A just-released report from the nation's premier medical advisory organization documents that patients have a one-in-ten chance of a filling error in prescriptions filled in hospitals. These errors harm 1.5 million people and kill several thousand each year in the United States, costing the nation at least $3.5 billion annually, according to the Institute of Medicine. Drug errors are so widespread that hospital patients should expect to suffer one every day they remain hospitalized.

Recommendations to correct these problems include systemic changes like electronic prescribing and tips for consumers like advising patients to carry complete listings of their prescriptions to every doctor's visit, the report said.
"The incidence of medication errors was surprising even to us," said J. Lyle Bootman, dean of the University of Arizona College of Pharmacy. "The solutions are complex and far-reaching and will present challenges."

Drug computer-entry systems, which are supposed to ensure that hospital patients get the right drugs at the right dose, are used in just 6 percent of the nation's hospitals. Electronic medical records can help ensure that patients do not receive toxic drug combinations. Thursda's report called for all prescriptions to be written electronically by 2010.

Just 3 percent of hospitals have electronic patient records. Few doctors prescribe drugs electronically. Even simple medication safety recommendations — block printing on hand-written prescription forms — are widely ignored.

Posted by David P. Hersh at 04:23 PM | Permalink | Comments (0) | TrackBacks (0)

According to the Associated Press, the Institute of Medicine released a study reporting that over 1.5 million Americans receive injuries annually because of drug errors in hospitals, doctor's offices and nursing homes. On average, one hospitalized patient is a victim of a medication error daily notwithstanding efforts by hospitals to correct these problems. While fixing these problems is challenging, doctors and hospitals have little or no financial incentive to make the reasonable changes needed to put an end to these injuries. The study identifies essential steps needed to prevent these injuries, including the recommendation that healthcare providers write all prescriptions electronically by 2010.

Posted by Scott J. Eldredge at 03:35 PM | Permalink | Comments (0) | TrackBacks (0)

According to a report by NEWS.com, Roche, a large prescription drug manufacturer, crossed an ethical boundary when it treated hundreds of doctors to expensive meals at some of Australia's most exclusive restaurants. One of these meals cost more than $65,000 USD as Roche paid the bill for over 200 cancer specialists to eat at the Guillaume at Bennelong, and exclusive restaurant inside the famous Sydney Opera House. This is just one example of the many times this drug manufacturer may have broken the pharmaceutical industry's code of conduct in Australia which states that meals sponsored by companies need to be "simple and modest." A drug marketing watchdog group has filed a formal complaint regarding this breach of ethical conduct. A specialist in ethics at Sydney University believes that this type of extravagant treatment leads to the high cost of prescription drugs to patients.

Posted by Seth A. Katz at 03:34 PM | Permalink | Comments (0) | TrackBacks (0)

The Court first explained that in making a reverse discrimination claim, an employee must show that the employer is actually discriminating against the majority - a fairly unusual occurrence. The Court concluded that Argo could not establish reverse discrimination in this case. Instead, Blue Cross showed that it hired many men for the same position and that it had employed Argo in the position, until his performance deteriorated so badly that it had not choice but to terminate his employment.

The Court was singularly unimpressed with Argo's claim that he had been subjected to a hostile work environment. As the Court explained, the supervisor's actions "two flirtatious comments, a mock-bawdy birthday card, and an incident of toe-touching--were incredibly mild. Even viewed in the light most favorable to Mr. Argo, they represent precisely the kind of "ordinary socializing in the workplace" and "intersexual flirtation" about which Title VII is unconcerned."

The Court also rejected the retaliation claim, finding that Blue Cross' reason for termination were based on Argo's performance problems and failure to respond to discipline.

This case illustrates the importance of the disciplinary process, particularly if the performance of a long term employee starts to slip. Likewise, the case illustrates how an employee can make it or break it, when faced with discipline for performance problems.

If you would like to read this saga for yourself, go to http://www.kscourts.org/ca10/cases/2006/07/05-3114.htm

Posted by Diane V. Smith at 03:58 PM | Permalink | Comments (0) | TrackBacks (0)

In recent weeks, dozens of e-mails between internal FDA officials were turned over to the New York Times. The e-mails show that at least four FDA officials had serious reservations about the safety of the popular antibiotic, Ketek, which was recently forced to change its label to include stronger warnings.

