Articles Posted in Product Liability & Design Defect Claims

With increased attention being put on improper financial influences in medicine, by both the lay and professional press, you may be wondering how you can find out if your doctor is getting brown paper bags of cash from Big Pharma or a medical device manufacturer. The next time a doctor recommends a drug or a medical device, check with the Association for Medical Ethics to see if your doctor has improper financial ties with the manufacturer. As a result of a U.S. Department of Justice settlement with four medical device companies, Zimmer, Inc., DePuy Orthopaedics, Inc., Biomet, Inc., and Smith & Nephew, Inc., these back door consulting agreements must now be made public. (See our earlier post about this: Financial Ties) The Association for Medical Ethics maintains a searchable database that will tell you if your doctor is on the payroll of the company whose product he has just recommended: www.ethicaldoctor.org. Some of the information is shocking: two physicians listed made more than $8 million each from Dupuy Orthopaedics.

Now that’s a fact you would want to know before the doctor operated, isn’t it?

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The Bush Administration has consistently sought to undermine consumer-oriented regulatory practices in favor of corporate interests. If it could also take a shot at plaintiffs and their demon trial lawyers, all the better. One of its more spectacular successes was the Supreme Court’s recent decision in a medical devices case, Riegel v. Medtronic, which stands for the proposition that the FDA’s approval of a medical device should preempt any litigation against the manufacturer in state claims by someone the product injures. As expected, every defendant with any conceivable preemption argument is now injecting that defense into products liability and negligence claims all across the country. FDA and Mercury Regulation;FAA Regulation. The Alaska Personal Injury Law Group just defeated a similar move by a defendant arguing that the FAA’s regulation of aircraft should preempt state claims against an air carrier.

The Supreme Court will next consider the application of the preemption doctrine in an injury claim against Wyeth by a Vermont guitarist who lost her arm below the elbow after she was injected with Phenergan, a nausea medicine. Wyeth v. Levine, Docket No. 06-1249. At issue is Wyeth’s claim that it should be immune from suit because of the FDA’s approval of Phenergan’s label. It reasons that the FDA’s regulatory approval should be enough to preempt the plaintiff’s claim that the manufacturer failed to warn about the dangers of IV injection of the drug. Remarkably, The New England Journal of Medicine has joined 47 state attorneys general and two past FDA commissioners in submitting amicus briefs to the Supreme Court warning that the FDA lacks the ability to serve “as the sole guarantor of product safety”.

It is well known that the FDA simply cannot know all the risks of a product or warning label it approves. This is especially true when the manufacturer intentionally skews clinical trial results, Newsday, Annals of Internal Medicine or otherwise keeps product risks from the FDA to achieve the lucrative benefits that come with the approval of a new drug or device, NEJM, Synthes Story. The FDA is not constituted to truly regulate this industry, and it cannot get to bedrock truth the way litigation can. Often, the FDA does not act until litigation proves the product’s dangers and makes public the evidence the manufacturer kept from the FDA when the drug or device was approved. Talbert v. E’ola Products, Inc.. If Big Pharma succeeds in the Wyeth matter, millions of Americans will be at risk from dangerous drugs. Without the protections of the legal system, their claims will be unrepresented, and corporate interests will run roughshod over the FDA. At this juncture, Congress will likely have to act to restore the balance of regulatory and legal interests the courts previously forged in protecting the rights of individuals to pursue state claims when injured by dangerous products approved by the FDA.

When we represent clients at the Alaska Personal Injury Law Group, we do our homework. When serious injuries occur, we have to become experts ourselves in the particular medicine being used to treat our clients. We thus comb through and rely extensively on medical literature in virtually every case we handle. We use it in our work with the medical experts we engage to help our clients, and we also share it with our clients.

And whether you realize it or not, you rely on medical literature every time you see a doctor or take any medication. This is because the engine of medicine runs on the data from medical literature. That data is what the FDA uses to decide whether to allow a medication or medical device to be sold, and what your doctor relies on to decide if a treatment, medical device, or medication will help you. Extraordinary rules and guidelines are put in place to make sure that the scientific findings in a particular study are objective and scientifically verified.

So it is always shocking when we learn that a manufacturer has taken liberties with the research data to make it appear that their product works when it really doesn’t. (We saw this repeatedly in the litigation against diet supplement manufacturers: Talbert v. E’ola Products, Inc.) We know why this happens: millions and sometimes billions of dollars are made by manufacturers in these endeavors, and greed can be a powerful motivator. Every time we learn about one of these situations, it reaffirms the need to vigilantly enforce the principles that guide regulators and researchers who develop research data. Western medicine is so profoundly effective because it is “evidence-based medicine”. If we allow clinical researchers to get into bed with the manufacturers, how can we trust that the research data they create for the manufacturers is valid, objective and truly “evidence-based”?

On January 5, 2008, a Servant Air Piper Navajo Chieftain with 10 people aboard crashed shortly after take off from Kodiak, Alaska. The pilot and five passengers tragically died in the crash. Surviving passengers reported that a baggage door popped open shortly after takeoff and the pilot was attempting to return to the airport. The National Transportation Safety Bureau (NTSB) is investigating the crash. Based on recent NTSB investigations in Alaska, that may take awhile. I represented a family who lost a loved one in the crash of a PenAir Cessna Caravan 208 shortly after takeoff from the Dillingham airport on October 10, 2001. The pilot and nine passengers died in that crash. The NTSB did not release its probable cause determination until January 23, 2003 — 15 months after the crash. I am presently representing a family who lost a loved one in the crash of a PenAir Piper Saratoga PA-32 shortly after takeoff from the Pt. Heiden airport on December 14, 2006. The NTSB recently released its “factual report” on that accident just over one year after the crash. The NTSB has yet to make its probable cause determination. This illustrates why it is important for families to promptly hire counsel to independently investigate an accident and not to wait a year or more to see what the NTSB concludes about the accident. The families who have lost a loved one will typically not know what the NTSB has been up to for a year or more. In the meantime, important evidence may be lost and important witnesses may have disappeared.