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Motion 16 - product liability motion to bar expert testimony

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Novartis Pharmaceuticals Corporation's Motion in Limine to Exclude Portions of Dr. Lawrence's Testimony

Novartis Pharmaceuticals Corporation, formerly known as Sandoz Pharmaceuticals Corporation (Sandoz), respectfully moves this Court to exclude testimony offered by plaintiffs' expert on the process of lactation, Dr. Ruth Lawrence, concerning her personal analysis of the risks and benefits of using Parlodel® for the prevention of physiological lactation (PPL) and her conclusion that Parlodel® is an unnecessary drug. Such testimony is not relevant, and even if it were relevant, it should be excluded because Dr. Lawrence lacks adequate qualifications and foundation to testify on these subjects. In addition, Sandoz seeks to exclude testimony concerning a nursing student's master's thesis because it is hearsay and irrelevant.


Plaintiffs' allegations in this drug product liability case hinge upon proving that Parlodel® caused Mrs. Colangelo's intracerebral hemorrhage and that the warnings provided to her prescribing physicians concerning Parlodel® were inadequate. These are the only issues in this case. Previously, plaintiffs also had in this case medical malpractice claims against Drs. Schied and Ziebel, the prescribing obstetricians. These claims were voluntarily dismissed in 1999, however.

Plaintiffs' expert, Dr. Lawrence, is a pediatrician with expertise in breast feeding. She will be offered to testify regarding her personal risk-benefit analysis of whether Parlodel® should ever be prescribed for PPL. See Plaintiff's Responses to Defendant Sandoz's Rule 213 Interrogatories, at 4 (Att. 1). As part of her analysis, Dr. Lawrence opines that Parlodel® is an ” “unnecessary drug, even though Mrs. Colangelo's prescribing physicians, Drs. Schied and Ziebel, believed it was safe and would benefit her. See letter from E. Relkin to A. Caputo dated June 16, 1999 (Att. 2) (Dr. Lawrence to testify about lack of need of the drug); Kittleson Trial Trans. (10/2/00) Vol. II at 1776-77 (Dr. Lawrence told you that... there is no need for this drug for postpartum lactation.) (argument of plaintiffs' counsel) (Att. 3); Ziebel Dep. at 38-39 (Parlodel® was a good medication for prevention of physiological lactation) (Att. 4).

As part of Dr. Lawrence's opinion on the lack of need for Parlodel®, Dr. Lawrence testifies about the Bohlen thesis, a research project performed by a student. Dr. Lawrence does not testify about the thesis findings, but about conversations that Ms. Bohlen allegedly had with patients and about statements of unidentified obstetricians made to Dr. Lawrence regarding their Parlodel® prescribing practices following completion of the research.

Dr. Lawrence will not present any expert opinion regarding adequacy of warning or the safety of Parlodel® with regard to stroke, the injury at issue in this case. See Lawrence Dep. at 15-17, 22-23, 73-74 (Att. 5).



1. Risk-Benefit Testimony Is Irrelevant Under Comment K For Pharmaceutical Product Liability Claims.

Dr. Lawrence's risk-benefit testimony is irrelevant because drug product liability is exempted by comment k of Section 402A of the Restatement (Second) of Torts from traditional risk-benefit analysis. See, e.g., Kirk v. Michael Reese Hosp. And Med. Ctr., 117 Ill. 2d 507, 516-17, 513 N.E.2d 387, 391 (1987) (applying Comment k in a productsliability case); cf. Besse v. Deere & Co., 237 Ill. App. 3d 497, 500-01, 604 N.E.2d 998, 1001 (1992) (assessment of unreasonably dangerous product requires risk-benefit analysis and consumer expectation test). Comment k states that the manufacturers of certain unavoidably unsafe products that are beneficial to society, such as drugs, cannot be held strictly liable if the product is properly prepared and given adequate warnings. Restatement (Second) of Torts, § 402 A, comment k, at 353-54 (1965). Parlodel® falls under the comment k exception; it benefits society by providing a convenient method of preventing lactation and possibly severe pain in postpartum women who choose not to breast feed. See Ziebel Dep. at 38-39 (Att. 4).

Plaintiffs may argue that comment k only applies to drugs that provide a unique benefit, i.e., those that remedy conditions that cannot be treated in any other manner. They argue, through Dr. Lawrence, that breast engorgement can be prevented or treated adequately by means other than Parlodel®, e.g., by use of breast binders, application of ice packs, and medication by analgesics. Comment k nevertheless still applies.

