Dear counsel:As the spoof letter indicates, this proposal is objectionable in that it would take all sorts of otherwise confidential, and even privileged (although the new draft tries to reduce that) evaluation of ongoing litigation – Will we win? How do we win? How much might we pay if we lose? How much will it cost to litigate? – and requires its public disclosure.
Please prepare a letter about the large cases you are defending for our company, honestly and completely explaining:
What are our risks in cases where we re being sued? Do you think we are going to win or lose? If we lose, how bad is it likely to be?
When do you think you will settle the case?
Include an evaluation of any cases where you are sure we will win and not owe anything, but if you’re wrong and the wheels fall off, the verdict will have a “severe impact” on our company. And then write about any cases where you're sure we’re going to win, but defending the case is going to be really expensive and disruptive – we want your evaluation of those cases, too.
And when you’re done writing all this down, we’re going to put it up on the internet where the other side can read all of your thoughts about these cases.
After you’ve shown all your cards, good luck defending the cases. Don’t let us get into trouble. And have a nice day.
- Product Liability Contingencies: Disclosures of exposure to material amount of loss arising from allegations of damages pertaining to and arising from one or more of the entity’s products. This element may be used for a listing and details of all of an entity’s disclosures about such loss contingencies.
- Product Liability Contingency: Information and financial data about the reasonably possible loss, the remote loss (certain contingencies), or the recognized loss from product liability contingencies related to an individual product.
- Product Liability Contingency, Description: Describes the damages allegedly caused by appropriate use of the product, such as death from a drug and injury from a toy, which the damaged party reasonably believed was attributable to dangers for which no warning or inadequate warning was provided, such as defects in labeling, construction, and inappropriate (impurities in) processing.
- Product Liability Contingency, Geographic Areas: Identifies the geographic areas in which the damages were alleged to have occurred.
- Product Liability Contingency, Management Assessment Process: Describes management’s process to evaluate allegations of damages pertaining to a product and to estimate the impact on the financial statements and ongoing operations.
- Product Liability Contingency, Accrual, Assumptions: Describes the important assumptions underlying the estimate of the product liability loss, and may describe any changes in the assumptions made since the last reporting period.
- Product Liability Contingency, Circumstances Impacting Precision of Estimate: Circumstances affecting the reliability and precision of damages estimates for a specified product.
- Product Liability Contingency, Loss Inestimable Explanation: Reason(s) why an estimate of the probable or reasonably possible loss or range of loss for product liability damages cannot be made.
- Product Liability Accrual, Material Components: Describes the material components of a loss accrual for damages arising from third-party use of the entity’s product(s) or process(es).
- Product Liability Accrual, Component Amount: Recorded amount of the accrual for a material component of a product liability contingency.
- Product Liability Accrual, Period Expense, Caption: Identifies the income statement line item in which the amount of loss reported during the period pertaining to product liability is reflected.
- Product Liability Accrual, Period Expense: The amount of loss reported during the period pertaining to product liability.
- Loss Contingency Accrual, Product Liability, Undiscounted, Due within One Year: The portion of the estimated aggregate undiscounted amount of the accrual for damages arising from third-party use of the entity’s product(s) or process(es) that is expected to be paid within one year of the balance sheet date.
- Loss Contingency Accrual, Product Liability, Undiscounted, Due in Second Year: The portion of the estimated aggregate undiscounted amount of the accrual for damages arising from third-party use of the entity’s product(s) or process(es) that is expected to be paid in the second year after the balance sheet date.
- Loss Contingency Accrual, Product Liability, Undiscounted, Due in Third Year: The portion of the estimated aggregate undiscounted amount of the accrual for damages arising from third-party use of the entity’s product(s) or process(es) that is expected to be paid in the third year after the balance sheet date.
- Loss Contingency Accrual, Product Liability, Undiscounted, Due in Fourth Year: The portion of the estimated aggregate undiscounted amount of the accrual for damages arising from third-party use of the entity’s product(s) or process(es) that is expected to be paid in the fourth year after the balance sheet date.
- Loss Contingency Accrual, Product Liability, Undiscounted, Due in Fifth Year: The portion of the estimated aggregate undiscounted amount of the accrual for damages arising from third-party use of the entity’s product(s) or process(es) that is expected to be paid in the fifth year after the balance sheet date.
- Loss Contingency Accrual, Product Liability, Undiscounted, Due after Fifth Year: The portion of the estimated aggregate undiscounted amount of the accrual for damages arising from third-party use of the entity’s product(s) or process(es) that is expected to be paid after the fifth year after the balance sheet date.
- Loss Contingency Accrual, Product Liability, Gross: The estimated aggregate undiscounted amount of the accrual for damages arising from third-party use of the entity’s product(s) or process(es) as of the balance sheet date. Loss Contingency
- Accrual, Product Liability, Discount: The amount of imputed interest necessary to reduce (reconcile) the estimated aggregate undiscounted amount of the accrual for damages arising from third-party use of the entity’s product(s) or process(es) to the present value recognized on the balance sheet (if the accrual qualifies for discounting).
- Loss Contingency Accrual, Product Liability, Net: Present value of the estimated aggregate accrual for damages arising from third-party use of the entity’s product(s) or process(es) as of the balance sheet date (if the accrual qualifies for discounting).
