pain patch that delivers medication transdermally through the skin. Fentanyl, the active ingredient in Duragesic(R), is an opioid analgesic that is contained in a gel form inside each patch. Duragesic(R) is indicated for patients requiring continuous treatment for moderate to severe chronic pain that cannot be managed by lesser means. The relevant package insert states that Duragesic(R) is to be used for 72 hours and then replaced with a new patch. (Ex. 11, Package Insert.)

Duragesic(R) is available in 12.5, 25, 50, 75, and 100 mcg/hr dosage strengths which measure the amount of fentanyl delivered to the patient per hour. In February 2004, Janssen voluntarily recalled one lot (lot number 0327192) of 75 mcg/hr Duragesic(R) patches when it was learned that a small percentage of the product from this particular lot exhibited improper sealing. (Ex. 12, February 17, 2004 Recall Notice, at 1.)[FN2] This improper sealing was due to a “fold-over” of backing film material along one edge of the patch. (Ex. 12.) In early April 2004, this voluntary recall was expanded to include four additional lots of 75 mcg/hr Duragesic(R) patches (lot numbers 0327193, 0327294, 0327295, and 0330362). (Ex. 13, April 7, 2004 letter to Pharmacists.)

    FN2. The estimated number was initially estimated to be no more than five percent of the patches from this lot and later determined to be less than one percent. (Ex. 12.)

Despite the fact that Adams died more than one year after the voluntary recalls, Defendants anticipate that Plaintiff may attempt to assert that the patch at issue came from one of these recalled lots. (Plaintiff's Complaint, Doc. No. 2, Counts I & II, at 118.) However, the only evidence in this case on this issue the deposition testimony of David Chullino refutes this point. (Ex. 14, See Chullino Dep., at 81-82.) According to Mr. Chullino, an ALZA engineer, the patches used by Adams were likely manufactured well after the recall and after ALZA implemented a series of corrective actions designed to prevent the improper sealing of patches during manufacturing. (Ex. 14 at 81-82 & 84.) Plaintiff has no evidence to the contrary. Additionally, Plaintiff has no unused patches, or any other product packaging from the April 2005 prescription, and has not identified the lot number of the patch Adams was using at the time of his death. (See Ex. 15, Plaintiff's Answer to Interrogatory No. 9; Ex. 16, Response to Request for Production No. 19; Ex. 2 Plaintiff Dep., at 68-71.)[FN3] Plaintiff, therefore, has no evidence whatsoever that the patch at issue came from one of the recalled lots.

    FN3. Plaintiff testified that she gave the box containing the remaining Duragesic(R) patches to emergency personnel and the hospital later told her that the patches and product packaging were destroyed. (Ex. 2 at 68-69.)

It is undisputed that Plaintiff has no evidence that the patch at issue was defective. It was not retained by Dr. Jacobi after the autopsy. (Ex. 9 at 22.) Most importantly, there has been testimony from both Plaintiff and Dr. Jacobi that they did not observe any defects in the patch at issue or any of the remaining patches from the April 2005 prescription. (Ex. 2 at 64.; Ex. 9 at 24-25.) Plaintiff did not observe a leaking patch, nor did she ever see a stain from fentanyl gel on her husband's clothes. (Ex. 2 at 64.) When Dr. Jacobi removed the patch from Adams's body during the autopsy it did not look unusual or distorted. (Ex. 9 at 24-25.) Plaintiff has no evidence rebutting these eyewitness observations of the patch at issue and has no other evidence whatsoever that this patch was defective in any way.
III. LEGAL ARGUMENT
A. Summary Judgment Standard

