Drug and Medical Device Manufacturers
July 28, 2005
Following a guilty plea last year by a major pharmaceutical company, Associate Attorney General Robert McCallum declared that "[t]he Department of Justice is committed to rooting out and prosecuting health care fraud. It is of paramount importance that the Department use every legal tool at its disposal to assure the health and safety of the consumers of America's health care system." The tools -- the variety of different criminal statutes and theories used to prosecute drug and device manufacturers -- are so diverse as to defy easy summary.
Should We All Move to Canada?
July 28, 2005
The high cost of prescription medications in the United States has been troubling health care providers and their patients for years. Physicians worry that it will do no good to prescribe a medication to someone who won't be able to afford to buy it, and patients who try to save money by taking less than the prescribed dose worry that that they're putting their health in danger. Any failed medical treatment that harms a patient is fertile ground for a lawsuit against the physician, even if he or she is not the one to blame. Should medical practitioners suggest imported drugs to their patients who might otherwise not be able to afford their prescribed medications?
Drug and Medical Device Manufacturers
July 28, 2005
Following a guilty plea last year by a major pharmaceutical company, Associate Attorney General Robert McCallum declared that "[t]he Department of Justice is committed to rooting out and prosecuting health care fraud. It is of paramount importance that the Department use every legal tool at its disposal to assure the health and safety of the consumers of America's health care system." The tools -- the variety of different criminal statutes and theories used to prosecute drug and device manufacturers -- are so diverse as to defy easy summary.
Practice Tip: Experts and the Morass of Mass Tort Litigation
July 28, 2005
An expert retained in mass tort litigation may be required to focus on multiple cases consolidated for discovery and trial, involving thousands of pages of medical records, deposition transcripts, and other discovery material. Expert opinions in mass tort litigation must address both case-specific and generic issues. A statement that is innocuous in one case may be harmful when applied to another. Taken together with the technical sophistication of the issues involved in each case, these issues necessitate a measured approach for dealing with experts.
FCPA Enforcement In A Sarbanes-Oxley World
July 28, 2005
American companies and their officers and employees doing business overseas are learning the hard way about the Foreign Corrupt Practices Act (FCPA). For many years after its enactment in 1977, the government initiated relatively few investigations and enforcement actions charging violations of the Act. This was largely due to the government's difficulties in evidence gathering. Recently, however, the number of such enforcement actions has increased significantly.
Improperly Attempting to Circumvent the Learned Intermediary Doctrine: Challenging the Adequacy of Warnings to Physicians
July 27, 2005
The learned intermediary doctrine is one of the most important doctrines for medical device and pharmaceutical drug defendants in product liability cases because under the doctrine, they are often able to obtain summary judgment on failure to warn claims. (The learned intermediary doctrine has been adopted and recognized in at least 45 states. <i>See Larkin v. Pfizer, Inc.</i>, 153 S.W.3d 758, 767 (Ky. 2005).) The learned intermediary doctrine provides that a manufacturer, designer or distributor of a medical device or pharmaceutical drug does not have a duty to directly warn patients of possible dangers associated with the use of the device or drug. <i>See Presto v. Sandoz Pharm. Corp.</i>, 487 S.E.2d 70 (Ga. Ct. App. 1997). Rather, "'a warning as to possible danger in its use to the prescribing physician is sufficient.'" <i>Id.</i> at 73.
Case Notes
July 27, 2005
Highlights of the latest product liability cases from around the country.
Extraterritorial Discovery Disputes: Do Foreign Litigants Stand a Chance?
July 27, 2005
Say you defend a British corporation that is subject to the laws of England and Wales against a U.S. plaintiff who is suing your client for the negligent design and manufacture of a vehicle that resulted in the death of her child. The plaintiff's claim alleges that your client was aware of the risks associated with the design of the vehicle and knew that safer alternative designs were available. Because of cost concerns, however, your client knowingly and intentionally decided to forego the added safety features and implement the cheaper alternative.
Medicare Liens: A Stumbling Block to Settlement
July 27, 2005
Faced with rising litigation costs and unpredictable juries, it is understandable that many product liability litigants — on both sides of the courtroom — eventually think about settlement in lieu of trial. In cases involving catastrophic injury, however, staggering medical expense liens often control the feasibility of reaching an acceptable agreement.
Online: Learn About Prescription Drugs on the Web
July 27, 2005
Public Citizen ("PC"), a public interest group, has released a new edition of "Worst Pills, Best Pills," a book analyzing at least 500 prescription drugs, and concluding that at least 200 of them may pose health risks. The group has launched a Web site, <i>www.worstpills.org</i>, which provides information about unsafe drugs, drug pricing and access to the entire contents of the just-published book for a subscription fee.
