Another challenge is the science utilized as evidence, as this leads to the conclusion of the case. In the courtroom, the answers offered by the legal approach versus the scientific approach could differ immensely.
Another problem is the jury is not specifically educated in law or science, yet they must make determinations on very complex information. Our change to the current Idaho Statute would alleviate this system failure. We propose to add section 123A: In the case of a product liability claim, the FDA will appoint an independent team to review the initial testing and research studies. If the independent body does not find that the initial study was faulty, and the product was appropriately approved/marketed, the case is closed, and there will be no litigation regarding product liability. If the Independent team finds the initial testing and research to be faulty, the case may proceed to litigation.
The current caps on the Idaho Statutes relating to Medical Product Liability are shown in Figure 1:
Figure 1: Idaho Statutes relating to Medical Product Liability
The plaintiffs in the video cases intended to demonstrate product liability by establishing the elements of negligence, failure to warn and/or a defect in manufacture, in order to secure a tort of strict liability against the manufacturers. Restatement of the Law, Third, Torts: Products Liability (1998) developed three distinct categories to consider a product defective:
- Manufacturing Defect - when the product departs from its intended design, even if all possible care was exercised.
- Design Defect - when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design, and failure to use the alternative design renders the product not reasonably safe.
- Inadequate Instructions or Warnings Defect – when the foreseeable risks of harm posed by the product could have been reduced or avoided by reasonable instructions or warnings, and their omission renders the product not reasonably safe.
In the case of Mahlum v. Dow Chemical, the plaintiff argued successfully that Dow and its subsidiaries failed to test the implant properly and failed to warn of the dangers associated with the use of the implant. Mahlum v. Dow Chemical, Nv., 114 (1995). The plaintiffs in Fentress v. Eli Lilly also presented evidence to maintain these same elements of product defect. Potter v. Eli Lilly and Co., Ky., 926 S.W.2d (1996).
Whether the product in question is a drug or a medical device such as a breast implant, product liability can now be assigned with greater ease when applying the warnings or manufacturing defect compared to the design defect. Ruff (1999, § III.B.(RAD), ¶ 1) stated that “The move from strict liability to negligence places a higher burden of proof on a plaintiff who proceeds under a design defect theory. The Third Restatement mandates that a risk-utility balancing test must determine the reasonableness of the manufacturer’s design.” Restatement of the Law, Third, Torts: Products Liability, (sec.)2 cmt. d (1998). When utilizing the manufacturing defect provision for a drug, plaintiffs will typically support a claim with evidence that a manufacturer failed to test a drug properly as opposed to checking the quality of or the process used to create the drug.
Since the Third Restatement appears to ease the burden of a manufacturing defect to a strict liability doctrine, we believe a greater good will be achieved for the public if Congress institutes a law giving the FDA the authority to require the disclosure of all clinical trial results for drugs to the public. Specifically, drug companies must publish all clinical trial results in an independent database accessible to the public within 60 days of receiving an approval letter from the FDA related to their New Drug Application (NDA) submission. This data will allow the FDA to monitor the safety and efficacy of drugs effectively, while the public also benefits from a reduced burden to obtain crucial data that supports potential product liability claims for warnings or manufacturing defect.
Authority of the FDA
The Food, Drug, and Cosmetic Act (FD&C), 21 U.S.C. §§ 301, et seq., was enacted by Congress in 1938 as a public health bill, in response to repeated problems with the sale and use of medicines and medical devices which were unsafe or simply did not do what was claimed (FDA,(n.d.),¶1). The FD&C granted authority to the FDA for enforcement of statutes aimed to ensure approval of all drugs before introduction to the market, to control medical devices and cosmetics, to enforce food standards and to require that drugs are labeled with instructions for safe use. Id.,¶3. The statutes in FD&C require drug manufacturers to establish the safety and effectiveness of a new drug before approval for use in this country.
Drug Development Process
The Center for Drug Evaluation and Research (CDER) is the arm of the FDA that evaluates new drugs and monitors existing ones for adverse reactions and/or negative side effects. To market a new product, a drug company must submit an NDA to the CDER for review. 21 U.S.C. §355(a),(b). The NDA must specify the methodology used in and the results from controlled clinical trials that demonstrate the safety and efficacy of the drug for its intended use, along with proposed labeling. Id. §355(b),(d). An outline of this process appears in Figure 2 (FDA, 1999):
Figure 2: The New Drug Development Process
CDER staff, including scientists, pharmacologists and statisticians, review the NDA to ensure significant scientific evidence exists for an accurate determination of the drug’s risk/benefit ratio. At the request of the CDER, an advisory committee of outside experts often reviews the application to offer their guidance on “whether the available information is adequate to support a determination that a particular drug meets the statutory standards for proof of safety and effectiveness necessary for marketing approval” (New Drug and Antibiotic Regulations, 1985). 21 U.S.C. §14.160-§14.174. If the CDER concludes the drug is safe and effective, an approval letter will be sent to the drug company and marketing of the drug can begin on that date. 21 U.S.C. §355(c). The drug holds exclusive rights for sale in the marketplace until the end of its patent life, which typically amounts to 20 years minus the time spent in FDA review.
