In this paper you will read the scenario and present a position on that issue.  Papers shall cite a minimum of three sources. One of the sources must be from the text, one must be an Internet source (with hyperlink) and the third may be from any source (print, personal experience, Internet, learned treatise, journal, etc.). You shall cite each source in APA format.

New medical treatments, by strict definition, are not the “current medical practice.” Should a physician be immune from liability for harm suffered from a patient who is among the first to be treated in a new and innovative manner in which the potential risks have not been discovered? Report on a new and possibly innovative medical treatment (i.e., medication or medical procedure, diagnostic tests, etc.) where there exist uncharted waters about the possible outcome. Review carefully the Perez case and the Hardi case as a starting point.

This week assignment I need a (650-words minimum). In this paper you will read the scenario and present a position on that issue.  Papers shall cite a minimum of three sources. One of the sources must be from the text, one must be an Internet source (with hyperlink) and the third may be from any source (print, personal experience, Internet, learned treatise, journal, etc.). You shall cite each source in APA format.

New medical treatments, by strict definition, are not the “current medical practice.” Should a physician be immune from liability for harm suffered from a patient who is among the first to be treated in a new and innovative manner in which the potential risks have not been discovered? Report on a new and possibly innovative medical treatment (i.e., medication or medical procedure, diagnostic tests, etc.) where there exist uncharted waters about the possible outcome. Review carefully the Perez case and the Hardi case as a starting point.

Remarks from the Prof. (hopeful we can improve this week) still have 3 more short story.

Good paper and commentary. It contained and illustrated several valid points. *Expand your discussion more fully for more points. Your reasoning could be further expanded. Good effort.

Reading ( you would have to goggle the cases)

Perez v. Wyeth Laboratories, Inc., available in Doc Sharing

– Liabilities created by pharmaceutical direct advertising to consumers

•         Hardi v. Mezzanotte, pp. 405-412

– Delayed, uncertain, or shared responsibility of medical error

•         Herskovits v. Group Health Cooperative of Puget Sound, pp. 425-435

– The “Loss of Chance” doctrine of damages

PEREZ v. WYETH LABORATORIES, INC.

713 A.2d 520 (1998)

313 N.J. Super. 511

Saray PEREZ, Cheryl Bailey, Kimberly Bartlett, Anna Cesareo and Soraya Arias, Plaintiffs-Appellants,1

v.

WYETH LABORATORIES, INC., a subsidiary of American Home Products Corporation; American Home Products Corporation; Wyeth-Ayerst Laboratories Division of American Home Products Corporation; Wyeth-Ayerst International Inc.; Wyeth-Ayerst Laboratories Company and Dow Corning France, S.A., Defendants-Respondents.

Superior Court of New Jersey, Appellate Division.

Argued May 19, 1998.

Decided June 12, 1998.

Richard Galex for plaintiffs-appellants (Galex, Tortoreti & Tomes, Brunswick, attorneys; Mr. Galex, on the brief).

Anita Hotchkiss, Morristown, for defendants-respondents (Porzio, Bromberg & Newman, attorneys; Ms. Hotchkiss and Linda Pissott Reig, on the brief).

Before Judges DREIER, KEEFE and PAUL G. LEVY.

The opinion of the court was delivered by DREIER, P.J.A.D.

Various plaintiffs, designated as the “bellwether” parties in consolidated product liability actions, have appealed from a summary judgment determining that defendants had no duty to warn these consumers of possible adverse effects attendant upon the insertion, maintenance and removal of defendants’ Norplant contraceptive medication. Judge Corodemus in her comprehensive decision of December 5, 1997, reported at 313 N.J.Super. 646, 713 A.2d 588 (Law Div.1997), traced the history of plaintiffs’ complaints, the State of New Jersey law, out-of-state authority, and how our statutory and common law learned intermediary rules bear upon a prescription drug provider’s duty to warn the consumer of its products. We agree with her analysis and decision to select bellwether plaintiffs, as such practice of using bellwether cases is firmly established in the law. See In re Norplant Contraceptive Products Liability Litigation, 955 F.Supp. 700 (E.D.Tex.1997), in which, incidentally, Chief Judge Schell reached the same substantive result as Judge Corodemus.

While we readily affirm the summary judgment based upon the clear and scholarly opinion of Judge Corodemus, some issues nevertheless need further elaboration.