Summary judgment is proper if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed.R.Civ.P. 56(c); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). Once a party properly supports a motion for summary judgment, the nonmoving party must demonstrate a genuine issue of material fact. Mere “speculation or conjecture” will not defeat a summary judgment motion. McCoy v. Harrison, 341 F.3d 600, 604 (7th Cir. 2003). “The nonmoving party must offer something more than a scintilla of evidence to overcome summary judgment, and must do more than simply show that there is some metaphysical doubt as to the material facts.” Roger Whitmore Auto. Services, Inc. v. Lake County, Illinois, 424 F.3d 659, 667 (7th Cir. 2005). If the nonmoving party fails to meet this burden, the moving party is entitled to judgment as a matter of law. Lewis v. Holsum of Fort Wayne, Inc., 278 F.3d 706, 709 (7th Cir. 2002).
B.Because Plaintiff Presents No Evidence of Product Defect – Expert or Otherwise – She Cannot Prove Either Her Negligence or Strict Liability Based Product Liability Claims

Plaintiff's complaint raises product liability claims based on strict liability and negligence. Under either a negligence or strict liability theory, there must be proof both that the product is defective and that the defect caused the plaintiff's injury. American Family Ins. Co. v. Village Pontiac GMC, Inc., 585 N.E.2d 1115, 1120 (1992) (liability under either strict liability or negligence is dependent upon condition of the product); Baltus v. Weaver Division of Kidde & Co., 557 N.E.2d 580, 585 (1990).

Under Illinois law, a product defect cannot be inferred from the fact of injury. Brown v. SmithKline Beecham Corp., 2008 WL 205410, at *4 (N.D. III. 2008). Ralston v. Casanova, 473 N.E.2d 444, 451(111. App. Ct. 1984) (plaintiffs testimony that he was injured in an accident while wearing his seat belt was insufficient by itself to establish that the seat belt was defective). Therefore, Plaintiff must establish through evidence, and not mere inference, that the Duragesic(R) patch worn by Adams at the time of his death was defective. Swiatlowski v. Werner Co., 2006 WL 644484, at *4 (N.D. III. 2006).

Further, because product liability claims often involve specialized knowledge or expertise, proof of defect must be by expert testimony. Ruane v. Amore, 677 N.E.2d 1369, 1377 (1997) (expert testimony is necessary to establish defect when nature of defect is beyond jury's understanding). Pharmaceutical product liability cases, in particular, require expert testimony because the product is sufficiently complex to be beyond a jury's understanding. Lawson v. G.D. Searle & Co., 356 N.E.2d 779 (1976). A plaintiff's failure to support product liability and negligence claims with expert testimony when that testimony is required properly subjects the plaintiff's claims to summary judgment. Baltus, 557 N.E.2d at 591; Ruane, 677 N.E.2d at 1378.
1. Plaintiff has produced no expert testimony that any of Adams's Duragesic(R) patches were defective.

Plaintiff has produced no expert testimony that the Duragesic(R) patches worn by Adams were defective. Her two experts, Dr. Kaufman and Dr. Leikin, are a pathologist and a toxicologist respectively. While these two experts claim that Dr. Jacobi was wrong in his cause of death determination, their testimony should be limited to their stated area of expertise. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 589 (1993).[FN4] Neither expert is qualified to testify as to the normal functioning of a complex product like a transdermal pain patch. Further, it is undisputed that they have absolutely no expertise regarding the design, manufacture, or labeling of Duragesic(R) patches and that neither expert saw the patch worn by Adams. Any testimony by these experts as to the normal functioning of Adams's patches is well beyond their expertise as a pathologist and toxicologist and would be nothing more than a stack of inferences.

    FN4. The depositions of Plaintiffs' experts occurred on February 13, 2009. Defendants will be moving to limit Plaintiffs' expert testimony under Daubert.

Moreover, aside from the lack of expert testimony of defect, Plaintiff has not submitted any evidence of a defect. The only people who observed the patch worn by Adams are Plaintiff and the independent medical examiner, Dr. Jacobi. In his deposition, Dr. Jacobi stated that there appeared to be no abnormalities with the patch when he removed it from Adams. (Ex. 9 at 24-25.) Dr. Jacobi testified that the patch he removed from Adams's body during the autopsy did not look unusual or distorted in any way. (Ex. 9 at 24-25.) Plaintiff did not observe a leaking patch, nor did she see ever see a stain from fentanyl gel on her husband's clothes. (Ex. 2 at 64.) Finally, Plaintiff has not produced any expert testimony as to the condition of the patches worn by Adams. As a result, the evidence is undisputed that no defect was present in Adams' patch.