Illinois courts have expressly held that unavoidably unsafe drugs include those that provide benefits that can be achieved through alternative means. See Glassman v. Wyeth Labs., Inc., 238 Ill. App. 3d 533, 538-39, 606 N.E.2d 338, 342 (1992) (birth control pills fall under the unavoidably unsafe exception even though there are other products and nonpharmacologic methods that involve fewer risks). Comment k should protect manufacturers of desirable and useful products from strict liability for those products , even if the benefits could be obtained with another product, because otherwise manufacturers would be discouraged from manufacturing new products that might confer new advantages over existing products that have the same purpose. Id. Therefore, that there are other methods of preventing or treating breast engorgement in postpartum women is irrelevant to whether Parlodel® falls under comment k.

Evidence that is irrelevant must be excluded. See Voykin v. Estate of DeBoer, 192 Ill. 2d 49, 59, 733 N.E.2d 1275, 1280 (2000) (affirming exclusion of evidence of plaintiff's prior injuries as irrelevant without expert testimony to assess their relationship to current injuries); People v. Schulz, 154 Ill. App. 3d 358, 366, 506 N.E.2d 1343, 1348 (1997) (reversing conviction due to trial court's erroneous admission of expert testimony regarding blood and semen samples which did not make defendant's guilt more or less likely). Because risk-benefit analysis has no application to this drug product liability case, Dr. Lawrence's opinions regarding her balancing of Parlodel®'s risks and benefits are irrelevant and must be excluded.

2. Dr. Lawrence's Closely-Related Opinions Concerning the Alleged Lack of ” “Need For Parlodel® Are Likewise Irrelevant.

Equally irrelevant to this case are Dr. Lawrence's opinions that Parlodel® was unnecessary for PPL. Such opinions merely restate the risk/benefit opinions addressed above. Although Dr. Lawrence may well harbor the opinion that Mrs. Colangelo's doctors should not have prescribed Parlodel® to her, at most this would raise a standard of medical care issue. However, there are no claims for medical malpractice in this case, and testimony regarding standard of care is irrelevant and misleading.

3. Dr. Lawrence Is Not Qualified To Testify About Parlodel®'s Risks And Benefits Or Need.

Even if testimony concerning Parlodel®'s risk-benefit ratio or need were relevant, Dr. Lawrence's opinions should be excluded because she is not qualified to offer them. A medical expert testifying about standard of care must prove that she possesses the necessary expertise in dealing with the plaintiffs medical problem and treatment by demonstrating [her] familiarity with the methods, procedures and treatments ordinarily observed by similarly situated physicians. Hubbard v. Sherman Hosp., 292 Ill. App. 3d 148, 155, 685 N.E.2d 648, 652-53 (1997) (excluding expert testimony by emergency room physician regarding appendix surgery because expert had only dealt with appendicitis patients as an attending physician and not as a surgeon). Similarly, [e]xpert testimony is only admissible if the proffered expert is qualified as an expert by knowledge, skill, experience, training or education and the testimony will assist the trier of fact in understanding the evidence. Grant v. Petroff, 291 Ill. App. 3d 795, 801, 684 N.E.2d 1020, 1024-25 (1997) (erroneous admission of testimony regarding credibility of another person because doctor lacked expertise). See also Broussard v. Huffman Mfg. Co., 108 Ill. App. 3d 356, 362, 438 N.E.2d 1217, 1221-22 (1982) (excluding testimony about design of gasoline can as outside witness's expertise); Northern Trust Co. v. Upjohn Co., 213 Ill. App. 3d 390, 406-07, 572 N.E.2d 1030, 1047 (1991) (emergency room doctor not allowed to testify about whether an obstetrician/ gynecologist correctly assessed the patient before using a drug to interrupt pregnancy); Thomas v. Univ. of Chicago Lying-In Hosp., 221 Ill. App. 3d 919, 925, 583 N.E.2d 73, 77 (1991) (excluding pediatric opinion about standard of care for a gynecologic procedure).

a. Dr. Lawrence Has Never Prescribed Parlodel®.

Because Dr. Lawrence has no direct experience with Parlodel®, she has no basis for testifying about its merits. She is a pediatrician, not an obstetrician. See Lawrence Trial Test., Globetti v. Sandoz Pharms. Corp., 3/8/01, at 882 (Att. 6). She has never prescribed Parlodel®, see Lawrence Dep./ Hernandez at 30 (Att. 7), so she has never directly observed any patient's experience with the drug. Her experiences with alternative treatments cannot save her testimony from being excluded. See Northern Trust Co., 213 Ill. App. 3d at 406-07, 572 N.E.2d at 1047 (expert's experience with emergency births was not enough to deem him an expert regarding obstetrician's abortion procedures). Because Dr. Lawrence has no experience with Parlodel®, she should be prohibited from testifying about whether the drug is an appropriate treatment for non-lactating postpartum women.

b. Dr. Lawrence Lacks Knowledge of Parlodel®'s Risks and Benefits.