It has been argued that the Restatement (Third) of Torts: Products Liability (1998) posits an additional basis for liability to be imposed upon a manufacturer of a prescription drug for failure to warn a patient. Section 6 of the new Restatement separates defects in prescription drugs or medical devices from those in other products. Although the rules governing manufacturing defects in prescription drugs or medical devices are the same as those governing other products under § 2(b) of the Restatement, design defects and warning defects receive separate treatment. The warning defect language, contained in § 6(d), reads:

(d) A prescription drug or medical device is not reasonably safe because of inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:

(1) prescribing and other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or(2) the patient when the manufacturer knows or has reason to know that health care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.

Subsection (d)(1) mirrors N.J.S.A. 2A:58C-4 which defines an adequate warning as

one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, … in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician.

The Restatement, however, adds subsection (d)(2), positing warnings being given directly to a patient “when the manufacturer knows or has reason to know that health care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.” The Reporters have appended Comment b, suggesting the application of this section to situations where the physician or health care provider has a “diminished role as an evaluator or decision maker.” In such an instance, the manufacturer would have a duty to provide direct warnings to the patient. Exceptions are further explored in Comment e. For example, in mass inoculations where health care providers are unable to supervise the administration of the drug and individually advise patients about the risks attendant upon the drug’s use, the manufacturer may have a duty to provide warnings.

Despite the Reporter’s suggestion of a manufacturer’s duty to warn in mass inoculations, we need not decide the outcome of such a case in New Jersey, even with the more restrictive language of N.J.S.A. 2A:58C-4. By the Legislature’s use of the words “the prescribing physician,” we might assume that it intended this statute to have effect only where there is such a prescribing physician (or other health care professional with the power to prescribe drugs, as is discussed infra). In instances such as mass inoculations where there may be no prescribing physician for the individual patients, some other form of warning might be necessary.

The more salient question in this case is whether the Legislature intended to define an adequate warning in the area of prescription drugs as one given to physicians only. It is true that the New Jersey statute speaks only of a prescribing “physician.” Are we to take this as a word of limitation limited to one licensed to practice medicine or surgery under N.J.S.A. 45:9-6, et seq.? It is clear that drugs may be prescribed by dentists (N.J.S.A. 46:6-19.5b), optometrists (N.J.S.A. 45:12-1), podiatrists (N.J.S.A. 45:5-7), nurse practitioners (N.J.S.A. 45:11-49), home health care service firms (N.J.S.A. 45:11-49.1), physician’s assistants (N.J.S.A. 45:9-27.16), or others similarly permitted to prescribe or administer drugs on a limited basis. It would be difficult to believe that the Legislature intended that warnings be geared only to those licensed to practice medicine and surgery, when the Legislature has authorized other health care professionals to provide a similar service. We thus assume that the Legislature intended to include within the term “physician” other such health care providers in the same manner as is stated in the Restatement.

In fact, in the case before us, plaintiff Perez had the Norplant® inserted by a nurse, Diane Brevet. As noted in the trial judge’s opinion, “Nurse Brevet is certified in women’s health by the National Association of Obstetricians and Gynecologists. She is authorized by law to prescribe and insert Norplant.” It would be incongruous to apply different rules to the physicians and Nurse Brevet.

We specifically agree with Judge Corodemus that the language of N.J.S.A. 2A:58C-4 precludes any general relaxation of the learned intermediary doctrine governing prescription drugs to the point where the warnings would be required to be given directly to patients, either in the general area where drugs have been advertised directly to consumers, or in the specific area of contraceptive products. The American Law Institute in Comment e to the new Restatement left this area of developing law to the progress of individual cases. The Reporters’ notes to Comment e chronicle the state of the law in this area and document the various calls to abandon the learned intermediary rule where manufacturers have marketed drugs directly to the public, but have inadequately warned the consumers. Apart from the mass inoculation situations noted earlier, where the answer might not be clear, it appears that in New Jersey the Legislature has effectively blocked the progress of the law to require such direct notification of consumers. This is consistent with the Legislature’s expressed intent to limit the expansion of product liability law in certain areas. See Roberts v. Rich Foods, Inc., 139 N.J. 365, 374, 654 A.2d 1365 (1995), and the cases there cited.