Plaintiff cannot avoid the requirement of submitting expert evidence by merely pointing to the postmortem fentanyl level of 12.2 ng/mL and claiming that it is evidence of a defect. Such an argument would be nothing more than a pyramid of inferences. Indeed, in order for the post-mortem fentanyl level of 12.2 ng/mL to be used as evidence of a defect, one would have to first infer the unknown antemortem fentanyl level from the known postmortem level. Then a defect would have to be inferred from this unknown level. This speculation is improper. As the independent toxicologist, Dr. Michael Evans, warned, a postmortem level cannot be used to “back-calculate what the level was at the time of life.” (Ex. 10 at 46).

Defendants expect Plaintiff to cite Tweedy v. Wright Ford Sales, Inc., 357 N.E.2d 449 (1976), and argue that, under Illinois law, circumstantial evidence can be used to establish a non-specific defect. Tweedy applies, however, only where there is no reasonable secondary cause of the injury. Parker v. Freightliner Corp., 940 F.2d 1019, 1026 (7th Cir. 1991). Once the defendant presents evidence as to reasonable secondary causes, a plaintiff will not avoid summary judgment unless she demonstrates that there is a disputed issue of material fact with respect to the existence of the secondary cause. Id. Further, since Plaintiff is using circumstantial evidence, she cannot negate other reasonable secondary causes unless her evidence “justifies an inference of probability [of defect] as distinguished from mere possibility.” Id. at 1027, quoting Varady v. Guardian Co., 506 N.E.2d 708, 711 (Ill.App.Ct.1987).

This Court recently refused to apply Tweedy in light of a reasonable secondary cause for the injury. Shawgo v. General Motors Corp., 2007 WL 2301315 at *6 (S.D.I1l., August 9, 2007). (Ex. 1.) In Shawgo, the plaintiff alleged a seat belt was defective but failed to support that claim with any expert testimony or direct evidence of a defect. This Court granted summary judgment and refused to apply Tweedy stating:

In this case, as GM points out, there are reasonable secondary causes for why Shawgo was not restrained by the belt, including her admission to an emergency room nurse that she was not wearing it.

Id. Much like Shawgo, this case contains evidence of a reasonable secondary cause for Adams's death-the independent medical examiner concluded that Adams died from a heart attack as opposed to a fentanyl overdose. (Ex. 9 at 15-16.) The Shawgo opinion went on to explain that expert testimony is needed where there is no “smoking gun.”

In this case, there is nothing, without expert testimony, to explain to a jury that Shawgo was not restrained by the seat belt because of a defect in the belt. In other words, there is no smoking gun such as a jammed brake or a melted vaporizer.

Id. Again, like Shawgo, this case presents no smoking gun of defect. The only two persons who actually observed Adams's patch, Plaintiff and Dr. Jacobi, testified that they did not observe any defects in the patch or observe any evidence of a leaking patch. (Ex. 2 at 64.; Ex. 9 at 24-25.) Finally, this Court's insistence in Shawgo that expert testimony establish a defect in cases dealing with a product that is “beyond the common knowledge of the average juror” is certainly appropriate in this case where the product is a transdermal patch.
2. Plaintiff cannot prove that it was a defective patch that caused an alleged fentanyl overdose.

As part of her prima facie case, Plaintiff must have evidence, not only that Adams's patches were defective, but that such a defect in one of his Duragesic(R) patches caused his death. This causation-in-fact requirement “is applicable to claims premised upon allegations of negligence, strict product liability, and willful and wanton misconduct.” Lewis v. Lead Industries Ass'n, Inc., 793 N.E.2d 869, 874-75 (Ill. App. Ct. 2003) (citations omitted). Further, proof of proximate cause requires expert testimony in product liability cases. See Brown v. SmithKline Beecham Corp., 2008 WL 205410, at *5 (N.D. Ill. Jan. 18, 2008) (granting summary judgment where the plaintiff lacked expert testimony that pharmaceutical product caused decedent's stroke); Grant v. Chemrex, Inc., 1997 WL 223071, at *12 (N.D. Ill. Apr. 28, 1997) (granting summary judgment where the plaintiff lacked expert testimony on proximate cause).

