Archive for the ‘medical device litigation’ Category

Recently, a series of lawsuits were brought against C.R. Bard, Inc. and Bard Peripheral Vascular Inc. on behalf of users of the Recovery IVC Filter and G2 IVC filter, both of which are produced, marketed, and sold by Bard, Inc. On June 9, 2009, a lawsuit was filed in the Superior Court of Arizona and on June 15, 2009 in federal court in New York. Plaintiffs in both cases are seeking damages as a result of defective use and life threatening injuries.

Since the IVC filters were first placed on the market, the medical community has been concerned with the permanent placement of these filters within the human body. It was believed these filters should only be within the body for a finite period of time and should be retrievable. The FDA, however, approved Bard’s Recovery IVC Filter System as a retrievable device, but one that was acceptable for placement for an indeterminate period of time. In 2003, published reports indicated the failure of the Recovery IVC Filter and patients experienced severe to fatal injuries as a result. The Recovery IVC Filters were found to fracture within the body and migrate to vital organs. Users of the defective IVC filters are now seeking damages for medical expenses, pain and suffering, lost wages, and more.  Read more about adverse side effects of defective IVC filters and Bard IVC Filter lawsuits.

After two recent incidents involving the crash of Airbus A330 jetliners, investigators are determining whether defective airspeed sensors were the cause. These defective device sensors are similar to those being investigated in the Air France Flight 447 last month. On two different airlines that ended in safe landings, the National Transportation Safety Board has identified separate defective devices, both appearing to be the same type of defects that occurred on the Air France A330 shortly before it crashed. The defects trigger a loss of autopilot and automatic throttle. Such airspeed issues, however, although detrimental to safety, aren’t enough to bring down a jetliner. In the Air France crash, investigators believe turbulent weather, possible computer glitches, pilot actions and perhaps other factors combined to bring the jet to its fatal crash.

Medication adherence, which is really the extent to which patients take medication as prescribed by their doctors, is important to the medication’s effectiveness to cure and treat the particular illness.  Poor medication adherence can have a particularly negative impact on the medication’s ability to treat many diseases, causing more severe complications from the illness and decreased quality of life for patients.   Many factors cause poor adherence; the most common ones being the inability to pay for medications, lack of belief that the treatment is necessary or helping, busy schedules, forgetfulness, and confusion about how and when to take the medication.

The Food Drug Administration recently published an article on its website, which discusses the importance of medication adherence and provides tips on how to take different types of medication correctly.  For example, when taking antibiotics, the FDA warns strict medication adherence is vital.  If antibiotics are not taken as prescribed by the doctor, a small number of bacteria is likely to survive and continue to replicate and become resistant to the antibiotics.  The same reasoning goes for the HIV virus.  When patients with AIDS skip or stop taking their prescribed medication, they might develop strains of HIV that are more resistant to the prescribed medication and even some medications that patients aren’t currently on.

The FDA advises people to communicate with their doctors or pharmacists if they are experiencing side effects of their prescribed medication and understand how long they need to take the medication.  Setting a daily routine to take medication, keeping medications in noticeable places, using daily dosing containers, and keeping written or computerized schedules are all good ways to help people remember to take their medication.

Ultimately, if there is ever an issue of negligence, consumers want to make sure it is medical negligence outside of their control and not negligence of their own.  Making sure you properly take medications, at least according to the FDA, is an important consumer health issue.

Pharmaceutical companies pay $995 a pop to send employees to a course to help their employees avoid the attention of Food and Drug Administration (FDA) investigators, prosecutors, and products liabilities attorneys.  The course, entitled “Dangerous Documents: Avoiding Land Mines in your FDA Records and Emails,” is apparently offered by the Medical Technology Learning Institute and Compliance Alliance, and has been attended by Allegan, Inc., Sepracor, Inc., Varian Medical Systems, Inc., Siemens AG, and Medtronic, Inc., the manufacturer of the InFuse Bone Graft, which has been the subject of off-labeling marketing inquiries.

Nancy Singer of the Compliance Alliance developed the course while working as counsel for a device firm. “I noticed that employees at the firm did not understand how a plaintiff’s lawyer could use their emails and other documents to the firm’s detriment if the firm was ever sued in a products liability action,” she said.  The “Dangerous Documents” seminar teaches companies to avoid any written communications whenever possible, and to use vague language that cannot be connected to any potentially illegal activity that the company is conducting.  The seminar also teaches what FDA investigators search when reviewing documents, words that attract the attention of prosecutors, the kind of information that should never be included in written documents, and practices that are likely to alert the attention of investigators.  By attending the seminar, corporate drug manufacturers learn how to placate government officials, and in the process, avoid lawsuits.

One example of such a lawsuit resulting from careless documentation is the Microsoft antitrust lawsuit of 1996.  Government lawyers found a memo from an AOL executive recounting a meeting in which Bill Gates said, “How much do we need to pay you to screw Netscape.”  The memo was used in the antitrust case against the company, which Microsoft eventually lost. 

As companies become aware of the tactics of prosecutors and plaintiff’s attorneys, whistleblowers will become invaluable to uncovering corporate fraud.  If you have knowledge of corporate activity that violates an FDA policy or any governmental regulation, you could bring a civil lawsuit on behalf of the government and collect a portion of the damages.  These are called whistleblower lawsuits, and are authorized by the False Claims Act (“FCA”).  FCA whistleblower lawsuits could lead to a reward for the whistleblower of up to 15-30% of the damages awarded by a judge.

By order dated June 9, 2009, the Judicial Panel on Multidistrict Litigation (JPML) centralized In re: Denture Cream Product Liability Litigation, MDL-2051, in the Southern District of Florida before Judge Cecilia M. Altonaga, who the JPML said “has the time and experience to steer this litigation on a prudent course.”  The transfer order and MDL denture cream updates are available in the ConsumerInjuryLawyers news section.

The JPML concluded that transfer under “Section 1407 will eliminate duplicative discovery; prevent inconsistent pretrial rulings; conserve the resources of the parties, their counsel and the judiciary.”  The court highlighted that “[t]hese actions share questions of fact arising out of the allegation that the levels of zinc contained in certain brands of denture cream can cause copper deficiency and neurological injuries.”

Bernstein Liebhard’s denture cream lawyers are pursuing denture cream lawsuits against the manufacturers of Poligrip and Fixodent.  We are also actively accepting denture cream case referrals and co-counsel relationships.  Our work on the denture cream litiagion has been the focus of media coverage, including Good Morning America.