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Justinian C. Lane is a personal injury attorney who focuses his practice on helping individuals injured by prescription drugs and medical devices.

It never ceases to amaze me that some people refuse to believe that corporations intentionally suppress safety information about their products due to marketing concerns.  Unfortunately, it keeps happening again, and again, and again.  This time, with Pradaxa:

Publishing the research results, she warned, could make it “extremely difficult” for the company to defend its long-held position to regulators that Pradaxa did not require testing.

And, Dr. Heinrich-Nols added in the email, the research, if known, would “undermine” the company’s efforts to compete with other new anticoagulants, such as Xarelto and Eliquis.

“I would like to ask you to check again whether this is really wanted,” she wrote about publishing the research.

Source: Study of Drug for Blood Clots Caused a Stir, Records Show – NYTimes.com

I’ve said it before – pharmaceutical companies could completely eliminate product liability lawsuits if they disclosed every bit of safety information they had about their drugs.  But doing so would hurt sales.  So instead, thousands of people every year die so that drugmakers can falsely claim that their product is superior.

Right now, thousands of vaginal mesh lawsuits are pending in the U.S. District Court for the Southern District of West Virginia. Just as the criminal justice system would collapse if every criminal case went to trial, so too would our civil justice system collapse if every vaginal mesh case went to trial. The vaginal mesh cases are all grouped together in what is called an MDL, which stands for “Multi-District Litigation.” An MDL is used when there are a variety of similar lawsuits filed in different federal court districts across the country. (There are 94 federal districts.)

There are several purposes of an MDL, but one of the most practical is to facilitate settlement of the hundreds or thousands of cases that are part of the MDL.  An MDL facilitates settlements through a series of special trials.  In a nutshell, the court picks a handful of cases to be tried.  The results of those trials then give both sides some idea of what juries are likely to do with any given case.  The parties can then decide upon terms of a mass settlement based upon the results of those trials.

The cases that the judge pick for trial have a special name: “Bellwether cases.”  You might guess that “Bellwether” is some fancy Latin term.  It actually is a fancy farming term.  In the vaginal mesh MDL, one of the mesh manufacturers filed a memorandum that explains the history of the term Bellwether:

[T]he etymology of the word “bellwether” refers to a neutered ram (a wether) with a large bell around its neck, responsible for keeping a flock of sheep together. In Judge Kramer’s words, the bellwether helps the flock “stay in line and follow him, so that there are no stragglers off doing their own thing, and they all go home together at the end of the day.” Judge Kramer drew the analogy to a bellwether case, adding that like the ram, it is very important that a bellwether case is not a “sexy” case – in other words, that it has no facts that would make it an outlier case or make it more favorable for one side or the other. He continued with the analogy, saying it was also important that the “other sheep don’t know that the wether isn’t sexy anymore” so that they continue to follow him and stay “with the flock” and so they can all “go home at the same time.”

The vaginal mesh manufacturer filed the memorandum because it does not want some of the proposed cases to be used as bellwethers.  The manufacturer argues that several of the cases are too “sexy.”  Sexy in this case of course means that the cases might lead to large jury verdicts against the manufacturer.

While the memorandum does a good job in arguing that all bellwether cases should be “run of the mill” and not extraordinary, that’s not really what the manufacturer would prefer.  Both sides want bellwether cases to be better than average, so the resulting jury verdicts can be used to negotiate a favorable settlement.  Politely worded motions aside, we do have an adversarial civil justice system.

I’ve attached the entire vaginal mesh lawsuit memorandum if you’d like to read it.  Since it contains a great deal of personal information, I’ve gone ahead and redacted the names of the proposed bellwether picks.

Two articles popped up in my inbox today.  The first tells the sad story of a man who died after taking a supplement known as “Stiff Nights.”

“A Kansas City man died last year after taking an unapproved erectile dysfunction drug allegedly labeled as a dietary supplement, a Jackson County lawsuit says.
 

David R. McElwee, 39, suffered a loss of blood pressure, which ultimately led to a fatal heart attack, after taking a product sold under the brand name Stiff Nights, according to the lawsuit filed in August on behalf of his children.

Source: Lawsuit blames man’s death on erectile dysfunction supplement – KansasCity.com

The second is an exposé on the supplement market in today’s issue of USA Today:

Far from an isolated case, a USA TODAY investigation finds that a wide array of dietary supplement companies caught with drug-spiked products are run by people with criminal backgrounds and regulatory run-ins. Consumers buying products from these firms are in some cases entrusting their health and safety to people with rap sheets for crimes involving barbiturates, crack cocaine, Ecstacy and other narcotics, as well as arrests for selling or possessing steroids and human growth hormone. Other supplement company executives have records of fraud, theft, assault, weapons offenses, money laundering or other offenses, the investigation shows.

Source: Makers of tainted supplements have criminal pasts

Both articles show that you should be comfortable with the company that makes any pill you take.