James Adams died of a cardiac arrhythmia -not a fentanyl overdose. Dr. Jacobi found 70% occlusion of Adams's circumflex coronary artery by atherosclerotic plaque. (Ex. 9 at 15-16.) He testified further that Adams also had hepatic steatosis (fatty liver), which could have also led to the cardiac arrhythmia with or without coronary artery disease. (Ex. 9 at 17-19.) According to Dr. Jacobi, Adams had a “double whammy” of both coronary artery disease and a fatty liver. (Ex. 9 at 19.) Even though Plaintiff counters this evidence with her own experts' claim that Adams died from a fentanyl overdose, neither Dr. Kaufman or Dr. Leikin tie this alleged overdose to a particular defect in the patches worn by Adams. Thus, Plaintiff's claims fail on causation as well defect.
C. Plaintiff Cannot Satisfy Her Burden to Present Evidence on the Remaining Elements of Either a Negligence or Strict Liability Claim.
1. Defendants are entitled to judgment as a matter of law on Plaintiff's negligence claim.

Count I alleges Defendants were negligent. To prevail on a negligence claim, Plaintiff must prove duty, breach of duty, and an injury to the plaintiff proximately caused by the breach. United States Fidelity & Guaranty Co. v. State Farm Mutual Insurance Co., 504 N.E.2d 123, 125 (1987). Plaintiff has no such evidence of negligence. She has not presented any evidence or expert opinion establishing that Defendants were negligent in the design, manufacture, or labeling of the Duragesic(R) patches worn by Adams. Plaintiff has also not produced any evidence of Hook-SupeRx's negligence as to the sale of Duragesic(R) to Adams. The total lack of proof of any negligence by any of the defendants subjects Count I to summary judgment. *
2. Defendants are entitled to judgment as a matter of law on Plaintiffs strict liability claim.

The claims in Count II seek damages under a theory of strict products liability. Under Illinois law, to prevail on a product liability claim based on strict liability, a plaintiff must prove that (1) the injury or damage resulted from a condition of the product; (2) the condition was unreasonably dangerous; and (3) the condition existed at the time the product left the defendant's control. Hunt v. Blasius, 384 N.E.2d 368, 372 (1978), citing Suvada v. White Motor Co., 210 N.E.2d 182, 188 (1965). A product can be unreasonably dangerous because of a defect in the product's design, manufacture, or in its warnings. Lamkin v. Towner, 563 N.E.2d 449, 457 (1990). In paragraph 21 of the complaint, Plaintiff throws out a number of possible ways in which she claims the Duragesic(R) patches worn by Adams were “unreasonably dangerous.” All of these claims can be grouped in three theories of recovery under Illinois product liability law: manufacturing defect, design defect, or failure to warn.
a. Defendants are entitled to judgment as a matter of law on Plaintiff's manufacturing defect claim.

In Blue v. Environmental Engineering, Inc., 828 N.E.2d 1128, 1137 (2005), the Illinois Supreme Court noted that a manufacturing defect occurs “in only a small percentage of units in a product line” when the units fail to conform to the intended design. Plaintiff has no evidence that the patches worn by Adams failed to conform to the intended design. Nor does Plaintiff present any expert testimony regarding the process for manufacturing Duragesic(R). See Fulton v. Theradyne Corp., 2007 WL 772953, at *5 (N.D. Ill. Mar. 12, 2007) (requiring expert testimony in design and manufacturing defect case involving healthcare device). Plaintiff cannot cite the 2004 Duragesic(R) recall as evidence of a manufacturing defect because the evidence in this case indicates that Adams's patches were not part of this recall. (Ex. 14 at 81-82.) In fact, the only evidence developed on this point indicates that Adams's patches were made after the post-recall improvements to the Duragesic(R) manufacturing process. (Ex. 14 at 81-82.)
b. Defendants are entitled to judgment as a matter of law on Plaintiff's design defect claim.

