Trent Lott

Mr. LOTT

Mr. LOTT. I understand that S. 378, introduced today by Senator Thompson, is at the desk, and I ask for its first reading.

Mr. LOTT

Mr. LOTT. Madam President, I thank the Chair.

Mr. LOTT. Mr. President, I wonder if the distinguished chairman of the Commerce Committee will yield for a question?

Mr. LOTT. Yes.

Mr. LOTT. I am glad the Senator put it so delicately, Madam President.

Mr. LOTT. I thank the Senator. As the chairman knows, the congressional leadership also has responsibility for appointing eight of the members of the commission. I wanted to confirm my understanding of the congressional leadership's responsibility for making appointments to the commission. Am I correct in believing that the congressional appointees were designed to ensure that the commission is not composed simply of people representing just the views of the administration?

Mr. LOTT. I will be delighted to yield.

Mr. LOTT. Madam President, I thank the distinguished chairman from Delaware for his efforts in this matter. I think it is clearly the right thing to do. The alternative would have been a catastrophe with our aviation programs in this country. We did not really have any alternative, and I think we have taken the right step. The proof that it is the right thing to do is that it passed overwhelmingly in the House, I think close to 370 votes perhaps, and in the Senate, while there are some reservations about it, we are able to move it with unanimous consent. So I thank the leadership of the committee.

Mr. LOTT. Mr. President, reserving the right to object, I would like to inquire. Is the Senator from Florida suggesting that he would like to make a statement at this point in the Record?

Mr. LOTT

Mr. LOTT. I urge our colleagues stay close to the floor because otherwise we will go into overtime. We had a couple of Senators, two or three this year, who have missed votes because they got away from the general area. We don't like that to happen. You have to stay close when we have a 10-minute count. I yield the floor. Amendment No. 13

Mr. LOTT. Mr. President, I ask unanimous consent that the second and third vote in this voting sequence be reduced to 10 minutes in length.

Mr. LOTT

Mr. LOTT. Mr. President, I ask unanimous consent the Senator from Delaware be allowed to proceed as in morning business for as long as he may need. We are waiting for the Democratic leader. We may perhaps interrupt for some agreements when he arrives.

Mr. LOTT

Mr. LOTT. Mr. President, for the information of all Senators, the Senate will close the debate on the Monday or the Tuesday session of the Senate with a final passage vote occurring on the constitutional amendment at 5:15 p.m. on Tuesday, March 4. I thank my colleagues for their cooperation and announce that no votes will occur on Friday of this week or Monday, March 3.

Mr. LOTT

Mr. LOTT. Mr. President, I ask unanimous consent that there now be a period for the transaction of morning business with Senators permitted to speak for up to 5 minutes each.

