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PART V: Medical Device Regulations Reports: Implications for Liability

MIKE JONES entered the offices of attorney John Smith with resolution fortified by three months of reluctance. After a brief preliminary interview, Mr. Smith asked Mr. Jones why he wanted to talk with an attorney. Mr. Jones explained that he is a diabetic, and, according to Mr. Jones' physician, Dr. Roberts, certain "difficulties" Jones was experiencing were attributable to his organic condition.

[Smith] "What difficulties?"

[Jones] "Well, I, er, it has to do with my wife."

[Smith] "Has she filed for divorce?"

[Jones] "No. Not yet, anyway."

[Smith] "But you have difficulties with your wife?"

[Jones] "Well, not exactly."

[Smith] "What is the problem then?"

[Jones] "The problem is me. I can't get an erection without help."

[Smith] "Help?"

[Jones] "Yes, you see, Dr. Roberts said that diabetics sometimes have this problem. He suggested a penile prosthesis using an inflatable device."

[Smith] "What did you do?"

[Jones] "It sounded great to me. So I told him to do it."

[Smith] "Did it solve your, er, problem?"

[Jones] "Did it ever! At first, it was fantastic."

[Smith] "Why just 'at first'?"

[Jones] "Then it started to swell."

[Smith] "Isn't that what it's supposed to do?"

[Jones] "Not so big."

[Smith] "What do you mean? How big?"

[Jones] "Dr. Roberts said it was 550 cc's."

[Smith] "That's over half a quart."

[Jones] "Yes, I had this huge erection, but it was quite painful."

[Smith] "How long did it last?"

[Jones] "Eight and a half days."

[Smith] "You had an erection for eight and a half days?"

[Jones] "Yes, a painful one."

[Smith] "What did you do?"

[Jones] "There was no way to get rid of it. Finally, it became so big and painful that I decided to make an appointment with Dr. Roberts. Then it went away."

[Smith] "It went away by itself? What did Dr. Roberts say?"

[Jones] "I decided, since it went limp, not to call him. But it still hurt."

[Smith] "For how long?"

[Jones] "Only a few days. Then, everything seemed okay. Then my wife and I decided to give it a try."

[Smith] "Er, do you mind saying what happened next?"

[Jones] "It didn't work."

[Smith] "What didn't work?"

[Jones] "It wouldn't inflate. Even with the implanted device I couldn't get an erection. Now isn't that the pits? Even with help, I'm impotent."

[Smith] "What did you do next?"

[Jones] "Nothing. I couldn't. My wife was very nice about it too. But I couldn't."

[Smith] "Did you try later?"

[Jones] "For several days. Then it started to hurt even worse than before. I called Dr. Roberts and he took it out. He told me there was a leak in the pump and a kink in the tubing. He said I had ruptured the," Mr. Jones referred to a piece of paper, "corpora cavernosa on both sides."

[Smith] "Both sides of what?"

[Jones] "Both sides of my penis. It still hurts like hell."

[Smith] "What do you want to do?"

[Jones] "Sue the SOBs who made the leaking pump and kinky tubing."

Mr. Smith called Dr. Roberts and identified the manufacturer of the penile prosthesis that had been implanted in Mr. Jones as Implant Corp. Dr. Roberts stated that he had been doing business with Implant Corp. for several years, and that they had never indicated to him that one of their implant devices could overinflate or leak. He confirmed that he had reported Jones' injury due to malfunction of the penile prosthesis to Implant Corp.

Next, Mr. Smith wrote a letter to the U.S. Food and Drug Administration requesting information under the Freedom of Information Act and Section 803.9 of the Medical Device Reporting Regulation about all reports of deaths, serious injuries, and malfunctions submitted under Part 803 to FDA since December 13, 1984.

The information Mr. Smith received enabled him to conclude that during the period December 13, 1984 to March 6, 1986 Implant Corp. had reported 546 malfunctions of their prosthesis devices all of which, if the malfunction were to recur, would be likely to cause serious injury. These malfunctions included 103 malfunctions of their anti-reflux prosthesis, 98 malfunctions of their tissue expander implant device, 216 malfunctions of their inflatable mammary prosthesis that had been implanted in Mr. Jones. In 119 malfunctions of the inflatable penile prosthesis, saline fluid was found to be leaking due to broken or kinked tubing; in 97 malfunctions, a connection between the tubing and the pump leaked; in 72 malfunctions, a pump cylinder leaked; and in 21 malfunctions, the device was removed because it inflated "automatically."

