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Doctor with mouth taped shut; image courtesy of www.nutritionsquared.com.
Doctor with mouth taped shut; image courtesy of www.nutritionsquared.com.

The latest development in the multidistrict litigation (MDL) over Ethicon’s Physiomesh for hernia treatment involves the parties squaring off over who – if anyone – is allowed to have ex parte contact with the plaintiffs’ treating physicians. What, exactly, is ex parte contact and why are the parties fighting over it?

The term ex parte (ex par-tay) is Latin and means “for one party.” In law, it’s standard practice that both parties be present during hearings, etc. with some notable exceptions like personal protective orders. It can also mean communication between one party and a non-party, as in the case of Physiomesh.

Generally, when dealing with MDLs involving drugs or medical devices, ex parte contact between the plaintiffs’ treating doctors and the defense counsel is not allowed. The reasons for this, as plaintiffs argue, are to protect the doctor-patient confidential relationship, to prevent the release of confidential information without limits, to eliminate a potential conflict of interest between the doctors and the defense, and to keep doctors from becoming expert witnesses against their own patients. The HIPAA Privacy Rule has also been cited as a reason to prohibit ex parte contact between plaintiffs’ doctors and the defense.

Ethicon Physiomesh packaging; image courtesy of www.idataresearch.com.
Ethicon Physiomesh packaging; image courtesy of www.idataresearch.com.

There is a fairly even split between jurisdictions on whether such contact is allowed. Those jurisdictions that allow it follow the belief that a plaintiff surrenders the right to doctor-patient confidentiality the moment the plaintiff brings suit based on a health condition.

In the instant case, the defense wants to speak to the plaintiffs’ treating doctors with a possible goal of retaining them as expert witnesses… for the defense. Why is this important to the defendants?

Typically, when dealing with drug and medical device suits, juries often consider the plaintiffs’ treating doctors’ opinions more trustworthy than those of paid expert witnesses. This occurs for a handful of reasons:

  • The treating doctors are usually neutral witnesses;
  • Their impressions and treatment decisions were made prior to the plaintiffs’ suit;
  • They aren’t getting paid to testify for a specific party

So, if the defense can secure the plaintiffs’ treating doctors as expert witnesses, it has a better chance of the jury deciding in its favor. Of course, this creates a potential conflict of interest that may be impossible to remedy if the plaintiffs’ doctors are also to be called as neutral fact witnesses during the trial.

Plaintiffs in the Physiomesh MDL are relying upon case law in the jurisdictions prohibiting such ex parte communications to shore up their argument in this case. In one such case, In re: All Individual Kugel Mesh Cases, the judge granted the plaintiffs’ motion to prohibit ex parte contact between the defense and plaintiffs’ doctors. The judge in Kugel wrote, in part, that such contact would be “highly prejudicial to the plaintiffs,” as well as creating the potential for conflicts of interest referenced earlier. Additionally, the judge held that the defense didn’t need to find its experts from the pool of plaintiffs’ treating doctors as, not “every knowledgeable physician in the country has performed surgery on one or more of the Plaintiffs in this matter.” Thus, the defense would have a larger pool of non-treating doctors from which to pull its experts.

Of course, the defendants are relying on case law from the jurisdictions that allow such ex parte contact.

In its motion for a protective order allowing these contacts, the defense wrote, “Plaintiffs’ proposed approach is not only unfair, but it is contrary to the law in many jurisdictions. There is obvious inequity in allowing only one side of the litigation unfettered ex parte contact with physicians prior to their depositions, with free reign to show them internal corporate documents they have never seen before, discuss medical literature the physicians did not rely on in their treatment, and present litigation theories—all in the hope that this one-sided view of the evidence will cause the physician to testify in a manner that is favorable to their clients.”

It should be noted that this is one of the plaintiffs’ concerns in allowing the defense such contacts, that the defense would do precisely what it’s saying the plaintiffs’ counsel wants to do.

One of the defense’s arguments in favor of the protective order is the “learned intermediary doctrine.” This rule essentially states that manufacturers (in this case, Ethicon) must only provide the doctors (the learned intermediary, or third party) with benefit and risk information about their products. It then becomes the doctors’ duty to inform their patients.