While short on substance or specifics, Plaintiff's design defect claims sound in both risk/benefit and consumer expectation theories. Plaintiff's complaint alleges that the risks of Duragesice exceeded the benefit of the design or that the risks were more dangerous than an ordinary consumer would expect. (Doc. No. 2 at ¶ 22.) As an initial matter, Plaintiff cannot apply the consumer expectation test to her design defect claim. To prove her strict liability claim premised on design defect, the appropriate test is the risk/utility test, not the “consumer expectation” test Plaintiff suggests. See Mikolajczyk etc. v. Ford Motor Co., et al., —.E.2d —, 2008 WL 4603565 (Ill.). According to the Illinois Supreme Court's recent decision in Mikolajczyk, the “consumer expectation” test (which merely asks what an ordinary consumer purchasing the product at issue would expect about the product and its safety) is subsumed by the risk/utility test (which consists of a broad range of factors' including “consumer expectation”). Id. Moreover, where, as here, the product at issue is a prescription drug, the ordinary “consumer expectation” does not apply even within the context of the risk/utility test, because the ordinary consumer is not likely to have sufficient knowledge about the biological mechanisms of a particular drug to form an independent expectation about its safety. At a minimum, the “consumer expectation” prong of the risk/utility test should be tailored to reflect the role of the physician in the prescribing decision, particularly given Illinois's adoption of the learned intermediary doctrine. See, section III(C)2 (c) infra.

More importantly, any design defect claim under either theory is barred under comment k of section 402A of the Restatement (Second) of Torts. “Illinois has long applied the concept of strict tort liability set out in section 402A of the Restatement (Second) of Torts (1965) to products liability cases.” Sorce v. Naperville Jeep Eagle, Inc., 722 N.E.2d 227, 237 (Ill. App. Ct. 1999). Comment k to that section states, “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs…. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.” Restatement (Second) of Torts § 402A, comment k (1965).

Illinois has adopted comment k as it applies to some prescription drugs: “Many prescription drugs are unavoidably unsafe products. Such a product is deemed to be unreasonably dangerous, subjecting the manufacturer or seller to liability, only if not manufactured properly or not accompanied by appropriate directions and warnings.” Leesley v. West, 518 N.E.2d 758, 761 (Ill. App. Ct. 1988) (internal citations omitted); see also Glassman v. Wyeth Laboratories, Inc., 606 N.E.2d 338, 341-42 (Ill. App. Ct. 1992). Thus, prescription drugs deemed to be “unavoidably unsafe” are not subject to design defect claims under Illinois law.

Duragesic(R) is an “unavoidably unsafe” drug. It is a potent narcotic analgesic incorporating the opioid drug fentanyl. ( See Ex. 11, Package Insert.) It is intended for use only in patients with moderate to severe chronic pain. (Ex. 11.) Like other opioid pain medications, Duragesic(R) has potentially severe side effects that are inherent to its use. (Ex. 11.) Specifically, because opioids like fentanyl provide pain relief by affecting neurotransmitters in the brain and central nervous system, Duragesic(R) carries the risk of respiratory depression. (Ex. 11.) Severe cases of respiratory depression can lead to respiratory failure and death. (Ex. 11.) In other words, the only way to eliminate the risk of respiratory depression for drugs like Duragesic(R) would be to eliminate their use altogether. Doing so, however, would deprive patients of the primary means for treating serious pain like that associated with cancer, which implicates the specific public policy underlying comment k. Accordingly, Duragesic(R) is “unavoidably unsafe” for purposes of comment k and Plaintiff has no design defect claim as a matter of law.