This shows that the FDA is more interested in protecting pharmaceutical companies than patients.  Note how Woodcock doesn’t want to force new trials because that requires human experimentation, which has risk.  A smarter regulator would realize that the risks increase in proportion to the size of the user base of the drug.  And allowing any American to use the untested drug carries more risk than the dozens or hundreds of people who would be in a test.

 

Also, note that some of these drugs are generics.  Which means that individuals injured by drugs that weren’t even tested still can’t sue the manufacturer.  And of course, there is no “fraud on the FDA” claim available…

 

  • In 2011, the FDA announced years’ worth of studies from a major drug research lab were potentially worthless.
  • About 100 drugs were on the U.S. market based in part on these tests.
  • The FDA let the drugs stay on pharmacy shelves with no new testing (in some cases until now).
  • As the FDA investigated and ordered re-tests, its European equivalent pulled seven drugs from the market.
  • The FDA says it has no evidence that any of the drugs were unsafe or that any patient has been harmed.
  • The FDA has never named the drugs, saying to do so would reveal trade secrets.
  • FDA Let Drugs Approved on Fraudulent Research Stay on the Market – ProPublica

    I knew there was a reason I got licensed to practice law in consumer-friendly Washington:

    A Washington state court yesterday denied Intuitive’s bid to throw out a lawsuit over the death of a patient operated on using the company’s da Vinci surgical system, according to court filings. The judge found the state’s product-liability laws require medical-device makers to properly train physicians who buy their products.

    Source: Intuitive Surgical Loses Bid to Throw Out Robot Lawsuit – Bloomberg

    So, the Supreme Court will decide two interesting cases.  The one below will decide whether or not a brand name manufacturer can simply pay generic companies not to bring generic drugs to market:

    WASHINGTON (AP) — Federal regulators are pressing the Supreme Court to stop big pharmaceutical corporations from paying generic drug competitors to delay releasing their cheaper versions of brand-name drugs. They argue these deals deny American consumers, usually for years, steep price declines that can top 90 percent

    Source: The Associated Press: Court: Can drug companies pay to delay generics?

    The second is whether or not generic manufacturers can be held liable if their drugs injure consumers.  One of the arguments against letting generic manufacturers be sued is that they may take their products off the market due to the cost of litigation.  This is an entirely false argument if for no other reason than generic manufacturers can buy insurance that covers any payouts.

    But, if you accept the premise that it’s too important to make sure generic drugs are on the market to allow generic manufacturers to be sued, then you should also accept the premise that brand name companies shouldn’t be allowed to pay to keep generics off the market.  It will be interesting to see which justices rule which way on both cases.

    Here’s a little more in-depth analysis of the generic drug argument before SCOTUS:

    Andre Mura, litigation counsel at the Center for Constitutional Litigation in Washington, D.C., said the government’s argument was troubling. “There were suggestions that the FDA shouldn’t be second-guessed, but as the Court said in Wyeth v. Levine, the FDA approval process does not mean, and should not be taken to mean, that a drug is absolutely safe even for approved uses,” said Mura, who wrote an amicus brief for AAJ in Bartlett. “Congress didn’t intend the FDA to provide the sole level of consumer protection, and a broad preemption ruling here would ignore that clear congressional intent.”

    Source:

    Supreme Court grapples with generic drugs and design defects

    Just imagine the sleazy sales manager who wrote the e-mail below”

    Company e-mails introduced in a lawsuit filed against Intuitive in Kitsap County, Washington, suggest salesmen lobbied hospitals to scale back doctor training. One manager’s e-mail lauded a salesman for persuading a hospital that five supervised operations were too many. In another, a manager told a sales team not to “let proctoring or credentialing get in the way” of meeting goals on the number of robot surgeries.

    Source: Intuitive Robosurgery Training Seen Lacking in Lawsuits – Bloomberg

    There’s also a BS line in here about how the company can’t require the doctors to do anything.  Wrong.  As part of a licensing agreement with the hospital the company could require the doctors to do as many supervised surgeries as it wanted. 

    On the one hand it’s disappointing to see them give up the fight.  On the other, at least this won’t lead to a SCOTUS ruling that strips the FDA of more power.  The fear of such a ruling is why I suspect the FDA gave up.

    (Reuters) – The government has dropped its push for cigarette labels to carry images of diseased lungs and other graphic health warnings, and will craft new anti-smoking ads that do not run afoul of free speech rights.

    In a letter to Republican House Speaker John Boehner last Friday, Attorney General Eric Holder said that the Food and Drug Administration would go back to the drawing board to develop the ads, as required by legislation passed by Congress in 2009.

    Source: Government changes course on graphic cigarette warnings | Reuters

    More on generic liability:

     

    During a one-hour oral argument justices questioned whether federal law, in this case the requirement that generics have same design as the name-brand version, prevents plaintiffs from making such claims under state law.

     

    Some justices signaled concern about juries making sweeping judgments about the effectiveness of drugs while others questioned how to differentiate the case from another case involving generics decided in 2011.

    ‘U.S. high court weighs generic drugmaker liability | Reuters