Performing a risk-benefit analysis for any drug necessarily requires expertise in both the risks and benefits of the drug. Nonetheless, Dr. Lawrence claims the ability to perform a risk-benefit analysis for Parlodel® while at the same time admitting that she is not an expert on the risks associated with Parlodel®:

Q: You do not consider yourself an expert on the risks of Parlodel®; is that correct?

A: Yes, that is correct.

See Lawrence/ Rider Dep., 10/23/98, at 80 (Att. 8). She has testified that her best knowledge of Parlodel®'s minor side effects comes from the drug's packet insert, not from direct patient observation. See Lawrence Dep. at 22 (Att. 5).

Dr. Lawrence also lacks expertise in Parlodel®'s benefits. She is a pediatrician, not an obstetrician. See Lawrence Trial Test.,Globetti. v. Sandoz Pharms. Corp., 3/8/01, at 882 (Att. 6). She admittedly has never prescribed Parlodel® for PPL or any other indication. See Lawrence Dep./ Hernandez at 32 (Att. 7). She has never practiced obstetrics, id.,and has never conducted a study of Parlodel®'s efficacy or safety, see Lawrence Dep. at 6-7 (Att. 5). In fact, she bases her opinions on observations of postpartum women who have not taken Parlodel®. See id. at 32. Dr. Lawrence's lack of direct experience with Parlodel® is remarkable, given that she plans to testify about whether the drug is necessary and effective. Because Dr. Lawrence lacks expertise in Parlodel®'s risks and benefits, any balancing test performed by her will be faulty and cannot be considered sufficiently reliable or helpful to the trier of fact to be admissible.

4. Dr. Lawrence Knows Nothing About The Facts of This Case.

In addition, Dr. Lawrence is not qualified to testify regarding her personal risk-benefit analysis or the need for Parlodel® for PPL because she is unable to connect her opinions to the specific facts of this case. Marshall v. First Am.Nat'l Bank of Nashville, 91 Ill. App. 2d 47, 53, 233 N.E.2d 430, 433 (1968) (granting new trial due to court's erroneous admission of expert testimony on cause of airplane crash, where opinion lacked an evidentiary basis). See also Kanne v. Metropolitan Life Ins. Co., 310 Ill. App. 524, 34 N.E.2d 732 (1941) (affirming trial court's exclusion of expert testimony that chronic myocarditis was cause of death, where there was no evidence in the record upon which the opinion could be based); Modelski v. Navistar Int'l Transp. Corp., 302 Ill. App. 3d 879, 886, 707 N.E.2d 239, 245 (1999) (finding reversible error in decision to allow expert testimony regarding events leading up to plaintiffs injuries, where there was no physical evidence to support such testimony).

Dr. Lawrence will not testify specifically about Mrs. Colangelo's experience with Parlodel®, Lawrence Dep. at 73 (Att. 5), nor will she present any opinions about medical causation, id. at 74, even though medical causation is the central issue of this case. Any risk-benefit analysis for a drug would require a patient-specific consideration of relevant factors. For this reason, the determination of whether a patient needs a certain drug lies within the discretion of the prescribing physician alone. See Mahr v. G.D. Searle & Co., 72 Ill. App. 3d 540, 561, 390 N.E.2d 1214, 1229-30 (1979) (prescribing physician makes initial determination about medication and patient's response to same). According to the Illinois Supreme Court, it is the physician who is in the best position to decide when to use and how and when to inform his patient regarding risks and benefits pertaining to drug therapy. Kirk, 117 Ill. 2d at 523, 513 N.E.2d at 395, quoting W. Prosser & W. Keaton, The Law of Torts, sec. 96 at 688 (5th ed. 1984). As a medical expert, the prescribing physician can take into account the propensities of the drug as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, and individualized medical judgment bottomed on a knowledge of both patient and palliative. Kirk, 117 Ill. 2d at 518, 513 N.E.2d at 392. It is not the role of plaintiffs' medical expert, who is not an obstetrician and did not examine Mrs. Colangelo after her pregnancy, to make a general determination about treatment in hindsight. Mrs. Colangelo had the right to determine whether she would take a drug to prevent the potentially severe pain that could result from engorgement.

Dr. Lawrence has never read Mrs. Colangelo's medical records or any other materials specific to this case. See letter dated June 16, 1999 (Att. 2). Simply put, Dr. Lawrence has formed a universal conclusion that Parlodel® is ” “neverindicated in the suppression of normal postpartum lactation. Lawrence Dep. at 52 (emphasis added) (Att. 5). She cannot consider, let alone balance, individual factors that would alter the risk-benefit analysis depending on the particular woman involved. She simply does not think that Parlodel® PPL is warranted under any condition. Id. at 53.