Post-marketing Commitments / Phase 4 Trials
Despite the rigor of approved clinical trials, the CDER is often unable to make a final determination on the safety of a new drug due to the relatively short duration of the trials (average of 3-5 years). Instead of withholding approval of the drug and delaying its entry into the market to help those patients for whom it was designed, the CDER commonly approves the NDA but requires the drug company to continue established studies for data collection necessary for analysis of the drug’s long-term safety and effectiveness relative to similar drugs on the market. This process represents a ‘post-marketing commitment’ or a Phase 4 trial.
The Food and Drug Administration Modernization Act of 1997 established the authority for CDER to require the on-going study of certain drugs (Modernization Act, 1997). In a recent report published in the Federal Register, the FDA (CDER) stated that 1,259 post-marketing commitments from drug companies were open in 2006 yet only 11% (144) of these studies were submitted (Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability, Table 1, 2007). Amazingly, this report also noted that 71% (899) of the required studies were only pending, not actually started. Id., Table 1. This means the FDA or the drug companies have not established the safety of hundreds of existing drugs and the FDA (CDER) appears powerless to force their compliance.
Necessary Change
The woeful record of compliance by the drug companies with the required post-marketing commitments necessitates a change in statute to force their hand. Withdrawal of the drug immediately from the market is not practical nor would it always be in the best interest of the patients currently using it. We propose to require drug companies to publish all clinical trial results in clinicaltrials.gov within 60 days of receiving an approval from the CDER related to their NDA submission. CDER would have the authority to rescind the approval letter for the new drug within 120 days if the manufacturer does not disclose these results.
To ensure the completion of post-marketing commitments by the drug companies, we propose the exclusivity of an existing drug expire after 5 years if the phase 4 trials are not submitted to CDER with a copy of the results uploaded to the clinicaltrials.gov database. We believe this change will create a huge incentive for drug companies to avoid the financial penalty associated with the loss of continued exclusivity and competition from manufacturers of generic versions of the drug.
If CDER has the authority to require all manufacturers to publish clinical trial results to clinicaltrials.gov as a condition of their approval, the increased transparency of the drug approval process will increase the public’s confidence in the safety of our system. This transparency will also incentivize the drug companies to take their responsibility for comprehensive testing seriously, since the data will be available for consumers to access. Establishing the right to limit exclusivity to 5 years will give CDER the leverage necessary to compel manufacturers to complete post-marketing commitments. The continual availability of this data will allow the FDA to monitor the long-term safety and efficacy of drugs effectively, ultimately giving physicians and patients the information necessary to make sound decisions regarding the benefits and risks of their medications.
Our final argument concentrates again on drug companies but with a different intent. Fentress v Eli Lilly and Mahlam v Dow Chemical are lawsuits that stemmed from consumers’ contention that a product deemed safe by the manufacturer and approved by the FDA caused harm. In each case, the manufacturer faced challenges in court for failure to provide a safe product, determined through adequate testing. The outcome was split with the jury finding in favor of the corporate defendant, Eli Lilly and in favor of the plaintiff, Mahlam. The World Almanac Video Landmark Consumer Rights Trials study guides (Choices, Inc, 2001) raised several questions related to the cases. The focus in both of these is safety. Specifically, it asked what the responsibility of the FDA is in approving drugs for release and assuring their safety.
The safe and appropriate use of prescription drugs for the treatment of infants and children is an area of FDA concern. Efforts to require or encourage drug manufacturers to produce evidence that drugs commonly prescribed for children are safe for their use have been ongoing through initiatives sponsored by the FDA. To encourage research into pediatric drugs one of these initiatives, the Food and Drug Administration and Modernization Act (FDAMA) (Public Law 105-115) incorporated an Exclusivity component. (Murphy, 2004) “The Modernization Act established economic incentives for manufacturers to conduct pediatric studies on drugs for which exclusivity or patent protection is available under the Drug Price Competition and Patent Term Restoration Act (Public Law 98-417) or the Orphan Drug Act (Public Law 97-414). These provisions attach 6 months of marketing exclusivity to any existing exclusivity or patent protection on a drug for which FDA has requested pediatric studies and the manufacturer has conducted such studies in accordance with the requirements of the Modernization Act.” (Food and Drug Administration, Department of Health and Human Services (FDA, HHS), 2001, p.2)
The 2002 Best Pharmaceuticals for Children Act (BCPA) re-authorized the exclusivity agreement. The BCPA also mandated that the FDA and National Institute of Health (NIH) create a prioritized list of “on-patent” and “off-patent” drugs for study by the industry. (Murphy, 2004) This list was completed on February 6, 2004. Among the criteria for inclusion on the list are the lack of patent protection or market exclusivity protection under the Federal Food, Drug, and Cosmetic Act and the need for determining safety and effectiveness in the pediatric population. The American Academy of Pediatrics and other experts in pediatric research and practice were consulted in developing this list. A priority list of twenty drugs was drafted with five drugs added after the original draft. (Department of Health and Human Services, National Institute of Health (HHS,NIH), 2004).