Mr. LOTT

Mr. LOTT. Mr. President, I am pleased today to join with my colleagues, Senator McCain and Senator Lieberman, in supporting biomaterials access assurance legislation to confront a looming health care crisis in our country. This legislation is of vital importance to the 8 million Americans who require life-saving and life-enhancing implantable medical devices. Most of us have a family member or friend who has benefitted from these wondrous products. The availability of the biomaterials necessary for medical device production is critical to the health of millions of Americans. The ramifications of unavailability are severe and, in the end, it is those in need of the devices who will suffer the most. This bill helps to curtail the impending health crisis by encouraging suppliers of raw materials and component parts to re-enter the medical implant market. Under the bill's provisions, a supplier of raw materials and/or component parts cannot be sued for design or manufacturing deficiencies of the final product unless the supplier can properly be classified as the designer, manufacturer or seller of the product as a whole. In recent years, and due in no small part to the prospect of derivative participation in broad-based lawsuits, major biomaterial suppliers have expressed their intent to limit or cease their shipments to manufacturers in the medical implant device market. Often, such a supplier has minimal or no knowledge or control of the design, manufacture or sale of an implant device. Nonetheless, under current product liability law, such a supplier can be named as a defendant in a product liability lawsuit based on the design, manufacture and sale of the device itself. And, although suppliers have been found not liable in the overwhelming number of such lawsuits, they must give great consideration to potential damage verdicts and the oppressive financial burden of lawsuit defense costs before deciding to supply manufacturers with raw materials and component parts. The detrimental effects of the biomaterials shortage are beginning to take their toll. Although the United States has been a leader in the medical implant field, that may change as our ability to focus on new technologies and to contribute funds to research and development is impaired by the diversion of available resources now directed to the search for and qualification of alternative biomaterials suppliers. As medical device manufacturers find it increasingly difficult to obtain needed raw materials and component parts, the industry's research and development resources, otherwise devoted to improving existing health care technologies, are drained and redirected to ensure material availability to meet current production demand. In some instances, no alternative sources for materials are found to exist. Just as many suppliers cannot afford the risk of liability suits, many manufacturers cannot afford the terms of indemnification contracts required by suppliers. Consider the case of Baxter Healthcare Corp., which operates a manufacturing plant in Cleveland, MS, employing approximately 1,000 people. A major manufacturer of life-saving and life-enhancing implantable medical devices such as heart valves, sewing rings, and left ventricular assist devices, Baxter is highly dependent upon medical-grade biomaterials for production. In facing a future based upon operation within this shortage scenario, Baxter is now diverting millions of dollars from research and development to fund its quest for finding alternative materials. Like manufacturers in other parts of the country, Baxter is dealing with suppliers that are faced with product liability risks that far exceed the benefit gained in dealing with a medical device manufacturer. For example, Baxter needed to purchase resin--less than 10 pounds a year--with a cost on the open market of less than $3 per pound. The supplier required an iron-clad indemnification contract before the materials could be sold to Baxter, and also demanded an annual fee of nearly $100,000 over and above normal material costs for continued use of the material--in other words, a surcharge for the risk associated with potential liability. This drain on manufacturers, as well as the uncertainty of obtaining any materials for the manufacture of their products, is directly attributable to the biomaterials shortage. Mr. President, the stability of the manufacturing process is in constant peril, and patients' lives hang in the balance. Let's act to limit liability to instances of genuine fault, and not encourage more frivolous lawsuits where they are, in fact, so often detrimental to consumer interests. It is my hope that the Senate will recognize the seriousness of the biomaterials shortage and that we will support this effort to encourage suppliers to re-enter the medical device market and to ensure that patients have available these critical, often life-saving options. Thank you, Mr. President, for the opportunity to articulate the urgency and criticality of this legislation.