Mr. Smith was able to pinpoint the cause of nearly all 129 penile prosthesis malfunctions. For example, a device implanted for diabetes-related impotence on August 1, 1984 was removed on May 20, 1985 because the device cylinders deflated and a leak was found in the pump tubing. A penile prosthesis implanted on February 26, 1985 following radical prostatectomy was explanted three months later because the connector was fractured. A device implanted on December 4, 1984 for peyronies disease was removed on May 23, 1985 because there were leaks between the connector and the reservoir and in the pump. A device implanted in July, 1983 was explanted two years later when the pump developed a leak in the pump tubing. A kink in pump tubing necessitated the removal of a device implanted on February 28, 1985. A penile prosthesis implanted on May 14, 1985 for organic impotence was removed eleven days later due to "autoinflation" which caused severe pain to the patient. A device implanted on August 28, 1984 was explanted seven months later due to fluid which was leaking from the left penile cylinder. A penile prosthesis implanted on December 10, 1984 was removed seven months later after the patient had experienced rupturing of the corpora cavernosa on both sides of the penis at least twice. A penile prosthesis implanted on September 2, 1983 was removed a year and a half later because the device never functioned. A device implanted on August 21, 1983 was removed six months later when the patient developed severe pain emanating from a large mass which developed at the base of the penis. A device implanted on June 28, 1985 was removed two years later due to a leak in fatigued reservoir tubing. A device implanted June 6, 1985 was removed four weeks later after the reservoir dropped into the patient's groin area.

These details, together with the details of 118 other Implant Corp. inflatable penile prosthesis devices which had malfunctioned in a manner that is likely to cause serious injury to the patient, were very useful to Mr. Smith during the preparation of Jones' claim against Implant Corp.

For example, the reports establish that Implant Corp. was aware of the possibility that tubing used in their penile prosthesis devices was capable of kinking, thereby causing malfunctions ranging from no function at all to severe pain and serious injury to the patient. The reports also establish that Implant Corp. was aware of the possibility that the pumps used in their penile prosthesis devices can leak saline fluid into the penis, thereby causing severe pain and serious injury to the patient. The reports also establish that Implant Corp. was aware of the possibility that the pumps used in their penile prosthesis devices can leak saline fluid into the penis, thereby causing severe pain and serious injury to the corpora cavernosa and other parts of the penis. The reports further establish that Implant Corp. was aware of the possibility that the inflation control mechanism of their penile prosthesis devices was capable of malfunctions which could result in permanent enlargement of the penis accompanied by severe pain.

The reports also indicate that Implant Corp. failed to take remedial action which would have avoided Jones' injury. According to the reports, Implant Corp. interpreted the problems with the tubing as being "surgeon error," and failed to introduce kink-resistant tubing into their product for over one year after the FDA reports revealed that kinked tubing posed a threat of serious injury. Even then, no recall of the device or of inventory was made by Implant Corp. Implant Corp. interpreted the rupturing of corpora cavernosa as being "due to the patient's weak corpora cavernosa" and "not product malfunction," and the uncontrolled inflation was interpreted as "autoinflation." After examining explanted devices associated with both problems, Implant Corp. concluded, "the device was not the cause of the problem." No improvements in pumps or the control of fluid flow have been reported by Implant Corp.

The penile prosthesis implanted in Mr. Jones was manufactured by Implant Corp. with regular tubing two months prior to the introduction of kink-resistant tubing. No one knows whether or not Jones had two weak corpora cavernosa prior to their rupture, but Dr. Roberts believes that he probably does not. Finally, no one knows why Jones "autoinflated," but Dr. Roberts say that now that Jones is no longer a suitable candidate for penile prosthesis, he won't have to worry about erections. Not ever again.