Dr. David Graham, part of the FDA's drug safety office, wrote in a message dated June 16 that the agency's approval of Ketek (telithromycin) was a mistake: "It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned." Referring to reports of adverse drug reactions voluntarily submitted to the FDA, Dr. Graham continued, "We don't really know if the drug works; no one is claiming it works better than other, safer drugs; and we're flying blind as far as safety goes, except for our own A.D.R. data that suggests telithromycin is uniquely more toxic than most other drugs." Dr. Graham believed that the FDA should recommend Ketek's "immediate withdrawal."

Ketek has been associated with an increased risk of severe liver damage and death, as well as vision problems and loss of consciousness.

Posted by Peter W. Burg at 03:31 PM | Permalink | Comments (0) | TrackBacks (0)

Sometimes, it really is all about performance. Or, in the words of Judge McConnell of the Tenth Circuit, "This case presents an especially weak Title VII sex discrimination claim."

The Plaintiff, Griff G. Argo, worked as an Individual Enrollment Specialist ("IES") for the Defendant Blue Cross Blue Shield of Kansas, Inc. ("Blue Cross"). Although he was an effective worker for several years, his work performance steadily declined in 2002. Within that year, Argo failed to meet one or more performance goals for nine consecutive months as well as his annual goal. Additionally, Argo received repeated warnings about tardiness and "attitude" problems, but Argo persisted in arriving late, misusing time, and failing to perform work as directed. Blue Cross repeatedly disciplined Argo, which apparently led to the filing of an internal complaint alleging that he was being sexually harassed by his supervisor. Despite the internal complaint, Blue Cross terminated Argo's employment when he was again late for work and again failed to perform work as directed.

After termination, Argo sued, claiming that Blue Cross had engaged in reverse discrimination and retaliation for the internal filing of a sexual harassment complaint. The federal trial court dismissed the claim and the 10th Circuit affirmed.

Posted by Diane V. Smith at 03:58 PM | Permalink | Comments (0) | TrackBacks (0)

On June 22, 2006, the United States Supreme Court rendered entered a new, sweeping decision concerning retaliation claims under Title VII, which gives victims of retaliation greater protection than victims of actual discrimination. In Burlington Northern & Santa Fe Railroad v. White, an opinion authored by Justice Breyer, the Supreme Court decided for the first time that an employer may be liable for retaliation if an employee can show that the employer's actions might well have "dissuaded" a reasonable worker from making or supporting a charge of discrimination

In other words, the anti-retaliation provision is not limited to discriminatory actions that affect the terms and conditions of employment, but can reach actions by an employer that cause harm to the employee outside the workplace. As the Supreme Court noted, "context matters" when deciding the issue of retaliation. Thus, a change to a work schedule may make little difference to many workers, but may matter enormously to a young mother with school age children. Likewise, exclusion from lunch would normally be trivial, but exclusion from a weekly training lunch that might impair professional development would be significant.

In this case, Sheila White, the lone female employee in the Maintenance of Way Department, complained about sexual harassment by her supervisor. Burlington Northern investigated, suspended the supervisor for 10 days, and ordered him to attend sexual harassment training. At the same time, Burlington Northern reassigned Ms. White to less desirable duties, claiming that it was responding to the complaints of a co-worker, a "more senior man." A number of events later transpired, including a charge of insubordination against Ms. White, and a suspension without pay for 37 days. The Supreme Court found that reassignment to dirtier, harder work and going more than a month without a paycheck would be a "serious hardship" to most employees and would be "materially adverse" to the employee, thus supporting a verdict for retaliation.

Justice Alito wrote a separate opinion agreeing with the result, but not the reasoning. In his view, the majority departed too far from the language of the statute.

Posted by Diane V. Smith at 03:55 PM | Permalink | Comments (0) | TrackBacks (0)

In a recent personal injury and product liability lawsuit filed in Federal court in St. Louis, Renu with MoistureLoc is being blamed for an eye infection (Fusarium Keratitis) and a subsequent cornea transplant. The suit alleges that Bausch and Lomb was negligent and failed to warn customers that the solution could cause serious and permanent injury. There have been 125 other similar cases across the country, 64 percent of them in contact lens wearers who used this Bausch and Lomb product.

In April, Bausch and Lomb stopped selling the solution after a federal investigation revealed users faced an increased risk of developing Fusarium Keratitis.

Bausch and Lomb was asked to comment on the lawsuit and provided this written statement:

As is often the case in heavily publicized recall situations, we expect that there will be many more claims than actual injuries, and that's why it's especially important for us to evaluate each claim independently and handle it appropriately. We'll be handling alleged MoistureLoc complaints on a case-by-case basis, evaluating medical information and specific information about product use and other relevant data, and Bausch & Lomb's response will be based on each case's available evidence.