Mr. LOTT

Mr. LOTT. Mr. President, I am pleased today to join with my colleagues, Senator McCain and Senator Lieberman, in supporting biomaterials access assurance legislation to confront a looming health care crisis in our country. This legislation is of vital importance to the 8 million Americans who require life-saving and life-enhancing implantable medical devices. Most of us have a family member or friend who has benefitted from these wondrous products. The availability of the biomaterials necessary for medical device production is critical to the health of millions of Americans. The ramifications of unavailability are severe and, in the end, it is those in need of the devices who will suffer the most. This bill helps to curtail the impending health crisis by encouraging suppliers of raw materials and component parts to re-enter the medical implant market. Under the bill's provisions, a supplier of raw materials and/or component parts cannot be sued for design or manufacturing deficiencies of the final product unless the supplier can properly be classified as the designer, manufacturer or seller of the product as a whole. In recent years, and due in no small part to the prospect of derivative participation in broad-based lawsuits, major biomaterial suppliers have expressed their intent to limit or cease their shipments to manufacturers in the medical implant device market. Often, such a supplier has minimal or no knowledge or control of the design, manufacture or sale of an implant device. Nonetheless, under current product liability law, such a supplier can be named as a defendant in a product liability lawsuit based on the design, manufacture and sale of the device itself. And, although suppliers have been found not liable in the overwhelming number of such lawsuits, they must give great consideration to potential damage verdicts and the oppressive financial burden of lawsuit defense costs before deciding to supply manufacturers with raw materials and component parts. The detrimental effects of the biomaterials shortage are beginning to take their toll. Although the United States has been a leader in the medical implant field, that may change as our ability to focus on new technologies and to contribute funds to research and development is impaired by the diversion of available resources now directed to the search for and qualification of alternative biomaterials suppliers. As medical device manufacturers find it increasingly difficult to obtain needed raw materials and component parts, the industry's research and development resources, otherwise devoted to improving existing health care technologies, are drained and redirected to ensure material availability to meet current production demand. In some instances, no alternative sources for materials are found to exist. Just as many suppliers cannot afford the risk of liability suits, many manufacturers cannot afford the terms of indemnification contracts required by suppliers. Consider the case of Baxter Healthcare Corp., which operates a manufacturing plant in Cleveland, MS, employing approximately 1,000 people. A major manufacturer of life-saving and life-enhancing implantable medical devices such as heart valves, sewing rings, and left ventricular assist devices, Baxter is highly dependent upon medical-grade biomaterials for production. In facing a future based upon operation within this shortage scenario, Baxter is now diverting millions of dollars from research and development to fund its quest for finding alternative materials. Like manufacturers in other parts of the country, Baxter is dealing with suppliers that are faced with product liability risks that far exceed the benefit gained in dealing with a medical device manufacturer. For example, Baxter needed to purchase resin--less than 10 pounds a year--with a cost on the open market of less than $3 per pound. The supplier required an iron-clad indemnification contract before the materials could be sold to Baxter, and also demanded an annual fee of nearly $100,000 over and above normal material costs for continued use of the material--in other words, a surcharge for the risk associated with potential liability. This drain on manufacturers, as well as the uncertainty of obtaining any materials for the manufacture of their products, is directly attributable to the biomaterials shortage. Mr. President, the stability of the manufacturing process is in constant peril, and patients' lives hang in the balance. Let's act to limit liability to instances of genuine fault, and not encourage more frivolous lawsuits where they are, in fact, so often detrimental to consumer interests. It is my hope that the Senate will recognize the seriousness of the biomaterials shortage and that we will support this effort to encourage suppliers to re-enter the medical device market and to ensure that patients have available these critical, often life-saving options. Thank you, Mr. President, for the opportunity to articulate the urgency and criticality of this legislation.

Mr. LOTT

Mr. LOTT. Mr. President, I ask unanimous consent that all amendments in order to the pending balanced budget constitutional amendment be limited to the following, and that they be first-degree amendments: Senator Bumpers amendment with regard to statutory alternative; Senator Boxers amendment with regard to disaster exemption; Two relevant amendments for Senator Byrd; Senator Conrad, a substitute; Senator Daschle, relevant; Senator Dorgan substitute, and sense of the Senate; Senator Durbin, tax cuts and shutdowns; two different amendments; Senator Feingold, one amendment on ratification time period, one with regard to surplus, one with regard to enforcement, and one relevant; Senator Feinstein, substitute; Senator Graham, public debt; Senator Hollings, one on campaign finance and one relevant; Senator Kennedy, one on judicial review and one on impoundment; Senator Kohl, capital budget; Senator Lautenberg, implementation language, and one relevant; Senator Leahy, debt limit, and one identified as relevant; Senator Levin, implementing legislation; Senator Moynihan, debt limit; Senator Reid, Social Security; Senator Rockefeller, Medicare; Senator Torricelli, capital budget; Senator Wellstone, proportionality, children, and sense of the Senate, all identified as one amendment; Senator Lott, two relevant amendments; Senator Hatch, two relevant amendments; and Senator Kempthorne, Social Security, sense of the Senate. I further ask that all amendments must be offered no later than 5 p.m. on Wednesday, February 26, and that any amendment not offered by 5 p.m. no longer be in order to the balanced budget constitutional amendment.