Lest it be thought that N.J.S.A. 2A:58C-4 could be read to require direct notification of consumers, because the language merely speaks of the adequacy of the warning, not to whom the warning must be given, we look at the Senate Judiciary Committee Statement included with the legislative history of the Products Liability Act. N.J.S.A. 2A:58C-1a provides that such “committee statements that may be adopted or included in the legislative history of this act shall be consulted in the interpretation and construction of this act.” That statement, which has been reproduced following N.J.S.A. 2A:58C-1 states in its relevant portion:

[A] manufacturer or seller is not liable in a warning-defect case if an adequate warning is given when the product has left the control of the manufacturer or seller…. The subsection contains a general definition of an adequate warning and a special definition for warnings that accompany prescription drugs, since, in the case of prescription drugs, the warning is owed to the physician.

We see, therefore, that the warning not only must be that which would be adequate to a prescribing physician, but also “is owed to the physician.” If the warning is legislatively deemed adequate and has been given to the proper party, we cannot find a warning defect under the Products Liability Act.

Even if the New Jersey statute did not provide the limitation that it does, the learned intermediary doctrine is firmly established in New Jersey in the area of prescription drugs. It stands for the proposition that “a pharmaceutical manufacturer generally discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug’s dangerous propensities.” Niemiera v. Schneider, 114 N.J. 550, 559, 555 A.2d 1112 (1989). See also Torsiello v. Whitehall Labs., 165 N.J.Super. 311, 323, 398 A.2d 132 (App. Div.), certif. denied, 81 N.J. 50, 404 A.2d 1150 (1979) (noting the wide acceptance of the learned intermediary doctrine in the context of prescription drug cases). Under this doctrine, the pharmaceutical manufacturer is relieved of the duty to warn patients of a drug’s potential adverse side effects if adequate warnings are given to physicians. Spychala v. G.D. Searle & Co., 705 F.Supp. 1024, 1031 (D.N.J.1988); Niemiera, supra, 114 N.J. at 559, 555 A.2d 1112; New Jersey Products Liability & Toxic Torts Law, § 6:3-3 at 68-70 (Gann 1998). Thus, the treating physician, as the learned intermediary, is solely responsible for communicating to the patient the risks involved in taking the drug. 114 N.J. at 559, 555 A.2d 1112. The rationale behind this rule is that because of the complexity of prescription drugs, “the physician is in the best position to take into account the propensities of the drug and the susceptibilities of the patient, and to give a highly individualized warning to the ultimate user based on the physician’s specialized knowledge.” Spychala, supra, 705 F.Supp. at 1031-32.

Finally, a question was raised by plaintiffs at oral argument before us concerning whether the summary judgment entered by Judge Corodemus effectively terminated the litigation involving these plaintiffs as to all claims or merely as to their complaints concerning pain and scarring, or even whether this determination is limited to the individual “bellwether” plaintiffs selected for consideration by the trial judge. We note that in this case there was no claim against the prescribing physicians for failure to warn the particular patients of the dangers covered in the manufacturers’ warnings or otherwise known to the physicians. While there may be portions of other cases for which we have not been provided the full records, it appears that in the claims before us as well as those from which these were selected to be bellwether or test cases, the only claim is against the manufacturers. Furthermore, the claim against the manufacturers has been limited to their failure to warn the patients directly, and has not included any assertion of a design or manufacturing defect in the product or a failure to provide an adequate warning to the prescribing physicians. As this is our understanding, it appears that Judge Corodemus’s resolution of the bellwether cases and this affirmance thereof, effectively disposes of all of the pending claims, and not merely those asserted in the test cases. If in fact, however, there are other claims in the cases not pending before us, we do not, nor could we, adjudicate such claims, nor can we predict the effect of this decision upon them.

In sum, while there may be a sound basis for expansion of liability in this area, the matter is one both for legislative determination and for the Supreme Court’s review of the learned intermediary doctrine as it has applied it in this area of the law.

As noted earlier, we have in this opinion merely supplemented Judge Corodemus’s opinion to answer issues raised at oral argument or in the appellate briefs that may not have been presented to her. We have not done so by way of limitation. With these additions, we affirm the summary judgment, as stated earlier, substantially for the reasons expressed in her opinion of December 5, 1997.

FOOTNOTES

1. The caption has been amended to show as plaintiffs the five “bellwether” individuals chosen from five consolidated cases, all against the same defendants. The other plaintiffs are: Camellia Daniels, Debra Little, Dria Moore, Melinda Rojas, Jamella Muhammad, Veda Sellers, Michelle Diaz and Sayed B. Pacha Said.