As the fictitious example described above indicates, the filing of a Medical Device Report (MDR) under Part 803 of the Medical Device Reporting Regulation has products liability implications. Since the FDA is generally required under the Freedom of Information Act (5 U.S.C.  552) to make reports publicly available,  803.9 of the Regulation states, "Any report, including any FDA record of a telephone report, submitted under this part is available for public disclosure ... ." Since MDRs are available to attorneys representing injured parties, they are likely to be used in products liability and negligence cases against manufacturers; since the reports are also available to the individuals who select the medical devices to be used in connection with diagnosis and treatment, MDRs are also likely to be used in malpractice cases against health care providers.

An MDR contains the following information:

  1. Name of the manufacturer of the device.
  2. Type of Report, i.e., "Death," "Serious injury" or "Malfunction."
  3. The date the report was received by FDA.
  4. Access number.
  5. Name of the product.
  6. Model number.
  7. Lot number.
  8. Final event description.
  9. Final assessment (optional).

MDRs are not admissions of liability.  803.24(f) of the Regulations states, "A report or information submitted by a manufacturer ... does not necessarily reflect a conclusion by the manufacturer ... that the report or information constitutes an admission that the device caused or contributed to a death or serious injury or malfunctioned." However, since  803.24(f) continues, "A manufacturer...need not admit, and may deny, that the report or information submitted under this section constitutes an admission that a device caused or contributed to a death or serious injury or malfunctioned.", many attorneys advise the MDRs contain a disclaimer stating that the report (1) is based on information that may not be verified or may be inaccurate or incomplete, and (2) does not constitute an admission that a device was causally connected with a death or injury or malfunctioned.

Many attorneys feel that the manufacturer in this situation is (unfairly) on the horns of a dilemma. A disclaimer of all responsibility may also be used to indicate callous disregard for remedying the causes of a malfunction whereas the implementation of a remedy may be taken as a admission of a defect. The former seems far more dangerous legally than the latter because it extends the legal risks into the future whereas the latter confines them to past events for which not much can be done anyway. Such disclaimers should convey the manufacturer's past and present concern for the safety of patients using its medical device and not leave the impression that the manufacturer is ignoring the dangerous implications of the reported malfunction.

MDRs will certainly be considered by the courts as evidence that a manufacturer met its duty to provide a product that is not unnecessarily dangerous to patients. Failure to identify causes of reported device malfunctions and introduce improvements which would reduce the risks of such malfunctions, may be introduced as evidence of negligence in the design or manufacture of medical devices. Where it is impossible to identify the cause of a malfunction, failure to recall the product, or at least suspend distribution of inventory, may be used to indicate that a product is unreasonably dangerous or defective for purposes of products liability. Failure to include information describing the possibility of injuries or malfunctions reveled in MDRs may be used as evidence that the manufacturer failed to meet its duty to adequately warn of the dangers of a product.

MDRs should be evaluated by the manufacturer as a basis for recalling a device, removing a device from inventory, improving the design of a device, and/or reconsidering the adequacy of the labeling for a device.

MDRs will also be considered by the courts as evidence that a health care provider failed to meet its duty to provide competent service. The use of devices which are the subject of a substantial number of MDRs, rather than competing devices which are not, may be introduced as evidence of professional negligence. Where less controversial devices are not available, the use of any device which is the subject of a substantial number of MDRs without adequate warning to the patient may be used as evidence that the patient did not provide informed consent to the use of the device. The use of a device for which a substantial number of MDRs indicate a specialized danger to patients with a specific complication, if used in connection with such patients, may be introduced as evidence of professional malpractice.

MDRs should be evaluated by health care providers or health care provider groups as basis for evaluating the use of the device on a specific patient or whether or not to use the device on any patient, and, if so, as a source of information to assist the patient to decide whether or not to consent to the use of the device.

CONCLUSION

MDRs comprise an important source of public information which manufacturers and health care professionals should use to provide patients with safer, more effective medical devices. If manufacturers ignore this new source of information, patients who are injured thereby are likely to use the nonuse of the information as evidence that a product was manufactured in a negligent manner and/or is unreasonably dangerous. If health care providers ignore information publically available in MDRs, patients who are injured thereby are likely to use the nonuse of the information as evidence of negligence and professional malpractice.

 


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