Even if Plaintiff could assert her design defect claims under Illinois law, she has failed to identify any experts who will support her design defect theory or explain how a feasible alterative design would have prevented Adams's death. Her failure to do so subjects her claim to summary judgment, as Illinois law requires proof of defect by expert testimony in product liability cases because “[p]roduct liability actions … often involve specialized knowledge or expertise outside the layman's knowledge.” Baltus, supra, (requiring expert testimony in design and manufacturing defect case); Muller v. Synthes Corp., 2002 WL 460827, at *6 (N.D. Ill. Mar. 26, 2002) (requiring expert testimony in design defect case involving medical device).
c. Defendants are entitled to judgment as a matter of law on Plaintiff's failure to warn claim.

Without further explanation, Plaintiff's complaint claims that Adams's Duragesic(R) patches were unreasonably dangerous because of inadequate instructions, warnings, or patient prescription information. (Doc. No. 2 at ¶ 22.) Nowhere does Plaintiff identify specifically how the Duragesic(R) warnings were inadequate. Plaintiff presents no evidence or expert testimony on this issue. Langer v. Dista Products Company, 1996 WL 526763, at *2 (N.D. Ill. Sept. 12, 1996) (requiring expert testimony in failure to warn case involving pharmaceutical product); Northern Trust Co. v. Upjohn Co., 572 N.E.2d 1030, 1037 (Ill. App. Ct. 1991) (requiring expert testimony in failure to warn case involving pharmaceutical product).

A warning defect occurs when a product is “unreasonably dangerous,” “not because of some defect inherent in the product itself, but because of the absence of an adequate warning accompanying the product.” Woodill v. Parke Davis & Co., 402 N.E.2d 194, 196 (1980). Illinois has adopted the “learned intermediary” doctrine whereby “manufacturers of prescription drugs have a duty to warn prescribing physicians of the drugs' known dangerous propensities, and the physicians, in turn, using their medical judgment, have a duty to convey the warnings to their patients.” Kirk, 513 N.E.2d at 392.

Pursuant to this “learned intermediary” doctrine, a failure to warn claim fails, and a manufacturer-defendant is entitled to summary judgment, where “the prescribing physician is aware of the risks associated with a drug.” Wooten v. Johnson & Johnson Prods. Inc., 635 F. Supp. 799, 803 (N.D. Ill. 1986). The manner in which the physician becomes informed of the risks is irrelevant. The true inquiry is whether the physician was informed from any source whatsoever, and not whether the physician was informed directly by the manufacturer, Koncz v. Burroughs Wellcome Co., 1994 WL 178320 (N.D. Ill. May 9, 1994). The FDA-approved label plainly lists the various side effects, including death from hypoventilation when used inappropriately or when used simultaneously with other central nervous system depressants. ( See Ex. 11.) Dr. Grimm, testified he was familiar with the package insert at the time he prescribed Duragesic(R) to Adams. (Ex. 5 at 28-29.) Dr. Grimm also testified that Duragesic(R) is safe and effective and he continues to prescribe it. (Ex. 5 at 36-37.)
D. Plaintiff's Design Defect and Failure to Warn Claims are Preempted by Federal Law.

Although Plaintiff's design defect and failure-to-warn claims are completely unsupported by expert testimony, these claims would also be preempted under federal law. Federal statutes have the power to preempt state law. Crosby v. National Foreign Trade Council, 530 U.S. 363, 372 (2000). The power to preempt state law may come by an express directive, or it may be implied when federal law conflicts with state law. Id. at 372; Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977). State law is an obstacle to Congressional objectives when it conflicts with the methods utilized by a federal agency to carry out those objectives and/or it interferes with agency judgments and mandates. International Paper Co. v. Ouellette, 479 U.S. 481, 494 (1987). Under the “implied” preemption doctrine, “federal regulations have no less pre-emptive effect than federal statutes.” Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153 (1982).

