There are some good things produced by Big Pharma - antibiotics, some cancer drugs and numerous other drugs.   However, if you want to see some of the bad things caused by Big Pharma, you can spend a week at Novus Medical Detox Center.  You will see the harm done by OxyContin addiction and other opioid addiction, Xanax and other benzodiazepine addiction, and the ravages caused by the improper use of psychotropic drugs.  These people were not using the drugs illegally but in the manner that Big Pharma advised doctors was safe.

   In the past, we have commented on the duplicity and actual immorality of the drug companies.  We have also been very critical of the FDA and their "cozy" relationship with Big Pharma.  We have pointed out that the FDA believes that Big Pharma, not the consumer, is the client of the FDA.  However, the relentless pursuit of profit at the expense of the public health may be granted a "Get Out of Jail Free" card by the United States Supreme Court in the case labeled Wyeth v. Levine.  If Wyeth wins, then Big Pharma may well escape liability for their misdeeds. 
 
FACTS OF THE CASE

    In this case, Diana Levine, a musician, was given Phenergan improperly in a Vermont emergency room and ended up losing her arm.  Levine sued Wyeth Pharmaceuticals, the maker of Phenergan, because Wyeth had not warned against the procedure used in the emergency room on the Phenergan drug label.

    Levine won a $6.8 million judgment against Wyeth and Wyeth appealed.  The Vermont Supreme Court upheld the judgment and Wyeth appealed to the U.S. Supreme Court.  The U.S. Supreme Court agreed to hear the case and briefs are being filed before the Court.
 
THE ISSUE BEING DECIDED
 
   The issue before the U.S. Supreme Court is whether Ms. Levine's suit should be dismissed.  Wyeth argued that the Vermont courts should never have heard the case because Congress had "pre-empted" state law.  This is a very complicated legal argument, but Wyeth is asserting that any issue that was subject to FDA approval must only be addressed in federal court and that state courts have no jurisdiction.
 
   There are two consequences if Wyeth's position is upheld by the Supreme Court. The first is that anyone damaged by a drug company's misleading or even false claims is not entitled to bring suit under a state's consumer protection laws.  Instead, these lawsuits must be brought in the already overcrowded federal courts.  This alone would not cut off all remedies for consumers, but the second consequence will do that.
 
   Wyeth's second argument effectively cuts off any recourse that consumers have if they are harmed by these drugs.  Wyeth is arguing that if the FDA approved the drug for release to the public and approved the drug label, these approvals mean that no one can sue the drug companies for failing to warn doctors and the public about side effects or problems with the drug. 
 
   To all of us familiar with the way that Big Pharma provides a substantial amount of funding to the FDA, offers lucrative jobs when FDA employees leave the agency, and routinely "forgets" to provide information to the FDA that reflects badly on their products, this is very troubling.
 
AMICUS BRIEFS
 
   In lawsuits before the U.S. Supreme Court, it is a common practice for interested parties, in addition to the parties named in the legal action, to file amicus briefs. Amicus simply means "friend of the court" and while "brief" is often a misleading term for documents that can be many pages long, their purpose is to "assist" the court to see legal and practical arguments.
 
   Both sides are spending millions of dollars in legal fees to file amicus briefs.  To date, the attorneys-general of 47 states, two former FDA commissioners, constitutional experts, and the current editor and nine former editors of The New England Journal of Medicine, have all filed briefs arguing against preemption.
 
   The former FDA commissioners, Dr. Donald Kennedy and Dr. David Kessler, argue:
 
   • Nothing in the federal law or regulations relieves a manufacturer of its duty to warn physicians and patients of emerging safety risks as soon as that information becomes available;
 
   • Litigation like Levine's protects consumers from dangerous drugs whose risks were either not understood when the FDA approved them, but either were evident or became evident to the drug companies at a later time and were not disclosed to the consumer;
 
   • The FDA does not have the resources to monitor a drug's safety record and has to rely on the drug companies and lawsuits like Levine's to obtain safety data.
 
   An even more compelling argument against Wyeth's position was made by the editors of the New England Journal of Medicine.  The following is a summary of their argument:
 
   • The FDA is seriously hampered in its ability to determine the risks of drugs before they are approved for sale and has proven inadequate to the task of addressing hazards that only become apparent after a drug has been widely marketed to an unsuspecting public.
 
