|
|
||
|
|
||
|
July
25, 2000
UP TO THE MINUTE STOCK QUOTES FOR ALL OF "OUR" MANUFACTURERS ~*~*~*~*~*~*~*
Dan Buck's Times Editorial Response
~*~*~*~*~*~*~*~ BILL OF PARTICULARSATTORNEY ISSUES Be
Wary of Liens That Impact Settlements and Verdicts The existence of a hospital lien or a Medicare lien can pose a trap for an insurer and its defense counsel. Under many local statutes, a hospital may file a lien in a county court where the services were rendered in order to recover unpaid medical expenses from any third party that may subsequently be found liable for causing the patient's injuries. Payments of Medicare or Medicaid made on behalf of a patient automatically create a "super lien" that gives Medicare and Medicaid superior rights to recovery from any insurance carrier who might ultimately be held liable for the patient's injuries. Both entities are entitled to full reimbursement of the amounts paid, but Medicare will provide the patient with a pro rata discount for the costs necessary to collect the settlement or judgment. The dangerous aspects of the Medicare/Medicaid liens arise out of their ability to pursue the liability insurer, rather than just the patient, for payment of the lien. Thus, if a patient is subject to such a lien and obtains a settlement from a liability insurer, Medicaid/Medicare reserves the right to pursue the amount from the patient or from the liability carrier, even if the liability carrier has already paid the full settlement to the plaintiff! Defense counsel must be careful to examine each case for the possible existence of local liens or Medicare/Medicaid liens. Although some attorneys have tried to draft settlement agreements around the Medicare/Medicaid liens by apportioning the settlement proceeds for "injuries" (like pain and suffering) which were not the subject of Medicare/Medicaid payments, several courts have stricken such agreements. In a recent New York case, it was determined that Medicaid liens may be recovered from the full amount of a settlement, and not just the portion of a settlement allocated for past medical expenses. Some recoveries, however, may escape the Medicare/Medicaid lien if they are for the survivors or consortium claimants who are separately bringing claims on behalf of the party that actually incurred the Medicare/Medicaid expenses. Some attorneys recommend inserting indemnity language in settlement agreements stating that it is the plaintiff's responsibility for payment of any and all liens and that, should a lien holder pursue the insurance carrier for repayment of the lien, the plaintiff will come forward and resolve that debt. However, these indemnity provisions do not affect the ability of Medicare/Medicaid to separately pursue the liability carrier, and they are only as good as the financial stability of the plaintiff (who may immediately spend the money and be unable to reimburse the insurance carrier). Other attorneys recommend indemnity agreements that provide that the plaintiff and their attorney shall be responsible for reimbursing any amounts that an insurance carrier might additionally have to pay because of a subsequent lien action. This method provides additional incentive for the plaintiff attorney to discover and resolve any potential liens prior to settlement. Some carriers resolve known liens with the plaintiff attorney by issuing separate checks at settlement to ensure that a lien is satisfied (one check to the plaintiff and their attorney, and one check to the lien holder). Because liens are not always made known by the plaintiff attorney during a lawsuit, it behooves defense attorneys or claim managers to investigate whether Medicare/Medicaid was used to pay any of the patient's medical costs and to ensure that no liens are on file in a local court. Although it is not a frequent occurrence, it would certainly be unpleasant for a company to pay a large settlement to a plaintiff and then have to turn around and pay a significant amount again to the federal government in satisfaction of the Medicare/Medicaid lien. Eliminating Plaintiff's Causation Expert In a medical malpractice lawsuit, as in most lawsuits, the plaintiff must provide testimony that the defendant's acts caused plaintiff's injuries. Even if a defendant's conduct is negligent, there may be no damages if the conduct did not legally cause the plaintiff's injuries. Thus, the key witness for a plaintiff may be the so-called "causation expert." Beginning in 1923, the basic test for the admissibility of expert/scientific evidence on causation was whether or not the theory, study, or technique used to form the expert's opinion had gained "general acceptance" in the relevant scientific community. In many cases, this simply amounted to counting the noses of people in the scientific community who agreed or disagreed with the position taken by the testifying expert. Unfortunately, as the attorney-hired "professional" witness became more commonplace, a certain number of professional noses could always be counted on to support the admissibility of "junk science" into evidence. The Federal Rules of Evidence ("FRE") were established in 1975 to bring consistency to evidentiary matters in the federal court system. Rule 702 governs admissibility of scientific expert witness testimony and it requires that the trial judge ensures that scientific testimony/evidence be both relevant and reliable. The judge is supposed to determine whether the expert is proposing to testify to "scientific knowledge" and whether such