Plaintiff's design defect claim is preempted. Under the risk/utility test for design defects, a plaintiff may prevail on a design defect claim only if she or he demonstrates that the magnitude of the dangers presented by the challenged design outweigh its benefits. Calles v. Scripto-Tokai Corp., 864 N.E.2d 249, 257 (2007). Congress, however, has expressly assigned the responsibility for weighing of the risks and benefits of a prescription drug to the FDA, and the Agency makes this assessment only after an extensive review of the investigative record submitted by the manufacturer. 71 Fed. Reg. at 3934. Because risk-benefit assessments performed by juries are characteristically focused on a single plaintiff or group of plaintiffs, they can interfere with the FDA's effort to comply with its statutory mandates, which require it to strike a delicate balance between the competing objectives of ensuring drug safety and facilitating the public's access to beneficial and life-saving pharmaceuticals. See Riegel v. Medtronic, Inc., —U.S. —, 128 S.Ct. 999, 1007-08, 1009 L.Ed.2d 892 (2008), “[a] jury … sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.” It is the FDA that is charged with approving design of drugs. Because Plaintiff's claims flatly contradict the FDA's findings and impede its objectives, these claims are preempted.

Plaintiff's failure to warn claim is also preempted. The FDA closely regulates the content, wording, and appearance of drug labels. See 21 U.S.C. § 352. If the label submitted by a drug manufacturer is regarded by the FDA as “false or misleading in any particular,” the NDA must not be approved. 21 U.S.C. § 355 (d)(7). The FDA's control over a drug's label persists for the life of the drug. See 21 C.F.R. § 314.70(a)(2)(v).

Plaintiff claims that the Duragesic(R) patch used by Adams lacked adequate warnings and instructions. (Doc. No. 2 at ¶ 22.) The FDA, however, approved the Duragesic(R) label after ALZA informed the FDA of the risks associated with the Duragesic(R) patch, including its side effects. The FDA-approved label plainly lists the various side effects, including death from hypoventilation when used inappropriately or when used simultaneously with other central nervous system depressants. (See Ex. 11.) The Duragesic(R) label approved by the FDA represents the FDA's expert determination of the appropriate warning about potentially fatal hypoventilation, based on its review of the available scientific evidence.

Thus, Plaintiff's claims are preempted to the extent they allege that ALZA failed to include warnings and instructions about side effects in its label or in patient information based on that label. To impose liability on ALZA for an FDA-approved label would place state law in conflict with the FDCA. As the Solicitor General argued in his amicus brief in Wyeth v. Levine, No. 06-1249, cert. granted, — U.S. —, 128 S.Ct. 1118, 169 L.Ed.2d 845 (2008), “imposition of liability based on … use of FDA-approved labeling would interfere with FDA's expert weighing of risks and benefits” of the drug and likewise is preempted. (See Amicus Br., Ex. 17 at 19.)
E. The Strict Product Liability Count Against Hook-SupeRx Should be Dismissed as a Matter of Law.

735 ILCS 5/2-621 provides that a product liability defendant other than a manufacturer shall be dismissed “if it certifies the correct identity of the manufacturer of the product which allegedly caused the injury.” Murphy v. Mancari's Chrysler Plymouth, Inc., 887 N.E.2d 569, 573 (Ill. App. Ct. 2008). If the product manufacturer is named as a defendant and has answered the Complaint, the strict liability claim against the non-manufacturer must be dismissed. Murphy, 887 N.E.2d at 573. The only three exceptions to this mandatory rule apply only if the plaintiff can establish that the defendant (1) exercised significant control over the product's design or manufacturing or provided warnings to the manufacturer relative to the alleged defect, (2) had “actual knowledge of the defect … which caused the injury [or] death,” or (3) created the defect. Id. (citing 735 ILCS 5/2-621(c) (West 2006)). There is no dispute that ALZA is the manufacturer of Duragesic(R) and Plaintiff has completely failed to develop any evidence establishing that any of the three above exceptions apply to Hook-SupeRx. (Ex. 18, Affidavit of Philip D. Wilcox.) Accordingly, the strict liability count against Hook-SupeRx should be dismissed.
IV. CONCLUSION

This is a case in search of a defect – but there is none. Adams's Duragesic(R) patch did not have a manufacturing defect, a design defect, or a warnings defect. While his premature death is tragic, cases such as this must be decided on the facts and the law. Based on the undisputed facts and legal authorities cited above, this Court should grant summary judgment to defendants on all counts of Plaintiff's Complaint.