According to the evidence, appellee was treated by Dr. John O’Connor in 1990 for diverticulitis, an infectious process affecting the colon. In January and February of 1994, she experienced symptoms which she believed to be a recurrence of that illness. After trying without success to reach Dr. O’Connor, she saw Dr. Hardi, a Board-certified gastroenterologist, on February 3, 1994, and informed him of her suspicions and provided him with a copy of an x-ray report that Dr. O’Connor ordered after he treated her for diverticulitis. The doctor took appellee’s history and noted on her chart that Dr. O’Connor had treated her previously with antibiotics for diverticulitis. During his physical examination of appellee, Dr. Hardi felt a mass which he thought to be of gynecological origin. However, he also understood that the mass could be caused by a recurrence of diverticulitis. His medical chart does not show alternate likely causes of appellee’s condition or specify diverticulitis as one such cause. Dr. Hardi did not order a CAT-Scan, a test typically ordered when diverticulitis may be present, or initiate a course of antibiotic therapy. He informed appellee that her problems were gynecological in nature and referred her to Dr. Joel Match, a gynecologist, for a work-up with respect to the mass.

On February 8, 1994, Dr. Match saw appellee. He ordered a CA-125 blood test, which he testified is 80% reliable in predicting the existence of gynecological cancer. The test was negative for the disease. The report from the ultrasound examination, which Dr. Match ordered, revealed that there was a mass in the left lower quadrant of appellee’s abdomen, but it could not be determined whether it was diverticular or gynecological in origin. Therefore, the radiologist recommended a “close clinical and sonographic follow-up.” Notwithstanding the results of the tests, Dr. Match concluded that appellee had ovarian cancer and scheduled a complete hysterectomy (the surgical removal of her uterus, fallopian tubes and ovaries) for March 1994. Dr. Match informed Dr. Hardi of the test results. Although the blood test did not reveal cancer, and the ultrasound exam did not reveal an enlarged uterus, Dr. Hardi “cleared” the performance of gynecological surgery. Dr. Match requested that Dr. Hardi undertake further testing within his specialty in order to rule out the possibility that appellee was suffering from any gastrointestinal diseases.

On February 21, 1994, Dr. Hardi performed a sigmoidoscopy on appellee, which entailed the introduction of an endoscope into her sigmoid colon for purposes of observation. He was unable to complete the procedure after multiple attempts because of an apparent obstruction of the colon caused by the diverticulitis. Appellee’s expert witness, Dr. Robert Shapiro, explained that such an obstruction is a “red flag,” telling the doctor “there is 978*978 something wrong with the bowel.” Dr. Hardi scheduled a more intrusive procedure, a colonoscopy, performed under general anesthesia, for March 2, 1994. He attempted the procedure multiple times, without success, due to the obstruction, and desisted finally because of “fear of perforation.” He ordered Dr. Odenwald, a Sibley Hospital radiologist, to perform a third exploratory procedure, a barium enema of the sigmoid colon, but it could not be completed due to the same obstruction. Dr. Odenwald discussed with Dr. Hardi the possibility that the obstruction resulted from a gastrointestinal disease rather than gynecological cancer.

Immediately following the exploratory procedures on March 2, 1994, appellee’s condition deteriorated markedly. These procedures had exerted pressure on her sigmoid colon and caused the spread of her diverticular infection. Appellee was admitted as an emergency patient to Columbia Hospital for Women on March 7, 1994. By then, her diverticular abscess had ruptured, resulting in peritonitis (i.e., infection of the abdomen). Dr. Match ordered a CAT-Scan on March 7, 1994. However, appellee’s condition precluded the use of contrast media. Dr. Match also ordered an ultrasound that day, which proved to be non-diagnostic. On March 8, 1994, appellee had surgery which involved removal of her noncancerous reproductive organs. During surgery, multiple infectious abscesses and pus were encountered. Dr. Hafner, the general surgeon who performed the operation, removed the infectious matter from the patient’s abdomen, excised the affected portion of her bowel, and performed a colostomy. After surgery, Dr. Hafner informed appellee’s husband that she had diverticulitis, not gynecological cancer. Appellee had a slow recovery due to peritonitis and associated complications, and ultimately, she was required to undergo four additional surgical procedures, involving a “take-down” of her colostomy and the correction of hernias caused by the related weakening of her abdominal wall. These surgical procedures extended into March 1996. Appellee spent a total of eighty-three days as an inpatient at Columbia Hospital for Women and George Washington University Hospital, and a nursing home.