Mr. LOTT. Mr. President, I thank the Democratic leader for that cooperation. We will continue to have discussions and deal honestly and fairly with each other. This is a long list. But as he suggests, I hope they will not all be offered and that we can begin then to identify a time for those amendments to be considered in a regular order and move toward completing action on this debate on this amendment by next Tuesday. In that regard, Mr. President, for the information of all Senators, having had several discussions with the Democratic leader as to how to bring to a close this important constitutional amendment, it appears that it is the first step toward reaching final passage time by having this list offered now, which I hope would be in the late afternoon of Tuesday, March 4. All Senators who intend to offer amendments to this constitutional amendment must be included in the list just submitted. Also, the Senator on the list must then offer his or her amendment for consideration prior to 5 p.m. on Wednesday. Following the 5 p.m. deadline on Wednesday, the managers will then be able to determine how much work remains leading up to the final passage vote. We will be able to identify the amount of time and get some time agreements on the amendments that will be offered. And, of course, we will have adequate closing time for leaders. We should be able to come up with some time late Tuesday afternoon. But we will work through that, and we will keep the Senators informed as to how that will work through. At this point, until we see these amendments that are offered, we still can't say exactly what will be the situation on Friday or on Monday. It is anticipated that we will, as we have been doing, have a vote or votes on Monday afternoon. But we will work through that very carefully and will keep the Senators informed once we get the list and get some time agreements entered into. So I thank all of my colleagues for their cooperation. I think we are making some progress by obtaining this list. I yield the floor.

Mr. LOTT. That would not be my intent. I did intend to reserve the right to have that motion to recommit.

Mr. LOTT

Mr. LOTT. Mr. President, the bill that was just placed on the calendar is the so-called Smith-Oberstar U.N. population funding bill. I now ask unanimous consent the Senate turn to H.R. 581 by the close of business on Thursday, February 27, and there be 30 minutes for debate, equally divided in the usual form, with no amendments in order, and that following the conclusion or yielding back of the time, the bill be read a third time and the Senate proceed to a vote on passage of H.R. 581 with no intervening action or debate.

Mr. LOTT

Mr. LOTT. So, now, for the information of all Senators, tomorrow morning the Senate will be resuming debate on the pending Reid amendment to the balanced budget resolution. At 2:10 p.m. tomorrow the Senate will begin 5 minutes of closing remarks followed by a rollcall vote on adoption of House Joint Resolution 36, the resolution regarding U.N. population funding. Following that vote, the Senate then will resume debate on the Reid amendment, with a vote occurring on or in relation to the amendment at 6 p.m. on Tuesday afternoon. As a reminder, the Senate will debate Senator Feinstein's amendment on Wednesday morning, from the hours of 9 a.m. to 11 a.m. Following the vote at 11 on or in relation to the Feinstein amendment, Senator Torricelli will be recognized to offer an amendment relating to capital budgeting. That amendment is limited to 3 hours for debate. I thank my colleagues for their cooperation in allowing us to schedule these votes, and I hope we can continue to make progress on this important matter. It is my understanding that just prior to our weekly party conferences, the Democratic leader and I will be able to consult, and hopefully he will be in a position to enter into an agreement outlining the remaining amendments in order to the constitutional amendment. Once that agreement is reached, then we will be in a better position to notify our Members with respect to votes during the remainder of this week. It is my intention at this time to have votes on Friday on amendments, if necessary, unless we can get an agreement to the contrary. We should know about this tomorrow, and we will let the Members know for sure about votes on Friday and/or Monday. We want to have, and we have had, a full and fair debate on this very important constitutional amendment, and there have been amendments to that language that have been fully discussed. We continue to reach agreements on those amendments, including a Feinstein amendment, the Reid amendment, and for the Torricelli amendment. But I do think there is a point, at some time, when we need to come to closure on the amendments that are in order, have those debated and voted on if necessary, and then get to final passage. I hope we can get that worked out in the next couple of days.

Mr. LOTT

Mr. LOTT. Mr. President, I ask unanimous consent that the Senate recess from the hours of 12:30 to 2:10 p.m. for the weekly policy conferences to meet.

Mr. LOTT. Mr. President, I ask unanimous consent that when the Senate completes its business today, it stand in adjournment until the hour of 9 a.m. on Tuesday, February 25, I further ask unanimous consent that immediately following the prayer, the routine requests through the morning hour be granted and the Senate then resume consideration of Senate Joint Resolution 1, the constitutional amendment requiring a balanced budget.

Mr. LOTT

Mr. LOTT. I object to further proceedings on this matter at this time.

Mr. LOTT. Mr. President, I understand there is a bill due for its second reading.