Ethicon's Case Study

Ethicon demurred to the first amended complaint, contending that the products liability claim was time-barred by the one-year statute of limitations under Code of Civil Procedure former section 340, former subdivision 3. (Stats.1982, ch. 517, � 97, p. 2334; see fn. 3, post.) In opposition, Fox noted that she had no knowledge that the gastric bypass surgery would involve the use of a stapler or any similar device.

Fox further stated that she never learned during the postsurgical care following the gastric bypass operation that the stapler had malfunctioned or could have caused the leakage and other problems, and that she first discovered the possibility of a stapler malfunction when her counsel notified her of Dr. Gladen's deposition testimony. Finally, Fox offered to file a second amended complaint to clarify the facts supporting her assertion that she had no reason to suspect the stapler until after Dr. Gladen's testimony, and that no reasonable person would have suspected

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666 that the Ethicon product had malfunctioned.

Question 1

What is the maintenance dose of phenytoin in seizures arising as a

complication of chronic renal failure?

Question 2

I know that the loading dose of phenytoin in status epilepticus is

20 mg/kg with an upper limit of 1000 mg but if the same situation arose

as a complication of chronic renal failure (on regular dialysis), should

this dose remain the same or be reduced? If reduced, what should the

dose be?

Question 3

1. What is the most effective antiepileptic for a patient with simple

partial motor status epilepticus who is not responding to a loading

dose of phenytoin?

2. How long does phenytoin, given in a loading dose, take to work?

Question 4

Is valproate effective if given rectally in status epilepticus and, if so, what

dose is recommended?

Question5

In simple partial motor status epilepticus, if the patient does not respond

to diazepam and phenytoin, is it justifiable to proceed to anaesthetic

medication?

Question 6

What is the recommended upper limit dose of lamotrigine when

combined with both carbamazepine and valproate?

Question 7

Is a valproate-lamotrigine combination more effective than

carbamazepine on its own against partial seizures?

Question 8

Why is the incidence of parkinsonism less common in smokers?

Question 9

Is it recommended to start the treatment of parkinsonism with dopamine

agonists alone in elderly (over 60 years old) patients, and to delay using

L-dopa until the disease has progressed much further? Is there a rationale

for this protocol in younger patients?

Question 10

Does amantadine increase the endogenous release of dopamine, thus

aiding early treatment of parkinsonism final 120"

What is the maintenance dose of phenytoin in seizures arising as a complication of chronic renal failure?

 Phenytoin has a different pharmacokinetics in patients with chronic renal failure and therefore the maintenance dose is usually lower. It is between 100 and 200 mg per day, but may be raised or lowered according to the level of serum potassium.

 Is the initial dose of phenytoin in status epilepticus to be lowered in chronic renal failure and if yes, what should be the dose?

 Yes, the loading dose should be reduced, perhaps to account for the patient’s smaller size. In case of chronic renal failure the dose should be reduced to about 10 to 15 mg/kg but not more than 500 to 750 mg and should be titrated according to clinical response and monitoring.

 What is the best agent to use in a patient with simple partial motor status epilepticus who has failed to respond to a loading dose of phenytoin? In how much time does phenytoin, given in a loading dose, become effective?

 In simple partial motor status epilepticus which does not respond to phenytoin, levetiracetam is often advised. It may be 1 to 2 hours before phenytoin begins to show its effect after the loading dose.

 Does rectally given valproate work in status epilepticus, and if it does, what dose should be used?

 Of course, valproate can be effective when given rectally. The usual oral dose is 20 to 30 mg of the drug per kilogram of the patient’s weight.

 In simple partial motor status epilepticus, if the patient fails to respond to diazepam and phenytoin, is it reasonable to go for anaesthetic medication?

 Of course, one can proceed to anaesthetic medication including propofol or midazolam if the patient does not respond to diazepam and phenytoin.

 What is the maximal daily dose of lamotrigine that should be used when patient is on both carbamazepine and valproate?

 The dosage of lamotrigine that should not exceed when used with carbamazepine and valproate is 200mg/day and the doses should be adjusted according to the response and tolerance.

 Is the use of valproate and lamotrigine better than carbamazepine in the treatment of partial seizures?

 Of course, the combination of valproate and lamotrigine is more efficient than carbamazepine for some patients with partial seizures, since it is more comprehensive.

 What could be the possible explanation for the fact that parkinsonism affects fewer smokers?

 Parkinsonism is relatively rare in smokers, which may be attributed to the protective mechanisms of nicotine and other substances contained in tobacco on the dopaminergic system. ”

 Is it advisable to initiate the management of parkinsonism with dopamine agonists in elderly subjects without initiating L-dopa? What is the evidence for using this protocol in the younger patients?

 Indeed, in elderly patients, it is common to begin treatment with dopamine agonists only to defer the use of L-dopa and minimize motor side effects. In paediatric patients this approach is also employed to protect motor function over the long term and to minimize the risk of dyskinesias.

 Does amantadine enhance dopamine release endogenously and thus serve as effective in early treatment of parkinsonism?

 Yes, amantadine enhances endogenous dopamine release and, therefore, may help in the early phase of parkinsonism to decrease motor deficits.