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| Thursday, June 29, 1995 · Page A 6 | © 1996 San Francisco Examiner | |
Michael Dougan
OF THE EXAMINER STAFF
| SAN RAFAEL - A 26-year-old Tiburon athlete has been awarded $3.4 million by a jury for injuries he suffered when the front wheel came off of his mountain bike during a ride on Mount Tamalpais nearly 2-1/4 years ago. Attorneys for Mark Fiorito, who suffers epileptic seizures as a result of severe head injuries stemming from the accident, said the award by Marin County Superior Court jurors dramatized dangers inherent in quick-release mechanisms that allow a bike's front wheel to be removed for easy transportation and storage. Because two of four defendants named in the suit have already settled out of court, Fiorito will actually receive less than the $3.4 million set by the jury. His lead attorney, Mark Webb, said Fiorito would end up getting about $1.5 million. Fiorito, a world-class competitive swimmer, not only has seizures because of the accident, but also suffers the onset of a rare disorder that prevents him from taking anti-seizure medication, according to Webb and Andrew Rhine,who also represented Fiorito. They said that the disorder, called Stevens-Johnson syndrome, also stems from the accident. Bike lacked safety devicesWebb argued in court that the front wheel on Fiorito's Mongoose bicycle had come loose during a two-hour ride on Jan. 23, 1993, and fallen off because the quick-release device designed to secure the wheel to the fork didn't have safety devices incorporated in many bicycles since 1989. A quick release consists of a long skewer that passes through the wheel's axle. One end is fitted with a nut and the other with a short lever that must be closed to tighten the wheel to a bicycle's fork or frame. The popular device, used in place of nuts and bolts, allows cyclists to remove and reinstall a wheel quickly without a wrench. Safety enhancements adopted for quick-release mechanisms include special washers or a small lip on the fork that prevents wheels from falling off if the quick-release is disengaged, said a spokesman for the Baltimore-based League of American Bicyclists. Ralph Robinson, one of two defense attorneys, contended after the verdict that the safety devices were not necessary. "If you lock the quick-release, the wheel doesn't come off," he said. During the trial Webb and Rhine showed jurors a chart listing 15 other lawsuits against Mongoose and Merida Industries, the Taiwan company that assembles Mongoose bicycles. "I believe that each of these cases represents the same (quick-release)defect," said Webb after the verdict. "To the best of my knowledge,all of these accidents happened because there was no safety device." Fiorito's attorneys also called world-famous bicycle racer John Howard to the stand. He testified that he had once been injured when his quick-release mechanism failed and the front wheel popped off his bike. Mongoose and Rogers had already reached pretrial settlements. Fiorito declined comment on the award. Webb said his client "feels vindicated and hopes this never happens to anybody else." |
As I walk around Interbike meeting with various people, I am hearing much discussion about the Fiorito v. Mongoose case. And rightly so. As you may recall, a Northern California rider, Mark Fiorito, claimed that the front wheel suddenly fell off his mountain bike. He was badly injured.Fiorito successfully sued the distributor, Mongoose; the bike's manufacturer, Merida; the fork's manufacturer, Spinner; and the Tiburon,California, retailer who sold him the bike.
Manufacturers and legal experts are concerned by a decision the California judge made to exclude any reference at trial to federal regulations pertaining to quick-releases and positive retention features.
What Is the Regulation? Before discussing why the judge kept the jury from hearing about the federal regulations, let's take a look at what the consumer products Safety Commission (CPSC) has to say about wheel fasteners:
The agency requires that wheels be secured with a positive lock device.Front hubs not equipped with lever-operated quick-release devices must have appositive retention feature to assure that when the locking devices are released the wheel will not separate from the fork.The term "positive retention feature" is undefined. But one section of the regulations indicates that the positive retention device must retain the front wheel after locking nuts have been loosened and a separation force of at least 25 pounds is applied to the hub on a line along the dropout slots.
The problem in the Fiorito case was that the bike was equipped with a quick-release front hub and a safety washer as opposed to forged tips or recessed dropout faces, which are harder to remove than the washers.