Posted by Seth A. Katz at 03:44 PM | Permalink | Comments (0) | TrackBacks (0)

According to the Philadelphia Inquirer, dentists are asking patients whether they have used bone-density medications such as Fosamax before treatment or diagnosis. These drugs, known as bisphosphonates, are linking in numerous studies to a condition known as osteoncrosis of the jaw, or a rotting of the jawbone. Osteoncrosis is causing substantial injuries to victims that in some cases many cases may be permanent. Drugs like Fosamax increase bone density by slowing down the replacement of bone cells. Experts speculate that drugs that are especially efficient in limiting bone regeneration like Fosamax may facilitate the advancement of osteonecrosis.

Posted by Peter W. Burg at 02:20 PM | Permalink | Comments (0) | TrackBacks (0)

According to the Associated Press, Merck failed to report to authorities about tests in which users of Vioxx were at greater risk for death then people given placebo. This is according to Dr. Edward Scolnick, the former head of Merck's research laboratories. Dr. Scolnick also testified that in two clinical trials people on Vioxx death was more than two times as likely for those on Vioxx. Merck failed to report these results to the Food and Drug Administration. Additional Information Available Here.

Posted by Peter W. Burg at 02:18 PM | Permalink | Comments (1) | TrackBacks (0)

In a recent Bloomberg.com article hedge-fund fraud was identified as a growing concern for investors. A taskforce designated by the President Bush to investigate corporate crime is meeting in July to discuss this threat. Hedge funds are lightly regulated and according to the head of the taskfoce, Deputy Attorney General Paul McNulty, hedge funds are "a good example of an emerging threat that we would want to talk about and ensure that we are handling." In 2002 the Securities and Exchange Commission filed only 10 civil cases against hedge funds. In 2005 that number rose to 29. Investors should make every effort to protect themselves from this type of fraud.

Posted by Kerry N. Jardine at 02:02 PM | Permalink | Comments (0) | TrackBacks (0)

As a regulatory agency, the authority of the FDA is limited to the creation of regulations which implement the responsibilities delegated to FDA by Congress. Since Congress did not expressly preempt state law tort claims, FDA has no authority to establish express preemption.

FDA has no authority to interpret the law. The doctrines of conflict preemption are judicially created and judicially determined. FDA, as a regulatory agency, has no authority to determine the legal force and effect of its regulations. FDA is an arm of the Executive Branch of the Government. Under the U. S. Constitution, Congress enacts legislation and may choose to delegate to an administrative agency of the executive branch the authority to establish implementing regulations. The courts retain the authority to interpret the legislation enacted by Congress and the regulations promulgated by federal agenci4es.

The FDA has no authority to interpret the law. This attempt by the FDA to impose federal preemption and to determine the legal impact of its own regulations violates the separation of powers in the United States Constitution. First, it violates the power given to Congress to enact legislation. Second, it violates the power given to the courts to interpret the law.

Posted by Michael S. Burg at 03:59 PM | Permalink | Comments (0) | TrackBacks (0)

FDA recognizes that FDA's regulation of drug labeling will not preempt all State law actions. The Supreme Court has held that certain State law requirements that parallel FDA requirements may not be preempted (Medtronic, Inc. v. Lohr, 518 U.S. 4790, 495 (1996)) (holding that the presence of a State law damages remedy for violations of FDA requirements does not impose an additional requirement upon medical device manufacturers but "merely provides another reason for manufacturers to comply with *** federal law").

The analogy to Medtronic v. Lohr is flawed. FDA's reference to the Supreme Court's holding in Medtronic v. Lohr has no application to the issue of federal preemption in prescription drug cases.

Lohr concerned the express preemption language in the Medical Device Amendment. Lohr did not involve implied preemption or conflict preemption.