According to the American Bar Association, “…prescription drug manufacturers’ duty to warn consumers flows through the patients’ prescribing physicians, not directly to consumers. For prescription drug manufacturers, the rationale behind the doctrine is based largely on the fact that prescription drugs’ actions are complex and the prescribing physician is the one best able to determine the drug’s potential benefits and risks for a particular patient.”

In product liability cases such as Physiomesh, many jurisdictions require the plaintiffs to show that “but for the alleged inadequate warning… [the] physician would not have prescribed…” and, of course, this makes the treating doctors’ testimony crucial to the case.

The defense argues that this role is so great that it is unfair to allow the plaintiffs’ counsel “unfettered access” to the plaintiffs’ treating doctors. They reiterate the goal of protecting doctor-patient relationships while stating that “unfettered access” allows the plaintiffs’ counsel a “leg up” during trial. The defense cites some courts’ holdings that plaintiffs’ ex parte contact with treating doctors should be limited to “the care and treatment of the plaintiff—not litigation theories or internal company documents.”

The defense responded to the plaintiffs’ November 1 motion, proposing a “level playing field.” The three points in their November 8 response are:

  1. “Defendants will not designate a treating physician as a retained expert in a case involving a Plaintiff who is that physician’s current or former patient.
  2. Defendants will not discuss with a retained expert his or her care and treatment of a specific Plaintiff, except during a deposition or at trial.
  3. Plaintiffs’ counsel will not refer a Plaintiff for treatment to a physician who has been retained as an expert by the defense for the purpose of creating a conflict to prevent the expert from testifying as a retained expert in that case.”

Plaintiffs’ counsel filed its own response on November 8. They cite decisions wherein item #2 above has been disallowed in other MDLs. Two of those opinions apply obvious reasoning. The first states that, “[a]s a practical matter, the Defendants already have information, including documentation, regarding what its representatives told the treating physicians about [the subject devices]. Therefore, the Defendants don’t need the doctors to tell them in ex parte conferences what they already know.”

The second case makes the point even more clearly, “stating ‘it is disingenuous for defendants to ask to be put on ‘equal footing’ with plaintiffs when to date the physicians have been subject to defendants’ marketing communications which likely extolled the benefits of their [products].’”

The plaintiffs’ counsel further argues that restricting its access to the treating doctors would seriously limit its ability to argue the plaintiffs’ case. In its response, plaintiffs’ counsel explains:

“Because, Plaintiffs contend, the Defendants knew of risks, complications and defects associated with Physiomesh that they failed to disclose to Plaintiffs’ doctors, this information bears directly on the failure to warn and learned intermediary issues presented in these cases. What the physician was told – or not told – by the Defendants in light of Defendants’ knowledge are important questions of fact. Likewise, what these doctors would have done had they been made aware of information known to the Defendants (whether or not the doctor would have implanted the Physiomesh, or counseled the patient differently) are fundamental questions with respect to the failure to warn claims in these cases. The only way for Plaintiffs to address these issues in preparation is to ask the doctor “did you know ‘x’ and ‘y’ that Defendants knew (about the Physiomesh risks, complications and/or defects),” and “would this information have made any difference in how you treated or advised this patient?” It is not only appropriate, it is necessary for Plaintiffs to address these important issues with Plaintiffs’ treating physicians in preparing these cases for trial.”

The issue is now in the hands of U.S. District Judge Richard W. Story in the Northern District of Georgia. Judge Story is overseeing the Physiomesh MDL. Legal Reader will continue to follow developments in the MDL, and specifically, this issue.

General Information on the MDL

Plaintiffs allege that Ethicon’s Physiomesh hernia product was defectively designed and that the defendant’s failed to provide adequate warnings of the potential risks of having the device implanted.

Those risks (and injuries) include:

“Chronic pain;

Recurrence of hernia;

Foreign body response;

Rejection;

Infection;

Inadequate or failure of incorporation/ingrowth;

Migration;

Scarification;

Deformation of mesh;

Improper wound healing;

Excessive and chronic inflammation;

Adhesions to internal organs;

Erosion;

Abscess;

Fistula formation;

Granulomatous response;

Seroma formation;

Nerve damage;

Tissue damage and/or death; and other complications.”

Sources:

Plaintiffs’ Motion to Preclude Defendants’ Ex Parte Communications with Plaintiffs’ Treating Physicians for Purposes of Retaining Expert Witnesses
Defendants’ Motion and Brief in Support of a Protective Order Regarding Contacts with Treating Physicians

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