For example, one of Parlodel®'s benefits is that it prevents pain. Dr. Lawrence admits that the perception of pain and feelings about pain are subjective, yet has made no effort to consider Mrs. Colangelo's subjective feelings concerning pain or her breasts. Dr. Lawrence's blanket opinion that Parlodel® is not necessary for all women is at odds with her admissions:

^ that pain is subjective, and some people may experience greater pain than others as a result of the same event, seeLawrence Dep./ Hernandez at 48-49 (Att. 7);

^ that some people have a much greater fear of pain than other people, id. at 49;

^ that a new mother will want to reduce any pain she may feel during the first few days that she is home with her baby, id. at 49-50;

^ it is not possible to know in advance whether a woman will experience pain and severe breast engorgement, which is why prophylactic treatment is used, id. at 92-93;

^ that some women do not get relief from breast engorgement pain through the use of nonpharmacologic methods and acetaminophen, see Lawrence Dep. at 31 (Att. 5); and

^ that if a woman is given full informed consent, she has the right to take Parlodel® if she chooses, id. at 73.

To render an educated opinion regarding Mrs. Colangelo's need for Parlodel®, Dr. Lawrence would have had to consider subjective factors, such as her prior successful use of the medication, see S. Colangelo Dep., 12/19/95, at 13-14, her affirmative choice to take Parlodel® again, see id. at 41-42 (Att. 9), that she had the flu and was already experiencing a significant degree of discomfort, see id. at 29, 40, and the experiences of her prescribing physicians with the medication in their other patients, see Ziebel Dep. at 38-39 (physicians prescribe Parlodel® prophylactically so that new mothers will not suffer severe pain that can impair the quality of the first few days they spend with their newborns) (Att. 4). A mentally competent patient, such as the plaintiff here, has not only the capacity, but the right, to make a reasoned decision regarding his or her need for medical treatment. Prairie v. Univ. of Chicago Hosps., 298 Ill. App. 3d 316, 328, 698 N.E.2d 611, 619 (1998) (reasonable jury could find nurse negligent for forcing patient out of bed when patient was in pain and asked to stay in bed). Because plaintiffs have failed to present a factual foundation sufficient to justify the broad-brush conclusions advanced by Dr. Lawrence that purport to encompass literally everypostpartum women on the planet, her risk-benefit analysis must be excluded.

5. Dr. Lawrence's Opinions Intrude Upon The Special Relationship Between Mrs. Colangelo And Her Physicians.

Only a patient and her physician can make an individualized assessment and determine whether she needs a particular drug. It is undisputed that Parlodel® was approved by FDA for PPL at the time that it was prescribed to Mrs. Colangelo. Dr. Lawrence's opinion that Parlodel® is unnecessary and, by implication, that Mrs. Colangelo should not have been given a prescription for the drug, simply seeks to impose her personal judgment for that of Drs. Schied and Ziebel and directly intrudes upon Mrs. Colangelo's relationship with her physicians. See Petrillo v. Syntex Lab., Inc., 148 Ill. App. 3d 581, 593, 499 N.E.2d 952, 960 (1986) (disallowing ex parte communications between physician and opposing counsel because the sanctity of the doctor-patient relationship must be protected). A doctor has a special relationship with his patient that must be protected from interference by third parties. See Miceikis v. Field, 37 Ill. App. 3d 763, 768, 347 N.E.2d 320, 324 (1976) (physicians have a duty of disclosure, but can exercise some discretion in disclosing risks to patients), cf. Eldridge v. Eli Lilly & Co., 138 Ill. App. 3d 124, 127, 485 N.E.2d 551, 553 (1985) (pharmacist has no duty to warn patients because he is not allowed to interject himself into the doctor-patient relationship.)


As note above, the Bohlen thesis was a research project performed by a nursing student under Dr. Lawrence's partial oversight, but Dr. Lawrence does not testify about the findings of the thesis itself but about the conversations that Ms. Bohlen allegedly had in the course of her research or about conversations that Dr. Lawrence had with obstetricians who conveyed their own practices regarding Parlodel®. These statements consist of double or single hearsay (patient to Ms. Bohlen to Dr. Lawrence; doctors to Dr. Lawrence) and, in any event, are irrelevant and likely to confuse and mislead the jury. As shown above, the availability of alternative methods to ease the pain of engorgement has no bearing on this case. The jury may give testimony about the Bohlen thesis undue weight because it sounds scientific even though Dr. Lawrence does not testify about the actual findings of the research and the study has never been subjected to peer-review or replication. See, e.g., Gill v. Foster, 157 Ill. 2d 304, 313, 626 N.E.2d 190, 194 (1993) (excluding testimony regarding medical bills).


For the foregoing reasons, Sandoz respectfully requests that its motion be granted and that this Court exclude testimony at trial of Dr. Lawrence concerning her personal risk-benefit analysis, the need for Parlodel, and the Bohlen thesis.

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