Tomorrow: A conclusion or two

Posted by Michael S. Burg at 03:45 PM | Permalink | Comments (0) | TrackBacks (0)

Consistent with its court submissions and existing preemption principles, FDA believes that at least the following claims would be preempted by its regulation of prescription drug labeling:

1. Claims that a drug sponsor breached an obligation to warn by failing to put in Highlights or otherwise emphasize any information the substanc4e of which appears anywhere in the labeling;
2. Claims that a drug sponsor breached an obligation to warn by failing to include in an advertisement any information the substance of which appears anywhere in the labeling, in those cases where a drug's sponsor has used Highlights consistently with FDA draft guidance regarding the "brief summary" in direct-to-customer advertising;
3. Claims that a sponsor breached an obligation to warn by failing to include contraindications or warnings that are not supported by evidence that meets the standards set forth in this rule, including § 201.57(c)(5) (requiring that contraindications reflect "[k]nown hazards and not theoretical possibilities") and (c)(7);
4. Claims that a drug sponsor breached an obligation to warn by failing to include a statement in labeling or in advertising, the substance of which had been proposed to FDA for inclusion in labeling, if that statement was not required by FDA at the time plaintiff claims the sponsor had an obligation to warn (unless FDA has made a finding that the sponsor withheld material information relating to the proposed warning before plaintiff claims the sponsor had the obligation to warn);
5. Claims that a drug sponsor breached an obligation to warn by failing to include in labeling or in advertising a statement the substance of which FDA has prohibited in labeling or advertising; and
6. Claims that a drug's sponsor breached an obligation to plaintiff by making statements that FDA approved for inclusion in the drug's label (unless FDA has made a finding that the sponsor withheld material information relating to the statement).

Tomorrow: FDA's Concession About State Court Claims

Posted by Michael S. Burg at 03:32 PM | Permalink | Comments (0) | TrackBacks (0)

State law actions also threaten FDA's statutorily prescribed role as the expert federal agency responsible for evaluating and regulating drugs. State actions are not characterized by centralized expert evaluation of drug regulatory issues. Instead, they encourage, and in fact require, lay judges and juries to second-guess the assessment of benefits versus risks of a specific drug to the general public, the central role of FDA, sometimes on behalf of a single individual or a group of individuals. That individualized reevaluation of the benefits and risks of a product can result in relief, including the threat of significant damage awards or penalties, that creates pressure on manufacturers to attempt to ad warnings that FDA has neither approved nor found to be scientifically required. This could encourage manufacturers to propose "defensive labeling" to avoid State liability, which, if implemented, could result in scientifically unsubstantiated warnings and underutilization of beneficial treatments.

Tomorrow: FDA Conclusions on Preemption

Posted by Michael S. Burg at 03:17 PM | Permalink | Comments (0) | TrackBacks (0)

We'd like to alert you to recent developments concerning Ketek, a popular antibiotic marketed by Sanofi-Aventis SA. Ketek has been associated with severe liver damage and death. In April 2004, Ketek was approved for upper respiratory infections in patients 18 years and older. The FDA had rejected the drug in 2001 and 2003, asking for more safety information. Although Sanofi's clinical studies were so outrageously flawed and fraudulent as to be useless, the FDA relied on the drug's safety record in Europe and Japan, where it had been approved since 2001, to approve the drug for sale in the United States. The Senate Finance Committee is now conducting an investigation into the FDA's approval, and Sen. Charles Grassley, Chairman, told the Wall Street Journal, "The Ketek allegations appear to be as serious as anything I've seen so far." On June 29, 2006, the FDA issued a safety alert concerning Ketek's association with serious liver injury, liver failure and 4 reported deaths, and announced new safety information to be added to Ketek's label.

In light of concerns that Ketek may be up to four times more toxic than other antibiotics, the FDA called for the halt of a clinical trial of Ketek in nearly 4,000 infants and children, in which it was being studied for ear infections and tonsillitis, in spite of its having caused liver failure, blurred vision, and loss of consciousness in adults. One of the lead investigators of a key clinical trial is now in federal prison after pleading guilty to fraud charges.

FDA had previously published a January 20, 2006 Safety Information Alert, citing liver problems, including three cases of serious liver toxicity (one recovered, one had a liver transplant, one died). All three patients had previously been healthy.

More than 5 million prescriptions have been written in the U.S. since Ketek's approval on 4/1/04. According to IMS Health, 3.5 million prescriptions were written in the U.S. in 2005, with sales of $193 million.

If you are interested in a co-counsel relationship with Burg Simpson on Ketek cases you acquire, please contact Seth Katz (skatz@burgsimpson.com) or Kerry Jardine (kjardine@burgsimpson.com).

Posted by Peter W. Burg at 05:30 PM | Permalink | Comments (0) | TrackBacks (0)

State law requirements can undermine safe and effective drug use in other ways and over-warning, just like under-warning, can similarly have a negative effect on patient safety and public health.