On Fiorito's bike, which was bought second-hand, the devices had been removed or lost. The manufacturers argued that the CPSC does not require positive retention features on quick-release hubs.
But Fiorito's counsel argued that the rule only states that they must be provided on nutted hubs, not on quick-release hubs.
Compliance Is No Defense. The most serious obstacle for the manufacturers was the judge's reliance upon a federal rule that provides, in part, that compliance with consumer product safety rules shall not relieve any person from liability at common law or under state statutory law.
This does not mean that the quick-release provisions must be kept from the jury. Fiorito's attorney argued that allowing the jury to hear of the regulations would have prejudiced the jury in favor of the manufacturers.
The jury may have thought the federal regulations were the last word on the subject and that liability could not be imposed if the manufacturer had complied with them. The soundness of this argument may be subject to attack on appeal.
Other Cases Shed Light. In Ramirez v. Plough, the California Supreme Court found that federal and state regulations governing the labeling of non-prescription drugs essentially required the court to adopt the standard set down by the legislature. Thus, the plaintiff had no cause for action against a drug manufacturer for failing to provide Spanish language warnings of an adverse reaction. The case did not address the issue of admissibility before a jury. The industry could avoid these types of arguments by enacting standards, such as those promulgated by ISO and ASTM.
Specific and up-to-date standards, with test results and certification to back them up, would help experts and attorneys defend these cases. In some cases, the admission of standards will make a difference in the outcome. But we need to create and use the standards first.
BAY AREA REPORTER
4 July 1996
SF docs finds cancer drug
is potential HIV wasting treatment
"I recognized that what was for SunPharm a complication or side effect, was exactly the thing we were looking for."
Dr. Dean Rider
by Shaun Schwartz
A new drug poses great potential for some advanced AIDS patients, and a recent court settlement involving the drug company and a San Francisco physician should speed its approval by the U.S. Food and Drug Administration.
The new drug, DEHOP, still in its clinical trial phase with the FDA, promises to relieve the severe diarrhea and wasting syndrome that adversely affects more than 60 percent of AIDS patients, leading to life-threatening malnutrition and weight loss.
Dr. Dean Rider, a San Francisco internist and gastroenterologist who specialized in HIV and AIDS-related illnesses, first learned of DEHOP in 1992 when he was consulting with the drug company that developed it, SunPharm Corporation of Jacksonville, Florida.
DEHOP was being researched for use with cancer patients, and Rider learned that one of DEHOP's side-effects was severe constipation.
Rider told the Bay Area Reporter he realized then that DEHOP could have enormous potential in treating patients suffering from the wasting syndrome that usually accompanies later stages of AIDS.
"I recognized that what was for them (SunPharm) a complication or side effect, was exactly the thing that we were looking for," he said.
The diarrhea experienced by advanced AIDS patients often can't be adequately treated with currently available drugs," Rider said, and the treatments are very expensive, are complicated to administer, and produce side effects of their own. Sometimes, he said, the exact cause of the diarrhea can't even be determined.
"The other drugs out there have variable successes," Rider said, "we we try to alleviate the symptoms rather than the cause of the diarrhea."
While current drugs are either anti-motality -- slowing the workings of the digestive tract - or anti-secretory - slowing the secretions of the digestive system, DEHOP has both properties. This difference, Rider said, poses the greatest hope for the use of DEHOP for AIDS patients experiencing severe diarrhea and wasting syndrome.
DEHOP is administered as a pill, Rider said, which also makes dispensing and use easier than current effective treatments for diarrhea.
A lawsuit brought in San Francisco federal district court alleges that SunPharm breached an agreement with Rider to credit him for his discovery, according to attorney Mark L. Webb, who represented Rider in the suit. But Rider and SunPharm reached a settlement in June, Webb said, and both parties hope for rapid approval of DEHOP.
"The resolution of this dispute facilitates the progress of the company to get this drug approved faster," Webb said. "That was our motivation for settling the dispute, and I think it was also the motivation of the company."
SunPharm successfully completed Phase I clinical trials of DEHOP in pursuit of FDA approval and is hoping to have complete approval by 1997.
San Francisco Examiner