- Loss Contingency Accrual, Product Liability, Net, Explanation of Material Change in Accrual: Describes the nature or cause of a material change in the expected aggregate amount since the prior balance sheet date, other than a change resulting from pay-down of the obligation.
- Product Liability Contingency, Accrual, Discount Rate: Rate applied to the undiscounted amount of estimated damages for product liability to arrive at the present value recorded as of the balance sheet date.
- Product Liability Contingency, Accrual, Discount Amount: The amount of imputed interest necessary to reduce (reconcile) the estimated aggregate undiscounted amount of the accrual for damages arising from third-party use of the entity’s product(s) or process(es) to the present value recognized on the balance sheet (if the accrual qualifies for discounting).
- Product Liability Contingency, Accrual, Present Value: Present value of the accrual for product liability contingencies as of the balance sheet date (if the accrual qualifies for discounting).
- Product Liability Contingency, Accrual, Caption: Identifies the balance sheet line item in which the accrual for the product liability loss contingency is reflected.
- Product Liability Contingency, Indication Accrual May Change: Disclosure that it is reasonably possible that a change in an estimate of the obligation will occur in the near term when information available prior to issuance of the financial statements indicates that it is at least reasonably possible that the product liability accrual estimate will change due to one or more future confirming events.
- Product Liability Contingency, Loss Exposure Not Accrued, Description: Nature of the reasonably possible allegations of damages and estimate of the loss exposure for product liability for which no accrual has been recorded.
- Product Liability Contingency, Loss Exposure Not Accrued, Best Estimate: Best estimate of the loss exposure for a reasonably possible liability for product liability damages for which no accrual has been recorded.
- Product Liability Contingency, Loss Exposure Not Accrued, Low Estimate: Low-end of the range estimate for a reasonably possible liability for product liability damages for which no accrual has been recorded.
- Product Liability Contingency, Loss Exposure Not Accrued, High Estimate: High-end of the range estimate for a reasonably possible liability for product liability damages for which no accrual has been recorded.
- Standard Label Definition Codification Reference Product Liability Contingency, Loss Exposure Not Accrued, Third Party Recovery Commentary: Describes the extent to which disclosed but not recognized contingent losses from product liability damages are expected to be recoverable through insurance, indemnification arrangements, or other sources, and any material limitations of that recovery.
- Product Liability Contingency, Loss Exposure in Excess of Accrual, Description: Nature of the reasonably possible loss contingency and estimate of the reasonably possible loss exposure in excess of the amount accrued for damages pertaining to a specified product.
- Product Liability Contingency, Loss Exposure in Excess of Accrual, Best Estimate: Best estimate of the reasonably possible loss exposure in excess of the amount accrued for damages pertaining to a specified product.
- Product Liability Contingency, Loss Exposure in Excess of Accrual, Low Estimate: Low-end of the range estimate of the reasonably possible loss exposure in excess of the amount accrued for damages pertaining to a specified product.
- Product Liability Contingency, Loss Exposure in Excess of Accrual, High Estimate: High-end of the range estimate of the reasonably possible loss exposure in excess of the amount accrued for damages pertaining to a specified product.
- Product Liability Contingency, Unasserted Claims: Extent to which unasserted claims are reflected in an accrual or may affect the magnitude of the site contingency.
- Product Liability Contingency, Uncertainties from Joint and Several Liability: Uncertainties with respect to joint and several liability that may affect the magnitude of the contingency.
- Standard Label Definition Codification Reference Product Liability Contingency, Uncertainties from Insurance: Uncertainties with respect to the legal sufficiency of insurance claims or the solvency of carriers for product liability damages.
- Product Liability Contingency, Time Frame of Disbursements: Estimated time frame of disbursements over which the accrued or presently unrecognized amounts may be paid out for damages pertaining to a specified product.
- Product Liability Contingency, Recovery from Third Party Product Liability Contingency Recovery From Third Party Of Environmental Remediation Cost: Amount of the estimated recovery from third parties recorded in the period pertaining to product liability damages from specified products.
If your clients (or your company, for you in-house folks) haven’t commented on this proposal, it’s something to consider. In the pharma business, it’s all about “an ounce of prevention being worth a pound of cure.”
1 comment:
I have a question. My sister almost died after having a Cyberonics vns device implanted to treat a seizure disorder, and she is now permanetly disabled because of it. That has led me to find out more about this device, it's approval, etc. This device is a Class III, which is suppossed to have a much stricter and rigorous approval process, but in their depression approval order, P970003/S050 it states FAILURE TO COMPLY WITH ANY POST APPROVAL REQUIREMENT CONSTITUTES FOR WITHDRAWAL OF APPROVAL OF PMA, and I feel that has been ignored and Regel vs. Medtronics should not cover this company. In November of 2008 they were allowed to submit a proposal to the FDA to have those original COA changed, and the FDA accepted. That was wrong. If there was a problem with the approval order, it should have been discussed at the time of the signing, not years later when those conditions were just about due. This made me wonder if quite possibly the company DID have the original amount of people required but some test results were so negative they just didn't want to include them. Rather then include them, they sought an ammendment, and got it. That brings me to FAS-5. According to Section 215 it gives the government extreme power to secretly obtain peoples' business records. Could our government obtain their records going back to 2005 to see if there were any hidden and excluded clinical trial results? Could they even, under Ammendment No. 2874 obtain a "sneak and peak" warrant and search their hard drive?
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