State law actions can rely on and propagate interpretations of the act and FDA regulations that conflict with the agency's own interpretations and frustrate the agency's implementation of its statutory mandate. For example, courts have rejected preemption in State law failure-to-warn cases on the ground that a manufacturer has latitude under FDA regulations to revise labeling by adding or strengthening warning statements without first obtaining permission from FDA. ... In fact, the determination whether Labeling revisions are necessary is, in the end, squarely and solely FDA's under the act. A manufacturer may, under FDA regulations. strengthen a labeling warning, but in practice manufacturers typically consult with FDA before doing so to avoid implementing labeling changes with which the agency ultimately might disagree (and that therefore might subject the manufacturer to enforcement action).

Another misunderstanding of the act encouraged by State law actions is that FDA labeling requirements represent a minimum safety standard. According to many courts, State law serves as an appropriate source of supplementary safety regulation for drugs by encouraging or requiring manufacturers to disseminate risk information beyond that required by FDA under the act. In fact, FDA interprets the act to establish both a "floor" and a "ceiling," such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading. Given the comprehensiveness of FDA regulation of drug safety, effectiveness, and labeling under the act, additional requirements for the disclosure of risk information are not necessarily more protective of patients. Instead, they can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use.

Tomorrow: State Law Actions and FDA's Statutorily Prescribed Role

Posted by Michael S. Burg at 02:45 PM | Permalink | Comments (0) | TrackBacks (0)

FDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old, or new format, preempts conflicting or contrary State law. Indeed, the Department of Justice (DOJ), on behalf of FDA, has filed a number of amicus briefs making this very point. In order to more fully address the comments expressing concern about the product liability implications of revising the labeling for prescription drugs, we believe it would be useful to set forth in some detail the arguments made in those amicus briefs. The discussion that follows, therefore, represents the government's long standing views on preemption, with a particular emphasis on how that doctrine applies to State laws that would require labeling that conflicts with or is contrary to FDA approved labeling.

FDA Preemption Position
Under the act, FDA is the expert federal public health agency charged by Congress with ensuring that drugs are safe and effective, and that their labeling adequately informs users of the risks and benefits of the product and is truthful and not misleading. Under the act and FDA regulations, the agency makes approval decisions based not on an abstract estimation of its safety and effectiveness, but rather on a comprehensive scientific evaluation of the product's risks and benefits under the conditions of use prescribed, recommended, or suggested in the labeling (22 U.S.C. 355(d)).

FDA considers not only complex, clinical issues related to the use of the product in study populations, but also important and practical public health issues pertaining to the use of the product in day-to-day clinical practice, such as the nature of the disease or condition for which the product will be indicated, and the need for risk management measures to help assure in clinical practice that the product maintains its favorable benefit-risk balance. The centerpiece of risk management for prescription drugs generally is the labeling which reflects thorough FDA review of the pertinent scientific evidence and communicates to health care practitioners the agency's formal, authoritative conclusions regarding the conditions under which the product can be used safely and effectively. FDA carefully controls the content of labeling for a prescription drug, because such labeling is FDA's principal tool for educating health care professionals about the risks and benefits of the approved product to help ensure safe and effective use.

Changes to labeling typically are initiated by the sponsor, subject to FDA review, but are sometimes initiated by FDA. Under FDA regulations, to change labeling (except for editorial and other minor revisions), the sponsor must submit a supplemental application fully explaining the basis for the change (§§ 314.70 and 601.12(f) (21 CFR 314.70 and 601.12) (f))). FDA permits two kinds of labeling supplements: (1) Prior approval supplements, which require FDA approval before a change is made (Sec. 314.70(b) and 601.12(f) (l)); and (2) "changes being effected" (CBE) supplements, which may be implemented before FDA approval, but after FDA notification (§§ 324.70(c) and 601.1.2(f)(2)). While a sponsor is permitted to add risk information to the FPI without first obtaining FDA approval via a CBE supplement, FDA reviews all such submissions and may later deny approval of the supplement, and the labeling remains subject to enforcement action if the added information makes the labeling false or misleading under section 502(a) of the act (21 U.S.C.352). Thus, in practice, manufacturers typically consult with FDA prior to adding risk information to labeling. As noted in response to comment 5, however, a sponsor may not use a CBE supplement to make most changes to highlights.

Since the proposed rule was published, FDA has learned of several instances in which product liability lawsuits have directly threatened the agency's ability to regulate manufacturer dissemination of risk information for prescription drugs in accordance with the act. [citations omitted.]

