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Case Notes

By ALM Staff | Law Journal Newsletters |
May 01, 2003

LAP Not Admissible to Prove Drug Defect

Evidence of a Limited Access Program in a product liability case involving Propulsid was not admissible to prove a defect in the drug. In re Propulsid Products Liability Litigation: Civil Action No. 00-2577 (Diez), MDL No. 1355 Section “L,” E.D. La., March 11, 2003.

The spouse of a decedent who died as a result of using a drug that was subsequently removed from the market sued the manufacturer. In the course of the litigation, the plaintiff sought to admit evidence of the Limited Access Program (LAP) ' which was created subsequent to her husband's death ' to prove the defect in the product. The defendants moved to exclude evidence of subsequent remedial measures. The federal district court handling the Multi-District Litigation (MDL) granted the motion with regard to warning labels issued after the death of the decedent. It originally reserved ruling as it related to the LAP, and in this decision, it granted the motion to exclude the evidence as it related to the LAP.

The LAP was instituted to allow some patients to continue to use Propulsid because it was the only treatment for certain conditions. The program requires patients to meet certain health and safety criteria and be approved by the FDA. The plaintiff argued that the LAP was not a subsequent remedial measure because Propulsid was still on the market, available on a restricted basis.

The court discussed the rational behind Federal Rule of Evidence (FRE) 407, which excludes evidence of subsequent remedial measures for the purpose of proving negligence or defect in a product or product design. The rule was established to encourage people to take “steps in furtherance of added safety.” There is an exception if the evidence is admitted for the purpose of proving ownership, control, or the feasibility of precautionary measures. The only issue before the court, however, was whether an LAP adopted after the decedent's death would have made his death less likely to occur. Rule 407 excludes subsequent remedial measures that may have reduced the likelihood of injury. Restricted use may have reduced the decedent's access to the drug and thus lessened the likelihood of harm. The court, therefore, concluded that evidence of the LAP was subject to the exclusionary rule of FRE Rule 407.

Manufacturer Not Liable for Third-party Alterations to Machine

A manufacturer or distributor is not liable for injuries caused by a machine that has been substantially altered by a third party. Patino v. Lockformer Co., Inc., 2002-00930, N.Y.App.Div., March 31, 2003.

The plaintiff was injured when he caught his hand in a roll-forming machine. He sued the manufacturer and distributor, alleging the machine was defective. When the machine was purchased, it was equipped with safety devices including a top cover, side covers, top and end curtains. There was no interlock to prevent it from operating if the top cover was removed, modified or damaged, but it had three warning stickers. Neither the manufacturer nor the distributor performed any service on the machine after it was sold. Sometime before the accident, however, someone removed the top and side covers.

The plaintiff claimed the machine was dangerous and defective because it was not equipped with adequate safety guards. The defendants moved for summary judgment on the grounds they could not be liable for an injury caused by a third party who had removed the safety devices. The plaintiff argued that there were questions of fact because the safety guards were easily removable. The trial court denied the motion for summary judgment and the defendants appealed. The appellate court reversed. It reiterated the established rule that a manufacturer or distributor could not be held liable where a subsequent modification that substantially changes a product causes the injury. The plaintiffs contended that the exception to that rule applied, ie, where the product is intentionally made to allow its use with the safeguards. The appellate court rejected the argument. It found that the evidence clearly demonstrated that the machine was initially equipped for safety and that a third party had removed the guards. The plaintiff had failed to raise a question of fact that the manufacturer had made the machine in a way that let it be used without the safety devices to furnish added versatility. Moreover, said the court, the absence of an interlock device was inadequate to impose liability on the manufacturer. It reversed the order for summary judgment.

LAP Not Admissible to Prove Drug Defect

Evidence of a Limited Access Program in a product liability case involving Propulsid was not admissible to prove a defect in the drug. In re Propulsid Products Liability Litigation: Civil Action No. 00-2577 (Diez), MDL No. 1355 Section “L,” E.D. La., March 11, 2003.

The spouse of a decedent who died as a result of using a drug that was subsequently removed from the market sued the manufacturer. In the course of the litigation, the plaintiff sought to admit evidence of the Limited Access Program (LAP) ' which was created subsequent to her husband's death ' to prove the defect in the product. The defendants moved to exclude evidence of subsequent remedial measures. The federal district court handling the Multi-District Litigation (MDL) granted the motion with regard to warning labels issued after the death of the decedent. It originally reserved ruling as it related to the LAP, and in this decision, it granted the motion to exclude the evidence as it related to the LAP.

The LAP was instituted to allow some patients to continue to use Propulsid because it was the only treatment for certain conditions. The program requires patients to meet certain health and safety criteria and be approved by the FDA. The plaintiff argued that the LAP was not a subsequent remedial measure because Propulsid was still on the market, available on a restricted basis.

The court discussed the rational behind Federal Rule of Evidence (FRE) 407, which excludes evidence of subsequent remedial measures for the purpose of proving negligence or defect in a product or product design. The rule was established to encourage people to take “steps in furtherance of added safety.” There is an exception if the evidence is admitted for the purpose of proving ownership, control, or the feasibility of precautionary measures. The only issue before the court, however, was whether an LAP adopted after the decedent's death would have made his death less likely to occur. Rule 407 excludes subsequent remedial measures that may have reduced the likelihood of injury. Restricted use may have reduced the decedent's access to the drug and thus lessened the likelihood of harm. The court, therefore, concluded that evidence of the LAP was subject to the exclusionary rule of FRE Rule 407.

Manufacturer Not Liable for Third-party Alterations to Machine

A manufacturer or distributor is not liable for injuries caused by a machine that has been substantially altered by a third party. Patino v. Lockformer Co., Inc., 2002-00930, N.Y.App.Div., March 31, 2003.

The plaintiff was injured when he caught his hand in a roll-forming machine. He sued the manufacturer and distributor, alleging the machine was defective. When the machine was purchased, it was equipped with safety devices including a top cover, side covers, top and end curtains. There was no interlock to prevent it from operating if the top cover was removed, modified or damaged, but it had three warning stickers. Neither the manufacturer nor the distributor performed any service on the machine after it was sold. Sometime before the accident, however, someone removed the top and side covers.

The plaintiff claimed the machine was dangerous and defective because it was not equipped with adequate safety guards. The defendants moved for summary judgment on the grounds they could not be liable for an injury caused by a third party who had removed the safety devices. The plaintiff argued that there were questions of fact because the safety guards were easily removable. The trial court denied the motion for summary judgment and the defendants appealed. The appellate court reversed. It reiterated the established rule that a manufacturer or distributor could not be held liable where a subsequent modification that substantially changes a product causes the injury. The plaintiffs contended that the exception to that rule applied, ie, where the product is intentionally made to allow its use with the safeguards. The appellate court rejected the argument. It found that the evidence clearly demonstrated that the machine was initially equipped for safety and that a third party had removed the guards. The plaintiff had failed to raise a question of fact that the manufacturer had made the machine in a way that let it be used without the safety devices to furnish added versatility. Moreover, said the court, the absence of an interlock device was inadequate to impose liability on the manufacturer. It reversed the order for summary judgment.

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