   • Much of this stems from the fact that the FDA is heavily dependent on the drugmakers themselves for the information on which the agency bases its decisions. Pharmaceutical companies at times learn about dangers caused by their drugs long before the FDA does but have failed to disclose this information to the FDA--all the while continuing to market their unsafe drugs to an unsuspecting public. In some cases, literally tens of thousands of American lives have been lost or ruined long after the manufacturers realized that the drugs were not safe.
 
   • Petitioner's argument that failure-to-warn suits actually pose a danger to public health is very misleading. The theory that the risk of tort liability causes drug manufacturers to "over-warn" of the dangers of their drugs (thereby scaring patients away from drugs they need) not only has no empirical support, but it ignores the fact that under-warning has, unmistakably and tragically, exacted a terrible toll on public health and safety.
 
   • The prescription drug industry earns global revenues of more than $700 billion per year, an increase of $178 billion over the last five years. Wyeth's argument that tort suits have led Americans to underutilize prescription drugs or companies to limit product development is baseless. As of 2004, Americans were responsible for $248 billion in pharmaceutical sales, accounting for nearly 45 percent of all revenue worldwide. Despite representations of a so-called explosion of stifling litigation, the pharmaceutical market has grown, not shrunk. And it has done so dramatically: In 2007 alone, there were approximately 445 million more prescriptions written than in 2003.
 
   • Wyeth fails to consider that the tort system has played a crucial role in assisting the FDA in evaluating the benefits and risks of prescription drugs.
 
   • State lawsuit litigation costs pale in comparison to promotional costs. Drug companies now spend over $29 billion annually just to promote their products, including $11.4 billion on advertising. Nothing demonstrates this better than the case of Vioxx. In 2000, Vioxx was the number one direct-to-consumer advertised drug at $160 million - larger than the campaigns that year for Pepsi and Budweiser.
 
   • Discovery conducted during the course of product liability litigation has revealed that the pharmaceutical companies were aware of serious ADR's (adverse drug reactions) long before the FDA was, but that they failed to provide information to the FDA even while patients were being injured. As a result, tens of thousands of patients were unnecessarily exposed to potentially life-threatening conditions.
 
   In an appendix to their brief, over 50 drugs were listed that were approved by the FDA and then forced to be withdrawn because of the damage that they were doing to consumers.  Many of these drugs were withdrawn because of the attention brought by the very lawsuits that Wyeth seeks to ban.
 
CONCLUSION

   There are many things wrong with our legal system.  People correctly point out that personal injury lawyers who attempt to make being in an accident akin to winning the lottery have drastically increased the costs of automobile insurance.  Because of the costs of defense, many "ethically challenged" personal injury lawyers bring suits that are only marginally valid because they know that insurance companies will settle rather than spend the money defending the lawsuit.
 
   But, as we pointed out last week, there are some situations where personal injury lawyers are all that stand between us and Big Pharma refusing to tell us about the risks of their products.  In the Levine case, Wyeth seeks to eliminate these pesky lawsuits by people harmed by their products in their relentless pursuit of profit. 
 
   Lawsuits are really our system's way of criticizing another in court and not with our fists. As Winston Churchill said about criticism, "Criticism may not be agreeable, but it is necessary. It fulfils the same function as pain in the human body. It calls attention to an unhealthy state of things."
 
   Does anyone think that Merck would have volunteered to pay $4.8 billion to the victims of Vioxx if no lawsuits could be filed?  Does anyone think that Big Pharma would volunteer to pay billions of dollars to consumers and their families  because of the side effects of antidepressants?
 
   All too often, it has been the threat of large payments to their victims and not their conscience or care for the consumer that has forced the Big Pharma executives to add warnings to their drug labels or to withdraw unsafe drugs from the market.  In a better world, Big Pharma will be motivated more by doing good than by making money.  Until then, we need every possible weapon to keep this behemoth from harming us all with their drugs.

NOTE: This information is provided for general educational purposes only and is not intended to constitute (i) medical advice or counseling, (ii) the practice of medicine, health care diagnosis or treatment, or (iii) the creation of a physician patient or clinical relationship.  If you have or suspect that you have a medical problem or that this information may be useful to you or others, please consult with your health care provider before applying any information from our articles to your personal situation or to the personal situation of others.

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