Tomorrow: New Rules on Prescription Drug Preemption and State Law

Posted by Michael S. Burg at 02:37 PM | Permalink | Comments (0) | TrackBacks (0)

Comment 12: Some manufacturers expressed concerns that, by highlighting selected information from the FPI to the exclusion of information not highlighted, they make themselves more vulnerable to product liability claims. some of these comments also stated that the highlights limitation statement, which states that highlights do not contain all the information needed to prescribe a drug safely and effectively and that practitioners should also refer to the FPI, would not constitute an adequate legal defense in a case alleging failure to provide adequate warning of a drug's risks.

FDA response to Comment 12: FDA believes the statement will be effective in reminding prescribers that the information in the highlights should not be relied on exclusively in making prescribing decisions and that it is important to consult the more detailed information in the FPI. We also believe that this limitation statement will help to ensure that the labeling will be considered in its entirety in any product liability action.

FDA acknowledges the comment's concerns and, as discussed more fully in response to comment 13, believes that under existing preemption principles such product liability claims would be preempted.

Comment 13: Some comments stated that the new format requirements might have product liability implications for drugs that are not subject to the new requirements. These comments expressed concern that Labeling in the old format might be characterized by plaintiffs as inferior to labeling in the new format and, as a result, could be used as evidence that a manufacturer did not provide adequate warnings. They requested that the agency state in the final rule that FDA approval of labeling, whether it be in the old or new format, preempts conflicting or contrary State law, regulations, or decisions of a court of law for purposes of product liability litigation.

FDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old, or new format, preempts conflicting or contrary State law. Indeed, the Department of Justice (DOJ), on behalf of FDA, has filed a number of amicus briefs making this very point. In order to more fully address the comments expressing concern about the product liability implications of revising the labeling for prescription drugs, we believe it would be useful to set forth in some detail the arguments made in those amicus briefs. The discussion that follows, therefore, represents the government's long standing views on preemption, with a particular emphasis on how that doctrine applies to State laws that would require labeling that conflicts with or is contrary to FDA approved labeling.

Tomorrow: FDA and Existing Preemption Principles

Posted by Michael S. Burg at 02:30 PM | Permalink | Comments (0) | TrackBacks (0)

New FDA labeling regulations were effective June 30, 2006. Announced January 18, 2006, these regulations, 21 CFR 201, 314 and 601, have the claimed purpose of providing new labeling guidelines for prescription drugs, to make drug labeling easier to read and understand and to include requirements to highlight certain information and to promote minor changes in graphics and content of drug labels.

The real purpose of the Rule is to provide FDA an opportunity to establish federal preemption of state law tort claims involving prescription drugs. In recent years, the FDA has begun to intervene in state law tort cases involving persons injured by prescription drugs, to argue that their claims are barred by federal preemption. In these cases, the FDA has filed amicus briefs supporting the drug companies which is a reversal of the historic position of the FDA on these matters. Despite efforts by the FDA to undermine state law tort claims, courts have consistently rejected the FDA's arguments of direct or indirect conflict preemption. See Witczak v. Pfizer, 377 F. Supp.2d 726 (D.Minn.2005)

Apparently frustrated by its failure to preclude tort claims by victims injured from defective drugs, FDA has adopted a new approach. At the urging of the drug companies, FDA acted at the eleventh hour to insert language and commentary supporting federal preemption in its new Final Rule approving highlighting and graphic changes in drug labeling.

Tomorrow: FDA's statement and response regarding Comments 12 and 13

Posted by Michael S. Burg at 04:55 PM | Permalink | Comments (0) | TrackBacks (0)

As we celebrate the 4th of July and our constitutional form of government built on checks and balances, it is trendy to complain that the legal system is broken by pointing to selected "facts" about it. Upon closer examination, those "facts" are often demonstrably inaccurate or taken out of context.

The fact of the matter is that our liberties and our prosperity are protected by the legal system we enjoy. Our legal system, while imperfect, protects the individual from the tyranny of the powerful. Trials must be open. Accusers must be faced. Citizens, not paid professionals, make the decisions [the jury].

The right to a jury trial, in both civil and criminal matters, is a great equalizer that makes our legal system work. Jurors, peers of the parties, make factual decisions in cases. And while jurors are subject to influence and biases, the fact that any wronged citizen has the right to bring that wrong to a jury of his or her peers for ultimate resolution serves as a bridle in the mouth of wrongdoers.

So as we celebrate the birth of our nation, and as we continue to work to improve our governmental system, we should also be grateful for the blessings of the jury, an integral cog in our legal machinery.

Posted by David P. Hersh at 04:31 PM | Permalink | Comments (0) | TrackBacks (0)