Appellants argue that the trial court awarded costs to appellee which are not recoverable. Specifically, they contend that the costs related to the earlier mistrial are not taxable against them in the second trial. Alternatively, they challenge specific costs, including certain witness fees, deposition transcripts, copying costs, and medical records. Appellee responds that some of appellants’ arguments are moot, as the trial court reduced the amount she requested originally, excluding some of their requested costs. Further, she contends that costs associated with the first trial were awarded properly, as the second trial was based upon the testimony and exhibits from the first.

Pursuant to Super. Ct. Civ. R. 54(d), costs may be awarded to the prevailing party. Harris v. Sears Roebuck & Co., 695 A.2d 108, 109 (D.C.1997) (citing Super. Ct. Civ. R. 54(d)(1)) (other citations omitted). The rule provides that “costs other than attorneys’ fees shall be 986*986 allowed as of course to the prevailing party unless the Court otherwise directs ….” Super. Ct. Civ. R. 54(d)(1). “The authority of a court to assess a particular item as costs is partly a matter of statute (or court rule), and partly a matter of custom, practice, and usage.” Robinson v. Howard Univ., 455 A.2d 1363, 1368-69 (D.C.1983) (citing Newton v. Consolidated Gas Co., 265 U.S. 78, 44 S.Ct. 481, 68 L.Ed. 909 (1924) (annotation and other citation omitted)). Under Super. Ct. Civ. R. 54-I(b), the costs of depositions and transcripts may be taxed as costs, in the trial court’s discretion. Witness fees are recoverable as costs upon compliance with certain technical requirements of Super. Ct. Civ. R. 54-I(a). Whether to award costs is committed to the trial court’s discretion, and, upon review, it is not for the appellate court to substitute its discretion for that of the trial court. Harris, 695 A.2d at 110; Robinson, 455 A.2d at 1369 (citations omitted). With these general principles in mind, we consider the trial court’s order awarding costs and appellants’ challenges to it.

The trial court awarded costs to appellee in the amount of $14,903.92.[6] Appellants contend that there was included improperly in this amount costs incurred in the first jury trial associated with the claim against Dr. Match and the mistrial. They contend that it was error to award these costs because appellee was not the prevailing party on either claim in the first trial. Further, they contend that the only costs necessary for the retrial of appellee’s claims were for trial transcripts, which totaled $3,773.00.

In support of their argument that costs related to the mistrial are not taxable, appellants cite United States v. Deas, 413 F.2d 1371 (5th Cir.1969). Deas concerned whether costs of a mistrial could be taxed under a federal statute, 28 U.S.C.A. § 1918(b), to a criminal defendant convicted in a subsequent trial. Id. at 1372-73. The statute permitted an assessment of costs upon conviction.[7] The court held that where the previous mistrial was “due solely to the jury’s failure to agree upon a verdict,” separate court costs were not encompassed within the provisions of the statute. Id. In reaching this conclusion, the court considered that: (1) levying such costs upon a criminal defendant “is a deprivation of property that may be imposed only in accordance with reasonable and narrowly defined standards;” (2) it would have the effect of penalizing a defendant for the government’s failure of proof in the first case; and (3) it might have a deterrent effect on the right of the accused to plead not guilty and go to trial the second time. Id. at 1372. No similar statute or considerations are present here.

Moreover, in this case, there was no new presentation of the evidence, since the parties agreed to a second trial by the court based on the record of the testimony and evidence adduced at the first trial. Thus, the costs incurred for the first trial essentially were used to produce the evidence used again in the second 987*987 trial. Appellee had not previously recovered the costs of the presentation upon which she later prevailed. Under these circumstances, the trial court could properly exercise its discretion to award these costs, which were necessary for the presentation of appellee’s case.[8] “An appellant contesting an award of costs `bears the burden of convincing this court on appeal that the trial court erred …. [and] the burden is even greater when the standard of review is abuse of discretion. “`Talley v. Varma, 689 A.2d 547, 555 (D.C.1997) (quoting Robinson, supra, 455 A.2d at 1370). Appellants filed in the trial court an opposition in response to appellee’s bill of costs in which it attempted to meet this burden, and appellee filed a reply. With all this information before it, the trial court, with a full knowledge of the issues and arguments, rejected appellants’ argument that the costs it awarded were not necessary to the presentation of appellee’s medical malpractice action. Having reviewed the record related to the costs awarded, we conclude that appellants have failed to demonstrate that the trial court abused its discretion in this regard.

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