scientific knowledge will assist the trier of fact (the jury) to understand the case. In 1993, the United States Supreme Court issued a ruling in Daubert v. Merrell Dow Pharmaceuticals, Inc. that provided more "teeth" to Rule 702. The opinion outlined general considerations judges should take into account when determining whether or not to admit scientific expert testimony into evidence. The decision was aimed at eliminating "junk science" from the courtroom. In at least thirty-five states FRE were used as the basis of similar state laws and, therefore, the "relevant and reliable" standard of Rule 702 and the Daubert rationale applies in most states as well. It is important for defense counsel to understand the policy considerations behind Daubert, as many current cases are being resolved by motions for summary judgment against plaintiffs because their expert's "junk science" or subjective opinions do not meet the "relevant or reliable" criteria from Daubert. Challenges against admissibility of the plaintiff's causation expert testimony may be raised through motions for summary judgment, at pretrial hearings to narrow the issues for trial, or through motions made at trial. The following issues have been identified by the judges in Daubert, and in subsequent decisions, as leaning heavily against the relevancy or reliability of an expert's testimony:
Recently, the Supreme Court determined that the appropriate level of review by an appellate court when examining a lower court's application of Daubert to exclude scientific testimony will be "abuse of discretion." Thus, it will be difficult for a plaintiff to appeal a decision where their expert's testimony has been barred, since district court judges have broad discretion. Unfortunately, not all state courts implement a pure Daubert analysis, as some state evidentiary statutes admit any testimony that appears relevant. Some state court judges allow all testimony and let the jury apportion the appropriate "weight" to be given to the credibility of the expert. Nonetheless, defense counsel should still attempt to have the expert testimony stricken if quirks or inconsistencies appear in methods the plaintiff's expert used to formulate their opinion. At this time, one critical opinion impacts the Daubert decision in medical malpractice cases. In Moore v. Ashland Chemical, Inc., a three-judge panel in the Circuit Court of Appeals in the Fifth Circuit (Texas) determined that "clinical medicine" is not the same as "hard science," so the expert testimony of a treating physician should not be subject to a Daubert analysis as the principles and methodology of clinical medicine are broad and well-grounded. The full Fifth Circuit Court of Appeals Panel has elected on its own to rehear that opinion en banc as it differs from all other post-Daubert cases in its interpretation that physician testimony differs from scientific testimony. Hopefully, the Fifth Circuit will soon overturn the Moore decision and again permit a Daubert analysis to be applied to expert medical testimony. A Daubert analysis has been used to exclude plaintiff's expert causation testimony: in cases where a relationship between silicone and autoimmune disease has been alleged; in cases where plaintiff's expert on damages used "unique" methods of calculating future damages; in automobile cases; and in other types of cases across the country. Information concerning the Daubert case and examples of briefs and court opinions on Daubert issues are available from the Legal Affairs Unit. Les W. Meredith is Vice President Senior Legal Affairs Counsel of The Medical Protective Company® in Fort Wayne, Indiana. ~*~*~*~*~*~*~*~ Breast Implants http://www.all-beauty.net/bustlines/cutting.htm
Internal Scarring Although the majority of the original breast tissue is pushed forward, some internal scaring also occurs inside of the breast cavity because the surgeon may have to scrape away some of the original tissue in order to make room for the artificial implant. Scar tissue forms in all types of breast implants and although this is seldom dangerous or unhealthy, an abnormal formation of internal scar tissue can make the new breast extremely hard, mis-shaped, un-natural looking, and uncomfortable. Since scar tissue could virtually encapsulate the entire breast, post-operative breast care always involves careful observation and breast implant patients are generally advised to follow a set of manipulative procedures to diminish the formation of scar tissue. This is not a complicated procedure for the patient and usually involves no more than simple breast massage on a regular basis. Many physicians feel that under-the-muscles implants are much less prone to the formation of internal scar tissue. Women with new breast implants should heed the physician's advise carefully about after surgery care because the formation of excessive scar tissue will make the new breasts virtually rock hard and very un-natural looking. In cases, where excessive scarring does occur, there are only three options for the patient. Most commonly, the physician can break up the internal scar tissue by using external force and manipulation. This procedure often works but it is a very uncomfortable process for the patient. The second and third options are more complicated and involve either additional surgery to remove the scar tissue or removal of the entire implant. Fortunately, such extreme measures are not common and properly installed breast implants can feel quite natural to the touch.
