[Congressional Record Volume 143, Number 142 (Tuesday, October 21, 1997)]
[Extensions of Remarks]
[Pages E2015-E2016]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  A CALL FOR PRODUCT LIABILITY REFORM

                                 ______
                                 

                         HON. WILLIAM M. THOMAS

                             of california

                    in the house of representatives

                       Tuesday, October 21, 1997

  Mr. THOMAS. Mr. Speaker, I rise to address an issue that may soon 
have severe implications for our health industry. Within the next year 
there may be a shortage of critical medical devices on the market due 
to the unavailability of biomaterials. Biomaterials, such as teflon, 
polyurethane, and polyester yarn, are necessary components in medical 
devices, for hip and knee implants, pacemakers, and catheters. What 
makes these biomaterials special is that their biological nature will 
not be rejected by the immune system. Their chemical properties are 
specialized to fit the durability and the malleability that is needed 
in constructing implants, like the tiny cochlear ear implant which 
enhances hearing.
  What has caused this short supply of biomaterials? Biomaterials 
suppliers are leaving the market of medical devices because of an 
onslaught of litigation. The suppliers of biomaterials have rarely been 
found liable for defects in the manufacture of a medical device. The 
reason is that the biomaterial seldom has anything to do with defect of 
the product. With so many victories, why would the biomaterials makers 
continue to face litigation threats? Why do plaintiffs and trial 
lawyers pursue innocent, though hapless, suppliers of biomaterials? 
Because they can. In the United States, anyone willing to pay a court 
filing fee can bring a lawsuit for any reason and pursue it through 
actual trial even with no hope of success. And while manufacturers of 
medical devices are relatively small and go bankrupt when forced to pay 
large litigation settlements, suppliers of biomaterials have deep 
pockets and thereby attract the voracious appetites of the major trial 
lawyers.
  Thus, biomaterial suppliers, most of which are companies that sell a 
small percentage of its overall production to medical device 
manufacturers, are subject to litigation for products that it had no 
say or responsibility. Biomaterial suppliers are being litigated 
against for simply supplying the raw materials.
  One example of the problem with litigation reaching too far in the 
biomaterials industry involves DuPont, a maker of synthetic materials. 
DuPont sold teflon to a manufacturer that made temporo mandibular joint 
implants. The manufacturer was sued on the grounds of tort law, where 
the plaintiff believed that the implant was defective. The manufacturer 
went bankrupt so the plaintiff held DuPont liable for the defective 
implant. With only about 5 cents' worth of teflon in each mandibular 
joint implant, DuPont was named in over 250 different

[[Page E2016]]

cases. DuPont won every case. However, the litigation cost was almost 
$50 million over 8 years. Result: DuPont left the medical device market 
after it decided, without too much difficulty, that its sales for 5 
cents of teflon resulted in millions of dollars in legal expenses.
  Do we hold steel mills responsible for the criminal use of a gun? Do 
we hold makers of car paint liable for every auto accident? The law 
does not, Juries do not. This Congress should not. As the chairman of 
the Health Subcommittee on Ways and Means, I fear this trend. In a time 
of rising health care costs, we can ill afford to lose the technologies 
that have helped patients live their lives with better quality and 
care. A shortage of raw materials for medical devices and implants will 
only raise health costs and limit access to the few. In the ongoing 
process of trying to provide more accessible health care at costs 
sustainable to our Nation's future, present product liability laws has 
the potential of running a lot of biomaterial suppliers out of the 
medical device market, even though many of them are completely without 
fault with regards to the design and manufacture of defective implants.
  It would be wise to look at recent health care history for a 
perspective. Just 40 years ago, children who were afflicted with 
hydrocephalus--water in the brain--died of brain damage in early 
childhood. With a device called an implantable shunt, doctors are now 
able to save these children by relieving the fluid pressure. Before 
pacemakers were created, heart attack victims would not have survived 
without something pacing the beat of their heart. Technology has now 
allowed us to achieve this. We can manufacture knee implants that allow 
crippled people to walk again. We now have hip and jaw implants. Our 
technology has been pushed forward with ambitious thinkers, courageous 
entrepreneurs, and a public with increasing demand for quality in their 
lives. In the end, every American benefits from these advances in 
medical technology. More than 75 percent of biomaterial suppliers have 
already left the medical device implant market. In responding to the 
influence that made them leave the market, 100 percent of the suppliers 
cited the fear of litigation costs.
  The medical device industry has almost $50 billion in annual domestic 
sales, with almost an additional 120 billion dollars' worth of sales in 
the foreign market. Because nearly a third of all medical device 
companies reside in California, a loss of this revenue to the 
California and U.S. economy would be significant. With the current rate 
of biomaterial suppliers leaving the market, the medical device 
companies may be left without the precious biomaterials to make 
implants and be forced to close their businesses.
  The many effects that current product liability law provides for with 
regards to biomaterials simply illustrates one segment of the 
detrimental effects of overlitigation on our economy. The biomaterials 
shortage is only one piece of a much larger puzzle. The problem remains 
excessive litigation while the solution is comprehensive product 
liability reform. It is not in the best interests of the American 
people to cease all litigation on defective or harmful products. 
However, we must provide an environment where consumers can be 
protected from bad products, while also limiting senseless litigation 
so that businesses can continue to operate, innovate, and provide for 
the American consumer. Piecemeal reform of certain industries, while 
ignoring the problems that excessive litigation is having on other 
industries, is not the solution. We tried, in 1995, to enact product 
liability reform but it was vetoed by the President. I ask Congress to 
enact comprehensive product liability reform.

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