In December 2003, the Pediatric Research Equity Act (Public Law 108-155) (PREA) was signed into law. It requires new drug applications seeking addition of ingredients or changes in dosing or administration route to contain a pediatric assessment. In addition, those drugs and biological product that have had previous approval can be required to submit pediatric assessment. Generic drugs are exempt from the requirements. (Guidance for Industry)
We propose that, in addition to federal law and FDA or NIH encouragement, a state statue must change to hold manufacturers liable for marketing and selling drugs without assuring the safety for use in known populations. We propose that changes occur in:
Idaho Code, Section 6-1405
Idaho Code, §6-1405 relates to the relevance of industry custom, safety or performance. More specifically it states that “evidence of changes….is not admissible for the purpose of providing that the product was defective in design or that a warning or instruction should have accompanied the product at the time of the manufacture.” (Idaho Code, Title 6)
The change in the statute would be made by striking the words, “is not admissible” and changing this to “is admissible” “for the purpose of providing that the product was defective in design or that a warning or instruction should have been provided at the time of manufacture.”
This change would hold drug manufacturers liable for knowingly providing a drug to the pediatric population without providing the research to assure the safety of its use in this population.
Idaho State Title 37
Idaho State Title 37- Food, Drugs and Oil would be a second state statute that could address the product liability issue of using a drug in a way that has not been proven safe. The State Title acknowledges that a product should be misbranded for use unless its branding has addressed the directions for use, dangers to health, and unsafe dosages. Furthermore, the title states that “if the drug sold was written on a prescription pad and signed by the medical professional such drug shall be exempt from these requirements” (Idaho Code, Title 37). The proposed change is to add, “And (3) if current pharmacological research supports such branding of the drug.”
It is of concern that, even though the FDA and NIH, through the Department of Health and Human Services, have identified baclofen as being a drug that urgently needs to be studied for use with the pediatric population, this drug continues widespread use in the treatment of spasticity (muscle stiffness) associated with children suffering from Cerebral Palsy. Prescriptions of this drug to children continue, without supporting research on its possible side effects.
Baclofen was third on the “List of Drugs for Which Pediatric Studies Are Needed.” (HHS, NIH 2004). Baclofen serves as a muscle relaxant acting primarily at the spinal level by inhibiting reflex response. It is rapidly absorbed and excreted primarily by the kidneys. In the literature search of information provided by the manufacturers, it is not recommended for use in children under the age of 12 or for treatment of cerebral palsy as efficacy has not been established. (MayoClinic.com, 2003) However, Micromedex Healthcare Series provides a recommended dosage (Micromedex Healthcare Series, 2006).
Efficacy studies document the use of baclofen in children. Vargus-Adams, Michaud, Kinnet, McMahon, and Cook (2004) studied the effects of oral baclofen on children with cerebral palsy. ……Scheinberg, Hall, Lam, and O”Flaherty (2006) completed a randomized cross-over study of oral baclofen vs a placebo. Using tests designed to measure functional ability the scores of children on baclofen improved compared to those taking the placebo. The mean age of the fifteen children used in the study was 7.4 years, indicating that a portion of the children were below the approved age use of the drug, 12 years. (MayoClinic.com, 2003).
When individuals, parents, and physicians know that a drug has a positive effect in the functional abilities of a child, it may be more difficult to withhold the drug even though the safety has not yet been determined. We must take measures to require drug manufacturers to test the dosage and side effects of currently approved drugs for children under the age of 12 years. These additional tests would allow parents, physicians and other professionals to use these drugs with confidence.
Conclusion
In summary, it would be our position that both Idaho Statutes and Federal Legislation, as it relates to the FDA, fail in its current methodology for product and drug testing. Our proposals would serve to ensure that both the public and the manufacturers of these devices and/or products are given the maximum protection feasible. This would allow drug companies the opportunity to present their findings and perhaps “gain” the trust of the public. The additions to these laws would inevitably save money in claims regarding personal harm for both the manufacturers and the drug companies. Finally, the promotion of additional drug testing on unknown populations would give physicians and parent’s more peace of mind when giving medications to their children and loved ones.
References
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Angell, M. (1996) Science on Trial: The Clash of Medical Evidence and the Law in the Breast
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Colacicco v. Apotex, Inc., et al., Civ. No. 05-cv-5500, 2006 WL 1443357 (E.D. Pa. May 26, 2006)
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Frontline/WGBH Educational Foundation: Breast Implant Chronology Retrieved March 28,
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Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301,et seq. (1999)
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Scheinberg, A., Hall, K., Lam, LT., & O’Flaherty, S. (2006) Oral baclofen in children with cerebral palsy: A double-blind cross-over pilot study. Journal of Paediatrics and Child Health, 42 (11), 715-720.
Vargus-Adams, JN., Michaud, LJ., Kinnett, DG., McMahon, MA., & Cook, FE. (2004) Effects of oral baclofen on children with cerebral palsy. Dev Med Child Neurol, 46(11), 787- 789.