~*~*~*~*~*~*~*~*~ WASHINGTON -- The Supreme Court ruled in an important product-liability case Wednesday that consumers injured by faulty medical devices, like cardiac pacemakers, may seek damages under state law against the manufacturers even if the devices comply with federal regulations. The court rejected a broad argument put forward by the medical device industry that a 1976 law that for the first time brought medical devices under federal regulation also had the effect of barring any private suits for damages. Under this argument, the federal law, the Medical Device Amendments of 1976, pre-empted all state-court damage actions, including those based on claims that a device was faulty in design or manufacture or that it failed to provide adequate warnings about possible dangers from its use. All nine justices, in an opinion by Justice John Paul Stevens, agreed that claims of faulty design were not barred from state court. The vote was 5-4 in two other sections of the opinion, permitting suits based on negligent manufacture and failure to warn. The stakes for consumers and the industry were high in this case because federal law provides only for regulatory action against medical device manufacturers and provides no damages remedy for individual consumers. Consequently, a victory for the manufacturers would have had the effect of barring all private damage suits, in any court. Stevens said this would have been a "perverse" result, given that Congress passed the 1976 law to protect consumers, after serious health risks associated with a number of medical devices, including the Dalkon Shield, a contraceptive device, had come to light. The decision reinstated elements of a lawsuit against Medtronic of Minneapolis, the manufacturer of a pacemaker wire that failed suddenly while implanted in the heart of a 27-year-old woman, necessitating an emergency operation. The 11th Circuit U.S. Court of Appeals in Atlanta ruled last year that although the patient, Lora Lohr, could sue the manufacturer for damages based on allegations of negligent design, her claims based on negligent manufacturing and failure to warn were pre-empted by the federal law under which Medtronic had received approval to market the device. Although the ruling Wednesday has implications for the analysis of federal pre-emption in other areas, limitations in the court's opinion make the implications unclear. The justices may feel obliged to review other cases to explore the full range of issues. The decision was addressed to a particular category of medical devices that were exempted under the 1976 law from having to go through the Food and Drug Administration's full regulatory review because they were "substantially equivalent" to devices that had been on the market when the law took effect. Eighty percent to 90 percent of all medical devices now on the market, including a large majority of the new ones that come onto the market each year, fall within this category. So while the decision applies to the great majority of medical devices, it does not apply to all of them. The court may find that there are stronger reasons to pre-empt private damage suits involving devices that have received full regulatory review, a process that takes about 1,200 hours compared with the 20 hours the FDA spends reviewing devices in the "substantially equivalent" category. For future pre-emption cases, the most important but by no means the most clear part of the ruling is likely to be the court's discussion of its 1992 decision in a case involving smokers' lawsuits against cigarette companies. That decision, Cipollone vs. Liggett Group, held that the federal law requiring warning labels on cigarettes operated to pre-empt any damage suits based on state-law theories of inadequate warnings of the dangers of smoking. The Cipollone decision was widely seen as bolstering manufacturers' defenses, on the basis of federal pre-emption, against damage suits for nearly any product that is subject to some degree of federal regulation. On Wednesday, Stevens, who wrote the Cipollone decision, said that ruling was in fact not so broad. He said that the 1992 decision interpreted only the particular federal law at issue, the Public Health Cigarette Smoking Act of 1969, and that the court did not mean to establish a presumption that state courts were generally barred from permitting consumer lawsuits against manufacturers of products subject to federal regulation under other laws. The Medical Device Amendments should be interpreted as essentially never pre-empting a private damage suit, Stevens said. But Justice Stephen G. Breyer, who provided a fifth vote for the majority in crucial parts of the opinion, departed from this analysis in a separate opinion. Breyer said there could be cases in which state law bases a theory of liability that has the effect of imposing a requirement on the manufacturer different from or in addition to a requirement of federal law. A lawsuit based on such a theory would be pre-empted, Breyer said, although he agreed with Stevens that there was no pre-emption in this particular case. The members of the court who joined all of Stevens' opinion, Medtronic vs. Lohr, No. 95-754, were Justices Anthony M. Kennedy, David H. Souter, and Ruth Bader Ginsburg. Justice Sandra Day O'Connor filed a dissenting opinion that Chief Justice William H. Rehnquist and Justices Antonin Scalia and Clarence Thomas joined. They agreed that the portion of the suit based on negligent design was not pre-empted because, under the "substantial equivalency" process, the federal regulators placed no particular requirements on the Medtronic device beyond ascertaining that it was like one that was marketed before 1976. But the dissenters said the claims for defective manufacture and failure to warn were pre-empted by the FDA's "comprehensive requirements" governing manufacturing practices and labeling. Lars Noah, a law professor at the University of Florida who filed a brief without supporting either side, said in an interview Wednesday that the decision had failed to clear up the confusion that reigns in this area of law. "There is lots here for lawyers and law professors to play with for years to come," Noah said. ~*~*~*~*~*~*~*~ HUMOR
~*~*~*~*~*~*~
|
|
|
| E-mail Myrl | |
